List of NGSP Certified Methods

(updated 7/20, 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 Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Nihon Kohden @Celltac Chemi Immuno- July ‘20 89005 CEN008 0.0%, 4.4%, - ReCCS
Corporation HbA1c N on assay 6.7%, 9.6%, ASRL#1
CHM-4100 12.9%
Furuno Electric Centronic Immuno- July ‘20 HF04201E- 906005 0.0%, 5.5%, - ReCCS
Co. Ltd. HbA1c assay 005, 8.0%, 11.3%, ASRL#1
turbidimetric HF04201E- 15.5%
immunoassay on 005,
CA-800 HF04201EL
Y-005
Boditech Med Immuno-assay Immuno- July ‘20 AAQCB12F 906004 5.1%, 7.2%, - ReCCS
Inc. on AFIAS-1 assay 10.0%, 13.0% ASRL#1
Immuno-assay Immuno- July ‘20 AAQCB12F 906004 5.1%, 7.2%, - ReCCS
on AFIAS-6 assay 10.0%, 13.0% ASRL#1
Immuno-assay Immuno- July ‘20 AAQCE87 906004 5.5%, 7.5%, - ReCCS
on ichroma assay 10.5%, 13.8% ASRL#1
Reader
Immuno-assay Immuno- July ‘20 AAQCE87 906004 5.5%, 7.5%, - ReCCS
on ichroma II assay 10.5%, 13.8% ASRL#1
Getein Biotech, Immunofluoresc Immuno- July ‘20 YBC20071 - - - Zhongshan
Inc. ence Assay on assay Hospital ASRL#2
Getein 1100
Immunofluoresc Immuno- July ‘20 P01920009 - - - Zhongshan
ence Assay on assay Hospital ASRL#2
Getein 1600
Colloidal Gold Immuno- July ‘20 6BC20035 - - - Zhongshan
on assay Hospital ASRL#2
FIA8600/8000
Instrumentation HbA1c Enzymatic July ‘20 I0520178 I0520179, 3.83, 15.46 - European
Laboratory Enzymatic I0520179 µmol/L Reference Lab
(Manual HbA1c; 98.2, ESRL#14
pretreatment) on 146.5 µmol/L
Ilab Taurus Hb
(%NGSP=HbA1c/T
Hb*91.48+2.152)
HbA1c Enzymatic July ‘20 I0520178 I0520179, 3.83, 15.46 - European
Enzymatic I0520179 µmol/L Reference Lab
(Manual HbA1c; 98.2, ESRL#14
pretreatment) on 146.5 µmol/L
Ilab Aries Hb
(%NGSP=HbA1c/T
Hb*91.48+2.152)

1
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Hunan Yonghe- YH-30 HPLC Ion- June ‘20 20191105, 20191223, 5.60%, 20200225 Zhongshan
Sun exchange 20200225 20191223 10.80% Hospital ASRL#2
Biotechnology HPLC
Co., Ltd
Changsha PCH-100 Immuno- June ‘20 0A0311 - - - Zhongshan
Sinocare Inc. assay Hospital ASRL#2
iCARE-2000 Immuno- June ‘20 09P1219 - - - Zhongshan
assay Hospital ASRL#2
iCARE-2100 Immuno- June ‘20 09P1219 - - - Zhongshan
assay Hospital ASRL#2
Sebia Capillarys Capillary June ‘20 26097/01, 06029/01, 36.5, 86.9 - European
HbA1c on Electro- 31108/01, 07029/01 mmol/mol Reference Lab
Capillarys 2 phoresis 02058/01 ESRL#10
Flex Piercing
%NGSP=0.0914
8 x [IFCC]
(mmol/mol) +
2.152
Minicap HbA1c Capillary June ‘20 18020/80, 06115/01, 36.8, 83.8 - European
%NGSP=0.0914 Electro- 30107/01, 09115/01 mmol/mol Reference Lab
8 x [IFCC] phoresis 26067/01 ESRL#10
(mmol/mol) +
2.152
CAPI 3 HbA1c Capillary June ‘20 18020/80, 06029/01, 36.5, 86.9 - European
on Capillarys 3 Electro- 07059/80, 07029/01 mmol/mol Reference Lab
%NGSP=0.0914 phoresis 02058/01 ESRL#10
8 x [IFCC]
(mmol/mol) +
2.152
Human HumanNex A1c Ion- June ‘20 200113, 20190723, 5.83%, 200113 Univ. of Missouri.
