List of NGSP Certified Methods

(updated 4/16, 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/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Nova
Biomedical

Allegro,
Immunoassay

Immunoassay

Apr ‘16

16022010

-

Boditech Med
Inc.

Immuno-assay
on AFIAS
HbA1c
Colloidal Gold
on Getein
8600/8000
Immunofluore
scence Assay
on Getein
1600
Immunofluore
scence Assay
on Getein
1100
Boronate
Affinity on
A1c EZ 2.0

Immunoassay

Apr ‘16

AAMAA05F

502101

Immunoassay

Apr ‘16

6BC16006

16006

Immunoassay

Apr ‘16

PBC16005

Immunoassay

Apr ‘16

Boronate
affinity

Capillarys
HbA1c on
Capillarys 2
Flex Piercing

Getein
Biotech, Inc.

Wuxi
Biohermes Bio
& Medical
Technology
Co., Ltd.
Sebia

Calibrator
Assigned
Value
-

Column
Lot

5.1%, 8.1%,
10.8%,
13.5%
5.25%,
10.55%

-

-

ReCCS
ASRL#1

16006

5.25%,
10.55%

-

ReCCS
ASRL#1

YBC16006

16006

5.25%,
10.55%

-

ReCCS
ASRL#1

Apr ‘16

AP151208
05

-

-

-

ReCCS
ASRL#1

Capillary
Electrophoresis

Apr ‘16

14095/01,
20075/01,
12035/01

08045/01,
09045/01

35.5, 86.4
mmol/mol

-

European
Reference Lab
ESRL#10

Capillary
Electrophoresis

Apr ‘16

08065/01,
02094/80,
11055/01

07015/01,
08015/01

37.4, 85.8
mmol/mol

-

European
Reference Lab
ESRL#10

-

Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9
ReCCS
ASRL#1

%NGSP=0.09148
x [IFCC]
(mmol/mol) +
2.152

Minicap
HbA1c
%NGSP=0.09148
x [IFCC]
(mmol/mol) +
2.152

1

H2A003 - ReCCS ASRL#1 - Secondary Reference Laboratory European Reference Lab ESRL#10 %NGSP=0. 173500. 174050. 13.3% - Immunoassay QF51103.65. of Missouri.0%. 169310 173490. 0. 174050.45 g/dL HbA1c.45 g/dL HbA1c. 173520 0. SRL #9 Immunoassay Apr ‘16 174050.31 g/dL Hb - Univ. 12035/01 Immunoassay Apr ‘16 174040. F9A005.3% 0. 13.3%. 174050.65. of Missouri. 174040.15 t HbA1c v2 Turbitest AA on CB 350i 91. 1.0%.89.45 g/dL HbA1c.5*HbA1c/Hb + 2.6%. 0.15 t HbA1c v2 Turbitest AA on CM 250 91.7 g/dL Hb - Univ. 174040.15 t HbA1c Turbitest AA on CB 350i 91. 9. 174040. 9. SRL #9 Immunoassay Apr ‘16 174050.6%. 2. 4. 173520 0.49. 13. 169310 173490. 173510.883 g/dL HbA1c. 173520 0.8%. of Missouri. 12. of Missouri.49. 13.5*HbA1c/Hb + 2.89.15 t HbA1c Turbitest AA on CT 600i 91. 174050.31 g/dL Hb - Univ. of Missouri.15 t HbA1c v2 Turbitest AA on CT600i 91. 174040. 12. 4. 174040.45 g/dL HbA1c. of Missouri.5*HbA1c/Hb + 2. 169310 151007 2. 173510. 20075/01.15 Fujirebio Inc. 83.09148 x [IFCC] (mmol/mol) + 2.8%. SF50603 F9A005. 174040. 2. 13. 13. 173520 0. 174040. SRL #9 Immunoassay Apr ‘16 174050.49. 173500. 169310 173490. 6. of Missouri.15 tHbA1c v2 Turbitest AA on CMD 800i X1 91.883 g/dL HbA1c.5*HbA1c/Hb + 2. 173510.8%.89.152 Wiener Laboratorios tHbA1c Turbitest AA on CMD 800i X1 91. 173500.List of NGSP Certified Methods (Updated 4/16. 174050. 1.3%.31 g/dL Hb - Univ. 2. 174050. SRL #9 Immunoassay Apr ‘16 174040.8 mmol/mol Sebia CAPI 3 HbA1c on Capillarys 3 Capillary Electrophoresis Apr ‘16 14095/01. 169310 151007 2. RF51103.6%. 13. 9. 09115/01 Calibrator Assigned Value 36.8. 0.15 t HbA1c Turbitest AA on CM 250 91.65.5*HbA1c/Hb + 2. RF51103. 169310 151007 2.65. SRL #9 Immunoassay Apr ‘16 174040.49.5*HbA1c/Hb + 2. 169310 173490.3%. of Missouri. 1.0%.89. 12. 6. 1.5*HbA1c/Hb + 2. 2. SF50603 VF51103 0. SRL #9 Immunoassay Apr ‘16 174040. 0. 173510.883 g/dL HbA1c.31 g/dL Hb - Univ.3% - ReCCS ASRL#1 Immunoassay Apr ‘16 VF51103 ReCCS ASRL#1 Apr ‘16 0.7 g/dL Hb - Univ. 174040. 6. 12. t Rapidia Auto HbA1c-L on BiOLis24i Premium t Rapidia Auto HbA1c-L on JCA-BM9130 t AU-Synchron Reagent HbA1c on AU680 2 H1A005 . listed by date certified) Manufacturer Method/ Instrument Method Type Date Certified Reagent Lot Calibrator Lot Column Lot 06115/01. 174050.7 g/dL Hb - Univ.5*HbA1c/Hb + 2. 173500.883 g/dL HbA1c. 169310 151007 2. 4.7 g/dL Hb - Univ. SRL #9 Immunoassay Apr ‘16 QF51103. 174050. SRL #9 Immunoassay Apr ‘16 174050.

