List of NGSP Certified Methods                                        (updated 7/12, listed by date certified) The NGSP ha...
List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer     Method/         Method      Date ...
List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer     Method/       Method      Date   ...
List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer     Method/         Method       Date...
List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer      Method/           Method       D...
List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer     Method/         Method       Date...
List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer         Method/       Method       Da...
List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer        Method/     Method      Date  ...
List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer     Method/       Method     Date    ...
List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer     Method/       Method      Date   ...
List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer         Method/       Method       Da...
List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer       Method/        Method       Dat...
List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer          Method/     Method       Dat...
List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer         Method/      Method       Dat...
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อ้างอิง 2 ngsp list certified methods

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อ้างอิง 2 ngsp list certified methods

  1. 1. List of NGSP Certified Methods (updated 7/12, listed by date certified) The NGSP has certified the following methods and reagents as having documented traceability to the Diabetes Control and Complications Trial Reference Method. Manufacturers are awarded Certificates of Traceability for successfully completing bias testing for specific methods, reagent lots, calibrator lots and instrumentation used. Traceability to the DCCT applies only to results from fresh blood samples. Analysis of processed (e.g. lyophilized) material may be subject to matrix effects and any comparisons to the DCCT using results from processed specimens should be made with caution. The NGSP recommends that manufacturers certify their methods each year; the certificate of traceability expires after 1 year. During the year it is the responsibility of the manufacturer to insure that the results of their method remain consistent over time throughout the year and between lots. It is not the intent of the NGSP to certify each lot of reagents.Manufacturer Method/ Method Date Reagent Calibrator Calibrator Column Secondary Instrument Type Certified Lot Lot Assigned Lot Reference Value Laboratory Ceragem t Boronate Boronate July ‘12 H21A181, - - - Univ. ofMedisys Inc. Affinity on affinity H21A182, Missouri. Cera-Stat 2000 H12A18EW SRL #9 Analyzer t Boronate Boronate July ‘12 H02E311, - - - Univ. of Affinity on affinity H02E312, Missouri. LabonaCheck H02E31EW SRL #9 A1c HbA1c Analyzer Apex Immunoagglut Immuno- June ‘12 S10301 BBC00005 4.20%, - EuropeanBiotechnology ination on assay AL, 7.60%, Reference Lab Corp. Eclipse A1c BBC00005 10.20% ESRL#9 AM, BBC00005 AH Sakae Latex t Immuno- June ‘12 411112 - - - ReCCS Corporation agglutination assay ASRL#1 on A1c GEAR Roche TQ HbA1c Immuno- June ‘12 650720, 165575 2.809, 1.682, - Univ. of Diagnostics Gen. 2 assay 652814 (Std. 1-6) 1.405, 0.562, Missouri. hemolysate 0.112, 0.000 SRL #9 (ME) on g/dL HbA1c; Cobas Integra 12.784, 2.538 800 g/dL Hb (HbA1c/Hb*91.5+ 2.15) TQ HbA1c Immuno- June ‘12 650720, 165575 0.02809, - Univ. of Gen. 2 whole assay 655740 (Std. 1-6) 0.01682, Missouri. blood (ME) on 0.01405, SRL #9 Cobas Integra 0.00562, 800 0.00112, (HbA1c/Hb*91.5+ 0.00000 g/dL 2.15) HbA1c; 0.12784, 0.02538 g/dL Hb 1