Gesellschaft fur exchange 200113, 20190723 11.03% SRL #9
Biochemica und HPLC 200113
Diagnostica
mbH
Shanghai HPLC on MQ- Ion- June ‘20 PTHbA1c20 20191030 5.88%, PTHbA1c20 Univ. of Missouri.
Medconn 2000PT exchange 0113Z, 11.18% 0113Z SRL #9
Medical HPLC PTHbA1c20
Technology Co. 0113Z,
Ltd (China) PTHbA1c20
0113Z
HPLC on MQ- Ion- June ‘20 20191209G, 20191030 5.77%, 20191209G Univ. of Missouri.
6000 exchange 20191209G, 10.88% SRL #9
HPLC 20191209G
ACON On Call Immuno- June ‘20 OGHB9110 - - - Zhongshan
Laboratories, MultiPro assay 001 Hospital ASRL#2
Inc. and Acon System-HbA1c
Biotech
(Hangzhou) Co.,
Ltd.
On Call A1c Boronate June ‘20 gHb9110002 - - - Zhongshan
affinity Hospital ASRL#2
Greencross Boronate Boronate June ‘20 R10C061 - - - Univ. of Missouri.
Medical Science Affinity on affinity SRL #9
Greencare-A1c;
also sold as
QDx A1c
Advance, Pocket
Chem A1c
Advanced,
Horron A1c and
Hemo G Smart

2
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Ortho Clinical %A1c on Vitros Immuno- June ‘20 8191 3149 0.168, 0.898, - Univ. of Missouri.
Diagnostics 5,1 FS assay 1.82, 4.031 SRL #9
g/dL HbA1c;
-0.756, 3.001,
7.4, 16.298
g/dL Hb
%A1c on Vitros Immuno- June ‘20 8191 3149 0.167, 0.887, - Univ. of Missouri.
4600 assay 1.786, 4.029 SRL #9
g/dL HbA1c;
-0.756, 3.001,
7.4, 16.298
g/dL Hb
%A1c on Vitros Immuno- June ‘20 8191 3149 0.167, 0.887, - Univ. of Missouri.
5600 assay 1.786, 4.029 SRL #9
g/dL HbA1c;
-0.756, 3.001,
7.4, 16.298
g/dL Hb
%A1c on Vitros Immuno- June ‘20 8191 3149 0.167, 0.887, - Univ. of Missouri.
XT 7600 assay 1.786, 4.029 SRL #9
g/dL HbA1c;
-0.756, 3.001,
7.4, 16.298
g/dL Hb
Siemens DCA Vantage Immuno- June ‘20 0654030, - - - Univ. of Missouri.
Healthcare assay 0655030 SRL #9
Diagnostics
Wuxi Boronate Affinity Boronate June ‘20 EAZ20021803 - - - Zhongshan
Biohermes Bio on A1cChek affinity Hospital ASRL#2
& Medical Express
Glycohemoglobin
Technology Co.,
Analysis System
Ltd.
Boronate Affinity Boronate June ‘20 EAP20031705 - - - Zhongshan
on A1C EZ 2.0 affinity Hospital ASRL#2
Glycohemoglobin
Analysis System
Boronate Affinity Boronate June ‘20 EAV20030304 - - - Zhongshan
on A1cChek Pro affinity Hospital ASRL#2
Glycohemoglobin
Analysis System
Boronate Affinity Boronate June ‘20 EAG20031601 - - - Zhongshan
on GluCoA1c affinity Hospital ASRL#2
Blood Glucose
and
Glycohemoglobin
Analysis System
HC-880 Ion- June ‘20 191216-C030 2020032901 5.18%, 9.63% G191115- Zhongshan
Automatic exchange C030 Hospital ASRL#2
Glycohemoglobin HPLC
Analysis System
Roche TQ HbA1c Gen. Immuno- June ‘20 452526, 348467 0.138, 0.355, - European
Diagnostics 3 on cobas c 501 assay 443461 0.703, 0.980, Reference Lab