10. 5. S5001 5.1) Ionexchange HPLC Apr ‘16 t ADAMS A1c HA-8160 (Ver. 9. 13. 15120714 15091611.3% - 10176087 - 15071731.6%. 15111955 6C1011.2%.2%. S5001 5. 5.6%. 9. 6A1022.3%. 10. 15120714 15071731.0%. 15061612.3%. 10. 5.6%. 5.2%.7% 5G041W ReCCS ASRL#1 5D76. 10. NF50702 QF51103.6%. S5001 5. 10. 9.2%. Inc. RF51103.2%.List of NGSP Certified Methods (Updated 4/16. 6. listed by date certified) Manufacturer Fujirebio Inc. 5I1051 6C1011.3% 0. S5001 5. S5001 5. 13. RF51103.6%. 15061612. 15111955 15121757. 10. 6A1022.3%.5% 5H051F ReCCS ASRL#1 5D82. 15041033. 15082858.2%.4) Ionexchange HPLC Apr ‘16 t ADAMS A1c HA-8170 Ionexchange HPLC Apr ‘16 t ADAMS A1c HA-8180 Apr ‘16 t ADAMS A1c HA-8180V Variant mode Ionexchange HPLC Ionexchange HPLC t ADAMS A1c HA-8180V Fast mode Ionexchange HPLC Apr ‘16 t ADAMS A1c HA-8180T Ionexchange HPLC Apr ‘16 Apr ‘16 Column Lot - Calibrator Assigned Value 0. 10. 13.3% 0. Alere Technologies AS Arkray. 15121134.2%. S5001 5. 5.5%.2%. 5.2%. 10. SF50603 10176087 Boronate affinity Apr ‘16 Ionexchange HPLC Apr ‘16 t t ADAMS A1c HA-8160 TP mode Ionexchange HPLC Apr ‘16 t ADAMS A1c HA-8160 (Ver. 5I1051 3 VF51103 - Secondary Reference Laboratory ReCCS ASRL#1 - ReCCS ASRL#1 - ReCCS ASRL#1 - European Reference Lab ESRL #11 - - European Reference Lab ESRL #11 5D76. 15051535.2%. 15120714 15121757. 10. S5001 5.2%.7%. 6A1022. 5I1051 6C1011.6% 5H101U ReCCS ASRL#1 CA85D51. RF51103.5% 5H291G ReCCS ASRL#1 CA85D53.2%. 10. 10. 10.7%. 10.7%.6% 5J001N ReCCS ASRL#1 CA85D51.6%. 6A1022. 5. 15061612. 10.0%. 15062613. 5I1051 6C1011. 10.0%. 10. 4.2%.8%. 5D1401. 10. 5.2%.6%.2%.8%. 5E1601. 15072759. 4. 6. 5D1401. S5001 5. S5001 5.5%. 6.6% 5H007L ReCCS ASRL#1 VF51103 . 5. Method/ Instrument Method Type Date Certified Reagent Lot Calibrator Lot Rapidia Auto HbA1c-L on AU680 t Rapidia Auto HbA1c-L on Hitachi 7170s t Rapidia Auto HbA1c-L on TBA-120FR Afinion HbA1c / Afinion AS100 Analyzer Afinion HbA1c Dx / Afinion AS100 Analyzer t ADAMS A1c HA-8160 VP mode Immunoassay Apr ‘16 VF51103 Immunoassay Apr ‘16 Immunoassay Apr ‘16 Boronate affinity Apr ‘16 QF51103.7% 5K001X ReCCS ASRL#1 5D82.6% 5H101U ReCCS ASRL#1 CA85D51. 15082858.2%. 10.2%. 4. 15072759.2%.7% 5H076Y ReCCS ASRL#1 5D76. SF50603 QF51103.8%.

5. 0915*HbA1c/Hb*10 00(IFCC)+2.1. 5. 11. 6. 5D1401. 5.6%. 7.9 µmol/L Hb - ReCCS ASRL#1 Enzymatic Apr ‘16 MFC03. 5D1401.95. Inc.54.6% 5G484N ReCCS ASRL#1 Enzymatic Apr ‘16 6C1011.2%.9 µmol/L Hb - ReCCS ASRL#1 Enzymatic Apr ‘16 MFC03. MFE03 CAC5C16 2.6%.2%. 6047.76. 10.6% 5K194U ReCCS ASRL#1 Ionexchange HPLC Immunoassay Immunoassay Apr ‘16 6C1011. 5I1051 CA85D53. S5001 5.31 µmol/L HbA1c.2%.6% 5J001N ReCCS ASRL#1 CA85D53.6%.31 µmol/L HbA1c.6%.31 µmol/L HbA1c.15 t CinQ HbA1c on JCABM9130 HbA1c%(NGSP)=0. MFE03 CAC5C16 2.2%. 96. 3. S5001 5. 6A1022. S5001 5. 151422255 C1L5D06. listed by date certified) Manufacturer Method/ Instrument Method Type Date Certified Reagent Lot Calibrator Lot Calibrator Assigned Value Column Lot Arkray. 6107. 5.6% 5K401N CA85D53. 5I1051 MFC03.9 µmol/L Hb - ReCCS ASRL#1 Enzymatic Apr ‘16 MFC03.9 µmol/L Hb - ReCCS ASRL#1 Ionexchange HPLC Ionexchange HPLC Apr ‘16 6C1011.6% 5K401N ReCCS ASRL#1 Apr ‘16 6C1011.2%.95. 5I1051 6C1011. 90. 90. 5. 6A1022. 10. 6082 2. 7. SRL #3 .6%.1. 10. 6A1022. 4. 0915*HbA1c/Hb*10 00(IFCC)+2.2%. Inc. 96. MFE03 CAC5C16 2. 6A1022. Siemens Healthcare Diagnostics SD MultiCare System Hemoglobin A1c 3 (A1c 3)Automated Pretreatment on Advia 1800 Trinity Biotech GHb/HbA1c HPLC Boronate Affinity on PDQ Boronate affinity HPLC 4 6018 Univ. 10. 10. 5.2%. 96.2%. 90. S5001 5.2%.95. S5001 5. 5.2%.95.74 g/dL Hb 5. 151422255 C1L5D06.15 t CinQ HbA1c on TBA-120FR HbA1c%(NGSP)=0.6% 5K194U ReCCS ASRL#1 Ionexchange HPLC Apr ‘16 6C1011.List of NGSP Certified Methods (Updated 4/16.2%.2%. 6A1022. t ADAMS HYBRID AH8290 t ADAMS A1c HA-8181 Ionexchange HPLC Ionexchange HPLC Ionexchange HPLC Apr ‘16 CA85D53.6% 5J001N ReCCS ASRL#1 Mar ‘16 MS1016001 - - - Mar ‘16 270 5HD051 (15) - Mar ‘16 6040. S5001 5. 151422255 C1L5D05. 90. of Missouri.2%. 10. 10. 10. 6133 6081. 10. 0915*HbA1c/Hb*10 00(IFCC)+2. 5I1051 6C1011. 10. 10. 0915*HbA1c/Hb*10 00(IFCC)+2.1. SRL #9 t ADAMS HYBRID AH8280 t CinQ HbA1c on BioMajesty JCA-BM6010 Apr ‘16 Apr ‘16 HbA1c%(NGSP)=0.15 t ADAMS A1c Lite HA-8380 t ADAMS A1c Lite HA8380V Fast mode t ADAMS A1c Lite HA8380V Variant mode t ADAMS A1c HA-8182 SD Biosensor.95. 7.2%. 10. 96.1.6%. 10. MFE03 CAC5C16 2.2%. 6A1022. of Missouri. 6A1022. 11.6%.31 µmol/L HbA1c. 10.15 t CinQ HbA1c on Hitachi LABOSPECT 006 Secondary Reference Laboratory ReCCS ASRL#1 HbA1c%(NGSP)=0. 10. S5001 5.74 µmol/L A1c.46. 7.3% ReCCS ASRL#1 Univ.