  2. 2. List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer Method/ Method Date Reagent Calibrator Calibrator Column Secondary Instrument Type Certified Lot Lot Assigned Lot Reference Value Laboratory Roche TQ HbA1c Immuno- June ‘12 650720, 165575 0.02809, - Univ. of Diagnostics Gen. 2 whole assay 655740 (Std. 1-6) 0.01682, Missouri. blood on 0.01405, SRL #9 Cobas Integra 0.00562, 800 0.00112, (HbA1c/Hb*87.6+ 0.00000 g/dL 2.27) HbA1c; 0.12784, 0.02538 g/dL Hb TQ HbA1c Immuno- June ‘12 650720, 165575 2.809, 1.682, - Univ. of Gen. 2 assay 652814 (Std. 1-6) 1.405, 0.562, Missouri. hemolysate on 0.112, 0.000 SRL #9 Cobas Integra g/dL HbA1c; 800 12.784, 2.538 (HbA1c/Hb*87.6+ g/dL Hb 2.27) TQ HbA1c Immuno- June ‘12 651459, 165575 0.131, 0.335, - Univ. of Gen. 3 assay 652814 (Std. 1-6) 0.664, 0.926, Missouri. hemolysate on 1.266, 1.808 SRL #9 cobas c501/502 mmol/L (HbA1c/Hb*91.5+ HbA1c; 2.15) 1.424, 7.677 mmol/L Hb TQ HbA1c Immuno- June ‘12 651459, 165575 0.131, 0.335, - Univ. of Gen. 3 whole assay 646263 (Std. 1-6) 0.664, 0.926, Missouri. blood on cobas 1.266, 1.808 SRL #9 c501/502 mmol/L (HbA1c/Hb*91.5+ HbA1c; 2.15) 1.424, 7.677 mmol/L Hb TQ HbA1c Immuno- June ‘12 651457, 165575 0.132, 0.339, - Univ. of Gen. 3 on assay 652814 (Std. 1-6) 0.671, 0.939, Missouri. Hitachi 1.280, 1.831 SRL #9 Modular P mmol/L (HbA1c/Hb*91.5+ HbA1c; 2.15) 0.000, 8.395mmol/L Hb t Tosoh G7 HbA1c Ion- June ‘12 G7-107P, ZS1001 6.08%, G Univ. of Corporation Standard exchange G7-201S, 11.09% Missouri. Analysis Mode HPLC 7-303S, SRL #9 (1.2 min) HW-15R HLC-723G7 t G7 HbA1c Ion- June ‘12 G7-107P, JS1001 5.87%, G Univ. of Standard exchange G7-201S, 10.94% Missouri. Analysis Mode HPLC 7-303S, SRL #9 (1.2 min) HW-15R HLC-723G7 G7 HbA1c Ion- June ‘12 H7-111S, ZS1001 6.08%, H Univ. of Variant exchange H7-203S, 11.09% Missouri. Analysis Mode HPLC 7-304R, SRL #9 (2.2 min) HW-15R HLC-723G7 2
  3. 3. List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer Method/ Method Date Reagent Calibrator Calibrator Column Secondary Instrument Type Certified Lot Lot Assigned Lot Reference Value Laboratory t Tosoh G8 HbA1c Ion- June ‘12 E8-101S, ZS1001 6.08%, E Univ. of Corporation Standard exchange E8-201S, 11.09% Missouri. Analysis Mode HPLC 8-302R, SRL #9 (1.0 min), HW-15R HLC-723G8 t G8 HbA1c Ion- June ‘12 E8-101S, JS1001 5.87%, E Univ. of Standard exchange E8-201S, 10.94% Missouri. Analysis Mode HPLC 8-302R, SRL #9 (1.0 min), HW-15R HLC-723G8 G8 HbA1c Ion- June ‘12 D8-101S, ZS1001 6.08%, D Univ. of Variant exchange D8-201S, 11.09% Missouri. Analysis Mode HPLC D8-301S, SRL #9 (1.6 min), HW-15R HLC-723G8 t G9 Ion- June ‘12 A9-101R, ZS1001 6.08%, A Univ. of HLC-723G9 exchange A9-201R, 11.09% Missouri. HPLC 9-301R, SRL #9 HW-15R t G9 Ion- June ‘12 A9-101R, JS1001 5.87%, A Univ. of HLC-723G9 exchange A9-201R, 10.94% Missouri. HPLC 9-301R, SRL #9 HW-15R t GX Ion- June ‘12 AX-101S, ZS1001 6.08%, A Univ. of HLC-723GX exchange AX-201S, 11.09% Missouri. HPLC AX-301S, SRL #9 HW-15R ST AIA-Pack Immuno- June ‘12 B915703, #5751 0.0, 3.3, 6.6, - Univ. of HbA1c (AIA- assay B960020, 9.8, 13.0, Missouri. 360) BZ70038, 17.3% SRL #9 C180054 ST AIA-Pack Immuno- June ‘12 B915703, #5751 0.0, 3.3, 6.6, - Univ. of HbA1c (AIA- assay B960020, 9.8, 13.0, Missouri. 600II) BZ70038, 17.3% SRL #9 C180054 ST AIA-Pack Immuno- June ‘12 B915703, #5751 0.0, 3.3, 6.6, - Univ. of HbA1c (AIA- assay B960020, 9.8, 13.0, Missouri. 900) BZ70038, 17.3% SRL #9 C180054 Siemens DCA 2000+ Immuno- June ‘12 0562042 - - - Univ. of Healthcare assay Missouri. Diagnostics SRL #9 DCA Vantage Immuno- June ‘12 0562042 - - - Univ. of assay Missouri. SRL #9 A. Menarini t HPLC AUTO Ion- June ‘12 201179, 201102 5.9%, 10.9% 1J63Y European Diagnostics A1c HA 8160 exchange 201109, Reference Lab ADAMS HPLC 201123, ESRL#7 201176 t HPLC AUTO Ion- June ‘12 1I1201, 201102 5.9%, 10.9% 1I014Q European A1c HA exchange 1I1211, Reference Lab 8180V HPLC 1F1501, ESRL#7 ADAMS 1I1221 3