GmbH / c 502 1.339, 1.913 ESRL #13
(HbA1c/Hb*91. mmol/L
5+2.15) HbA1c; 1.370,
7.387 mmol/L
Hb
TQ HbA1c Gen. Immuno- June ‘20 382581, 348467 0.156, 0.357, - European
3 Hemolysate on assay 461472, 0.675, 0.923, Reference Lab
cobas c503 436983 1.265, ESRL #13
(HbA1c/Hb*91. 1.787mmol/L
5+2.15) HbA1c; 1.43,
7.71 mmol/L
Hb

3
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
TQ HbA1c Gen. Immuno- June ‘20 382581, 348467 0.153, 0.358, - European
3 whole blood assay 461472 0.682, 0.934, Reference Lab
on cobas c503 1.283, 1.814 ESRL #13
(HbA1c/Hb*91. mmol/L
5+2.15) HbA1c; 1.43,
7.71 mmol/L
Hb
TQ HbA1c Gen. Immuno- June ‘20 437338, 348467 0.151, 0.353, - European
3 hemolysate on assay 436983, 0.673, 0.923, Reference Lab
cobas c513 451234 1.268, 1.794 ESRL #13
(HbA1c/Hb*91. mmol/L
5+2.15) HbA1c; 1.43,
7.71 mmol/L
Hb
TQ HbA1c Gen. Immuno- June ‘20 437338, 348467 0.147, 0.353, - European
3 whole blood assay 451234 0.679, 0.933, Reference Lab
on cobas c513 1.284, 1.820 ESRL #13
(HbA1c/Hb*91. mmol/L
5+2.15) HbA1c; 1.43,
7.71 mmol/L
Hb
t
Tosoh G7 HbA1c Ion- June ‘20 P7-101E, ZS9002 5.84%, P Univ. of Missouri.
Corporation Standard exchange P7-201E, 7- 10.71% SRL #9
Analysis Mode HPLC 302E, HW-
(1.2 min) HLC- 30E
723G7
t G8 HbA1c Ion- June ‘20 R8-104E, ZS9002 5.84%, R Univ. of Missouri.
Standard exchange R8-204E, 8- 10.71% SRL #9
Analysis Mode HPLC 303E, HW-
Ver. 5.24 (1.0 30E
min) HLC-
723G8
t G9 HbA1c, Ion- June ‘20 D9-105E, JS8003 5.85%, D Univ. of Missouri.
HLC-723G9, exchange D9-202D, 9- 11.02% SRL #9
Ver. 1.10 HPLC 302E, HW-
30E
G8 HbA1c Ion- June ‘20 N8-112E, ZS9002 5.84%, N Univ. of Missouri.
Variant Analysis exchange N8-212E, 10.71% SRL #9
Mode Ver. 5.24 HPLC N8-309E,
(1.6 min), HLC- HW-30E
723G8
G8 HbA1c Ion- June ‘20 N8-112E, ZS9002 5.84%, N Univ. of Missouri.
Variant Analysis exchange N8-212E, 10.71% SRL #9
Mode (1.6 min), HPLC N8-309E,
HLC-723G8 HW-30E
G8 HbA1c Ion- June ‘20 N8-112E, ZS9002 5.84%, N Univ. of Missouri.
Variant Analysis exchange N8-212E, 10.71% SRL #9
Mode Ver.5.23 HPLC N8-309E,
(1.6 min), HLC- HW-30E
723G8
G7 HbA1c Ion- June ‘20 M7-102E, ZS9002 5.84%, M Univ. of Missouri.
Variant Analysis exchange M7-201E, 10.71% SRL #9
Mode Ver.3.01 HPLC M7-302E,
(2.2 min), HLC- HW-30E
723G7
t GX, Ver.1.24 Ion- June ‘20 BX-101E, ZS9002 5.84%, B Univ. of Missouri.
HLC-723GX exchange BX-201E, 10.71% SRL #9
HPLC BX-301E,
HW-16E

4
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
t G11, Standard Ion- June ‘20 F1-101E, ZS9002 5.84%, F Univ. of Missouri.
Analysis Mode exchange F1-201E, 1- 10.71% SRL #9
Ver.3.06 (0.5 HPLC 305E, HW-
min), HLC- 30E
723G11
t G11, Variant Ion- June ‘20 B1-101F, ZS9002 5.84%, B Univ. of Missouri.
