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CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
CAP's Survey in Clinical Microscopy 2013
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CAP's Survey in Clinical Microscopy 2013

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CAP's Survey in Clinical Microscopy 2013

CAP's Survey in Clinical Microscopy 2013

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  • 1. CM-B AND ANATOMIC PATHOLOGY EDUCATION PROGRAMS SURVEYS 2013 Clinical Microscopy PARTICIPANT SUMMARY 0.25 Hours of Self-Reported Training Available This document is available on e-LAB Solutions™. © 2013 College of American Pathologists. The College does not permit reproduction of any substantial portion of the material in this Report without its written authorization. The College hereby authorizes participants in the program to use the material in this Report solely for educational purposes within their own institutions. The College prohibits use of the material in the Report — and any unauthorized use of the College’s name or logo — in connection with promotional efforts by marketers of laboratory equipment, reagents, materials, or services. Data from this program do not necessarily indicate the superiority or inferiority of instruments, reagents, or other materials used by participating laboratories. Use of these data to suggest such superiority or inferiority may be deceptive and misleading. The College will take all steps open to it under the law to prevent unauthorized reproduction of substantial portions of the material in this Report, deceptive use of any such material, and any unauthorized use of the College’s name or logo in connection with promotional efforts by marketers of laboratory equipment, reagents, materials, or services.
  • 2. TABLE OF CONTENTS Program Update ........................................................................................................................................................ 1 Evaluation Criteria ..................................................................................................................................................... 2 CMP/CMP1 – Clinical Microscopy Bilirubin .................................................................................................................................................................. 34 Bilirubin, IRIS iChemVELOCITY and iChem 100 (CMP1 only)............................................................................. 40 Blood or Hemoglobin ............................................................................................................................................. 42 Glucose ................................................................................................................................................................. 19 Ketones ................................................................................................................................................................. 26 Leukocyte Esterase ............................................................................................................................................... 49 Nitrite ..................................................................................................................................................................... 57 Osmolality ................................................................................................................................................................ 3 pH, Urine ............................................................................................................................................................... 10 Protein (Qualitative) ............................................................................................................................................... 13 Reducing Substance ............................................................................................................................................. 25 Specific Gravity........................................................................................................................................................ 7 Urobilinogen .......................................................................................................................................................... 60 Urine hCG................................................................................................................................................................ 4 Urine Sediment Photographs ................................................................................................................................ 63 Body Fluid Photographs ........................................................................................................................................ 67 Case Discussion: Pneumocystis in BAL ............................................................................................................... 73 CMMP – Clinical Microscopy Miscellaneous Photographs ...................................................................................... 75 OCB – Occult Blood.................................................................................................................................................. 81 GOCB – Gastric Occult Blood Gastric Occult Blood .............................................................................................................................................. 82 Gastric pH.............................................................................................................................................................. 83 DSC – Dipstick Confirmatory Bilirubin, Confirmatory ........................................................................................................................................... 84 Protein, Confirmatory ............................................................................................................................................ 84 Actions Laboratories Should Take when a PT Result is Not Graded ....................................................................... 85 Attestation of Participation for Self-Reported Training ............................................................................................. 86 HEMATOLOGY AND CLINICAL MICROSCOPY RESOURCE COMMITTEE Joan E. Etzell, MD, FCAP, Chair Sherrie L. Perkins, MD, PhD, FCAP, Vice Chair Kyle T. Bradley, MD, MS, FCAP David R. Czuchlewski, MD, FCAP John L. Frater Jr., MD, FCAP Tracy I. George, MD, FCAP George M. Girgis, MT Eric D. Hsi, MD, FCAP David F. Keren, MD, FCAP Martina Lefterova, MD, PhD Jennifer L. Oliveira, MD, FCAP Jay L. Patel, MD, FCAP Janet Piscitelli, MD, FCAP Kathryn A. Rizzo, DO, PhD, FCAP Luke R. Shier, MD, FCAP Anna K. Wong, MD, FCAP David L. Zwick, MD, FCAP Maria A. Proytcheva, MD, FCAP, Liaison
  • 3. 2013 CM-B PARTICIPANT SUMMARY Program Update Don’t Miss Out on this Educational Opportunity! With your participation in CAP’s Surveys programs, every member of your team can take part in education activities: earn Continuing Education (CE) credits or receive Self-Reported Training* at no additional charge. This Survey mailing includes a Self-Reported Training activity. By reviewing the discussion that begins on page 63, your laboratory staff can earn 0.25 education hours that can be used towards fulfilling education and certification maintenance requirements. For your convenience, a form has been included to document your staff’s participation in the activity. See page 86. *CAP Self-Reported Training activities do not offer CE credit, but can be used towards fulfilling requirements for certification maintenance by agencies such as the American Society of Clinical Pathology (ASCP). Please verify with your certifying agency to determine your education requirements. 1
  • 4. Evaluation Criteria QUALITATIVE For qualitative procedures in urinalysis, evaluation is based on participant consensus by method and instrument. For each analyte, a minimum of two, but not more than four, responses will be given a passing score. Analyte results graded “Good” performance must have 80% participant consensus. Eighty percent participant consensus can be determined by grouping the mode with the next one or two most frequent responses. This group will be given “Good” performance. “Acceptable” performance will be given to additional responses until a minimum of 90% of participant results are given a passing score. In the case of a negative specimen, negative responses must constitute 90% participant consensus. Specimens with results for one of more methods distributed over both negative and positive responses (non-consensus) will not be evaluated. Specimens for which there is greater than 90% of participant responses distributed over more than four responses will be graded as “Non-consensus”. Analyte Bilirubin, Confirmatory Gastric Occult Blood Gastric pH Nitrate Occult Blood Protein, Confirmatory Urine hCG QUANTITATIVE Analyte Gastric pH Osmolality Specific Gravity Evaluation Criteria 80% overall participant consensus/intended response 80% overall participant consensus/intended response 80% overall participant consensus/intended response 80% overall participant consensus/intended response 80% overall participant consensus/intended response 80% overall participant consensus/intended response 80% overall participant consensus/intended response Target Value Peer Group Mean Peer Group Mean Peer Group Mean Evaluation Criteria  3 SD  3 SD  2 SD or 0.010, whichever is greater Low and high values shown in the Participant Summary indicate the range of values reported. Low and high limits of acceptability are shown on the evaluation report. Data are not included for methods used by fewer than 10 laboratories. PHOTOGRAPHS Photographs are evaluated for CAP purposes according to 80% or greater consensus of either referees or participant laboratories. "Good" performance is given for the intended response. Additionally, the Hematology and Clinical Microscopy Resource Committee may, at its discretion, grant either "good" or "acceptable" performance for other equivalent responses. To provide a timely evaluation of your results, statistics presented in this Participant Summary reflect a minimum of 80% of participant enrollment. In the event a result is not graded, a numeric code will appear next to your result. A definition of the code will appear on the first page of the evaluation. Please see “Actions Laboratories Should Take when a PT Result is Not Graded” on page 85. 2