  4. 4. List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer Method/ Method Date Reagent Calibrator Calibrator Column Secondary Instrument Type Certified Lot Lot Assigned Lot Reference Value Laboratory Mindray Enzymatic on Enzymatic May ‘12 446142004 44612004 5.0%, 11.9% - ReCCS BS-800 ASRL#1 Siemens Hemoglobin Immuno- May ‘12 020 1BD163, 2.51, 3.85, - Univ. of Diagnostics A1c_3 (A1c_3) assay 1BD263, 5.24, 6.98 Missouri. on Advia 1200 1BD363, µmol/L A1c; SRL #9 Automated 1BD463 12.08, 11.40 Pretreatment g/dL Hb Hemoglobin Immuno- May ‘12 020 1BD163, 2.51, 3.85, - Univ. of A1c_3 (A1c_3) assay 1BD263, 5.24, 6.98 Missouri. on Advia 2400 1BD363, µmol/L A1c; SRL #9 Automated 1BD463 12.08, 11.40 Pretreatment g/dL Hb Siemens Hemoglobin Immuno- May ‘12 209063 008622 0, 0.1.81, - Univ. of Healthcare A1c (1st assay 2.69, 3.50, Missouri. Diagnostics generation) on 5.14, 7.29 SRL #9 Inc. Advia 1650 µmol/L A1c; Manual Pretreatment 18.0 g/dL THb Fisher Multigent on Immuno- May ‘12 87689UN11 125797 0, 0.386, - Univ. of Diagnostics ARCHITECT assay 0.682, 0.890, Missouri. c8000 1.308, 1.916 SRL #9 g/dL HbA1c; 18.0 g/dL THb Siemens HA1c on Immuno- May ‘12 GA2305 GA2305 0.00, 0.47, - Univ. of Healthcare Dimension assay 0.95, 1.55, Missouri. Diagnostics RxL RMS 2.65 g/dL SRL #9 HbA1c; 13.80, 13.90 g/dL Hb HA1c on Immuno- May ‘12 GA2305 GA2305 0.00, 0.47, - Univ. of Dimension assay 0.95, 1.55, Missouri. Xpand 2.65 g/dL SRL #9 HbA1c; 13.80, 13.90 g/dL Hb HA1c on Immuno- May ‘12 GA2305 GA2305 0.00, 0.47, - Univ. of Dimension assay 0.95, 1.55, Missouri. ExL w/LM 2.65 g/dL SRL #9 HbA1c; 13.80, 13.90 g/dL Hb HA1c on Immuno- May ‘12 11290AB 1KD067 0.00, 0.48, - Univ. of Dimension assay 0.94, 1.55, Missouri. Vista 1500 2.65 g/dL SRL #9 HbA1c; 13.80, 13.90 g/dL Hb Arkray, Inc. ADAMS A1c Ion- Apr ‘12 12020831, 2B68; 5.4%, 11.0%; 1K042Y Univ. of HA-8160 VP exchange 12011112, S2001 5.4%, 11.0% Missouri. mode HPLC 11092733, SRL #9 11091214 4
  5. 5. List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer Method/ Method Date Reagent Calibrator Calibrator Column Secondary Instrument Type Certified Lot Lot Assigned Lot Reference Value Laboratory Arkray, Inc. ADAMS A1c Ion- Apr ‘12 12020831, 2B68; 5.4%, 11.0%; 1I021W Univ. of HA-8160 TP exchange 12011112, S2001 5.4%, 11.0% Missouri. mode HPLC 11090934, SRL #9 11041535, 11091214 ADAMS A1c Ion- Apr ‘12 12022211, 2B68; 5.4%, 11.0%; 2B011X Univ. of HA-8160 exchange 12011112, S2001 5.4%, 11.0% Missouri. (Ver.1) HPLC 11100713, SRL #9 11091214 ADAMS A1c Ion- Apr ‘12 11090757, 2B58; 5.4%, 11.0%; 2B121F Univ. of HA-8160 exchange 11110458, S2001 5.4%, 11.0% Missouri. (Ver.4) HPLC 11080959, SRL #9 11121255 ADAMS A1c Ion- Apr ‘12 11090757, 2B58; 5.4%, 11.0%; 2B141G Univ. of HA-8170 exchange 11110458, S2001 5.4%, 11.0% Missouri. HPLC 11080959, SRL #9 11121255 ADAMS A1c Ion- Apr ‘12 2A1012, CA8 2B18; 5.4%, 10.9%; 2BN-1R Univ. of HA-8180 exchange 2C1021, CA8 2B20; 5.4%, 10.9%; Missouri. HPLC 1I1052 S2001 5.4%, 10.9% SRL #9 ADAMS A1c Ion- Apr ‘12 2A1012, CA8 2B18; 5.4%, 10.9%; 1L001U Univ. of HA-8180V exchange 2C1021, CA8 2B20; 5.4%, 10.9%; Missouri. HPLC 1G1401, S2001 5.4%, 10.9% SRL #9 1I1052 ADAMS A1c Ion- Apr ‘12 2A1012, CA8 2B18; 5.4%, 10.9%; 111226-010 Univ. of HA-8180T exchange 2A1021, CA8 2B20; 5.4%, 10.9%; Missouri. HPLC 1I239, S2001 5.4%, 10.9% SRL #9 1I1052 ADAMS Ion- Apr ‘12 2A1012, CA8 2B20; 5.4%, 10.9%; 1LR-1R Univ. of HYBRID AH- exchange 2C1021, S2001 5.4%, 10.9% Missouri. 