Analysis Mode exchange B1-201F, 10.71% SRL #9
Ver.3.06 (1.0 HPLC B1-306E,
min), HLC- HW-30E
723G11
Goldsite Aristo Immuno- June ‘19* 0572190607, ALO2961 5.50%, 8.10%, - ReCCS
Diagnostics Inc. assay 0572190607, 11.50%, ASRL#1
0572190607 16.30%
HbA1c on GSH- Boronate June ‘19* 20190906, ZS7002, 5.84%, - ReCCS
60 affinity 20190906, ZS7002 10.53% ASRL#1
20190906
HbA1c on Immuno- June ‘19* 0172190215, ALO2961 5.50%, 8.10%, - ReCCS
Nephstar assay 0172190215, 11.50%, ASRL#1
0172190215, 16.30%
0172190215
HbA1c on Immuno- June ‘19* 0272190116, ALO2961 5.50%, 8.10%, - ReCCS
Nephstar-Plus assay 0272190116, 11.50%, ASRL#1
0272190116, 16.30%
0272190116
HbA1c on Immuno- June ‘19* 0372200108, ALO2961 5.50%, 8.10%, - ReCCS
Omlipo assay 0372200108, 11.50%, ASRL#1
0372200108 16.30%
HbA1c on GNS- Immuno- June ‘19* 1172190215, ALO2961 5.50%, 8.10%, - ReCCS
400 assay 1172190215, 11.50%, ASRL#1
1172190215, 16.30%
1172190215
HbA1c on Immuno- June ‘19* 20190201 ALO2961 5.50%, 8.10%, - ReCCS
Alcgo assay 11.50%, ASRL#1
16.30%
HbA1c on GPP- Immuno- June ‘19* 1072190216, ALO2961 5.50%, 8.10%, - ReCCS
100 assay 1072190216, 11.50%, ASRL#1
1072190216, 16.30%
1072190216
Genrui Nephelometry Immuno- May ‘19* 20190201 - - - ReCCS
Biotech Inc on Specific assay ASRL#1
Protein
Analyzer
PA50/PA54
Nephelometry Immuno- May ‘19* 20190201 - - - ReCCS
on Fully-auto assay ASRL#1
Specific
Protein
Analyzer
PA120
Sakae MEDIDAS Immuno- May ‘20 462002 20A27 0.0%, 4.6%, - ReCCS
Corporation HbA1c on A1c assay 7.0%, 10.2%, ASRL#1
GEAR 14.0%
MEDIDAS Immuno- May ‘20 462002 20A27 0.0%, 4.6%, - ReCCS
HbA1c on A1c assay 7.0%, 10.2%, ASRL#1
iGear 14.0%
MEDIDAS Immuno- May ‘20 462002 20A27 0.0%, 4.6%, - ReCCS
HbA1c on A1c assay 7.0%, 10.2%, ASRL#1
iGear Quick 14.0%

5
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Shenzhen Boronate Boronate May ‘20 20191212 20190626, 5.6%, 9.2% - ReCCS
Labnovation Affinity Affinity 20190626 ASRL#1
Technologies, Chromatography
Inc. on LD-100, LD-
120, LD-160
Home Access Red blood Immuno- May ‘20 M911090, 1048A 0.174, 0.464, - Univ. of
Health cell-serum assay 1048A 0.847, 1.550, Missouri.
Corporation strip-based 2.364 g/dL SRL #9
cassettes on HbA1c;
Beckman 13.74 g/dL
AU680 with Hb
B00389
reagents
%HbA1c=A1c/TH
b*89.95+2.09
Abbott HbA1c Enzymatic May ‘20 55739UQ06, 55353UQ05, 5.30%, - Univ. of
Diagnostics (Hemolysate) 55739UQ06, 55353UQ05 11.00% Missouri.
on Architect 55739UQ SRL #9
c8000
%NGSP=HbA1c/
Hb*91.48+2.152
HbA1c Enzymatic May ‘20 55739UQ06, 55353UQ05, 5.30%, - Univ. of
(Hemolysate) 55739UQ06, 55353UQ05 11.00% Missouri.
on Architect 55739UQ SRL #9
c4000
%NGSP=HbA1c/
Hb*91.48+2.152
Abbott HbA1c Enzymatic May ‘20 55739UQ06, 55353UQ05, 5.30%, - Univ. of
Diagnostics (Whole Blood) 55739UQ06, 55353UQ05 11.00% Missouri.
on Architect 55739UQ SRL #9
c4000
%NGSP=HbA1c/
Hb*91.48+2.152
HbA1c Enzymatic May ‘20 55739UQ06, 55353UQ05, 5.30%, - Univ. of
(Whole Blood) 55739UQ06, 55353UQ05 11.00% Missouri.