  • 5. No. Labs Mean S.D. C.V. CM-14 Advanced Instruments ARKRAY Fiske Precision Systems 997 50 84 25 866.4 862.8 868.1 857.5 4.8 3.7 6.3 7.9 0.6 0.4 0.7 0.9 CM-15 Advanced Instruments ARKRAY Fiske Precision Systems 1001 49 86 25 763.7 763.0 765.2 758.2 4.0 3.1 4.7 5.4 0.5 0.4 0.6 0.7 CM-16 Osmolality - mOsm/kg (mmol/kg) Advanced Instruments ARKRAY Fiske Precision Systems 1001 51 85 25 418.0 419.5 420.2 414.0 3.7 3.1 4.5 7.1 0.9 0.7 1.1 1.7 3
  • 6. Urine hCG The hCG level was intended to be positive. CM-14 Manufacturer Manufacturer's Stated Sensitivity Level mIU/mL Abbott TestPack Plus Combo w/ or w/out OBC Acceava Combo II ACON One Step (urine only) Alere hCG Cassette (20) (Acceava) Alere hCG Cassette (25) (Clearview) Alere hCG Combo Cassette (20/10) Alere hCG Combo Cassette (25) (Clearview) Beckman Coulter ICON 20 Beckman Coulter ICON 25 Cardinal Health SP Brand Cassette Cardinal Health SP Brand Combo Cen-Med Elite Plus One Step hCG Clearview hCG Combo II Eiken Meridian ImmunoCard STAT Polymedco Poly stat (serum/urine) Quidel QuickVue One-Step Combo Quidel QuickVue One-Step Urine Quidel QuickVue+ One-Step Combo Ramco Quik-Trak Combi Test (serum/urine) Randox Direct SA Scientific (SAS) Ultra SA Scientific (serum/urine) Sekisui OSOM Sekisui OSOM Combo Siemens Clinitek Status Stanbio QuPID Stanbio QuPID Plus Stanbio QuPID Plus E.R. Stanbio True 20 Plus Sure-Vue (urine only) Sure-Vue (serum/urine) Sure-Vue STAT (serum/urine) Technologist Choice (serum/urine) Other and Methods with <10 responses 25 20 25 20 25 25 20 - 4 Negative Positive 2 1 1 1 1 1 1 - 11 16 37 17 26 72 50 125 354 111 628 89 45 10 48 34 431 217 471 10 14 16 19 34 334 29 18 51 15 36 84 306 374 16 357
  • 7. Urine hCG The hCG level was intended to be positive. CM-15 Manufacturer Manufacturer's Stated Sensitivity Level mIU/mL Abbott TestPack Plus Combo w/ or w/out OBC Acceava Combo II ACON One Step (urine only) Alere hCG Cassette (20) (Acceava) Alere hCG Cassette (25) (Clearview) Alere hCG Combo Cassette (20/10) Alere hCG Combo Cassette (25) (Clearview) Beckman Coulter ICON 20 Beckman Coulter ICON 25 Cardinal Health SP Brand Cassette Cardinal Health SP Brand Combo Cen-Med Elite Plus One Step hCG Clearview hCG Combo II Eiken Meridian ImmunoCard STAT Polymedco Poly stat (serum/urine) Quidel QuickVue One-Step Combo Quidel QuickVue One-Step Urine Quidel QuickVue+ One-Step Combo Ramco Quik-Trak Combi Test (serum/urine) Randox Direct SA Scientific (SAS) Ultra SA Scientific (serum/urine) Sekisui OSOM Sekisui OSOM Combo Siemens Clinitek Status Stanbio QuPID Stanbio QuPID Plus Stanbio QuPID Plus E.R. Stanbio True 20 Plus Sure-Vue (urine only) Sure-Vue (serum/urine) Sure-Vue STAT (serum/urine) Technologist Choice (serum/urine) Other and Methods with <10 responses 25 20 25 20 25 25 20 - 5 Negative Positive 1 2 1 1 1 1 2 11 16 37 17 26 72 50 126 353 111 627 89 45 10 48 34 430 216 473 10 14 16 19 34 334 29 18 51 15 36 85 306 375 16 355
  • 8. Urine hCG The hCG level was intended to be positive. CM-16 Manufacturer Manufacturer's Stated Sensitivity Level mIU/mL Abbott TestPack Plus Combo w/ or w/out OBC Acceava Combo II ACON One Step (urine only) Alere hCG Cassette (20) (Acceava) Alere hCG Cassette (25) (Clearview) Alere hCG Combo Cassette (20/10) Alere hCG Combo Cassette (25) (Clearview) Beckman Coulter ICON 20 Beckman Coulter ICON 25 Cardinal Health SP Brand Cassette Cardinal Health SP Brand Combo Cen-Med Elite Plus One Step hCG Clearview hCG Combo II Eiken Meridian ImmunoCard STAT Polymedco Poly stat (serum/urine) Quidel QuickVue One-Step Combo Quidel QuickVue One-Step Urine Quidel QuickVue+ One-Step Combo Ramco Quik-Trak Combi Test (serum/urine) Randox Direct SA Scientific (SAS) Ultra SA Scientific (serum/urine) Sekisui OSOM Sekisui OSOM Combo Siemens Clinitek Status Stanbio QuPID Stanbio QuPID Plus Stanbio QuPID Plus E.R. Stanbio True 20 Plus Sure-Vue (urine only) Sure-Vue (serum/urine) Sure-Vue STAT (serum/urine) Technologist Choice (serum/urine) Other and Methods with <10 responses 25 20 25 20 25 25 20 - 6 Negative Positive 1 1 1 1 1 1 2 11 16 37 17 26 72 50 127 354 111 627 89 45 10 48 34 429 215 473 10 14 16 19 34 334 29 18 51 15 36 84 306 375 16 355
  • 9. Specific Gravity No. Labs CM-14 C.V. 1.0200 1.0200 0.0000 0.0000 0.0 0.0 1.0144 0.0012 0.1 11 10 1.0200 1.0200 0.0000 0.0000 0.0 0.0 10 10 1.0200 1.0200 0.0000 0.0000 0.0 0.0 12 1.0186 0.0017 0.2 74 1.0245 0.0015 0.1 199 1.0151 0.0007 0.1 28 11 1.0142 1.0144 0.0008 0.0022 0.1 0.2 171 11 38 210 1.0145 1.0190 1.0153 1.0174 0.0013 0.0010 0.0007 0.0011 0.1 0.1 0.1 0.1 232 25 239 51 85 1.0113 1.0128 1.0129 1.0115 1.0128 0.0022 0.0025 0.0027 0.0025 0.0031 0.2 0.3 0.3 0.2 0.3 117 1.0174 0.0009 0.1 518 1.0172 0.0015 0.1 12 27 903 18 162 180 Method/Instrument S.D. 461 ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diag. Test Group Clarity Urocheck Reag. Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY IRIS Mass Gravity Meter ARKRAY/IRIS Aution Max/iQ200 IRIS iChemVELOCITY Refractometer ARKRAY/IRIS Aution Max/iQ200 Eiken US-3100R/3100Rplus IRIS iChemVELOCITY Visual Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Mean 10 10 Method/Instrument 1.0263 1.0259 1.0251 1.0175 1.0282 1.0215 0.0031 0.0046 0.0016 0.0016 0.0025 0.0039 0.3 0.5 0.2 0.2 0.2 0.4 Low High 1.030 1.030 1.029 1.029 1.030 1.030 1.030 1.030 No. Labs Median Greater-Than Values Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status 37 43 347 639 7 1.030 1.030 1.030 1.030
  • 10. Specific Gravity No. Labs CM-15 C.V. 1.0205 1.0200 0.0015 0.0000 0.1 0.0 1.0122 0.0012 0.1 11 10 1.0200 1.0200 0.0000 0.0000 0.0 0.0 10 10 1.0200 1.0200 0.0000 0.0000 0.0 0.0 11 1.0154 0.0007 0.1 76 1.0191 0.0022 0.2 201 1.0133 0.0008 0.1 30 11 1.0119 1.0126 0.0012 0.0022 0.1 0.2 170 11 38 210 1.0121 1.0153 1.0133 1.0145 0.0011 0.0005 0.0007 0.0009 0.1 0.0 0.1 0.1 235 25 238 51 86 1.0133 1.0136 1.0131 1.0127 1.0080 0.0030 0.0023 0.0030 0.0032 0.0037 0.3 0.2 0.3 0.3 0.4 116 1.0145 0.0008 0.1 515 1.0150 0.0010 0.1 13 27 917 17 202 183 Method/Instrument S.D. 466 ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diag. Test Group Clarity Urocheck Reag. Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY IRIS Mass Gravity Meter ARKRAY/IRIS Aution Max/iQ200 IRIS iChemVELOCITY Refractometer ARKRAY/IRIS Aution Max/iQ200 Eiken US-3100R/3100Rplus IRIS iChemVELOCITY Visual Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Mean 11 10 Method/Instrument 1.0269 1.0252 1.0250 1.0148 1.0276 1.0190 0.0025 0.0050 0.0001 0.0006 0.0027 0.0043 0.2 0.5 0.0 0.1 0.3 0.4 Low High 1.030 1.030 1.030 1.029 1.030 1.030 1.030 1.030 No. Labs Median Greater-Than Values Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status 35 42 241 599 8 1.030 1.030 1.030 1.030
  • 11. Specific Gravity No. Labs CM-16 C.V. 1.0155 1.0150 0.0015 0.0000 0.1 0.0 1.0154 0.0014 0.1 11 10 1.0155 1.0150 0.0015 0.0000 0.1 0.0 10 10 1.0150 1.0150 0.0000 0.0000 0.0 0.0 12 1.0218 0.0013 0.1 76 1.0136 0.0025 0.2 201 1.0156 0.0008 0.1 32 11 1.0153 1.0152 0.0018 0.0021 0.2 0.2 169 11 37 208 1.0155 1.0218 1.0155 1.0200 0.0016 0.0009 0.0006 0.0009 0.2 0.1 0.1 0.1 233 25 238 52 86 1.0126 1.0144 1.0139 1.0129 1.0150 0.0026 0.0022 0.0026 0.0027 0.0020 0.3 0.2 0.3 0.3 0.2 116 1.0199 0.0008 0.1 503 1.0206 0.0010 0.1 50 68 1255 19 813 185 Method/Instrument S.D. 463 ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diag. Test Group Clarity Urocheck Reag. Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY IRIS Mass Gravity Meter ARKRAY/IRIS Aution Max/iQ200 IRIS iChemVELOCITY Refractometer ARKRAY/IRIS Aution Max/iQ200 Eiken US-3100R/3100Rplus IRIS iChemVELOCITY Visual Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Mean 11 10 Method/Instrument 1.0243 1.0207 1.0211 1.0205 1.0235 1.0187 0.0020 0.0025 0.0021 0.0008 0.0024 0.0044 0.2 0.2 0.2 0.1 0.2 0.4 Low High 1.025 1.030 No. Labs Median Greater-Than Values Siemens Reagent Strips Siemens Clinitek Status 10 9 1.030