8280 HPLC 1I1052 SRL #9 ADAMS A1c Ion- Apr ‘12 2A1012, CA8 2B20; 5.4%, 10.9%; 2BN-1R Univ. of HA-8181 exchange 2C1021, S2001 5.4%, 10.9% Missouri. HPLC 1I1052 SRL #9 CinQ HbA1c Enzymatic Apr ‘12 MFD17, 1107 2.46, 6.84 - Univ. of on BioMajesty MFN13 µmol/L Missouri. JCA-BM6010 HbA1c; SRL #9 HbA1c%(NGSP)= 88.3, 97.8 0.09148* HbA1c/Hb*1000 µmol/L Hb (IFCC)+2.152 t Sebia Capillarys Capillary Apr ‘12 09031/20, 09090/01, 36.6 - European HbA1c on Electro- 16021/20, 10090/01 mmol/mol, Reference Lab Capillarys 2 phoresis 29070/01 85.8 ESRL#7 Flex Piercing mmol/mol %NGSP=0.09148 x [IFCC] (mmol/mol) + 2.152 t Wiener HbA1c Immuno- Apr ‘12 079220, 079220 0.48, 0.91, - Univ. ofLaboratories Turbitest AA assay 079220, 1.57, 2.31 Missouri. S.A.I.C. on CT600i 079220, g/dL HbA1c; SRL #9 91.5*HbA1c/Hb 072320 14.7 g/dL Hb + 2.15 5
  6. 6. List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer Method/ Method Date Reagent Calibrator Calibrator Column Secondary Instrument Type Certified Lot Lot Assigned Lot Reference Value Laboratory t Wiener HbA1c Immuno- Apr ‘12 079220, 079220 0.48, 0.91, - Univ. ofLaboratories Turbitest AA assay 079220, 1.57, 2.31 Missouri. S.A.I.C. on CM250 079220, g/dL HbA1c; SRL #9 91.5*HbA1c/Hb 072320 14.7 g/dL Hb + 2.15 t HbA1c Immuno- Apr ‘12 079220, 079220 0.48, 0.91, - Univ. of Turbitest AA assay 079220, 1.57, 2.31 Missouri. on CB350i 079220, g/dL HbA1c; SRL #9 91.5*HbA1c/Hb 072320 14.7 g/dL Hb + 2.15 ROHM Co., Banalyst Ace Immuno- Apr ‘12 1201DN640O 91103 0.0, 29.5, - ReCCS Ltd. HbA1c on assay 52.5, 79.5, ASRL#1 Banalyst Ace 110.0 NGSP=0.0981*I mmol/mol FCC+1.95 @ Alfa ACE No- Immuno- Apr ‘12 1271HA, 1BA1A02- 51, 83, 131, - Univ. of Minn Wasserman Pretreatment assay 1272HA, 1BA6A02 196, 268, 349 SRL #8 HbA1c Reagent 1299HA, µmol/L on the ACE 1298H HbA1c; 19.9 Clinical Chemistry g/dL Hb System @ ACE No- Immuno- Apr ‘12 1271HA, 1BA1A02- 51, 83, 131, - Univ. of Minn Pretreatment assay 1272HA, 1BA6A02 196, 268, 349 SRL #8 HbA1c Reagent 1299HA, µmol/L on the ACE 1298H HbA1c; 19.9 Alera Clinical Chemistry g/dL Hb System @ ACE No- Immuno- Apr ‘12 1271HA, 1BA1A02- 51, 83, 131, - Univ. of Minn Pretreatment assay 1272HA, 1BA6A02 196, 268, 349 SRL #8 HbA1c Reagent 1299HA, µmol/L on the ACE 1298H HbA1c; 19.9 Axcel Clinical Chemistry g/dL Hb System Ceragem Boronate Boronate Apr ‘12 H21A181, - - - Univ. ofMedisys Inc. Affinity on affinity H21A182, Missouri. Cera-Stat 2000 H12A18EW SRL #3 Trinity TriSTAT Boronate Mar ‘12 VT 0643- - - - Univ. of Biotech affinity 43 Missouri. SRL #3 GHb/HbA1c Boronate Mar ‘12 3560, 3704 3768, 3769 5.6%, 11.8% PPE-0110- Univ. of HPLC affinity 3667 Missouri. Boronate SRL #3 Affinity Whole Blood on CLC385 GHb/HbA1c Boronate Mar ‘12 3686, 3737 3768, 3769 5.4%, 11.5% PPE-0346- Univ. of HPLC affinity 3730 Missouri. Boronate SRL #3 Affinity Whole Blood on PDQ 6
  7. 7. List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer Method/ Method Date Reagent Calibrator Calibrator Column Secondary Instrument Type Certified Lot Lot Assigned Lot Reference Value Laboratory Trinity GHb/HbA1c Boronate Mar ‘12 3756, 3704 3768, 3769 5.6%, 11.8% PPE-0267- Univ. of Biotech HPLC affinity 3561 Missouri. Boronate SRL #3 Affinity Whole Blood on ultra2 @ GHb/HbA1c Boronate Mar ‘12 3725, 3790 3768, 3769 5.2%, 11.8% PPE-0437- Univ. of HPLC affinity 3587 Missouri. Boronate SRL #3 Affinity Whole Blood on Premier Hb9210 Wako Pure Autokit Immuno- Mar ‘12 EF140, EF140 0.45, 0.87, - ReCCS Chemical HbA1c on assay EF143 1.37, 2.35 ASRL#1Industries, Ltd. Hitachi 7170S g/dL HbA1c; 13.0g/dL Hb Hitachi Seratestum Enzymatic Mar ‘12 K1J810 - - - ReCCSChemical Co., A1C on ASRL#1 Ltd. Hitachi Clinical Analyzer ROHM Co., Banalyst Immuno- Mar ‘12 1201DN44 JDS Lot4 30.6, 37.1, - ReCCS Ltd. HbA1c on assay 0O 54.9, 78.6, ASRL#1 Banalyst 104.2 mmol/mol Sekisui Norudia N