on Architect 55739UQ SRL #9
c8000
%NGSP=HbA1c/
Hb*91.48+2.152
HbA1c Enzymatic May ‘20 55739UQ06, 55353UQ05, 5.30%, - Univ. of
(Hemolysate) 55739UQ06, 55353UQ05 11.00% Missouri.
on Alinity c 55739UQ SRL #9
%NGSP=HbA1c/
Hb*91.48+2.152
HbA1c Enzymatic May ‘20 55739UQ06, 55353UQ05, 5.30%, - Univ. of
(Whole Blood) 55739UQ06, 55353UQ05 11.00% Missouri.
on Alinity c 55739UQ SRL #9
analyzer
%NGSP=HbA1c/
Hb*91.48+2.152
Bio-Rad D-10 Dual Ion- Apr ‘20 AA90362, AA90394, 5.3%, 10.2% D70468AB Univ. of Minn
Laboratories A2/F/A1c exchange AA90363, AA90395 SRL #10
HPLC AA90366
Siemens Dimension Flex Immuno- Apr ‘20 GB0351 GB0351 0.10, 0.59, - Univ. of Missouri.
Healthcare HB1C on assay 1.12, 1.93, SRL #9
Diagnostics Inc. Dimension ExL 2.35 g/dL
HbA1c; 12.57,
12.35 g/dL Hb

6
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Dimension Flex Immuno- Apr ‘20 GB0351 GB0351 0.10, 0.59, - Univ. of Missouri.
HB1C on assay 1.12, 1.93, SRL #9
Dimension RxL 2.35 g/dL
Max HbA1c; 12.57,
12.35 g/dL Hb
Dimension Flex Immuno- Apr ‘20 GB0351 GB0351 0.10, 0.59, - Univ. of Missouri.
HB1C on assay 1.12, 1.93, SRL #9
Dimension 2.35 g/dL
Xpand HbA1c; 12.57,
12.35 g/dL Hb
Enzymatic Enzymatic Apr ‘20 190253, 9KS006, 3.29, 13.94 - Univ. of Missouri.
Hemoglobin 190253, 9KS006 µmol/L SRL #9
A1c (A1c E) – 190253, HbA1c; 97.8,
Automated 190253 146.8 µmol/L
Pretreatment on Hb
Atellica CH
Enzymatic Enzymatic Apr ‘20 150, 150, 9LS004, 2.87, 13.70 - Univ. of Missouri.
Hemoglobin 150, 150 9LS004 µmol/L SRL #9
A1c (A1c E) – HbA1c; 96.8,
Automated 148.1 µmol/L
Pretreatment on Hb
Advia XPT
Enzymatic Enzymatic Apr ‘20 150, 150, 9LS004, 2.87, 13.70 - Univ. of Missouri.
Hemoglobin 150, 150 9LS004 µmol/L SRL #9
A1c (A1c E) – HbA1c; 96.8,
Automated 148.1 µmol/L
Pretreatment on Hb
Advia 2400
Siemens Enzymatic Enzymatic Apr ‘20 150, 150, 9LS004, 2.87, 13.70 - Univ. of Missouri.
Healthcare Hemoglobin 150, 150 9LS004 µmol/L SRL #9
Diagnostics Inc A1c (A1c E) – HbA1c; 96.8,
Automated 148.1 µmol/L
Pretreatment on Hb
Advia 1800
Enzymatic Enzymatic Apr ‘20 150, 150, 9LS004, 2.87, 13.70 - Univ. of Missouri.
Hemoglobin 150, 150 9LS004 µmol/L SRL #9
A1c (A1c EM) – HbA1c; 96.8,
Manual 148.1 µmol/L
Pretreatment on Hb
Advia XPT
Enzymatic Enzymatic Apr ‘20 150, 150, 9LS004, 2.87, 13.70 - Univ. of Missouri.
Hemoglobin 150, 150 9LS004 µmol/L SRL #9
A1c (A1c EM) – HbA1c; 96.8,
Manual 148.1 µmol/L
Pretreatment on Hb
Advia 2400
Enzymatic Enzymatic Apr ‘20 150, 150, 9LS004, 2.87, 13.70 - Univ. of Missouri.
Hemoglobin 150, 150 9LS004 µmol/L SRL #9
A1c (A1c EM) – HbA1c; 96.8,
Manual 148.1 µmol/L
Pretreatment on Hb
Advia 1800
Nova Allegro, Immuno- Apr ‘20 19353015 - - - Univ. of Missouri.