1.88. 856RHM. Ltd. L type Norudia N HbA1c on Hitachi LST006 t L type Norudia N HbA1c on Hitachi LST008 t Norudia N HbA1c on Hitachi 7170S t Norudia N HbA1c on JCA-BM9130 t RC20 on Adams A1c mini 5 3.30% 6018 Secondary Reference Laboratory Univ.7. 6082 Calibrator Assigned Value 5. 137.83.62. 847RJM 013RIM - ReCCS ASRL#1 Ionexchange HPLC Mar ‘16 1106000315 1209000315 1006003415 ReCCS ASRL#1 Sekisui Medical Co. SRL #3 . listed by date certified) Manufacturer Method/ Instrument Method Type Date Certified Reagent Lot Calibrator Lot Trinity Biotech GHb/HbA1c HPLC Boronate Affinity on ultra2 GHb/HbA1c HPLC Boronate Affinity on Premier Hb9210 t Autokit HbA1c on Hitachi 7170S Boronate affinity HPLC Mar ‘16 6040.0 µmol/L Hb 3.83. 103.4%.83. 103.19 µmol/L HbA1c.1.6% 6089. 154.7 µmol/L Hb 3.7 µmol/L Hb 5. 11. 807RHM 905RIM - ReCCS ASRL#1 t Enzymatic Mar ‘16 807RIM. 847RJM 013RIM - ReCCS ASRL#1 Norudia N HbA1c on EV800 Enzymatic Mar ‘16 855RHM. 847RJM 013RIM - ReCCS ASRL#1 t Enzymatic Mar ‘16 855RHM.19 µmol/L HbA1c. 6082 5.43 g/dL HbA1c. 103.List of NGSP Certified Methods (Updated 4/16.62.19 µmol/L HbA1c. 97. 154.1.7 µmol/L Hb 3.7 µmol/L Hb 3.7. Column Lot 6081. 16.3%. 103. 807RIM.30% 1509030122 ReCCS ASRL#1 t Enzymatic Mar ‘16 855RHM.0 µmol/L Hb 3. 6047. KE436 YA003 - ReCCS ASRL#1 Ionexchange HPLC Mar ‘16 1503240008 1509140008 0. 137.. 847RJM 013RIM - ReCCS ASRL#1 t Norudia N HbA1c on TBA-120FR Enzymatic Mar ‘16 855RHM. 1. 6047. 13. 13. 154. 856RHM.56%. Ltd. 0.6% 5919 Univ. 103. 14. 11.83. 806RLM 806RLM - ReCCS ASRL#1 Enzymatic Mar ‘16 807RIM. 11.7 µmol/L Hb 3. 16. 16. 16.49. 856RHM.83. 807RIM.0 g/dL Hb 5.19 µmol/L HbA1c.77 µmol/L HbA1c.19 µmol/L HbA1c. SRL #3 Mar ‘16 YA003. 6115. 806RLM 806RLM - ReCCS ASRL#1 Enzymatic Mar ‘16 855RHM. 16.77 µmol/L HbA1c. 97. 856RHM.1.65. 154. 6115 Boronate affinity HPLC Mar ‘16 Immunoassay RC20 HbA1c AUTO TBA on TBA120FR Wako Pure Chemical Industries.56%. of Missouri. 11. 154. of Missouri. 2. 6005 6081.1. 856RHM.

15070211.7%.5% 0. 15070312 15070115.3%.0%. Method Type Date Certified Reagent Lot Calibrator Lot Immunoassay Mar ‘16 369AEK. 4. 13. 4. 5. 5. Diazyme Laboratories Shanghai Huizhong Medical Science and Technology Co. 6.0%. SRL #9 6.7%.2%.8%. TaiDoc Technology Corp.0%.8%.2%.1%. 9.5% 0.. HA201150 Human Gesellschaft fur Biochemica und Diagnostica mbH HAS101150.70%. 6. 15. Ltd. 6. 4.5% - Architect HbA1c on Architect i Immunoassay Jan ‘16 10445UP00 802905582 4. Nanjing LAOLA Electronic Co.3%. Ltd. 9.0%. 9/11. 11.8%.6%.7%.6%.7%. 9. 15.7% 0. 4. SRL #9 PTHbA1c1 50 302H 20151029 5.62% PTHbA1c15 0302H Univ. HAS201150 Ionexchange HPLC Jan ‘16 20150616B MQ-2000PT Glycated Hemoglobin Analyzer Ionexchange HPLC Jan ‘16 Immuno-assay on ichroma Reader Immunoassay Immunoassay on TD-4611 Determiner HbA1c on DM-JACK t Determiner HbA1c on JCA-BM9130 t Determiner L HbA1c on DM-JACK t Determiner L HbA1c on JCA-BM9130 t Determiner L HbA1c on Hitachi 7180 t Determiner L HbA1c on TBA-120FR Ion-exchange LPLC on JL760 Column Lot - Secondary Reference Laboratory ReCCS ASRL#1 - ReCCS ASRL#1 - ReCCS ASRL#1 - ReCCS ASRL#1 - ReCCS ASRL#1 - ReCCS ASRL#1 20150610 Univ. Axis-Shield Calibrator Assigned Value 0.8%. SRL #9 Jan ‘16 AALYA55 502101 5.5%.2% - ReCCS ASRL#1 Immunoassay Jan ‘16 15L103 415501-212 5.3%.67% 6K15071301 Univ.List of NGSP Certified Methods (Updated 4/16. 8. 138AEI 310AEI Immunoassay Mar ‘16 138AEI. 9.1%. of Minnesota SRL#10 20151029 5.5% 5.8%. of Missouri. 138AEI 310AEI Ionexchange HPLC Feb ‘16 15070110.0%. 9. 9. 138AEI 310AEI Immunoassay Mar ‘16 138AEI. 138AEI 310AEI Immunoassay Mar ‘16 138AEI.0%.3%. 11. 13. 9/15.2%.0%.0%. 10.5% 0.1% t 6 European Reference Lab ESRL#10 .5% - HumaMeter A1c Boronate Fluorescence quenching Jan ‘16 025196 2016-06 025196 2016-06 Barcode - European Reference Lab ESRL#9 European Reference Lab ESRL#12 European Reference Lab ESRL#10 HumaStar 300SR Immunoassay Jan ‘16 517601 2016-12 15002/201706 0/5. 15070312. 11. 15070125 Direct HbA1c Assay on Roche Modular P800 (On-Board Lysis) MQ-6000 Glycated Hemoglobin Analyzer Enzymatic Jan ‘16 HAL01150.0%. HA101150. 7.2%. 15. 9.0%. 15.5%. 5. 13. 13.0%. 13. Ltd. 13. 10. listed by date certified) Manufacturer Method/ Instrument Kyowa Medex Co. 8. 6. 7/8. 391AEK 509AFA Immunoassay Mar ‘16 138AEI. 12. t . 369AEL 507AEG Immunoassay Mar ‘16 391AEK.14.3% - Univ.0%. 12. 2% - Boditech Med Inc.42%.2%. of Missouri.8% 0. of Missouri.1%..