Enzymatic Mar ‘12 825RJI, 911RJI 3.81, 16.59 - ReCCS Medical Co., HbA1c on 822RJI, µmol/L ASRL#1 Ltd. Hitachi 7170S 823RLI HbA1c; NGSP=0.09148 106.8, 154.9 *IFCC+2.152 µmol/L Hb TFB, Inc. Rapidia Auto Immuno- Mar ‘12 QF11205, VF10503 0.0%, 4.1%, - ReCCS HbA1c-L on assay RF11205, 6.7%, 9.5%, ASRL#1 Hitachi 7170s NF11103 12.9% NGSP(%)=1.02 X JDS(%) + 0.25Kyowa Medex Determiner Immuno- Mar ‘12 353AAK, 417ABA 0.0%, 4.8%, - ReCCS Co., Ltd. HbA1c on assay 353AAK 8.6%, 12.6%, ASRL#1 DM-JACK 15.4% Determiner Immuno- Mar ‘12 375AAK, 417ABA 0.0%, 4.9%, - ReCCS HbA1c on assay 375AAK 8.7%, 12.6%, ASRL#1 JCA-BM9130 15.5% Determiner L Immuno- Mar ‘12 122AAI, 213AAK 0.0%, 4.6%, - ReCCS HbA1c on assay 122AAI 6.9%, 9.8%, ASRL#1 DM-JACK 13.4% Determiner L Immuno- Mar ‘12 122AAI, 213AAK 0.0%, 4.4%, - ReCCS HbA1c on assay 122AAI 6.9%, 9.7%, ASRL#1 JCA-BM9130 13.4% DiaSys oneHbA1c FS, Immuno- Feb ‘12 40, 14499 15830, 4.36%, - European Diagnostic Reference No. assay 15831, 6.99%, Reference Lab Systems 1 3329 00, on 15832, 11.2%, ESRL#7 GmbH InnovaStar 15833 14.6% HITADO Super ID Immuno- Feb ‘12 60067513, - - - European clinchem assay 230898 Reference Lab ESRL#9 7
  8. 8. List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer Method/ Method Date Reagent Calibrator Calibrator Column Secondary Instrument Type Certified Lot Lot Assigned Lot Reference Value Laboratory t Bio-Rad VARIANT II Ion- Jan ‘12 AA10824, AG11180, 5.3%, 10.0% YA82000 Univ. of MinnLaboratories Dual exchange AA10825, AG10832 SRL #8 (A2/F/A1c) HPLC AA10826 t VARIANT II Ion- Jan ‘12 AA10824, BA11089, 5.4%, 10.0% YA82000 Univ. of Minn Dual (A1C) exchange AA10825, AV10832 SRL #8 HPLC AA10826 VARIANT Ion- Jan ‘12 AA11181, AA10794 8.3% 60580H Univ. of Minn HbA1c exchange AA11182, SRL #8 HPLC GA10107, AA10791 VARIANT II Ion- Jan ‘12 AA11241N BN11502N 5.1%, 10.5% NU92450G Univ. of Minn HbA1c NU exchange U, U, SRL #8 HPLC AA11242N AN11503N U, U AA11243N U D-10 Dual Ion- Jan ‘12 GA11401, AA11632, 5.6%, 10.3% D00150M Univ. of Minn A2/F/A1c exchange GA11402, AA11631 SRL #8 HPLC AA11403 D-10 HbA1c Ion- Jan ‘12 AA11714, AA11415, 5.6%, 10.3% A00150AH Univ. of Minn exchange AA11715, AA11416 SRL #8 HPLC AA11716 VARIANT II Ion- Jan ‘12 AA11465, AA11502, 5.3%, 10.1% DA02200 Univ. of Minn T HbA1c exchange AA11466, AA11504 SRL #8 HPLC GA11412 VARIANT II Ion- Jan ‘12 AA11442, BA11630, 5.4%, 10.2% LV02100B Univ. of Minn TURBO exchange AA11443, BA11631 SRL #8 HbA1c HPLC AA11894 VARIANT II Ion- Jan ‘12 GA11442, VA11630, 5.4%, 10.2% LLV02100A Univ. of Minn TURBO Link exchange GA11443, VA11631 SRL #8 HbA1c HPLC AA11024 VARIANT II Ion- Jan ‘12 AA11671, AA11089, 5.5%, 10.2% 92500P Univ. of Minn TURBO exchange AA11672, AA11090 SRL #8 HbA1c Kit – HPLC AA11162 2.0 DiaSys oneHbA1c FS, Immuno- Jan ‘12 15617- 15103, 4.78%, - European Diagnostic Reference No. assay 15619, 15104, 7.37%, Reference Lab Systems 1 3329 00, 3 14499 15105, 11.5%, ESRL#7 GmbH component 15106 15.1% version on Hitachi 917 HbA1c net FS, Immuno- Jan ‘12 15637, 15546, 0.270, 0.930, - European Reference No. assay 15638 15547 g/dL HbA1c; Reference Lab 1 3348 00, on 5.50, 16.0 ESRL#7 Hitachi 917 g/dL Hb oneHbA1c FS, Immuno- Jan ‘12 15617- 15103, 4.82%, - European Reference No. assay 15617, 15104, 7.47%, Reference Lab 1 3329 00, 2 14499 15105, 11.3%, ESRL#7 component 15106 15.3% version on Hitachi 917 oneHbA1c FS, Immuno- Jan ‘12 15617- 15103, 4.82%, - European Reference No. assay 15617, 15104, 7.47%, Reference Lab 1 3329 00, on 14499 15105, 11.3%, ESRL#7 respons 910 15106 15.3% 8