Biomedical Immunoassay assay SRL #9
SD Biosensor, MultiCare Immuno- Apr ‘20 MS1019045 - - - ReCCS
Inc. Analyzer assay ASRL#1
tHbA1c v.2
Wiener Immuno- Apr ‘20 350430, 348600 2.708 g/dL - Univ. of Missouri.
Laboratorios Turbitest AA on assay 350400, HbA1c; 13.35 SRL #9
S.A.I.C. CB 350i 350340, g/dL Hb
91.5*HbA1c/Hb 354470
+ 2.15

7
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
tHbA1c v2 Immuno- Apr ‘20 350430, 348600 2.708 g/dL - Univ. of Missouri.
Turbitest AA on assay 350400, HbA1c; 13.35 SRL #9
CT600i 350340, g/dL Hb
91.5*HbA1c/Hb 354470
+ 2.15
tHbA1c v2
. Immuno- Apr ‘20 350430, 348600 2.708 g/dL - Univ. of Missouri.
Turbitest AA on assay 350400, HbA1c; 13.35 SRL #9
CM 250 350340, g/dL Hb
91.5*HbA1c/Hb 354470
+ 2.15
tHbA1c v2 Immuno- Apr ‘20 350430, 348600 2.708 g/dL - Univ. of Missouri.
Turbitest AA on assay 350400, HbA1c; 13.35 SRL #9
CMD 600 350340, g/dL Hb
91.5*HbA1c/Hb 354470
+ 2.15
tHbA1c v2 Immuno- Apr ‘20 350430, 348600 2.708 g/dL - Univ. of Missouri.
Turbitest AA on assay 350400, HbA1c; 13.35 SRL #9
CMD 800i X1 350340, g/dL Hb
91.5*HbA1c/Hb 354470
+ 2.15
t Rapidia Auto
Fujirebio Inc. Immuno- Apr ‘20 QF91105, VF90703 0.0%, 4.3%, - ReCCS
HbA1c-L on assay RF91105, 6.9%, 9.6%, ASRL#1
BiOLis24i SF90703 13.3%
Premium
t Rapidia Auto Immuno- Apr ‘20 QF91105, VF90703 0.0%, 4.3%, - ReCCS
HbA1c-L on assay RF91105, 6.9%, 9.6%, ASRL#1
JCA-BM9130 SF90703 13.3%
t AU-Synchron
Fujirebio Inc. Immuno- Apr ‘20 F9A022, H1A023 0.0%, 4.3%, - ReCCS
Reagent HbA1c assay F9A022, 6.9%, 9.6%, ASRL#1
on AU680 H2A015 13.3%
t Rapidia Auto Immuno- Apr ‘20 QF91105, VF90703 0.0%, 4.3%, - ReCCS
HbA1c-L on assay RF91105, 6.9%, 9.6%, ASRL#1
AU680 SF90703 13.3%
t Rapidia Auto Immuno- Apr ‘20 QF91105, VF90703 0.0%, 4.3%, - ReCCS
HbA1c-L on assay RF91105, 6.9%, 9.6%, ASRL#1
Hitachi 7180 SF90703 13.3%
t Rapidia Auto Immuno- Apr ‘20 QF91105, VF90703 0.0%, 4.3%, - ReCCS
HbA1c-L on assay RF91105, 6.9%, 9.6%, ASRL#1
TBA-120FR SF90703 13.3%
Abbott Afinion HbA1c / Boronate Apr ‘20 10206198 - - - European
Diagnostics Afinion AS100 affinity Reference Lab
Technologies Analyzer ESRL #11
AS
Afinion HbA1c Boronate Apr ‘20 10201094 - - - European
Dx / affinity Reference Lab
Afinion AS100 ESRL #11
Analyzer
NycoCard Boronate Apr ‘20 10205489, - - - European
HbA1c on affinity 10204605, Reference Lab
NycoCard 10205933 ESRL #11
Reader II
Afinion HbA1c Boronate Apr ‘20 10201094 - - - European
Dx / affinity Reference Lab
Afinion 2 ESRL #11
Analyzer
Afinion HbA1c / Boronate Apr ‘20 10206198 - - - European
Afinion 2 affinity Reference Lab
Analyzer ESRL #11
t ADAMS A1c