Manual hemolyzation. of Minn SRL #10 Jan ‘16 AA40128. of Minn SRL #10 Jan ‘16 64025852. 10.936 mmol/L Hb - Immunoassay Jan ‘16 L986. AA50316 10. ref 981947.48.5%. 64014744.0 (screen and diagnosis) Vitros d%A1c 7 . 64012157 64010672 5. 64015995 5.1% FB20900 Univ. 64011701 5.15 Bio-Rad Laboratories t VARIANT II Dual (A1c) t VARIANT II Dual (A2/F/A1c) D-10 Dual A2/F/A1c D-10 HbA1c D-100 HbA1c Variant II HbA1c NU Ortho Clinical Diagnostics VARIANT II TURBO HbA1c VARIANT II TURBO Link HbA1c VARIANT II TURBO HbA1c Kit – 2. -1.2%.84%. 64016867 64012445. 64028214 64026941. L734 L246 1. 1. listed by date certified) Manufacturer Method/ Instrument Method Type Date Certified Reagent Lot Calibrator Lot Calibrator Assigned Value Column Lot Secondary Reference Laboratory European Reference Lab ESRL#9 Thermo Fisher Scientific Oy t HbA1c for Konelab. 10.0 VARIANT II TURBO HbA1c Kit – 2.2% A40035Q Univ.List of NGSP Certified Methods (Updated 4/16. of Minn SRL #10 Jan ‘16 64012980. AA50208 AA50370.62. 0.2% S31342C Univ. 64012446 5. 10. 64023629. 64026942 5.5*HbA1c/Hb +2. 91. ref 981947.2%. 10. 8.4%. 64006957 64011685.00. of Minn SRL #10 Ionexchange HPLC Ionexchange HPLC Ionexchange HPLC Ionexchange HPLC Ionexchange HPLC Ionexchange HPLC Ionexchange HPLC Jan ‘16 AA50357. 2. 64011236. on Indiko Plus. of Minn SRL #10 Ionexchange HPLC Jan ‘16 64019508.936 mmol/L Hb - European Reference Lab ESRL#9 Ionexchange HPLC Ionexchange HPLC Jan ‘16 64023628. 64011683 5.533 mmol/L HbA1c. 1845 18451. 0.5*HbA1c/Hb +2.15 t HbA1c for Indiko. 64023629. 18454. 5. 10. 18455 0. of Minn SRL #10 Immunoassay Dec ‘15 1845. 14.3% 31500U Univ. 10. AA50358.3% D40035H Univ. 9.51 g/dL HbA1c. Immunoassay Jan ‘16 L986.1%. 10.3% 31500U Univ. AA50371 5.2%. Manual hemolyzation. AA50372 AA50315. 64019494 64015994. 64012446 5. 64012977. of Minn SRL #10 Jan ‘16 64012978. L734 L246 1. 10.89. of Missouri. 64012201 64011680.2%. SRL #9 91.2%. 64019494 64015998. of Minn SRL #10 Jan ‘16 AA50354.5% NU31453E Univ. 64018314. AA50355.2% LLV31342F Univ. 64015996 5.1% FB20900 Univ.3%.12% 31037AG Univ. 64016867 64012445.38. 18453. AA40129. of Minn SRL #10 Jan ‘16 64023628.533 mmol/L HbA1c. of Minn SRL #10 Jan ‘16 64019508. 8. 18452.06 g/dL Hb - Univ.

SRL #9 - Univ.5%.55.05. listed by date certified) Manufacturer Method/ Instrument Method Type Date Certified Reagent Lot Calibrator Lot Shenzhen Lifotronic Technology Co. 5. SRL #9 - Univ.65 g/dL Hb - Univ. 15059 15239 - Dimension Flex on RxL Immunoassay Dec ‘15 GC6167 GC6167 Dimension Flex on ExL Immunoassay Dec ‘15 GC6167 GC6167 Cobas b 101 HbA1c Immunoassay Dec ‘15 528131-01 - 4.o.77%.77%.39%.940 g/dL HbA1c.53 g/dL HbA1c. 8.2% 4. of Missouri. respons910 HbA1c net FS. A1CNow SELFCHECK HbA1c Latex Immunoassay on EasyRA Medica Corporation Siemens Healthcare Diagnostics.88. 21481.9. Biomajesty oneHbA1c FS. 12.380. 20760 - European Reference Lab ESRL#10 Ionexchange HPLC Boronate Affinity Dec ‘15 HBR-003.4%. 17.2% 0.53 g/dL HbA1c. 8.39%. 1. 10. 21507 E28/14 - European Reference Lab ESRL#10 Immunoassay Dec ‘15 82. SRL #9 Univ. 2.89.r. SRL #9 Univ.2%.88. of Missouri. Reference No. 12. 5.6. Reference No. of Missouri. 17. Ltd Ion-exchange HPLC on GH900 Ionexchange HPLC Dec ‘15 821514 Ion-exchange HPLC on H-9 Ionexchange HPLC Immunoassay Dec ‘15 DiaSys Diagnostic Systems GmbH 2015090801 Calibrator Assigned Value 5. 11.List of NGSP Certified Methods (Updated 4/16.16. 1.54%. 21507 E28/14 - European Reference Lab ESRL#10 Immunoassay Dec ‘15 21506. Reference No. 6.2% 5.8 g/dL Hb 4. HbA1c net FS.05. 1. 0. Roche Diagnostics International Ltd 8 Column Lot Secondary Reference Laboratory ReCCS ASRL#1 - Univ. 11. of Missouri. 21672.16. 21482 B041538CM 0. 1.65 g/dL Hb 0. SRL #9 . 1 3329 00.2% 2015100901 ReCCS ASRL#1 Dec ‘15 21506. HBR-003 21670.89.6%.55. 1 3348 00.2 g/dL Hb 0. 15.365. 13. 1 3348 00.99%. 11. 12. 11. 21480. 0. 20760 - European Reference Lab ESRL#10 Immunoassay Dec ‘15 2136921371. Reference No.5%. InnovaStar oneHbA1c FS. SRL #9 Univ. 2. Inc.05 g/dL HbA1c. of Missouri.72%. 14. of Missouri. Hitachi 917 ERBA HbVario Trinity Biotech Tri-stat HbA1c Assay PTS Diagnostics A1CNow+. SRL #9 Erba Lachema s. of Missouri.5% 2015092204 841502 2015101201 5. 1 3329 00. 11.. 21671.59% HBR-002 Dec ‘15 5850 (0y) - - - Immunoassay Dec ‘15 1513111 - - - Immunoassay Dec ‘15 15125. 0. 21673 21479. 11. 1.