  9. 9. List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer Method/ Method Date Reagent Calibrator Calibrator Column Secondary Instrument Type Certified Lot Lot Assigned Lot Reference Value Laboratory DiaSys oneHbA1c FS, Immuno- Jan ‘12 15617- 15103, 4.82%, - European Diagnostic Reference No. assay 15617, 15104, 7.47%, Reference Lab Systems 1 3329 00, on 14499 15105, 11.3%, ESRL#7 GmbH respons 920 15106 15.3% Axis-Shield AxSym Immuno- Dec ‘11 10115UP00 802886134 4.0, 5.5, 7.5, European HbA1c assay 9.0, 12.0, Reference Lab 14.5% ESRL#9 Roche TQ HbA1c Immuno- Dec ‘11 648039, 162296 0,0.00111, - Univ. of Diagnostics Gen. 2 (ME) assay 650225 0.00552, Missouri. Cobas Integra 0.01380, SRL #9 400 0.01653, HbA1c/Hb*91.5 0.02706 g/dL +2.15 HbA1c; 0.02306, 0.11846 g/dL Hb TQ HbA1c Immuno- Dec ‘11 648039, 162296 0,0.00111, - Univ. of Gen. 2 assay 650225 0.00552, Missouri. Cobas Integra 0.01380, SRL #9 400 0.01653, HbA1c/Hb*87.6 0.02706 g/dL +2.27 HbA1c; 0.02306, 0.11846 g/dL Hb TQ HbA1c Immuno- Dec ‘11 648052, 162296 0,0.00136, - Univ. of Gen. 2 (ME) assay 646256 0.00537, Missouri. Cobas c111 0.01292, SRL #9 HbA1c/Hb*91.5 0.01540, +2.15 0.02549 g/dL HbA1c; 0.02306, 0.11846 g/dL Hb TQ HbA1c Immuno- Dec ‘11 648052, 162296 0,0.00136, - Univ. of Gen. 2 assay 646256 0.00537, Missouri. Cobas c111 0.01292, SRL #9 HbA1c/Hb*87.6 0.01540, +2.27 0.02549 g/dL HbA1c; 0.02306, 0.11846 g/dL Hb TQ HbA1c Immuno- Dec ‘11 648039, 162296 0.672, 1.173, - Univ. of Gen. 2 (ME) assay 650227 1.512, 1.854, Missouri. Cobas c501 2.893, 3.466 SRL #9 HbA1c/Hb*91.5 g/dL HbA1c; +2.15 2.369, 11.846 g/dL Hb TQ HbA1c Immuno- Dec ‘11 648039, 162296 0.672, 1.173, - Univ. of Gen. 2 assay 650227 1.512, 1.854, Missouri. Cobas c501 2.893, 3.466 SRL #9 HbA1c/Hb*87.6 g/dL HbA1c; +2.27 2.369, 11.846 g/dL Hb 9
  10. 10. List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer Method/ Method Date Reagent Calibrator Calibrator Column Secondary Instrument Type Certified Lot Lot Assigned Lot Reference Value Laboratory Drew DS360 HbA1c Ion- Dec ‘11 73381, 6002, 8002 5.5%, 12.3% 105 Univ. of Scientific exchange 73361, Missouri. HPLC 72584 SRL #9Home Access Red Blood Immuno- Nov ‘11 9528, 1854 0029 0.048, 0.258, - Univ. of Health Cell-Serum assay 0.434, 0.626, Missouri.Corporation Strip-based 1.072, 1.687 SRL #9 cassettes on g/dL HbA1c; Olympus 20.22 g/dL Au640e THb @ Abbott Architect Immuno- Nov ‘11 100DEV002 300DEV003 4.0-14.5% - EuropeanLaboratories HbA1c assay Reference Lab ESRL#9 Beckman HbA1c Immuno- Nov ‘11 1939, 1337, ODR3032 0.018, 0.161, - European Coulter Manual assay 9386 0.268, 0.387, Reference Lab Biomedical Application 0.661, 1.052 ESRL#9 Ltd. AU400 mmol/L HbA1c; 12.51 mmol/L THb HbA1c Immuno- Nov ‘11 1939, 9386, ODR3032 0.018, 0.161, - European Manual assay 2032 0.268, 0.387, Reference Lab Application 0.661, 1.052 ESRL#9 AU480 mmol/L HbA1c; 12.51 mmol/L THb HbA1c Immuno- Nov ‘11 1939, 1337, ODR3032 0.018, 0.161, - European Manual assay 9386 0.268, 0.387, Reference Lab Application 0.661, 1.052 ESRL#9 AU640 mmol/L HbA1c; 12.51 mmol/L THb HbA1c Immuno- Nov ‘11 1939, 1337, ODR3032 0.018, 0.161, European Manual assay 9386 0.268, 0.387, Reference Lab Application 0.661, 1.052 ESRL#9 AU680 mmol/L HbA1c; 12.51 mmol/L THb HbA1c Immuno- Nov ‘11 1939, 1337, ODR3032 0.018, 0.161, European Manual assay 9386 0.268, 0.387, Reference Lab Application 0.661, 1.052 ESRL#9 AU2700 mmol/L HbA1c; 12.51 mmol/L THb HbA1c Immuno- Nov ‘11 1939, 1337, ODR3032 0.018, 0.161, European Manual assay 9386 0.268, 0.387, Reference Lab Application 0.661, 1.052 ESRL#9 AU5800 mmol/L HbA1c; 12.51 mmol/L THb 10