  • 12. pH, Urine ≤3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 - - - - - - - 10 10 - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7.5 8.0 8.5 ≥9.0 - - - - 674 6 - - - 8 3 - - - - - - 11 10 - - - - - - - 10 - - - - - - - - 10 - - - - - - - - - 24 5 - - - - - - - - - 84 - 1 - - - - - - - 4 - 260 - - - - - - - - - - 1 - 242 26 252 55 101 1 1 - - - - - - - - - - 126 - - - - - - - - - - - 543 1 - - - - - - - - 1 1 1 1 1 20 1 2 33 75 1327 18 865 119 21 1 3 89 1 2 - - CM-14 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur* Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual** Roche Urisys Cassette* Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual * Roche pH Instrumentation Users: Results should be reported in whole numbers from 5.0 to 9.0, with the exception of 6.5. ** Roche pH Visual Users: Results should be reported in whole numbers, 0.5 increments are not allowed. 10
  • 13. pH, Urine ≤3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 - - - - - - - - 10 10 - - - - - - - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8.0 8.5 ≥9.0 - - - 581 98 - - 10 1 - - - - 1 - 10 10 - - - - - - 10 - - - - - - - 10 - - - - - - - - 5 24 - - - - - - - - - 85 - - - - - - 1 2 4 - 254 - 3 - - - - - - 1 - 1 6 3 1 1 2 187 25 247 49 94 - 54 5 3 - - - - - 1 - 6 1 118 - - - - - - - - - 1 538 4 - - - - - - - 2 1 3 1 5 2 5 174 1 23 13 12 62 588 16 493 86 40 8 584 281 106 1 1 1 70 - - CM-15 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur* Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual** Roche Urisys Cassette* Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual * Roche pH Instrumentation Users: Results should be reported in whole numbers from 5.0 to 9.0, with the exception of 6.5. ** Roche pH Visual Users: Results should be reported in whole numbers, 0.5 increments are not allowed. 11
  • 14. pH, Urine ≤3.5 4.0 4.5 5.0 5.5 6.0 6.5 - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7.0 7.5 8.0 8.5 ≥9.0 10 10 - - - - 5 675 - - - - 1 9 1 - - - - - - 1 - 10 10 - - - - - - - - 10 - - - - - - - - - 10 - - - - - - - - - - 29 - - - - - - - - - - - 75 - 10 - - - - - - - 2 - 260 - - 2 - - - - - - 1 1 1 1 1 1 241 24 253 54 100 - 1 - - - - - - - - - - 126 - - - - - - - - - - 69 475 - - - - - - - 1 1 - 3 4 1 3 30 3 5 8 51 73 1315 15 863 190 2 8 2 2 - 1 CM-16 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur* Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual** Roche Urisys Cassette* Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual * Roche pH Instrumentation Users: Results should be reported in whole numbers from 5.0 to 9.0, with the exception of 6.5. ** Roche pH Visual Users: Results should be reported in whole numbers, 0.5 increments are not allowed. 12
  • 15. Protein – Qualitative, Method 1 CM-14 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ - - - - 10 10 - - - 1 42 204 - - - - 3 5 2 - - - - 11 10 - - - - - 10 - - - - - 10 - - - - - 13 15 - - - 1 25 - - - - 5 87 1 1 - 1 1 - 1 3 1 10 105 38 9 73 53 13 1 - - - 1 27 4 - - - 1 208 18 1 - 2 1 2 125 1 16 20 18 333 15 371 110 4 10 1 21 49 13
  • 16. Protein – Qualitative, Method 1 CM-15 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ - - - - 10 10 - 1 - 1 243 1 1 - - - 8 2 - - - - 1 - 10 10 - - - - - 10 - - - - - 10 - - - - 1 27 - - - - 4 22 - - - - 86 7 - 1 - - 1 1 - 27 18 1 38 80 51 13 47 24 8 - - - - 16 14 2 - - - 12 209 5 1 - - 1 1 3 7 425 2 5 45 15 18 38 14 368 114 3 3 20 16 14
  • 17. Protein – Qualitative, Method 1 CM-16 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ - - - - 10 10 - - - - 2 236 9 - - - - 3 7 - - - - 11 10 - - - - - 10 - - - - - 10 - - - - - 7 21 - - - - 26 - - - - 3 89 1 - - - 1 1 7 107 32 8 77 62 14 1 - 1 - - 25 6 - - - 1 179 46 1 1 1 - 1 2 1 12 2 19 21 18 442 13 371 93 4 13 2 19 63 15
  • 18. Protein – Qualitative, Method 2 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual 75 mg/dL 10-20 30-70 (Roche Negative mg/dL mg/dL only)* 100-200 mg/dL 300-600 mg/dL ≥500 mg/dL (IRIS only)* >600 or ≥1000 mg/dL 2 - - - 84 339 10 2 - - - - 1 2 56 - 1 - - - 18 9 141 - - - - - 4 2 23 1 2 132 16 132 32 17 3 - 1 1 - - - - 7 85 1 - - - - - 3 291 - 16 2 - 1 - - - 5 1 252 1 1 26 54 620 470 49 - 1 1 3 1 12 * Not appropriate for Roche Urisys 1100 users. . 16
  • 19. Protein – Qualitative, Method 2 CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual 75 mg/dL 10-20 30-70 (Roche Negative mg/dL mg/dL only)* 100-200 mg/dL 300-600 mg/dL ≥500 mg/dL (IRIS only)* >600 or ≥1000 mg/dL 1 - 1 - 429 6 - - - - - - 8 2 49 - 2 - 1 - 144 1 21 - - - 1 - 43 11 83 6 6 93 7 73 27 12 2 - 1 1 - - - 1 53 38 1 - 1 - - - 28 279 - 2 1 3 1 1 - - - 13 2 832 12 9 18 53 43 456 46 - 1 1 1 6 * Not appropriate for Roche Urisys 1100 users. 17
  • 20. Protein – Qualitative, Method 2 CM-16 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual 75 mg/dL 10-20 30-70 (Roche Negative mg/dL mg/dL only)* 100-200 mg/dL 300-600 mg/dL ≥500 mg/dL (IRIS only)* >600 or ≥1000 mg/dL - - - - 3 383 36 15 - - - - - 2 57 - - - - - 7 9 153 - - - - - 1 3 - 135 18 152 33 18 3 - 1 2 - - - - - 91 1 1 - - - - 2 245 - 63 1 - 1 - - - 2 24 2 1 30 55 849 469 36 - 1 4 1 25 * Not appropriate for Roche Urisys 1100 users. 18
  • 21. Glucose, Method 1 CM-14 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 10 10 - - - - - 220 - - - - - 10 - - - - - 11 10 - - - - - 10 10 - - - - - 28 - - - - - 25 - 3 - - - 92 - - - - - 100 89 23 32 - - 1 - 1 - 30 - - - - - 220 - - - - - 22 23 453 17 390 94 - - - 1 - - 19
  • 22. Glucose, Method 1 CM-15 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 10 10 - - - - - 220 - - - - - 10 - - - - - 11 10 - - - - - 10 10 - - - - - 28 - - - - - 27 - 1 - - - 92 - - - - - 99 89 23 33 - - - - - 30 - - - - - 219 - - - - - 22 23 453 17 389 93 - - - - - 20
  • 23. Glucose, Method 1 CM-16 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual 4+ Negative Trace 1+ 2+ 3+ - - 10 10 - - - - 1 1 23 194 1 - - - 6 4 - - - 11 10 - - - - - 10 10 - - - - - - 26 2 - - - 1 6 18 3 - 1 - 2 87 2 1 1 - - 1 1 1 1 80 20 5 1 15 61 14 11 2 6 3 20 - - - 5 22 3 - - 191 28 1 - 1 4 2 - 5 2 2 10 7 122 14 244 34 9 11 294 3 128 33 2 4 26 12 17 1 3 1 7 21
  • 24. Glucose, Method 2 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative 30-100 mg/dL 150-300 mg/dL 500* mg/dL >500 or ≥1000 or ≥2000 mg/dL 463 - - - - 54 3 - - - 171 - - - - 144 17 165 33 70 - - 1 - - 95 - - - - 323 - - - - 33 54 897 482 139 - 1 - 1 - - *Roche Glucose Visual Users: Results may be reported as 500 mg/dL. All other Roche Glucose Method users should NOT report 500 mg/dL. Analyzers are not able to discern results of 500 vs. 1000 mg/dL. 22
  • 25. Glucose, Method 2 CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative 30-100 mg/dL 150-300 mg/dL 500* mg/dL >500 or ≥1000 or ≥2000 mg/dL 462 1 - - - 56 1 - - - 171 - - - - 145 17 166 33 70 - - - - 94 - - - - 323 - - - - 33 54 897 481 138 1 - 1 1 1 - - *Roche Glucose Visual Users: Results may be reported as 500 mg/dL. All other Roche Glucose Method users should NOT report 500 mg/dL. Analyzers are not able to discern results of 500 vs. 1000 mg/dL. 23
  • 26. Glucose, Method 2 CM-16 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual >500 or ≥1000 or ≥2000 mg/dL Negative 30-100 mg/dL 150-300 mg/dL 500* mg/dL - - 438 20 5 - - 20 35 2 - - 4 31 136 - 1 - 126 14 145 26 10 1 2 20 16 3 19 7 40 - - 22 1 72 - 1 290 28 3 1 7 3 - 1 7 5 1 15 10 231 273 41 14 29 583 178 54 3 14 71 24 44 *Roche Glucose Visual Users: Results may be reported as 500 mg/dL. All other Roche Glucose Method users should NOT report 500 mg/dL. Analyzers are not able to discern results of 500 vs. 1000 mg/dL. 24
  • 27. Reducing Substance CM-14 Method/Instrument Bayer Clinitest, 2 Drop* Visual Bayer Clinitest, 5 Drop Siemens Clinitek 500, Advantus Visual CM-15 Method/Instrument Bayer Clinitest, 2 Drop* Visual Bayer Clinitest, 5 Drop Siemens Clinitek 500, Advantus Visual CM-16 Method/Instrument Bayer Clinitest, 2 Drop* Visual Bayer Clinitest, 5 Drop Siemens Clinitek 500, Advantus Visual ¼% Negative (Trace) ½% ¾%* 1% ≥2% 203 1 - - - - 11 2189 1 - 1 2 1 ½% ¾%* 1% ≥2% ¼% Negative (Trace) 199 5 - - - - 11 2185 8 - - 1 - ½% ¾%* 1% ≥2% ¼% Negative (Trace) 2 4 11 5 49 133 12 12 39 2 239 5 1234 4 660 * Please note ¾% is not an appropriate response for the Bayer Clinitest, 2-drop method. 25
  • 28. Ketones, Method 1 CM-14 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Visual Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace Small - - - - 10 10 - - - 1 44 - - - - 10 10 - - - - 10 - - - - 10 - - 5 22 1 1 - - - 1 1 3 9 16 12 - - - 6 13 1 3 - 4 1 - 29 2 7 26 38 96 26 Moderate Large
  • 29. Ketones, Method 1 CM-15 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Visual Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace Small Moderate Large 10 10 - - - - 45 - - - - 10 10 - - - - 10 - - - - 10 - - - - 28 - - - - 10 18 15 - - - - 19 - - - - 60 40 102 - - 1 2 27
  • 30. Ketones, Method 1 CM-16* Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Visual Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace Small Moderate Large 10 10 - - - - - 3 40 2 - 10 10 - - - - 10 - - - - 10 - - - - - 17 11 - - - 1 1 1 7 9 8 2 8 5 1 - 12 7 - - 5 4 64 40 22 24 14 11 7 1 2 7 1 1 4 * Specimen CM-16 was not graded due to lack of participant consensus. 28
  • 31. Ketones, Method 2 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 2 - - 14 227 2 - - - 7 3 - - - - 2 26 - - - - 17 12 - 1 - 10 69 6 - 1 - 1 2 3 9 13 100 37 16 67 1 60 - - - - 2 31 4 - - - 65 160 1 2 - 1 - 15 1 - 5 1 265 3 22 4 16 16 152 13 228 43 1 2 111 5 29
  • 32. Ketones, Method 2 CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 245 - - - - - 10 - - - - - 28 - - - - - 29 - - - - - 86 - - - - - 104 97 26 82 - 1 - - - 37 - - - - - 225 - - - - - 21 18 438 16 362 51 - - 1 - - 30
