CAP's Survey in Clinical Microscopy 2013

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
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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

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

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

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

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

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)

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

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
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

Urine hCG

CM-15

Manufacturer

Sensitivity Level
mIU/mL

Acceava Combo II
Eiken
Randox Direct
Sekisui OSOM
Sekisui OSOM Combo
Stanbio QuPID
Stanbio QuPID Plus

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

Urine hCG

CM-16

Manufacturer

Sensitivity Level
mIU/mL

Acceava Combo II
Eiken
Randox Direct
Sekisui OSOM
Sekisui OSOM Combo
Stanbio QuPID
Stanbio QuPID Plus

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

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
IRIS iChemVELOCITY
Refractometer
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
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 Clinitek 50

37
43
347
639

7

1.030
1.030
1.030
1.030

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

Visual
Visual
Visual
Eiken Uropaper
IRIS iChem 100
IRIS iChemVELOCITY
IRIS iChemVELOCITY
Refractometer
IRIS iChemVELOCITY
Visual
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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 Clinitek 50

35
42
241
599

8

1.030
1.030
1.030
1.030

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

Visual
Visual
Visual
Eiken Uropaper
IRIS iChem 100
IRIS iChemVELOCITY
IRIS iChemVELOCITY
Refractometer
IRIS iChemVELOCITY
Visual
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

10
9

1.030

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
Visual
BioSys/Consult Diag/PSS
Select/YD Diag Reagent Strips
Select/YD Diag Urine Analyzer
CTMI / Thermo Fisher Reagent
Strips
Visual
Diagnostic Test Group Clarity
Urocheck Reagent Strips
Urocheck 120
Visual
Eiken Uropaper
IRIS iChem 100
IRIS iChemVELOCITY Reagent
Strips (800-7212)
IRIS iChemVELOCITY
Roche Chemstrip/Combur*
Roche Urisys 1100
Visual**
Roche Urisys Cassette*
Roche Urisys 2400
Siemens Clinitek 50
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

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
Visual
Strips
Visual
Urocheck 120
Visual
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual**
Roche Urisys 2400
Siemens Clinitek 50
Visual


11

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
Visual
Strips
Visual
Urocheck 120
Visual
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual**
Roche Urisys 2400
Siemens Clinitek 50
Visual


12

Protein – Qualitative, Method 1

CM-14

Method/Instrument
Visual
Strips
Visual
Urocheck 120
Visual
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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


CM-15

Method/Instrument
Visual
Strips
Visual
Urocheck 120
Visual
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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


CM-16

Method/Instrument
Visual
Strips
Visual
Urocheck 120
Visual
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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


CM-14

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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


CM-15

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
Visual

75
mg/dL
10-20 30-70 (Roche

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


17


CM-16

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
Visual

75
mg/dL
10-20 30-70 (Roche

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


18

Glucose, Method 1

CM-14

Method/Instrument
Visual
BioSys/Consult Diag/PSS Select/YD
Diag Reagent Strips
Diag Urine Analyzer
Strips
Visual
Urocheck 120
Visual
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

Glucose, Method 1

CM-15

Method/Instrument
Visual
Diag Reagent Strips
Diag Urine Analyzer
Strips
Visual
Urocheck 120
Visual
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

Glucose, Method 1

CM-16

Method/Instrument
Visual
Diag Reagent Strips
Diag Urine Analyzer
Strips
Visual
Urocheck 120
Visual
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

Glucose, Method 2

CM-14

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

Glucose, Method 2

CM-15

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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
-

-


23

Glucose, Method 2

CM-16

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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


24

Reducing Substance

CM-14

Method/Instrument
Bayer Clinitest, 2 Drop*
Visual
Bayer Clinitest, 5 Drop
Visual

CM-15

Method/Instrument
Visual
Visual

CM-16

Method/Instrument
Visual
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

Ketones, Method 1

CM-14

Method/Instrument
Visual
Strips
Visual
Urocheck 120
Visual
Strips (800-7212)
IRIS iChemVELOCITY
Visual
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

Ketones, Method 1

CM-15

Method/Instrument
Visual
Strips
Visual
Urocheck 120
Visual
Strips (800-7212)
IRIS iChemVELOCITY
Visual
Visual