3 cobas c311 (whole blood) HbA1c/Hb*91. 3 cobas c311 (hemolysate) HbA1c/Hb*91.54 mmol/L Hb 0. 7.00549. SRL #9 . 0. 2 Cobas c111 (whole blood) HbA1c/Hb*91. 2 Cobas Integra 400 (hemolysate) Immunoassay Dec ‘15 604503. 2 Cobas Integra 400 (whole blood) HbA1c/Hb*91. 0.5 +2. 1. 7. 7. 0.278.35. 0. 610045 185997 0. 0.414 g/dL Hb - Immunoassay Dec ‘15 610611. 0. Clover A1c Self. 1. 7.334.15 TQ HbA1c Gen. 610071. SRL #9 Univ.82 mmol/L HbA1c. 0.12052. 0. SRL #9 Immunoassay Dec ‘15 617092.215.196.15 TQ HbA1c Gen. 3 cobas c513 (whole blood) HbA1c/Hb*91. of Missouri.35.326. 1.02607.936. SRL #9 Boronate Affinity Nov ‘15 F15F02F16 DL - - - Boronate Affinity Nov ‘15 C15F22G0 6DL - - - Univ. 0.286. 1. 0. 0.069. 0. of Missouri.40.679. 0.00137.5 +2.5 +2. 1. of Missouri. 0 g/dL HbA1c. 0.5 +2. of Missouri.641. 610071 185997 - Univ. SRL #9 Immunoassay Dec ‘15 617092. SRL #9 HbA1c/Hb*91. 1. 0 g/dL HbA1c.02386 g/dL Hb 0. 0.02414 g/dL Hb 0. listed by date certified) Manufacturer Method/ Instrument Method Type Date Certified Reagent Lot Calibrator Lot Calibrator Assigned Value Column Lot Roche Diagnostics TQ HbA1c Gen.12069.5 +2.357. 0.131.01321.54 mmol/L Hb - Univ.154. 0. 0. 1. 1.415. 1. 610045 185997 2. of Missouri.682. SRL #9 Immunoassay Dec ‘15 618064. 3 cobas c513 (hemolysate) HbA1c/Hb*91.891. 12. 1. of Missouri. of Missouri.00076. of Missouri.5 +2. Checkart 9 Secondary Reference Laboratory Univ.931. 2.02796.279 mmol/L Hb 0.List of NGSP Certified Methods (Updated 4/16. 1. of Missouri.15 TQ HbA1c Gen.15 TQ HbA1c Gen. 617546.703.078.01575.868.145. 617543 183640 - Univ. 0.279 mmol/L Hb 0.40.15 Infopia Co.15 TQ HbA1c Gen. 0.639.0053.0138. 1. 0.357. 0.15 TQ HbA1c Gen. 0. 610045 185997 - Univ. 1.5 +2. 0.697 mmol/L HbA1c.806 mmol/L HbA1c. SRL #9 Immunoassay Dec ‘15 618064. Ltd Frontier and HemoCue HbA1c 501 Clover A1c. 1.882. 0 g/dL HbA1c. 617546 185997 - Univ. 614514. SRL #9 Immunoassay Dec ‘15 604503. 0. 614514 185997 - Univ.544. 0. mmol/L HbA1c.152.733.0166.

SRL #9 ReCCS ASRL#1 HbA1c WB Whole Blood Pentra C400 Immunoassay Oct ‘15 1504101 1501801 - European Reference Lab ESRL#10 Immunoassay Oct ‘15 1504101 1501801 - European Reference Lab ESRL#10 Immunoassay Oct ‘15 1504101 1501801 0.9%. 16.20.30% 5. 4J1053 5E1012. 24. 82. 7.8.5% - - - Univ.90. Inc. 4. of Missouri.20.00%. 7.02% 5. Hitachi Chemical Co. A1Care HbA1c assay (Enzymatic method) Ion-Exchange HPLC on LD500 Enzymatic Nov ‘15 DBJGA - Ionexchange HPLC Nov ‘15 20150623.90.80 µmol/l HbA1c. 7. of Missouri.80 µmol/l HbA1c. 119. 10.42*X)+2. 4.20.85%.40%.25% 20150506 ReCCS ASRL#1 1533FD07 7O WC0014 - ReCCS ASRL#1 Oct ‘15 802905118 802902331802902335 - European Reference Lab ESRL#12 Immunoassay Oct ‘15 AR957 806 - European Reference Lab ESRL#9 Ionexchange HPLC Oct ‘15 S4002 4J101U Univ. 4L1401.00. 10.43*X)+2.4%.60. 10.00.00. listed by date certified) Manufacturer Method/ Instrument Method Type Date Certified Reagent Lot Calibrator Lot i-SENS. 9. 2. SRL #9 Ionexchange HPLC Oct ‘15 S4002 5. 10.00. HORIBA Medical Calibrator Assigned Value - Column Lot 150609K 5. 68. 5E1021. 11. Ltd.90%.0. Axis-Shield Archem Diagnostic Industry Ltd.06 t HbA1c WB Hemolysate Pentra C200 Y=(0.60.25 t HbA1c WB Hemolysate Pentra C400 Y=(0. 20150623. 9. 2. 1.4%. 51.0 mmol/mol 0. 20150623 Spotchem Banalyst HbA1c on SI3620 Axis-Shield HbA1c kit on AU400 Immunoassay Oct ‘15 Immunoassay Shenzhen Labnovation Technologies. 10.List of NGSP Certified Methods (Updated 4/16. ROHM Co. 1. SRL #9 Ionexchange HPLC Oct ‘15 S4002 5.24 10 - Secondary Reference Laboratory ReCCS ASRL#1 . 5E1021. 4J1053 Y5C617 0. 2.0. 4. 13..35*X)+2. Inc.00. Ltd.5% 4J101U Univ. of Missouri.00%. 7. Inc. 10.60.80 µmol/l HbA1c. 68.00.70%.05%. 11. 4L1401.4%.0.29 µmol/l Hb 0.29 µmol/l Hb 0.29 µmol/l Hb - European Reference Lab ESRL#10 HbA1c Direct Method (2 Reagents) Immuno-assay ADAMS A1c Lite HA8380V Variant mode ADAMS A1c Lite HA8380V Fast mode ADAMS A1c Lite HA-8380 t Y=(0.90..5% 4J206N Seratestum A1C Enzymatic Oct ‘15 5E1012. 1. Arkray. 4. 5E1021. 4J1053 5E1012. 68.