  • 33. Ketones, Method 2 CM-16* Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ - 3 228 12 2 - - 3 7 - - - 27 1 - - - - - - 28 1 - - - 48 35 4 - - 1 14 4 2 58 26 24 45 42 47 1 21 23 1 1 - - - 4 30 3 - 7 127 94 - - - 34 22 27 15 9 279 12 140 14 6 9 124 4 186 4 2 15 4 3 - * Specimen CM-16 was not graded due to lack of participant consensus. 31
  • 34. Ketones, Method 3 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative 5-10 mg/dL 1 - - 15-20 mg/dL 40 - 60 mg/dL 80 - 100 mg/dL 1 14 372 3 - - - 39 14 1 - 18 1 126 1 - - 1 - 4 5 2 9 1 2 - 125 12 136 19 - - 1 - - 86 - - 1 89 205 3 1 - 1 - 1 11 - 6 6 486 26 6 18 47 339 319 45 4 1 7 119 16 Negative 5-10 mg/dL 15-20 mg/dL 40 - 60 mg/dL 80 - 100 mg/dL ≥150 mg/dL 390 - - - 1 - 53 - - - - - 147 - - - - - 131 17 140 28 - - - - - 87 - - - - - 299 - - - - - 31 54 842 463 67 - - - - 1 1 - 32 ≥150 mg/dL
  • 35. Ketones, Method 3 CM-16* Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual 5-10 mg/dL 15-20 mg/dL - 221 157 - - - 80 - 100 mg/dL ≥150 mg/dL 12 1 - 44 2 3 - 75 68 - 2 - 1 1 - 6 5 3 - 74 9 76 24 49 3 59 4 1 - 1 - - 1 9 75 2 - 9 172 111 2 - - 2 3 70 30 35 23 27 472 204 20 6 23 289 205 8 4 14 4 1 - - Negative * Specimen CM-16 was not graded due to lack of participant consensus. 33 40 - 60 mg/dL
  • 36. Bilirubin, Method 1 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Ictotest Visual Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Ictotest Visual Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace/Small Positive/Moderate Large 370 - - - 28 29 - - - 20 - - - 320 - - - 11 - - - 32 54 862 492 115 1 - 3 - 2 - Negative Trace/Small Positive/Moderate Large 370 - - - 27 29 - - - 20 - - - 320 - - - 11 - - - 32 53 865 492 115 - 1 - 1 - 34
  • 37. Bilirubin, Method 1 CM-16 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Ictotest Visual Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace/Small 2 - 51 317 - - 10 13 17 16 - 1 4 15 2 1 162 153 1 - 6 4 3 1 2 - 4 3 640 8 8 28 51 225 481 106 35 Positive/Moderate Large
  • 38. Bilirubin, Method 2 CM-14 Method/Instrument ACON Mission Reagent Sticks ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 10 10 - - - - - 208 - - - 2 - 10 - - - - - 11 11 - - - - - 10 - - - - - 10 - - - - - 27 - - - - - 100 10 83 22 90 - 1 - - - 32 - - - - - 207 - - - - - 20 15 375 16 300 66 - 1 - 1 - - 1 - 36
  • 39. Bilirubin, Method 2 CM-15 Method/Instrument ACON Mission Reagent Sticks ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 10 10 - - - - - 210 - - - - - 10 - - - - - 11 11 - - - - - 10 - - - - - 10 - - - - - 27 - - - - - 99 10 83 22 91 - - 1 - - - 32 - - - - - 206 - - - - - 20 15 377 16 301 66 - - - - - 37
  • 40. Bilirubin, Method 2 CM-16 Method/Instrument ACON Mission Reagent Sticks ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ - - - - 10 10 - - 1 3 - 57 149 - - - - 10 - - - - 1 11 10 - - - - - 10 - - - - - 10 - 4 - - - 23 - - 1 - 3 2 - 99 7 80 22 90 1 1 - - - - - 32 - - - 1 111 94 1 1 - - 1 - 3 264 7 1 5 16 15 112 9 298 57 1 4 38
  • 41. Bilirubin, Method 3 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 CM-16 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Negative 0.5 -1.0 mg/dL 2.0 – 4.0 mg/dL 6.0 – 10.0 mg/dL >10.0 mg/dL 81 - - - - 111 16 132 27 - - - - 67 - - - - Negative 0.5 -1.0 mg/dL 2.0 – 4.0 mg/dL 6.0 – 10.0 mg/dL >10.0 mg/dL 81 - - - - 111 16 131 27 - - 1 - - 67 - - - - Negative 0.5 -1.0 mg/dL 2.0 – 4.0 mg/dL 6.0 – 10.0 mg/dL >10.0 mg/dL - - 1 13 67 - - - 111 16 129 27 3 - - 1 - 66 - 39
  • 42. Bilirubin, IRIS iChemVELOCITY and iChem 100, Method 1 CMP1-04 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CMP1-05 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CMP1-06 Method/Instrument Negative Trace/Small Positive/Moderate Large 28 - - - 146 - - - Negative Trace/Small Positive/Moderate Large 28 - - - 147 - - - Negative IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Trace/Small Positive/Moderate Large 1 - 10 16 2 25 113 6 Bilirubin, IRIS iChemVELOCITY and iChem 100, Method 2 CMP1-04 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CMP1-05 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CMP1-06 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Negative Trace 1+ 2+ 3+ 4+ 17 - - - - - 61 - - 1 - - 1+ 2+ 3+ 4+ Negative Trace 17 - - - - - 62 - - 1 - - 1+ 2+ 3+ Negative Trace 4+ - - - 3 13 1 3 - 7 53 - - 40
  • 43. Bilirubin, IRIS iChemVELOCITY and iChem 100, Method 3 CMP1-04 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CMP1-05 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CMP1-06 Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Negative 0.5 -1.0 mg/dL 2.0 – 4.0 mg/dL 6.0 – 10.0 mg/dL >10.0 mg/dL 22 - - - - 25 - - - - Negative 0.5 -1.0 mg/dL 2.0 – 4.0 mg/dL 6.0 – 10.0 mg/dL >10.0 mg/dL 22 - - - - 25 - - - - Negative 0.5 -1.0 mg/dL 2.0 – 4.0 mg/dL 6.0 – 10.0 mg/dL >10.0 mg/dL - - 22 - - 2 - 23 - - 41
  • 44. Blood or Hemoglobin, Method 1 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Marked Positive/Moderate Positive/Large Negative Trace/Small 1 2 197 159 - - - 40 1 2 124 29 - - - 24 24 - - - 18 1 - 8 302 1 - 2 6 38 57 3 32 51 842 418 143 Negative Trace/Small - 1 304 54 - - 6 34 1 2 121 32 - 1 - 24 23 - - - 18 1 - 9 301 1 1 - 1 1 - 3 8 38 86 9 29 48 840 386 139 42 Marked Positive/Moderate Positive/Large
  • 45. Blood or Hemoglobin, Method 1 CM-16 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Marked Positive/Moderate Positive/Large Negative Trace/Small - 2 95 262 - - 2 38 - 2 92 62 - - 1 - 23 24 - - - 18 1 - 3 307 - 1 1 2 2 20 17 2 32 56 859 457 144 43
  • 46. Blood or Hemoglobin, Method 2 CM-14 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 5+ - - - - 10 10 - - - - - 146 108 1 - - - - - 11 11 - - - - - - 10 - - - - - - 10 - - - - - 5 23 - - - - 1 5 27 - - - - 2 68 18 - - 1 1 - - - 7 6 10 7 10 101 32 14 18 47 - - - - - 13 19 4 1 - 1 5 224 2 - 1 - - 1 2 13 54 1 20 15 419 16 299 75 1 1 2 1 2 2 44
  • 47. Blood or Hemoglobin, Method 2 CM-15 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 5+ - - - - 10 10 - - - - - 215 40 - - - - - - 11 11 - - - - - - 10 - - - - - - 10 - - - - - 22 6 - - - - 1 6 26 - - - - 2 66 20 - - - 1 - 8 4 11 8 11 100 31 14 18 47 - - - - - 11 21 4 1 - 1 6 222 2 - 1 1 - - 1 4 9 1 92 3 19 12 423 15 262 73 1 2 2 1 1 2 45
  • 48. Blood or Hemoglobin, Method 2 CM-16 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ 5+ - - - - 10 10 - - - - - 69 186 - - - - - - 11 11 - - - - - - 10 - - - - - - 10 - - - - - - 28 - - - - 1 2 30 - - - - 2 52 34 - - 1 1 - - 7 5 10 6 1 10 100 34 14 18 47 - - - - - 11 21 4 - - - 2 229 2 - 1 1 - - - 3 16 1 20 17 429 15 337 74 1 1 4 1 2 2 46
  • 49. Blood or Hemoglobin, Method 3 5 – 25 CM-14 CM-15 Method/Instrument Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status CM-16 Method/Instrument Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status Negative Ery/µL Ery/µL Ery/µL 1 1 - - 1 2 1 - 106 16 139 33 64 - - - 71 - 1 2 8 30 29 50 – 150 250 Negative Ery/µL Ery/µL Ery/µL - - 1 2 1 108 17 138 34 63 1 - - 70 - 1 2 9 30 28 5 – 25 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status 250 5 – 25 Method/Instrument 50 – 150 50 – 150 250 Negative Ery/µL Ery/µL Ery/µL - - 1 2 1 - 107 16 139 34 64 - - - 71 1 1 2 2 30 34 47
  • 50. Blood or Hemoglobin, Method 4 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY CM-16 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY ±0.03 mg/dL Negative 0.06 – 0.10 mg/dL 0.20 – 0.50 mg/dL ≥1.0 mg/dL - - - 31 30 - - - 2 10 - - - 10 8 0.06 – 0.10 mg/dL 0.20 – 0.50 mg/dL ≥1.0 mg/dL ±0.03 mg/dL Negative - - - 48 13 - - - 1 11 - - - 10 8 0.06 – 0.10 mg/dL 0.20 – 0.50 mg/dL ≥1.0 mg/dL ±0.03 mg/dL Negative - - - 10 51 - - - - 12 - - - 9 9 48
  • 51. Leukocyte Esterase, Method 1 CM-14 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace Large Positive* - - - - 10 10 - - - 1 1 354 1 - - - - 10 10 - - - - - 10 - - - - - 10 - - - - - 37 - 1 - - - 140 11 1 - - 5 6 16 11 2 - - - - 4 14 - - 1 - 12 285 1 1 - 1 - 4 8 4 107 2 14 31 695 188 51 12 19 180 176 79 2 4 1 * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 49 Small Moderate
  • 52. Leukocyte Esterase, Method 1 CM-15 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace Small Moderate Large Positive* 10 10 - - - - - 357 - - 1 - - 10 10 - - - - - 10 - - - - - 10 - - - - - 33 2 2 - - - 151 1 - - - - 23 17 - 1 - - - 18 - - - - - 299 - - - - - 30 56 879 475 129 1 1 1 1 - 2 1 - * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 50
  • 53. Leukocyte Esterase, Method 1 CM-16 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Negative Trace Small - - - - 10 10 - - - 3 3 350 1 - - - - 10 10 - - - - - 10 - - - - - 10 - - - - 1 36 - - - - 4 137 11 - - - 4 6 17 11 2 1 - - - 5 13 - - 1 - 96 201 1 1 1 1 1 4 15 38 7 11 46 456 403 76 18 3 401 4 38 5 6 31 9 2 1 1 * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 51 Moderate Large Positive*
  • 54. Leukocyte Esterase, Method 2 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual 1+ 2+ 3+ 4+ Positive* - - 6 185 8 - - - - 4 6 - - - - - - 20 - - - - - - 16 - 1 - - - 2 83 1 - - - 1 3 106 29 8 70 3 59 13 17 1 - 1 - - - - 20 16 - - 1 - - 7 216 2 1 1 1 - 2 - 1 1 3 76 - 17 11 345 168 47 5 5 79 16 118 31 1 1 2 - - Negative Trace 1 * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 52
  • 55. Leukocyte Esterase, Method 2 CM-15 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 ** IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ Positive* 199 - - - 1 - - 10 - - - - - - 20 - - - - - - 12 2 3 - - - - 86 - - - - - - 111 89 21 90 - - - - - - 36 - - - - - - 224 - 1 - 1 - - 23 18 430 16 365 77 1 - - - 1 - - * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. ** Specimen CM-15 for this peer group was not graded due to lack of participant consensus. 53