Negative

Trace

Small

Moderate

Large

10
10

-

-

-

-

45

-

-

-

-

10
10

-

-

-

-

10

-

-

-

-

10

-

-

-

-

28

-

-

-

-

10
18
15

-

-

-

-

19

-

-

-

-

60
40
102

-

-

1

2

27

Ketones, Method 1

CM-16*

Method/Instrument
Visual
Strips
Visual
Urocheck 120
Visual
Strips (800-7212)
IRIS iChemVELOCITY
Visual
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

Ketones, Method 2

CM-14

Method/Instrument
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

Ketones, Method 2

CM-15

Method/Instrument
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

Ketones, Method 2

CM-16*

Method/Instrument
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

-


31

Ketones, Method 3

CM-14

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Roche Urisys 2400
Siemens Clinitek 50
Visual

CM-15

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Roche Urisys 2400
Siemens Clinitek 50
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

Ketones, Method 3

CM-16*

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Roche Urisys 2400
Siemens Clinitek 50
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


33

40 - 60
mg/dL

Bilirubin, Method 1

CM-14

Method/Instrument
Roche Urisys 2400
Siemens Ictotest
Visual
Siemens Clinitek 50
Visual

CM-15

Method/Instrument
Roche Urisys 2400
Siemens Ictotest
Visual
Siemens Clinitek 50
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

Bilirubin, Method 1

CM-16

Method/Instrument
Roche Urisys 2400
Siemens Ictotest
Visual
Siemens Clinitek 50
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

Bilirubin, Method 2

CM-14

Method/Instrument
ACON Mission Reagent Sticks
Visual
Diag Reagent Strips
Diag Urine Analyzer
Strips
Visual
Urocheck 120
Visual
Eiken Uropaper
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

Bilirubin, Method 2

CM-15

Method/Instrument
Visual
Diag Reagent Strips
Diag Urine Analyzer
Strips
Visual
Urocheck 120
Visual
Eiken Uropaper
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

Bilirubin, Method 2

CM-16

Method/Instrument
Visual
Diag Reagent Strips
Diag Urine Analyzer
Strips
Visual
Urocheck 120
Visual
Eiken Uropaper
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

Bilirubin, Method 3

CM-14

Method/Instrument
Roche Urisys 1100
Roche Urisys 2400

CM-15

Method/Instrument
Roche Urisys 1100
Roche Urisys 2400

CM-16

Method/Instrument
Roche Urisys 1100
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

Bilirubin, IRIS iChemVELOCITY and iChem 100, Method 1

CMP1-04

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY

CMP1-05

Method/Instrument
IRIS iChem 100
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 100
Strips (800-7212)
IRIS iChemVELOCITY

Trace/Small

Positive/Moderate

Large

1

-

10

16

2

25

113

6


CMP1-04

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY

CMP1-05

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY

CMP1-06

Method/Instrument
IRIS iChem 100
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


CMP1-04

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY

CMP1-05

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY

CMP1-06

Method/Instrument
IRIS iChem 100
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

Blood or Hemoglobin, Method 1

CM-14

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 2400
Siemens Clinitek 50
Visual

CM-15

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 2400
Siemens Clinitek 50
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


CM-16

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 2400
Siemens Clinitek 50
Visual

Marked

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


CM-14

Method/Instrument
Visual
Strips
Visual
Urocheck 120
Visual
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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


CM-15

Method/Instrument
Visual
Strips
Visual
Urocheck 120
Visual
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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


CM-16

Method/Instrument
Visual
Strips
Visual
Urocheck 120
Visual
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

5 – 25

CM-14
CM-15

Method/Instrument
Roche Urisys 1100
Visual
Roche Urisys 2400

CM-16

Method/Instrument
Roche Urisys 1100
Visual
Roche Urisys 2400

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 Urisys 1100
Visual
Roche Urisys 2400

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


CM-14

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY

CM-15

Method/Instrument
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY

CM-16

Method/Instrument
IRIS iChem 100
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

Leukocyte Esterase, Method 1

CM-14

Method/Instrument
Visual
Strips
Visual
Urocheck 120
Visual
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 2400
Siemens Clinitek 50
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


CM-15

Method/Instrument
Visual
Strips
Visual
Urocheck 120
Visual
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 2400
Siemens Clinitek 50
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

-


50


CM-16

Method/Instrument
Visual
Strips
Visual
Urocheck 120
Visual
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 2400
Siemens Clinitek 50
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


51

Moderate

Large

Positive*


CM-14

Method/Instrument
Diag Reagent Strips
Diag Urine Analyzer
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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