90.90.54. 7. 1.36.00.51 µmol/L HbA1c.07 µmol/L Hb 3.54. 10.29 µmol/l Hb - HORIBA Medical t HbA1c WB Whole Blood ABX Pentra 400 Immunoassay Oct ‘15 1504101 1501801 Immunoassay Oct ‘15 1504101 1501801 Boronate affinity Sept ‘15 H05G2901.51 µmol/L HbA1c. 15. listed by date certified) Manufacturer Method/ Instrument Method Type Date Certified Reagent Lot Calibrator Lot Column Lot - Calibrator Assigned Value 0. 15.20. 91. 68. 147. 91. 147.54.43*X)+1. 91. 2. 91.60. 68. 4. SRL #9 - - 3. 1. 91.29 µmol/l Hb 0.54.60. 15.07 µmol/L Hb 3. 15.14 t HbA1c WB Hemolysate Pentra 400 Y=(0.43*X)+2.20.98 Green Cross Medis Corp.51 µmol/L HbA1c.80 µmol/l HbA1c.List of NGSP Certified Methods (Updated 4/16.00. Inc.54. of Missouri.00. 91. A1Card HbA1c Analyzer t SD A1cCare System t Enzymatic on BS-200E t Enzymatic on BS-380 Enzymatic Sept ‘15 044615006 044615006 t Enzymatic on BS-400 Enzymatic Sept ‘15 044615006 044615006 t Enzymatic on BS-480 Enzymatic Sept ‘15 044615006 044615006 Enzymatic on BS-800/800M Enzymatic Sept ‘15 044615006 044615006 t Enzymatic Sept ‘15 044615006 044615006 t Enzymatic on BS2000/2000M 11 - Secondary Reference Laboratory European Reference Lab ESRL#10 - European Reference Lab ESRL#10 - Univ. 147.07 µmol/L Hb 3. 15.51 µmol/L HbA1c.36. H05G2902.51 µmol/L HbA1c.07 µmol/L Hb - ReCCS ASRL#1 ReCCS ASRL#1 - ReCCS ASRL#1 - ReCCS ASRL#1 - ReCCS ASRL#1 - ReCCS ASRL#1 - ReCCS ASRL#1 . 2.80 µmol/l HbA1c.07 µmol/L Hb 3. Mindray Boronate Affinity (LabonaCheck A1c HbA1c Analyzer. 147.36. 147.36. 10.07 µmol/L Hb 3.36. HM236GH UEW Immunoassay Sept ‘15 A1C02150021 - Enzymatic Sept ‘15 044615006 044615006 Y=(0. 4. 15. 7.54.36.51 µmol/L HbA1c. SD Biosensor.00. 147.

094.927. 0.427 mmol/L HbA1c. 1. 0. 1.892. 1. SRL #9 . 0. 0. 0. 0. 0.69 mmol/L THb 0. -0. 4.515.892.515. 1. Ortho Clinical Diagnostics Column Lot - Calibrator Assigned Value - 025173 - - - Sept ‘15 0020.094. 8. M405250 0020 HbA1c B00389 Manual Application AU680 Immunoassay Sept ‘15 0020.094.515. M405250 0020 - Immunoassay Sept ‘15 0020.219. 0.296 g/dL Hb 12 - Secondary Reference Laboratory European Reference Lab ESRL #11 European Reference Lab ESRL #11 European Reference Lab ESRL #9 - European Reference Lab ESRL #9 - European Reference Lab ESRL #9 - European Reference Lab ESRL #9 - European Reference Lab ESRL #9 - European Reference Lab ESRL #9 - Univ.200. 8.List of NGSP Certified Methods (Updated 4/16. M405250 0020 %A1c on Vitros 5.094.1 FS Immunoassay Sept ‘15 4386 3155 t %A1c on Vitros 4600 Immunoassay Sept ‘15 4386 3155 0.094. 3. 8.278.094.214.886. M405250 0020 HbA1c B00389 Manual Application AU480 Immunoassay Sept ‘15 0020.278. -0.278. listed by date certified) Manufacturer Method/ Instrument Method Type Date Certified Reagent Lot Calibrator Lot Quotient Diagnostics Limited Quo-Test on Quo-Test Boronate affinity Sept ‘15 020248 Quo-Lab on Quo-Lab Boronate affinity Sept ‘15 HbA1c B00389 Manual Application AU5800 Immunoassay HbA1c B00389 Manual Application AU2700 Beckman Coulter Ireland Inc. of Missouri.69 mmol/L THb 0.692. 0.515.515.435 g/dL HbA1c.158. 0.892. 0.296 g/dL Hb 0. 1.427 mmol/L HbA1c.922. 8. 1. 1. 17. 0. 8.427 mmol/L HbA1c.278.407 g/dL HbA1c.427 mmol/L HbA1c.515.892. SRL #9 - Univ. of Missouri. 1. 8.200.889. 3. 8.278. 0. 0. 0. 0. 8.278.892. 17.892.692.427 mmol/L HbA1c.69 mmol/L THb 0.69 mmol/L THb 0. 0. M405250 0020 HbA1c B00389 Manual Application AU400 Immunoassay Sept ‘15 0020.158. M405250 0020 HbA1c B00389 Manual Application AU640 Immunoassay Sept ‘15 0020. 0.427 mmol/L HbA1c. 4.69 mmol/L THb 0. 0. 0.69 mmol/L THb 0.