  • 56. Leukocyte Esterase, Method 2 CM-16 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Negative Trace 1+ 2+ 3+ 4+ Positive* - - - 7 185 8 - - - - 7 3 - - - - - 3 17 - - - - - - 16 - 1 - - - 3 82 1 - - - 2 1 20 105 29 7 61 2 59 13 9 1 - 1 1 - - - - 20 16 - - - - - 91 134 1 1 1 1 11 15 5 10 16 228 328 47 11 1 189 7 8 22 2 1 3 8 13 3 1 - - * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 54
  • 57. Leukocyte Esterase, Method 3 25 75 or 100 Negative µL µL 1 - - 250 or 500 Positive* - 113 4 - - 30 1 - - - 27 - 1 - - 1 - 106 17 144 32 1 - - - 71 - - - - 12 - - - 17 19 14 6 - 75 or 100 Negative µL µL 250 or 500 116 - 28 ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status Method/Instrument CM-15 µL 25 CM-14 Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status µL Positive* - 2 - 3 - - - 27 - - - - 107 17 144 33 - - 1 - - 71 - - - - 12 - - - - 31 25 - - - - * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 55
  • 58. Leukocyte Esterase, Method 3 25 CM-16 Method/Instrument 75 or 100 Negative µL µL - - - ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status 250 or 500 µL Positive* - 115 3 - - 30 1 - - - 27 - - - 1 - 107 17 144 32 1 - - 2 69 - - - 3 9 - - 3 28 20 4 1 - * Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 56
  • 59. Nitrite CM-14 Method/Instrument Negative ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (8007212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Positive 1 678 - 11 - 11 11 - 10 10 - 23 - 85 1 259 1 - 241 26 245 56 99 - 125 - 536 1 2 - 57 11 10 54 77 1339 18 861 210
  • 60. Nitrite CM-15 Method/Instrument Negative ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (8007212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Positive 2 677 - 11 - 11 11 - 10 10 1 22 - 85 1 259 1 2 - 240 26 244 56 99 - 125 2 533 5 4 2 58 11 10 54 76 1333 18 859 208
  • 61. Nitrite CM-16* Method/Instrument Negative ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (8007212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Positive - 11 10 3 675 10 1 - 11 11 - 10 10 22 1 17 68 23 237 225 23 193 54 83 15 3 53 2 16 108 15 - 536 1 2 8 2 11 95 53 75 1330 16 852 114 * Specimen CM-16 was not graded due to lack of participant consensus. 59
  • 62. Urobilinogen CM-14 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual 1.0 Negative 4.0 ≥8.0 or mg/dL or or 0.0 - 0.2 or 2.0/3.0 4.0/6.0 12.0 <2.0 mg/dL mg/dL mg/dL mg/dL mg/dL or or or or or <3.2 µmol/L 16 µmol/L 34 µmol/L 70 µmol/L ≥140 µmol/L Positive ** 11 10 - - - - - 365 278 - 1 - - 11 - - - - - 11 10 - - - - - 10 - - - - - 10 - - - - - 23 5 - - - - 66 14 - - - - 170 81 - - - - 221 25 245 54 89 2 2 1 - - - - 118 - - - - - 486 3 - - - - 48 63 1167 17 719 165 5 1 1 1 3 - - 2 1 1 2 - ** Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 60
  • 63. Urobilinogen CM-15 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual 1.0 Negative 4.0 ≥8.0 or mg/dL or or 0.0 - 0.2 or 2.0/3.0 4.0/6.0 12.0 <2.0 mg/dL mg/dL mg/dL mg/dL mg/dL or or or or or <3.2 µmol/L 16 µmol/L 34 µmol/L 70 µmol/L ≥140 µmol/L Positive ** 11 10 - - - - - 364 280 - - 1 - 11 - - - - - 11 10 - - - - - 10 - - - - - 10 - - - - - 23 5 - - - - 64 15 - - - - 168 83 - - - - 221 25 245 54 89 2 2 1 - - - - 118 - - - - - 488 1 - - - - 48 62 1170 17 720 167 5 1 - 1 3 - - - 1 - ** Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 61
  • 64. Urobilinogen CM-16 Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual 1.0 Negative 4.0 ≥8.0 or mg/dL or or 0.0 - 0.2 or 2.0/3.0 4.0/6.0 12.0 <2.0 mg/dL mg/dL mg/dL mg/dL mg/dL or or or or or <3.2 µmol/L 16 µmol/L 34 µmol/L 70 µmol/L ≥140 µmol/L Positive ** - - - 11 10 - - - 1 17 616 9 2 - - - - 11 - - - - 11 10 - - - - - 10 - - - - - 10 - - 1 - 6 21 - - - 1 1 4 69 5 - - 3 239 2 7 3 1 1 1 1 1 1 5 2 10 218 25 237 49 77 1 4 2 - - - - - 118 - - - 2 428 59 - 1 5 - 1 1 - 1 5 12 3 47 62 1163 5 723 162 3 2 1 ** Appropriate for IRIS iChemVELOCITY and iChem 100 users only. 62
  • 65. Urine Sediment Photographs CMP-17 Case History CMP-17 through CMP-20 This urine sample is from a 37-year-old man with advanced kidney disease, admitted through the emergency room (ER) for lower abdominal discomfort and painful urination. Laboratory data include: specific gravity = 1.017, pH = 5.0; blood, leukocyte esterase, protein, glucose, ketones, and nitrite = positive. CMP Participants No. % Identification Granular cast 4393 96.8 Performance Evaluation Good The arrowed object is a granular cast as correctly identified by 96.8% of the participants. Urinary casts are cylindrical objects that form in the distal tubules and collecting ducts as a result of solidification of protein within the renal tubular lumen. Casts are sub-classified based on their matrix composition (hyaline, waxy), inclusions (granules, fat, hemosiderin), or cellular composition (white cells, red cells, renal tubular epithelial cells, bacteria). Granular casts as depicted in this image are a common finding in urine specimens. This cast is made up of plasma proteins from degenerated cellular products and may have a fine or coarse granular appearance that is often evenly dispersed throughout the cast. Most granular casts are not pathological; however, these casts can be seen in urine from individuals with renal disease. 63
  • 66. CMP-18 Urine Sediment Photographs CMP Participants No. % Identification Erythrocyte, mature 4463 98.4 Performance Evaluation Good The arrowed object is a red blood cell that is correctly identified by 98.4% of the participants. Red blood cells in wet preparations appear as pale yellow-orange discs that are usually about 7 to 8 μm in diameter. The appearance of red blood cells depends upon the age and condition of the urine specimen. Old hypotonic urine specimens make red blood cells appear as “ghost-like,” faint, colorless circles. Red blood cells in hypertonic urine samples can appear more crenated. Oil droplets can mimic red blood cells but the refractile nature of oil droplets is a helpful distinction. Crenated red cells may be confused with white blood cells, which unlike red blood cells have multilobated nuclei. Generally, only a small number of red blood cells are seen in urine (less than 3/HPF); however, increased numbers of red blood cells can be associated with kidney disease, inflammation, trauma, or bleeding disorders. 64
  • 67. CMP-19 Urine Sediment Photographs CMP Participants Identification Performance No. Evaluation 4377 Waxy Cast % 96.5 Good The arrowed image is a waxy cast which was correctly identified by 96.5% of the participants. Waxy casts are usually broad and stubby with a homogenous smooth and dense appearance. The ends are often blunted with well-defined parallel margins that may be serrated or notched which reflect its brittle nature. Waxy casts are thought to arise from the degeneration of cellular casts and are frequently associated with severe or progressive chronic renal disease. These waxy casts can be differentiated from hyaline casts due to their highly refractile nature. 65
  • 68. CMP-20 Urine Sediment Photographs CMP Participants No. % Identification Calcium oxalate crystals 4533 99.9 Performance Evaluation Good The arrowed objects are calcium oxalate crystals which were correctly identified by 99.9% of the participants. Calcium oxalate crystals can have various forms. The classic form is the dihydrate form, as depicted in this image, which appears as a colorless octahedron with the morphologic features of an envelope. The monohydrate form has an oval, elliptical, or dumbbell shape. Large numbers of oxalate crystals can be seen in chronic renal disease, ethylene glycol (antifreeze) toxicity, or in patients who consume foods rich in oxalic acid (ie, tomatoes, apples, asparagus, oranges, or carbonated beverages). Calcium oxalate crystals can cause renal calculi. George Girgis, MT Hematology and Clinical Microscopy Resource Committee 66
  • 69. Body Fluid Photographs Case History CMP-21 through CMP-26 The patient is a 38-year-old, immunocompromised man who presents with fever, shortness of breath, and nonproductive cough. Bronchioalveolar lavage (BAL) is performed and shows: total nucleated cells = 6100/μL (6.1 × 10 /μL) and RBC = 400/μL (0.4 × 10 /μL). Referees No. % CMP-21 Identification CMP Participants No. % Performance Evaluation Monocyte/macrophage 3 33.3 1083 43.5 Non-consensus Mesothelial cells 3 33.3 746 29.9 Non-consensus Macrophage containing hemosiderin (Siderophage) 1 11.1 180 7.2 Non-consensus Bronchial lining cell 1 11.1 156 6.3 Non-consensus The arrowed cell represents a monocyte/macrophage, as was correctly identified by 43.5% of the participants. Monocytes and macrophages represent a continuum on the mononuclear phagocytic series, with monocytes typically referring to cells circulating in the blood, while macrophages represent more mature forms that have undergone further differentiation after migration into tissues. Alveolar macrophages typically are the predominant cells in bronchoalveolar lavage fluid and have similar morphology to the macrophages seen in other body fluids. They have an eccentric round nucleus and abundant blue-grey cytoplasm, with small numbers of azurophilic granules, vacuoles, and may contain ingested material such as hemosiderin, RBCs or nucleated cells, microorganisms, or lipid. Cytoplasmic black carbon particles can also be observed in alveolar macrophages of smokers. Mature macrophages can sometimes be difficult to differentiate from mesothelial cells in some types of specimens. An important clue here that the cell is a macrophage and not a mesothelial cell is the specimen source, namely bronchoalveolar lavage. Mesothelial cells are lining cells of the peritoneal, pericardial, and pleural cavities, whereas the lining cells of the bronchial tree have a distinctly different appearance and are columnar and ciliated. When peritoneal, pericardial, and pleural fluids are being examined, distinguishing features of mesothelial cells that may be helpful in differentiating from macrophages include the biphasic cytoplasmic staining, with a lightly staining perinuclear area and a deeper blue periphery; the more pronounced surface membrane projections; and the presence of “windows” between mesothelial cells in clusters, which are clear spaces between individual cells. 67