52


CM-15

Method/Instrument
Diag Reagent Strips
Diag Urine Analyzer
Eiken Uropaper
IRIS iChem 100 **
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

-

-

** Specimen CM-15 for this peer group was not graded due to lack of participant consensus.

53


CM-16

Method/Instrument
Diag Reagent Strips
Diag Urine Analyzer
Eiken Uropaper
IRIS iChem 100
Strips (800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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
-

-


54

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

IRIS iChem 100
IRIS iChemVELOCITY Reagent Strips
(800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Roche Urisys 2400

Method/Instrument

CM-15

µL

25

CM-14

Method/Instrument

IRIS iChem 100
(800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Roche Urisys 2400

µL

Positive*

-

2

-

3

-

-

-

27

-

-

-

-

107
17
144
33

-

-

1
-

-

71

-

-

-

-

12

-

-

-

-

31
25

-

-

-

-


55

25

CM-16

Method/Instrument

75 or 100

Negative

µL

µL

-

-

-

IRIS iChem 100
(800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Roche Urisys 2400

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

-


56

Nitrite

CM-14

Method/Instrument

Negative

Visual
BioSys/Consult Diag/PSS Select/YD Diag
Reagent Strips
Urine Analyzer
Visual
Diagnostic Test Group Clarity Urocheck
Reagent Strips
Visual
Eiken Uropaper
IRIS iChem 100
IRIS iChemVELOCITY Reagent Strips (8007212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

Nitrite

CM-15

Method/Instrument

Negative

Visual
Reagent Strips
Urine Analyzer
Visual
Reagent Strips
Visual
Eiken Uropaper
IRIS iChem 100
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

Nitrite

CM-16*

Method/Instrument

Negative

Visual
Reagent Strips
Urine Analyzer
Visual
Reagent Strips
Visual
Eiken Uropaper
IRIS iChem 100
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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


59

Urobilinogen

CM-14

Method/Instrument
Visual
Diag Reagent Strips
Diag Urine Analyzer
Visual
Urocheck 120
Visual
Eiken Uropaper
IRIS iChem 100
(800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

Urobilinogen

CM-15

Method/Instrument
Visual
Diag Reagent Strips
Diag Urine Analyzer
Visual
Urocheck 120
Visual
Eiken Uropaper
IRIS iChem 100
(800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

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
-


61

Urobilinogen

CM-16

Method/Instrument
Visual
Diag Reagent Strips
Diag Urine Analyzer
Visual
Urocheck 120
Visual
Eiken Uropaper
IRIS iChem 100
(800-7212)
IRIS iChemVELOCITY
Roche Urisys 1100
Visual
Roche Urisys 2400
Siemens Clinitek 50
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

-

-

-

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


62

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

CMP-18


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

CMP-19


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

CMP-20


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

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

CMP-22


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

CMP-23


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

CMP-24


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

CMP-25


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

CMP-26


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

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

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
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

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

CMMP-37


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

CMMP-38


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

CMMP-39


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

CMMP-40


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

CMMP-41


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

80

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

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

Cenogenics Corp.
Clearview
Hemosure iFOB
Polymedco OC-Light

81

OCB – Occult Blood

OCB-06

Method

Negative

Cenogenics Corp.
Clearview
Hemosure iFOB
Polymedco OC-Light

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

Method

Negative

Beckman Coulter Gastroccult
Other

109
1777
13

Positive
1
24
1

GOCB-05

Intended response was positive.
Method

Negative

Other

1
16
-

Positive
109
1787
14

GOCB-06

Method

Negative

Other

109
1767
14

82

Positive
1
35
-

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 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 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


-

237

1189

64

24

GOCB-05

Method

1

2

3

4

5-7

7+


-

-

6

4

118

1389

GOCB-06

GOCB – Gastric pH, Quantitative

Method

1

2

3

4

5-7

7+


-

257

1151

68

26

12

GOCB – Gastric pH, Qualitative

83

7+
1

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

Visual

Positive

Positive

94

3

DSC-04

DSC-03

Method/Instrument
Visual

Method/Instrument
Visual

Negative

9

Negative

361

1+

2+

3+

4+

4

15

107

237

1+

2+

3+

4+

-

1

4

5

DSC-04

DSC-03

Method/Instrument
Visual

Method/Instrument
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

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

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

CAP's Survey in Clinical Microscopy 2013

CAP's Survey in Clinical Microscopy 2013

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