  11. 11. List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer Method/ Method Date Reagent Calibrator Calibrator Column Secondary Instrument Type Certified Lot Lot Assigned Lot Reference Value Laboratory HORIBA HbA1c WB 3 Immuno- Oct ‘11 1103301 1101801 0.00, 1.60, - European Medical Hemolysat assay 2.90, 4.20, Reference Lab Pentra 400 7.00, 10.80 ESRL#7 Y=(0.518*X)+ µmol/l 1.824 HbA1c; 68.29 µmol/l Hb HbA1c WB 3 Immuno- Oct ‘11 1103301 1101801 0.00, 1.60, - European Whole Blood assay 2.90, 4.20, Reference Lab Pentra 400 7.00, 10.80 ESRL#7 Y=(0.535*X)+ µmol/l 1.930 HbA1c; 68.29 µmol/l Hb HbA1c WB Immuno- Oct ‘11 1103301 1101801 0.00, 1.60, - European Hemolysat assay 2.90, 4.20, Reference Lab Pentra C400 7.00, 10.80 ESRL#7 Y=(0.521*X)+ µmol/l 1.849 HbA1c; 68.29 µmol/l Hb HbA1c WB Immuno- Oct ‘11 1103301 1101801 0.00, 1.60, - European Hemolysat assay 2.90, 4.20, Reference Lab Pentra C200 7.00, 10.80 ESRL#7 Y=(0.428*X)+ µmol/l 2.083 HbA1c; 68.29 µmol/l Hb HbA1c WB Immuno- Oct ‘11 1103301 1101801 0.00, 1.60, - European Whole Blood assay 2.90, 4.20, Reference Lab Pentra C400 7.00, 10.80 ESRL#7 Y=(0.581*X)+ µmol/l 1.657 HbA1c; 68.29 µmol/l Hb t SEPPIM HbA1c on Immuno- Oct ‘11 R110575, R110583, 4.8%, 8.1%, - European Vital Scientific assay R110576, R110584, 12.4%, Reference Lab Selectra ProS R110577, R110585, 16.5% ESRL#7 R110084 R110586 t HbA1c on Immuno- Oct ‘11 R110575, R110583, 4.8%, 8.1%, - European Vital Scientific assay R110576, R110584, 12.4%, Reference Lab Selectra ProM R110577, R110585, 16.5% ESRL#7 R110084 R110586 t Quotient Quo-Test A1C Boronate Oct ‘11 10069 - - - European Diagnostics affinity Reference Lab Ltd ESRL#8 Infopia Co., Frontier Boronate Sept ‘11 FHA11D02, - - - Univ. of Ltd system and affinity FHA11D05, Missouri. HemoCue FHA11D22 SRL #9 HbA1c 501 system Clover A1c on Boronate Sept ‘11 HC11C02, - - - Univ. of Clover affinity HC11C17, Missouri. HC11D14 SRL #9 11
  12. 12. List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer Method/ Method Date Reagent Calibrator Calibrator Column Secondary Instrument Type Certified Lot Lot Assigned Lot Reference Value LaboratoryOrtho Clinical Vitros d%A1c Immuno- Sept ‘11 1861 18611, 0, 0.48, 0.89, - Univ. of Diagnostics Reagent on assay 18612, 1.45, 2.08 Missouri. Vitros 5, 1FS 18613, g/dL HbA1c; SRL #9 18614, 0, 13.6 g/dL 18615 HbThermo Fisher Multigent on Immuno- Sept ‘11 65574UN10 980301 0, 0.390, - Univ. of Architect assay 0.678, 0.894, Missouri. c4000 1.328, 1.911 SRL #9 HbA1c=HbA1c/ g/dL HbA1c; THb*100- 0, 18.0 g/dL 3+(0.2*THb) THb Siemens HB1C on Immuno- Sept ‘11 GA1205 GA1205 0.17, 0.66, - Univ. of Healthcare Dimension assay 1.29, 2.12, Missouri. Diagnostics Xpand 2.78 g/dL SRL #9 HbA1c; 14.82, 14.67 g/dL Hb HB1C on Immuno- Sept ‘11 GA1205 GA1205 0.17, 0.66, - Univ. of Dimension assay 1.29, 2.12, Missouri. ExL System 2.78 g/dL SRL #9 HbA1c; 14.82, 14.67 g/dL Hb HB1C on Immuno- Sept ‘11 11087AA 1CD033 0.16, 0.68, - Univ. of Dimension assay 1.18, 2.01, Missouri. Vista 1500 2.52 g/dL SRL #9 HbA1c; 15.71, 14.99 g/dL Hb HB1C on Immuno- Sept ‘11 GA1205 GA1205 0.17, 0.66, - Univ. of Dimension assay 1.29, 2.12, Missouri. RxL 2.78 g/dL SRL #9 HbA1c; 14.82, 14.67 g/dL Hb t JEOL Ltd. Enzymatic Enzymatic Sept ‘11 819RLH, 910RGI 3.67 µmol/L - Univ. of method on JCA- 822RLH, HbA1c, 108.5 Missouri. BM 6010/C 817RIH µmol/L Hb; SRL #9 NGSP(%)= 14.88 µmol/L HbA1c(µmol/L) HbA1c, 154.6 / Hb(µmol/L) * µmol/L Hb 91.5+2.15 Beckman HbA1c Immuno- Sept ‘11 M011412, M011412 0.00, 0.45, - Univ. of M010627 Coulter, Inc. (Hemolysate) assay 0.87, 1.46, Missouri. on 2.14 g/dL SRL #9 SYNCHRON HbA1c; 15.3 UniCel DxC g/dL Hb %NGSP=HbA1c/ Hb*91.48+2.152 HbA1c Immuno- Sept ‘11 M011412, M011412 0.00, 0.45, - Univ. of M010627 (Hemolysate) assay 0.87, 1.46, Missouri. on 2.14 g/dL SRL #9 SYNCHRON HbA1c; 15.3 LX g/dL Hb %NGSP=HbA1c/ Hb*91.48+2.152 12