Arkray, Inc. Ion- Apr ‘20 19100931, S9003 5.2%, 10.6%; 9LY-1R ReCCS
HA-8160 VP exchange 19072512, ASRL#1
mode HPLC 19100433,
19101714
8
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
t ADAMS A1c Ion- Apr ‘20 19100931, S9003 5.2%, 10.6%; 9LW-4R ReCCS
HA-8160 TP exchange 19072512, ASRL#1
mode HPLC 19102334,
19101735,
19101714
t ADAMS A1c Ion- Apr ‘20 19101857, S9003 5.2%, 10.6%; 9GF-1AR ReCCS
HA-8160 exchange 19062158, ASRL#1
(Ver.4) HPLC 19032959,
19051555
t ADAMS A1c Ion- Apr ‘20 19101857, S9003 5.2%, 10.6%; 9LG-1R ReCCS
HA-8170 exchange 19062158, ASRL#1
HPLC 19032959,
1951555
t ADAMS A1c Ion- Apr ‘20 190620101, S9003 5.2%, 10.6%; 9B078N ReCCS
HA-8180 exchange 190612102, ASRL#1
HPLC 190918105
ADAMS A1c Ion- Apr ‘20 190620101, S9003 5.2%, 10.6%; 9B143U ReCCS
HA-8180V exchange 190612102, ASRL#1
Variant mode HPLC 190315140,
190918105
t ADAMS A1c Ion- Apr ‘20 190620101, S9003 5.2%, 10.6%; 9B143U ReCCS
HA-8180V exchange 190612102, ASRL#1
Fast mode HPLC 190315140,
190918105
t
Arkray, Inc. ADAMS A1c Ion- Apr ‘20 190620101, S9003 5.2%, 10.6%; 9LL-1AR ReCCS
HA-8180T exchange 190612102, ASRL#1
HPLC 190514160,
190918105
t ADAMS Ion- Apr ‘20 190620101, S9003 5.2%, 10.6%; 9B078N ReCCS
HYBRID AH- exchange 190612102, ASRL#1
8290 HPLC 190918105

t ADAMS A1c Ion- Apr ‘20 190620101, S9003 5.2%, 10.6%; 9B078N ReCCS
HA-8181 exchange 190612102, ASRL#1
HPLC 190918105
t ADAMS Ion- Apr ‘20 9L1001, CA89F93 5.3%, 10.7% 9K398N ReCCS
HYBRID AH- exchange 9E1002, ASRL#1
8280 HPLC 9I1044
t ADAMS A1c Ion- Apr ‘20 190620101, S9003 5.1%, 10.7%; 9LV-1AR ReCCS
HA-8190V exchange 190612102, ASRL#1
Variant mode HPLC 190717364,
190918105
t ADAMS A1c Ion- Apr ‘20 190620101, S9003 5.1%, 10.6%; 9LV-1AR ReCCS
HA-8190V Fast exchange 190612102, ASRL#1
mode HPLC 190717364,
190918105
t CinQ HbA1c Enzymatic Apr ‘20 MFA16, CAC8J22 2.46, 7.40 - ReCCS
on JCA- MFE17 µmol/L ASRL#1
BM6010 HbA1c
HbA1c%(NGSP (IFCC); 95.9
)=0.0915*HbA1 µmol/L Hb
c/Hb*1000(IFC (IFCC)
C)+2.15
t CinQ HbA1c Enzymatic Apr ‘20 MFA16, CAC8J22 2.46, 7.40 - ReCCS
on TBA-120FR MFE17 µmol/L ASRL#1
HbA1c%(NGSP HbA1c
)=0.0915*HbA1 (IFCC); 95.9
c/Hb*1000(IFC µmol/L Hb
C)+2.15 (IFCC)

9
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
t CinQ HbA1c Enzymatic Apr ‘20 MFA16, CAC8J22 2.46, 7.40 - ReCCS
on JCA- MFE17 µmol/L ASRL#1
BM9130 HbA1c
HbA1c%(NGSP (IFCC); 95.9
)=0.0915*HbA1 µmol/L Hb
c/Hb*1000(IFC (IFCC)
C)+2.15
t CinQ HbA1c
Enzymatic Apr ‘20 MFA16, CAC8J22 2.46, 7.40 - ReCCS
on JCA-ZS050 MFE17 µmol/L ASRL#1
HbA1c%(NGSP HbA1c
)=0.0915*HbA1 (IFCC); 95.9
c/Hb*1000(IFC µmol/L Hb
C)+2.15 (IFCC)