  • 70. CMP-22 Body Fluid Photographs CMP Participants No. % 1653 Macrophage containing abundant small lipid vacuoles/droplets (Lipophage) Monocyte/macrophage 66.5 Educational 429 Identification Performance Evaluation 17.3 Educational Neutrophil/macrophage with phagocytized 133 5.3 Educational fungi Macrophage containing hemosiderin 70 2.8 Educational (Siderophage) The arrowed cell represents a lipophage, as was correctly identified by 66.5% of the participants. Identification as a monocyte/macrophage is also acceptable. A lipophage represents a macrophage containing numerous cytoplasmic small fat droplets, which result from ingestion of extracellular lipids, such as membranes from necrotic cells. Large numbers of lipophages can be observed in pleural fluid in the presence of chylothorax, or in cerebrospinal fluid following intrathecal chemotherapy or radiation therapy. 68
  • 71. CMP-23 Body Fluid Photographs Identification CMP Participants No. % Erythrocyte, mature 2481 99.3 Performance Evaluation Good The arrowed cell represents a mature erythrocyte, as was correctly identified by 99.3% of the participants. The presence of red blood cells (RBCs) in body fluids frequently indicates hemorrhage or traumatic contamination of the body fluid with peripheral blood. Their morphology in body fluids is similar to that observed in the peripheral blood: non-nucleated, round, with a zone of central pallor, although they can also appear crenated because of preservation artifact. 69
  • 72. CMP-24 Body Fluid Photographs Identification CMP Participants No. % Performance Evaluation Pneumocystis jirovecii 1821 73.4 Educational 167 6.7 Educational Bacteria - extracellular 94 3.8 Educational Macrophage containing hemosiderin (Siderophage) 73 2.9 Educational Degenerating cell, NOS 67 2.7 Educational Yeast/fungi, extracellular 47 1.9 Educational Stain precipitate The arrowed object represents Pneumocystis jirovecii, as correctly identified by 73.4% of the participants. Pneumocystis jirovecii (formerly Pneumocystis carinii) is an opportunistic fungal pathogen classified within phylum Ascomycota, which causes severe pneumonia in immunocompromised patients. The life cycle of the organism goes through a trophic and cystic form. Pneumocystis organisms are usually found within foamy amorphous material present within lung alveoli. Trophic forms can be visualized on Wright-Giemsa stained preparations and are typically 1-5 µm, pleomorphic, and contain a single nucleus. The wall of pneumocystis cyst forms does not stain on Wright-Giemsa, making this form more difficult to identify, although the presence of cyst forms may give the amorphous material a “honeycomb”-like appearance. Distinguishing Pneumocystis structures from artifact may be challenging and can be aided through the use of immunofluorescent monoclonal antibodies for direct detection in clinical specimens. 70
  • 73. CMP-25 Body Fluid Photographs Identification CMP Participants No. % Lymphocyte 2464 98.6 Performance Evaluation Good The arrowed cell represents a lymphocyte, as was correctly identified by 98.6% of the participants. Mature lymphocytes have round to oval nuclei with condensed chromatin and without visible nucleoli. The cytoplasm is typically scant, agranular, and basophilic. In body fluid specimens, particularly cerebrospinal fluid, centrifugation artifact can make mature lymphocytes appear to be larger than their counterparts in peripheral blood and to have visible nucleoli and more abundant cytoplasm. Care should be taken to distinguish such cytospin artifact from evidence of a hematolymphoid neoplasm. To the right of the lymphocyte, Pneumocystis jirovecii organisms are seen, including small trophic forms containing a single small nucleus, as well as several round lighter staining areas, representing cyst forms. 71
  • 74. CMP-26 Body Fluid Photographs CMP Participants No. % Identification Neutrophil, segmented or band 2463 98.6 Performance Evaluation Good The arrowed cell represents a neutrophil, as was correctly identified by 98.6% of the participants. Neutrophils are the most mature forms of the myeloid series with condensed nuclear chromatin and pale pink cytoplasm containing specific bluish granules. The nucleus is typically segmented with 3-5 distinct lobes connected by thin filaments. In the setting of infections, neutrophils can contain vacuoles, toxic granulation, Döhle bodies, or ingested microorganisms. In body fluid specimens, cellular degeneration may result in nuclear pyknosis and fragmentation. In some cases, pyknotic neutrophils may resemble nucleated red blood cells but can be correctly identified by the characteristics of the cytoplasm, which is more eosinophilic than that of nRBCs and may contain residual specific granules. Also of note is the Pneumocystis jirovecii present in the center of this image. 72
  • 75. Case Discussion: Pneumocystis in BAL This case illustrates an example of Pneumocystis jirovecii pneumonia in an immunocompromised patient, with evidence of Pneumocystis organisms in a bronchoalveolar lavage (BAL) specimen. Pneumocystis pneumonia (PCP) can occur in patients infected with human immunodeficiency virus (HIV) and CD4 T-lymphocyte counts <200/µL, where it is considered an acquired immunodeficiency syndrome (AIDS)-defining illness. PCP also can be seen in patients whose immune system is compromised by malignancies, chemotherapy, stem cell or solid organ transplantation, glucocorticoid use, particularly for rheumatologic conditions, or primary immune deficiencies. Because of the severity of Pneumocystis-associated disease, prompt treatment is required and prophylactic therapy is usually initiated in patients with low CD4 counts. Pneumocystis is classified in the fungal kingdom (phylum Ascomycota) based on gene sequence similarities with fungi, particularly in ribosomal RNA genes. Pneumocystis jirovecii refers to the human-specific form of the organism, which highlights the fact that unique Pneumocystis forms have been identified in various mammalian species with stringent host specificities. Pneumocystis is an obligate extracellular organism with a complex life cycle that involves sexual and asexual reproduction and two morphologic forms: trophic, which are usually haploid; and cystic, which can have 2-8 nuclei depending on the stage of development. Studying the genetics and life cycle of this pathogen has been challenged by inability to culture it ex vivo, ie, outside the host lung, although more recently advanced molecular and genomic techniques have been applied to elucidate its biology. According to the current understanding of PCP, acquisition of Pneumocystis occurs via the airborne route and person-toperson transmission. It is thought that immunocompetent individuals undergo asymptomatic infections and can therefore serve as a temporary reservoir for the organism. The clinical presentation of PCP differs between HIV-infected and non-HIV patients. In the context of HIV, PCP typically develops gradually, with low-grade fevers, progressive dyspnea, fatigue, and cough that is usually nonproductive and less commonly productive of clear sputum. In non-HIV patients, fulminant respiratory failure is common, requiring ventilatory support. Radiographic findings are similar in the two patient populations and characterized by bilateral diffuse interstitial infiltrates. High-resolution computed tomography (CT) findings of patchy or nodular ground-glass opacities are suggestive of PCP although not diagnostic. Given the relatively nonspecific clinical presentation and radiographic findings, the diagnosis of PCP depends largely on the laboratory identification of Pneumocystis, although that is somewhat limited by the inability to culture the organism. Microscopic identification of P. jirovecii is typically performed on BAL specimens obtained with bronchoscopy. While induced sputum can also be used and is less invasive, it is considered suboptimal due to decreased sensitivity and specificity compared to BAL, especially for patients receiving PCP prophylaxis. Lung biopsy tissue is also an appropriate diagnostic specimen, however, it is associated with high cost and invasiveness and is infrequently used. Various histochemical stains can be employed to detect P. jirovecii, but many of these conventional stains may be unable to simultaneously detect trophic and cystic forms. A recent study directly comparing four different staining techniques found that Grocott-Gomori methenamine silver stain (GMS) and Calcofluor white fungal stain (CW) have superior sensitivity compared to Diff-Quik staining (~ 75% vs. ~ 50%, respectively). In contrast, immunofluorescent monoclonal antibody staining can detect both life forms, providing the highest sensitivity of all microscopic techniques (> 90%), although it tends to be more costly, time consuming, and may be associated with a small decrease in specificity (~ 95% vs. >99% for the 3 conventional staining methods). Other methods have been developed recently for PCP diagnosis in order to increase the sensitivity of P. jirovecii detection and/or avoid the invasiveness of bronchoscopy. Various methods employing polymerase chain reaction (PCR) have been described and shown to have improved sensitivity compared to microscopy (94-100% 73