33. 15020078 24120047. 24120049. 15. 24120049. 118.8. 9. tImmuno Immunoassay Sept ‘15 15060009. 17. 9.33.38 µmol/L HbA1c.00%. 1.38 µmol/L HbA1c.8. HBA1c on UniCel DxC 800 Immunoassay Sept ‘15 M505354.70% - Univ. 19.60%. of Missouri. 12. 82. 15. 15.200. 15020078 24120047. 131AEE 135AEE t MetaboLead HbA1c on DMJACK Enzymatic Sept ‘15 131AEE. 0. 15.53 µmol/L HbA1c. 146. 15060010.8. 9. 15020078 24120047.9 µmol/L Hb - ReCCS ASRL#1 - ReCCS ASRL#1 - ReCCS ASRL#1 - ReCCS ASRL#1 - ReCCS ASRL#1 0..3 µmol/L Hb 2. 118. 131AEE 135AEE MetaboLead HbA1c on Hitachi-7180 Enzymatic Sept ‘15 131AEE. 11. 118.889. 12. M406277.154. listed by date certified) Manufacturer Method/ Instrument Method Type Date Certified Reagent Lot Calibrator Lot Ortho Clinical Diagnostics t %A1c on Vitros 5600 Immunoassay Sept ‘15 4386 3155 Kyowa Medex Co.582.60%.List of NGSP Certified Methods (Updated 4/16. Ltd. 15060010.853.3 µmol/L Hb 2.70% 4. 24120050 tImmuno assay on Mispa i3 Immunoassay Sept ‘15 15080027. 24120048.451.70%. t MetaboLead HbA1c on JCABM9130 Enzymatic Sept ‘15 131AEE.00%.472 g/dL HbA1c. 118. 24120050 Cation-exchange Chromatography on HbA1c Analyzer KH101 t Fluorescence immunoassay on Finecare FIA Meter Ionexchange HPLC Aug ‘15 20150102 Immunoassay Aug ‘15 F207F602A t assay on AGA1C assay on Mispa i2 Caretium Medical Instruments Co. 82. 3. 0. 0.10% 150210S ReCCS ASRL#1 - - - ReCCS ASRL#1 - Secondary Reference Laboratory Univ. 816RHL. t BM Test HbA1c on JCABM 6010/C Enzymatic Sept ‘15 816RHL. 24120048.70%. 2. 131AEE 135AEE JEOL Ltd.8.33..01 g/dL Hb 4.38 µmol/L HbA1c.692. 4.3 µmol/L Hb 2.927. 7. Limited Guangzhou Wondfo Biotech Co. 150575A 5. Inc. SRL #9 - European Reference Lab ESRL#10 - European Reference Lab ESRL#10 - European Reference Lab ESRL#10 150573A. of Missouri. 9.3 µmol/L Hb 3.2%. -0. 92. 24120049.9. 24120048.38 µmol/L HbA1c.00%.158.28. 7.. 12. 131AEE 135AEE t MetaboLead HbA1c on TBA120FR Enzymatic Sept ‘15 131AEE. 82. SRL #9 . 8. 816RLL 914RIL Beckman Coulter. 82.60%.33.407 g/dL HbA1c. M209413 M505354 Agappe Diagnostics Ltd.214.70%. 15060010. 24120050 tImmuno Immunoassay Sept ‘15 15060060. M506571. 1.70% 4. 13 Calibrator Assigned Value 0. Ltd.296 g/dL Hb Column Lot 2. 7.

HB-1501 5. 2 whole blood on Cobas Integra 800 (HbA1c/Hb*91. 201404.List of NGSP Certified Methods (Updated 4/16.3%. 0 g/dL HbA1c. 5305. 5A1221 201468.. SRL #9 Immunoassay on LabGEO PT10 Boronic Affinity Chromatography on HbA1c analyzer (HbA1c/Hb*91. 4J1211.5+ 2.0%.0%.392. 10.0%. 2 hemolysate on Cobas Integra 800 Immunoassay June ‘15 461503 STS011 - ReCCS ASRL#1 Immunoassay June ‘15 461503 STS011 - ReCCS ASRL#1 Immunoassay June ‘15 693374.15) TQ HbA1c Gen. listed by date certified) Manufacturer Method/ Instrument Method Type Date Certified Reagent Lot Calibrator Lot A.785.0%.80%. 2. 150201-21. 12. SRL #9 Immunoassay June ‘15 693374. 12. 9. 12.70%. 0 g/dL HbA1c.4% HB-1501 European Reference Lab ESRL#10 Ionexchange HPLC June ‘15 150402-20. 5.00559.6%. 150402-23. 0. 150401-24 150101-26. Ltd.8%. 0.2%.931.112. 4907 5211. 5162. 697646 180036 0. 1.0% 150401-48 Univ. Ltd. 14.2% 0. 0. 201412. 1.15) 14 3F014Q Secondary Reference Laboratory European Reference Lab ESRL#10 . 12.40% 0870-5313 June ‘15 Q00CAG4N JCCRM41 1-3 - Boronate affinity June ‘15 HC14101N HC14101N Univ.80%. 7. of Missouri.70% Column Lot 201401 5.7%. of Missouri.2% 2.01654.4%. 0. SRL #9 HbA1c HPLC kit on HbA1c Analyzer t Ion-exchange. 9. Sakae Corporation Roche Diagnostics Calibrator Assigned Value 5. 12. SRL #9 t Medidas HbA1c on A1c GEAR t Medidas HbA1c on A1c iGEAR TQ HbA1c Gen. 5. 0.586 g/dL Hb - Univ. 4J1501.02755.01382.70% 4J0354 European Reference Lab ESRL#10 4814.667.5% European Reference Lab ESRL#10 ReCCS ASRL#1 HB-1501 5. 0. AC6601 HbA1c Analyzer Ionexchange HPLC June ‘15 R002201408 21.00121.Menarini Diagnostics t Auto A1c HA-8180V ADAMS Ionexchange HPLC July ‘15 201401 t Auto A1c HA-8160 ADAMS Ionexchange HPLC July ‘15 5A1201. of Missouri. 9.8%. Zivak Technologies Jiangsu Audicom Medical Technology Co. 150101-27 5.02586 g/dL Hb - Univ. of Missouri.557. 0. R002201408 21. 10.0% 6. 0. 697646 180036 0. 12. 5212 5.0%. 201435 t HPLC Auto A1c on Premier Hb-9210 Boronate affinity July ‘15 t Immunoassay t @ Samsung Electronics GuangDong Unity Biotechnology Co.5+ 2. R002201408 21 HB-1501. 150402-22..2%.12931. 5. 11.0%. 14. 606814.