  13. 13. List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer Method/ Method Date Reagent Calibrator Calibrator Column Secondary Instrument Type Certified Lot Lot Assigned Lot Reference Value Laboratory Beckman HbA1c Immuno- Sept ‘11 M011412, M011412 0.00, 0.45, - Univ. of M010627 Coulter, Inc. (Hemolysate) assay 0.87, 1.46, Missouri. on 2.14 g/dL SRL #9 SYNCHRON HbA1c; 15.3 CX g/dL Hb %NGSP=HbA1c/ Hb*91.48+2.152 HbA1c2 Immuno- Sept ‘11 M009388 M009388 0.00, 0.45, - Univ. of (whole blood) assay 0.87, 1.46, Missouri. on 2.14 g/dL SRL #9 SYNCHRON HbA1c; 15.3 UniCel DxC g/dL Hb %NGSP=HbA1c/ Hb*91.48+2.152 HbA1c2 Immuno- Sept ‘11 M009388 M009388 0.00, 0.45, - Univ. of (whole blood) assay 0.87, 1.46, Missouri. on 2.14 g/dL SRL #9 SYNCHRON HbA1c; 15.3 LX g/dL Hb %NGSP=HbA1c/ Hb*91.48+2.152 Axis-Shield NycoCard Boronate Sept ‘11 10142787, - - - European PoC AS HbA1c / affinity 10151672, Reference Lab NycCard 10152442 ESRL #8 Reader II Afinion Boronate Sept ‘11 10143103 - - - European HbA1c / affinity Reference Lab Afinion ESRL #8 AS100 Analyzer Arkray, Inc. t ADAMS A1c Ion- Aug ‘11 10121031, 0M63 36mmol/mol, 1DW-1R Univ. of HA-8160 TP exchange 10101512, 97mmol/mol Missouri. mode HPLC 10121534, SRL #7 HbA1c% NGSP 10070735, =0.09148 * HbA1c mmol/mol 10111714 +2.152 t ADAMS A1c Ion- Aug ‘11 10121031, 0M63 36mmol/mol, 1C001Y Univ. of HA-8160 VP exchange 10101512, 97mmol/mol Missouri. mode HPLC 10102233, SRL #7 HbA1c% NGSP 10111714 =0.09148 * HbA1c mmol/mol +2.152 t ADAMS A1c Ion- Aug ‘11 11012057, 0M46, 36mmol/mol, 1B201F Univ. of HA-8160 exchange 10083058, 0M47, 97mmol/mol Missouri. HbA1c% NGSP HPLC 11031759, 0M48, SRL #7 =0.09148 * HbA1c mmol/mol 10070555 0M49, +2.152 0M50 t ADAMS A1c Ion- Aug ‘11 1F1012, CA80M10, 36mmol/mol, 0L175N Univ. of HA-8180 exchange 1A1021, CA80M11 97mmol/mol Missouri. HbA1c% NGSP HPLC 1B1051 SRL #7 =0.09148 * HbA1c mmol/mol +2.152 13
  14. 14. List of NGSP Certified Methods (Updated 07/12, listed by date certified)Manufacturer Method/ Method Date Reagent Calibrator Calibrator Column Secondary Instrument Type Certified Lot Lot Assigned Lot Reference Value Laboratory Arkray, Inc. t ADAMS A1c Ion- Aug ‘11 1F1012, CA80M10, 36mmol/mol, 0L020U Univ. of HA-8180V exchange 1A1021, CA80M11 97mmol/mol Missouri. HbA1c% NGSP HPLC 0J1401, SRL #7 =0.09148 * HbA1c mmol/mol 1B1051 +2.152 t CinQ HbA1c Enzymati Aug ‘11 MFV02, 1012 2.65, 7.16 - Univ. of on c MFQ02 µmol/L Missouri. BioMajesty HbA1c; SRL #7 JCA-BM6010 89.0, 98.5 HbA1c% NGSP µmol/L Hb =0.09148 * HbA1c/Hb*1000 IFCC +2.152 Roche TQ HbA1c Immuno- Aug ‘11 639372, 639372 0.47, 0.88, - Univ. of Diagnostics Gen. 2 on assay 631910 1.41, 2.40 Missouri. Hitachi g/dL HbA1c; SRL #7 Modular P 13.4 g/dL Hb (HbA1c/Hb*91.5+ 2.15) Bayer A1CNow+; Immuno- Aug ‘11 1114413, - - - Univ. of HealthCare A1CNow assay 1114423, Missouri. LLC SELFCHECK 1114424 SRL #9Thermo Fisher t HbA1c for Immuno- Aug ‘11 G367, G367 1.396 mmol/L - EuropeanScientific Oy Konelab, On assay G366 HbA1c; 8.502 Reference Lab board mmol/L Hb ESRL#9 hemolyzing 91.5*HbA1c/ Hb+2.15 t HbA1c for Immuno- Aug ‘11 G367, G367 1.396 mmol/L - European Konelab, assay G366 HbA1c; 8.502 Reference Lab Manual mmol/L Hb ESRL#9 hemolyzing 91.5*HbA1c/ Hb+2.15 @ Alfa ACE No- Immuno- Aug ‘11 1240HA, P10661- 51, 83, 131, - Univ. of Minn Wasserman Pretreatment assay 1241HA, P10666 196, 268, 349 SRL #8 Diagnostic HbA1c Reagent 1243HA, µmol/LTechnologies, on the ACE 1242HA HbA1c; 19.9 Clinical LLC Chemistry g/dL Hb System @ ACE No- Immuno- Aug ‘11 1240HA, P10661- 51, 83, 131, - Univ. of Minn Pretreatment assay 1241HA, P10666 196, 268, 349 SRL #8 HbA1c Reagent 1243HA, µmol/L on the ACE 1242HA HbA1c; 19.9 Alera Clinical Chemistry g/dL Hb System Diazyme Direct Enzymatic Aug ‘11 HBL02110, HBS101110, 5.3%, 9.9% - Univ. ofLaboratories Enzymatic HB1A03110, HBS201110 Missouri. HB1B02110, USA HbA1c Assay HB202110 SRL #3 on Hitachi 917 Bio-Rad in2it A1C Test Boronate Aug ‘11 072T146 - - - EuropeanLaboratories Affinity Reference Lab Deeside ESRL#8t Method is not available in the US@ Method is not currently available 14

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