  • 76. depending on the genomic target). The disadvantage of such assays is that they may also detect P. jirovecii DNA in patients who are colonized by P. jirovecii but do not have associated pneumonia, which may lead to unnecessary treatment. Efforts have also been made to detect markers of P. jirovecii infection in serum, the most promising of which is β-D-Glucan (BDG) and may offer a noninvasive alternative to BAL. Although assays detecting serum β-D-Glucan have been shown to perform well in HIV-infected patients, the characteristics of such assays need to be further evaluated in different patient populations, particularly in the context of therapy. Martina Lefterova, MD, PhD Joan E. Etzell, MD, FCAP Hematology and Clinical Microscopy Resource Committee References: 1. Krajicek BJ, Limper AH, Thomas CF Jr. Advances in the biology, pathogenesis and identification of Pneumocystis pneumonia. Curr Opin Pulm Med. 2008;14:228-234. 2. Procop GW, Haddad S, Quinn J, et al. Detection of Pneumocystis jiroveci in respiratory specimens by four staining methods. J Clin Microbiol. 2004;42:3333-3335. 3. Thomas CF Jr., Limper AH. Current insights into the biology and pathogenesis of Pneumocystis pneumonia. Nat Rev Microbiol. 2007;5:298-308. 4. Tietjen PA. Clinical presentation and diagnosis of Pneumocystis infection in HIV-infected patients. In: Basow DS, ed. UpToDate. Waltham, MA: Wolters Kluwer Health; 2011. http://www.uptodate.com/contents/clinicalpresentation-and-diagnosis-of-pneumocystis-infection-in-hiv-infected-patients. Accessed January 9, 2013. 74
  • 77. CMMP-36 CMMP – Clinical Microscopy Miscellaneous Photographs CMMP Participants No. % Identification Ferning is present 1364 92.9 Performance Evaluation Good Ferning is present in this image. Evaluation of an air-dried slide prepared from a sterile swab of the posterior vaginal pool is one of the most widely used tests to detect for the presence of amniotic fluid due to the rupture of fetal membranes and the early onset of labor. A positive test, indicating the presence of amniotic fluid, consists of an elaborate arborized crystallization pattern (ferning) best visualized when the substage condensor is lowered to accentuate the diffraction pattern. Inadvertent contamination of the specimen by cervical mucus, blood or urine may cause a falsely positive result; although, the crystal arborization pattern is less elaborate than true ferning from amniotic fluid. 75
  • 78. CMMP-37 CMMP – Clinical Microscopy Miscellaneous Photographs CMMP Participants No. % Identification Yeast/fungi present 2654 99.8 Performance Evaluation Good Yeast/fungi are present in this image. Yeast and fungi can have variable appearances depending on the species. The Candida species is a common cause of vaginitis. Its yeast forms are colorless and ovoid and measure 5 to 7 μm in diameter. These yeast forms are often admixed with pseudohyphae - elongated cells that measure up to about 50 μm and resemble mycelia. In response to a Candida infection, the body mounts an inflammatory response composed of lymphocytes and neutrophils resulting in a clinically apparent thick “cottage cheese-like” discharge. 76
  • 79. CMMP-38 CMMP – Clinical Microscopy Miscellaneous Photographs Identification CMMP Participants No. % Eosinophils absent 1969 99.6 Performance Evaluation Good Eosinophils are absent in this image. Eosinophils are large leukocytes (13 µm in diameter) with characteristically large bright orange-red spherical cytoplasmic granules, and typically display a bilobed nucleus that is separated by a thin nuclear filament. The distinctive large orange granules morphologically distinguish them from neutrophils. The identification of eosinophils and neutrophils in stool and nasal smears is of clinical importance. The presence of eosinphils in nasal smears can suggest an allergic rhinitis. Eosinophils in urine are abnormal and can be seen in patients with interstitial nephritis. 77
  • 80. CMMP-39 CMMP – Clinical Microscopy Miscellaneous Photographs CMMP Participants No. % Identification Pinworm present 1977 99.9 Performance Evaluation Good This egg morphology, depicted above, is highly characteristic of Enterobius vermicularis (pinworm), the most common intestinal helminithic infection. The eggs are elongate or ovoid, with thick colorless shells that measures 50 to 60 μm long and 20 to 32 μm wide. Conspicuously, the eggs are flattened on one side. E. vermicularis eggs are distinguished from Trichuris trichura by the absence of the bipolar refractile plugs that are distinctive of T. trichura. Humans are a common host for E. vermicularis with adult pinworms inhabiting the human appendix, cecum, and ascending colon. The gravid female descends the human colon nocturnally, emerging from the anus and depositing eggs in the perianal/perineal/vaginal areas. Since the eggs are not usually shed within the human intestine, the standard “O&P” stool exam is unlikely to reveal pinworm eggs. Instead, a cellulose tape technique is utilized to collect eggs near the perianal skin for the diagnosis of E. vermicularis. 78
  • 81. CMMP-40 CMMP – Clinical Microscopy Miscellaneous Photographs Identification CMMP Participants No. % Leukocytes present 2328 99.7 Performance Evaluation Good Leukocytes are present in this image. Neutrophils are large leukocytes (12 µm in diameter) with segmented nuclear lobes (two to five lobes) that are connected by a thin chromatin filament. There is abundant pale pink to colorless cytoplasm that contains many fine, lilac granules. The presence of neutrophils in a stool and nasal specimens is of clinical importance. Neutrophils in a stool smear can be seen in 70% of Shigella dysentery, 30-50% of Salmonella and Campylobacter, and 5% of noninvasive organisms, such as Rotavirus and toxigenic Escherichia coli. Neutrophils in nasal discharge are associated with non-allergic causes of rhinitis. 79
  • 82. CMMP-41 CMMP – Clinical Microscopy Miscellaneous Photographs Identification CMMP Participants No. % Sperm present Trichomonas absent Clue cells absent Epithelial cells absent 2282 3020 2755 2415 99.9 99.9 99.8 98.8 Performance Evaluation Good Good Good Good Trichomonas, clue cells, and epithelial cells are all absent, while sperm is present in this image. In wet preparations, the sperm head is about 4 to 6 μm long with an anteriorly tapered head and slender tail that measures 40 to 60 μm in length. Spermatozoa may be seen in the urine of males who have undergone prostatectomy, have retrograde ejaculation or in voided specimens obtained from males shortly after ejaculation. Anna K. Wong, MD Hematology and Clinical Microscopy Resource Committee 80
  • 83. OCB – Occult Blood Intended response was negative. OCB-04 Method Negative Aerscher Diagnostics HemaPrompt FG Beckman Coulter Hemoccult ICT Beckman Coulter Hemoccult/SENSA slide Cenogenics Corp. Clearview Helena ColoScreen/ColoScreen-ES Hemosure iFOB Immunostics Hema Screen/Specific Polymedco OC-Auto Micro 80 Polymedco OC-Light Polymedco OC-Sensor Diana Propper Seracult/Seracult Plus Quidel QuickVue iFOB Starline ColoScan/ColoScan-ES Sure-Vue/Sure-Vue ES Other and Methods with <10 responses 107 210 2275 23 11 110 161 57 177 69 22 250 57 50 107 185 Positive 2 2 4 1 1 - Intended response was positive. OCB-05 Method Negative Positive 3 2 10 1 1 2 1 1 107 210 2268 23 11 110 161 57 177 69 22 248 57 50 107 184 Aerscher Diagnostics HemaPrompt FG Beckman Coulter Hemoccult ICT Beckman Coulter Hemoccult/SENSA slide Cenogenics Corp. Clearview Helena ColoScreen/ColoScreen-ES Hemosure iFOB Immunostics Hema Screen/Specific Polymedco OC-Auto Micro 80 Polymedco OC-Light Polymedco OC-Sensor Diana Propper Seracult/Seracult Plus Quidel QuickVue iFOB Starline ColoScan/ColoScan-ES Sure-Vue/Sure-Vue ES Other and Methods with <10 responses 81
  • 84. OCB – Occult Blood Intended response was negative. OCB-06 Method Negative Aerscher Diagnostics HemaPrompt FG Beckman Coulter Hemoccult ICT Beckman Coulter Hemoccult/SENSA slide Cenogenics Corp. Clearview Helena ColoScreen/ColoScreen-ES Hemosure iFOB Immunostics Hema Screen/Specific Polymedco OC-Auto Micro 80 Polymedco OC-Light Polymedco OC-Sensor Diana Propper Seracult/Seracult Plus Quidel QuickVue iFOB Starline ColoScan/ColoScan-ES Sure-Vue/Sure-Vue ES Other and Methods with <10 responses 108 212 2262 23 11 109 160 57 177 69 22 249 57 50 106 184 Positive 2 17 2 1 1 2 1 GOCB – Gastric Occult Blood GOCB-04 Intended response was negative. Method Negative Aerscher Diagnostics HemaPrompt FG Beckman Coulter Gastroccult Other 109 1777 13 Positive 1 24 1 GOCB-05 Intended response was positive. Method Negative Aerscher Diagnostics HemaPrompt FG Beckman Coulter Gastroccult Other 1 16 - Positive 109 1787 14 GOCB-06 Intended response was negative. Method Negative Aerscher Diagnostics HemaPrompt FG Beckman Coulter Gastroccult Other 109 1767 14 82 Positive 1 35 -