345. 10. 10.86%. 9-301A. 0. listed by date certified) Manufacturer Method/ Instrument Method Type Date Certified Reagent Lot Calibrator Lot Calibrator Assigned Value 0.76%. HW-14W F8-101W. of Missouri. HW-14W B9-101W.345. 0. HLC-723G7 t GX HLC-723GX Ionexchange HPLC June ‘15 Ionexchange HPLC Ionexchange HPLC cobas c501/502 (HbA1c/Hb*91.86%. 7-303W. of Missouri.814 mmol/L HbA1c. 1. 0.76%. K7-203W. E8-201W. 3 hemolysate on Immunoassay June ‘15 608283.76%. HW-09Y JS4002 5. 1.0 min). 8-305W.749 mmol/L Hb 0. SRL #9 E8-106W. K7-203W. 10. SRL #9 5. B9-201Y. B9-201Y. 10. 7-303W. SRL #9 ZS4002 5. 0. 1. 1.86%.76% B Univ. SRL #9 June ‘15 AX-101W. 10. M7-301Y.76% A Univ. of Missouri.97% B Univ. F8-201W.142. E8-201W. HW-09Y ZS4002 5.15) Tosoh Corporation t G7 HbA1c Standard Analysis Mode (1.76%. of Missouri. 606814 180036 Immunoassay June ‘15 608283. of Missouri. SRL #9 15 . SRL #9 JS4002 5. SRL #9 c501/502 (HbA1c/Hb*91. HLC-723G8 G7 HbA1c Variant Analysis Mode (2.749 mmol/L Hb 5.5+ 2.76%. of Missouri. AX-301Y.935.6 min).152. 1. M7-201Y.76% E Univ. 7. 1. SRL #9 ZS4002 5.List of NGSP Certified Methods (Updated 4/16.2 min) HLC-723G7 t G7 HbA1c Standard Analysis Mode (1.0 min) HLC-723G8 t G8 HbA1c Standard Analysis Mode (1.2 min) HLC-723G7 t G8 HbA1c Standard Analysis Mode (1. HW-09W ZS4002 5. of Missouri.76% M Univ. SRL #9 B9-101W. 10.901. HW-09Y ZS4002 Ionexchange HPLC June ‘15 K7-104W.76% Column Lot Roche Diagnostics TQ HbA1c Gen. HW-09Y JS4002 Ionexchange HPLC June ‘15 E8-106W.97% E Univ. 0.76%.15) TQ HbA1c Gen. HW-09Y ZS4002 5. F8-301W. 3 whole blood on cobas - Univ.437.2 min). AX-201Y. HLC-723G9 Ionexchange HPLC June ‘15 G8 HbA1c Variant Analysis Mode (1.273. 10.437. of Missouri.731 mmol/L HbA1c. 8-305W.674. 604554 180036 Ionexchange HPLC June ‘15 K7-104W.654.76% F Univ. of Missouri. of Missouri. 10. HW-09Y Ionexchange HPLC June ‘15 Ionexchange HPLC June ‘15 G9 HbA1c. HLC-723G8 t G9 HbA1c.220. 0. 10. 7. SRL #9 June ‘15 M7-101Y.97% K Univ. HLC-723G9 t - Secondary Reference Laboratory Univ. of Missouri.5+ 2. 9-301A. SRL #9 K Univ.

25 g/dL Hb 0. HW-09W A1-101Y. SRL #9 JS4002 5. 98. 150.460. 10.13. 98.48+2. 1-301Y. HW-09Y 0912035 DCA Vantage Immunoassay June ‘15 Ion-exchange HPLC on H50/H50P Dimension Vista Flex HbA1c on Vista 1500 Ionexchange HPLC Immunoassay Beckman Coulter. 10.76% A Univ.48.48+2.8% 140908 ReCCS ASRL#1 May ‘15 14300BA 4KD063 - Univ. Inc. AX-201Y.97% Column Lot ZS4002 5. 0. of Missouri.144.869. 10. 46208UQ 46700UQ10 - Univ. 1-301Y. Abbott Diagnostics Calibrator Assigned Value 5. of Missouri. 46208UQ07. SRL #9 Immunoassay May ‘15 20150228 - 0. SRL #9 Immunoassay May ‘15 M407102 M410001 - Univ. SRL #9 - - - 0912035 - - - Univ. 150.59.15 µmol/L HbA1c. SRL #9 Enzymatic May ‘15 46208UQ07. 19.76%.10. SRL #9 Enzymatic May ‘15 46208UQ07. Uni Cel DxC Syr on UniCel DxC 800 Shenzhen Genius Electronics Co.86%. 16. 11. 2014071501 20141201 5. 0. SRL #9 %NGSP=HbA1c/ Hb*91. of Missouri.1 µmol/L Hb - Univ. 1.503. 2. 46208UQ 46700UQ10 3. 16.15 µmol/L HbA1c.10. 98. of Missouri. 150.List of NGSP Certified Methods (Updated 4/16. AX-301Y..1 µmol/L Hb 3. 2. listed by date certified) Manufacturer Method/ Instrument Method Type Date Certified Reagent Lot Calibrator Lot Tosoh Corporation t GX HLC-723GX Ionexchange HPLC June ‘15 JS4002 G11.5%.92. of Missouri.15 µmol/L HbA1c. 1. of Missouri. of Missouri.5 min).5 min). HLC-723G11 DCA 2000+ Ionexchange HPLC June ‘15 Ionexchange HPLC June ‘15 Immunoassay June ‘15 AX-101W.10. HW-09Y A1-101Y.152 HbA1c (Hemolysate) on Architect c4000 %NGSP=HbA1c/ Hb*91. 12. 46208UQ 46700UQ10 - Univ. HLC-723G11 t G11. of Missouri. 0. SRL #9 . 12. 2014081201. 46208UQ07.86%. Standard Analysis Mode (0.28 g/dL HbA1c.48+2.152 16 A Secondary Reference Laboratory Univ. Ltd.52. SRL #9 Univ. 16. of Missouri.09 g/dL Hb3 - - ReCCS ASRL#1 Enzymatic May ‘15 46208UQ07. A1-201Y.1 µmol/L Hb 3.152 HbA1c (Whole Blood) on Architect c8000 %NGSP=HbA1c/ Hb*91. SRL #9 May ‘15 2014081101. 0. Standard Analysis Mode (0. 46208UQ07.97% A Univ.372 g/dL A1c3. Nephelometry on Specific Protein Analyzer PA54/PA50 HbA1c (Hemolysate) on Architect c8000 t Siemens Healthcare Diagnostics Mindray Siemens Healthcare Diagnostics Inc. A1-201Y. of Missouri.

6.3% - %NGSP=HbA1c/ Hb*91. 13. 16. 9. SRL #9 ReCCS ASRL#1 .48+2.1 µmol/L Hb - Immunoassay May ‘15 85002 CEN001 0. 4.List of NGSP Certified Methods (Updated 4/16.4%.0%. of Missouri. 46208UQ 46700UQ10 3.15 µmol/L HbA1c.152 Nihon Kohden Corporation Celltac Chemi HbA1c on CHM-4100 (NGSP(%)=1.9%. 46208UQ07.7%. 98.25) t @ Method is not available in the US Method is not currently available 17 Secondary Reference Laboratory Univ.10. listed by date certified) Manufacturer Method/ Instrument Method Type Date Certified Reagent Lot Calibrator Lot Calibrator Assigned Value Column Lot Abbott Diagnostics HbA1c (Whole Blood) on Architect c4000 Enzymatic May ‘15 46208UQ07. 150.02* JDS(%)+0.