  • 85. GOCB-04 Method No. Labs Mean S.D. C.V. pH dipstick without reader pH meter pH paper 26 25 115 2.60 2.53 3.01 0.79 0.13 0.89 30.3 5.3 29.5 GOCB-05 Method No. Labs Mean S.D. C.V. pH dipstick without reader pH meter pH paper 28 29 116 8.48 9.12 8.59 0.71 0.27 0.71 8.4 2.9 8.3 GOCB-06 Method No. Labs Mean S.D. C.V. pH dipstick without reader pH meter pH paper 28 28 117 2.98 2.53 3.01 1.47 0.36 0.90 49.2 14.1 30.1 GOCB-04 Method 1 2 3 4 5-7 Beckman Coulter Gastroccult - 237 1189 64 24 GOCB-05 Method 1 2 3 4 5-7 7+ Beckman Coulter Gastroccult - - 6 4 118 1389 GOCB-06 GOCB – Gastric pH, Quantitative Method 1 2 3 4 5-7 7+ Beckman Coulter Gastroccult - 257 1151 68 26 12 GOCB – Gastric pH, Qualitative 83 7+ 1
  • 86. DSC-04 DSC-03 DSC – Bilirubin, Confirmatory Method Negative Icto test Other 12 8 Method 197 44 Negative Icto test Other Positive Positive 203 53 6 1 DSC-04 DSC-03 DSC – Protein, Confirmatory, Method 1 Method Negative Sulfosalicylic Acid (SSA) Visual 3 Method 94 Negative Sulfosalicylic Acid (SSA) Visual Positive Positive 94 3 DSC-04 DSC-03 DSC – Protein, Confirmatory, Method 2 Method/Instrument Sulfosalicylic Acid (SSA) Visual Method/Instrument Sulfosalicylic Acid (SSA) Visual Negative 9 Negative 361 1+ 2+ 3+ 4+ 4 15 107 237 1+ 2+ 3+ 4+ - 1 4 5 DSC-04 DSC-03 DSC – Protein, Confirmatory, Method 3 Method/Instrument Sulfosalicylic Acid (SSA) Visual Method/Instrument Sulfosalicylic Acid (SSA) Visual Negative 4 Negative 76 Trace - Trace 2 84 30 mg/dL 1 30 mg/dL - 100 mg/dL 3 200 mg/dL 1 100 mg/dL 1 300 mg/dL 21 200 mg/dL - 300 mg/dL 1 >100 or >600 mg/dL 51 >100 or >600 mg/dL 1
  • 87. Actions Laboratories Should Take when a PT Result is Not Graded The College uses Exception Reason Codes that signify the proficiency testing (PT) for an analyte has not been graded. The Exception Reason Code is located on the evaluation report in brackets to the right of the result. Your laboratory must identify all of the analytes with an Exception Reason Code and investigate the acceptability of performance with the same rigor as if it were an unacceptable performance. The actions accredited laboratories should take include but are not limited to: Code Exception Reason Code Description Action Required 11 Unable to analyze. 20 No appropriate target/response; cannot be graded. 21 Specimen problem. 22 Result is outside the method/ instrument reportable range. Incorrect response due to failure to provide a valid response code. Document why the specimens were not analyzed (eg, instrument not functioning or reagents not available). Perform and document alternative assessment (ie, split samples) for the period that commercial PT was not tested to the same level and extent that would have been tested. Document that the laboratory performed a self-evaluation using the data presented in the Participant Summary and compared its results to a similar method, all method, or all participant statistics if provided. If comparison is not available, perform and document alternative assessment (ie, split samples) for the period that commercial PT was not tested to the same level and extent that would have been tested. Document that the laboratory has reviewed the proper statistics supplied in the Participant Summary. Perform and document alternative assessment for the period that commercial PT was not tested to the same level and extent that would have been tested. Credit is not awarded in these cases. Document the comparison of results to the proper statistics supplied in the Participant Summary. Verify detection limits. Document the laboratory’s self-evaluation against the proper statistics and evaluation criteria supplied in the Participant Summary. Perform and document the corrective action of any unacceptable results. Document corrective action to prevent future failures. Document the investigation of the result as if they were unacceptable and review the proper reference documents to gain knowledge of the reason your response is not appropriate. Response to the CAP is not required. Laboratory should document its review. Document that the laboratory performed a self-evaluation and compared its results to the intended response when provided in the Participant Summary. If comparison is not available, perform and document alternative assessment (ie, split samples) for the period that commercial PT reached non-consensus to the same level and extent that would have been tested. Document that the laboratory performed a self-evaluation and compared its results to the proper statistics supplied in the Participant Summary. Verify detection limits. Document that the laboratory has reviewed the proper statistics supplied in the Participant Summary. Document that the laboratory has contacted the CAP and no replacements specimens were available. Perform and document alternative assessment (ie, split samples) for the period that commercial PT was not tested to the same level and extent that would have been tested. Document why results were not received, corrective action to prevent recurrence and the laboratory’s self-evaluation of the results by comparing results to the proper statistics and evaluation criteria supplied in the Participant Summary. If PT specimens were not analyzed, perform and document alternative assessment (ie, split samples) for the period that commercial PT was not tested to the same level and extent that would have been tested. The Participant Summary indicates which tests are graded (see evaluation criteria) and which tests are Not Evaluated/Educational. Updates to grading will also be noted. If a test is educational, the laboratory is not penalized for leaving a result(s) blank. The code 42 that appears on the evaluation is not a penalty. However, if a test is graded (regulated and non-regulated analytes) and your laboratory performs that test, results cannot be left blank. The laboratory is required to submit results for all challenges within that test or use an appropriate exception code or indicate test not performed/not applicable/not indicated. Exceptions may be noted in the Kit Instructions and/or the Result Form. Document corrective actions to prevent future failures. Verify that the drug is not tested on patient samples and document to ensure proper future reporting. 24 25 Inappropriate use of antimicrobial. 26 27,31 Educational challenge. Lack of participant or referee consensus. 28 Response qualified with a greater than or less than sign; unable to quantitate. Scientific Committee decision. 30 33 Specimen determined to be unsatisfactory after contacting the CAP. 40 41 Results for this kit were not received. Results for this kit were received past the evaluation cut-off date. 42 No credit assigned due to absence of response. 44 This drug is not included in our test menu. Use of this code counts as a correct response. Antimicrobial agent is likely ineffective for this organism or site of infection. 45 77 91 35, 43, 88, 92 Improper use of the exception code for this mailing. There was an insufficient number of contributing challenges to establish a composite grade. Various codes. Document that the laboratory performed a self-evaluation of written protocols and practices for routine reporting of antimicrobial susceptibility reports to patient medical records. Document that routine reporting of this result to clinicians for patient care is compliant with specific recommendations of relevant Medical Staff and Committees (eg, infectious Diseases, Pharmacy and Therapeutics, Infection Control). Response to the CAP is not required. Document the identification of the correct code to use for future mailings. Document the investigation of the result as if it were an unacceptable result. Perform and document the corrective action if required. No action required. 85 Rev 3/2011
  • 88. Attestation of Participation for Self-Reported Training* We the participants below have completed the review of the CAP CM-B 2013 Product Mailing, Year Summary/Final Critique report, and can self report the recommended 0.25 Education Hours Participant hours towards fulfilling education and certification of maintenance requirements. Participant Date Participant Director (or Designee) Signature - I have verified that the individuals listed Date Date above have successfully participated in this activity. Retain this page for record-keeping and auditing purposes. Individuals can also track their participation of educational activities through the CAP Learning Management System (LMS). 1. Create an account at cap.orglearning. 2. Enter your User ID and Password. 3. Under Personalized Options, select Training Transcript. 4. Select Learning Menu and choose Self-Reported Training. 5. Select New, enter the required information, and choose OK when complete. For assistance, call our Customer Contact Center at 800-323-4040 or 847-832-7000 option 1. *CAP Self-Reported Training activities do not offer CE credit, but can be used towards fulfilling requirements for certification of maintenance by agencies such as the American Society of Clinical Pathology (ASCP). Please verify with your certifying agency to determine your education requirements. 86 49215
  • 89. NOTES
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