t CinQ HbA1c Enzymatic Apr ‘20 HLS27 CAC8J22 2.46, 7.40 - ReCCS
on Hitachi µmol/L ASRL#1
LABOSPECT HbA1c
006 (IFCC); 95.9
HbA1c%(NGSP µmol/L Hb
)=0.0915*HbA1 (IFCC)
c/Hb*1000(IFC
C)+2.15
t ADAMS A1c Ion- Apr ‘20 190620101, S9003 5.2%, 10.6%; 9B078N ReCCS
Lite HA-8380 exchange 190612102, ASRL#1
HPLC 190918105
t ADAMS A1c Ion- Apr ‘20 190620101, S9003 5.2%, 10.6%; 9B143U ReCCS
Lite HA-8380V exchange 190612102, ASRL#1
Fast mode HPLC 190315140,
190918105
t
Arkray, Inc. ADAMS A1c Ion- Apr ‘20 190620101, S9003 5.2%, 10.6%; 9B143U ReCCS
Lite HA-8380V exchange 190612102, ASRL#1
Variant mode HPLC 190315140,
190918105
t ADAMS A1c Ion- Apr ‘20 9L1001, CA89F93 5.3%, 10.7% 9G692N ReCCS
HA-8182 exchange 9J1002, ASRL#1
HPLC 9K1043
@ CE119M1A1,
The Lab 001 Capillary Apr ‘20 - - - ReCCS
HbA1c%(NGSP)= Electroph CE119M2A1 ASRL#1
0.915*HbA1c/Hb* oresis
1000(IFCC)+2.15
Shenzhen Immunofluoresc Immuno- Mar ‘20 20190903, 20190903, 6.52% - Zhongshan
Microprofit ence assay 20190904, 20190903, 9.50%, Hospital ASRL#2
Biotech Co., Chromatograph 20191001 20190904, 6.51%,
Ltd. on MF-T1000 20190904, 9.50%,
Dry-Type 6.49%,
Immunofluoresc
20191001, 9.52%
ence 20191001
Quantitative
Analyzer
Thermos Fisher HbA1c for Immuno- Mar ‘20 S645, S372 S127 1.5824 - European
Scientific Oy Indiko, ref assay mmol/L Reference Lab
981947, 981948 HbA1c; 8.626 ESRL #13
(91.5*HbA1c/Hb* mmol/L Hb
+2.15)
HbA1c for Immuno- Mar ‘20 S645, S372 S127 1.5824 - European
Konelab, ref assay mmol/L Reference Lab
981947, 981948 HbA1c; 8.626 ESRL #13
(91.5*HbA1c/Hb* mmol/L Hb
+2.15)
UMA Co., Ltd MEASURE Immuno- Mar ‘20 328 AIL, 127AJA 0.0%, 5.5%, - ReCCS
194AJA
HbA1c II on assay 8.4%, 11.5%, ASRL#1
Hitachi 7180 15.4%
Fujikura Kasei HbA1c-FW on Immuno- Mar ‘20 W20A091W W19H022W 4.6%, 8.5%, - ReCCS
Co., Litd Hitachi 7180 assay 11.9%, 15.9% ASRL#1
10
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
HbA1c-F on Immuno- Mar ‘20 W19I191C W19H021C 4.6%, 8.6%, - ReCCS
Hitachi 7180 assay 12.2%, 16.4% ASRL#1
J. Mitra & Co. Fluorescence Immuno- Mar ‘20 HBQ/XI/101219 - - - European
Pvt Limited immunoassay on assay Reference Lab
i-Quant ESRL #10
Analyser
PTS Diagnostics A1Cnow+; Immuno- Mar ‘20 1810914 - - - Univ. of Missouri.
A1Cnow assay SRL #9
SELFCHECK
Trinity Biotech Boronate Boronate Mar ‘20 8384, 10330, 9951, 9952 5.1%, 11.7% 8069 Univ. of Missouri.
10267, 8380
Affinity HPLC affinity SRL #11
on PDQ HPLC
Boronate Boronate Mar ‘20 8384, 10330, 9851, 9852 5.3%, 12.4% 8069 Univ. of Missouri.
10267, 10502
Affinity HPLC affinity SRL #11
on ultra2 HPLC
Boronate Boronate Mar ‘20 10333, 10330, 9851, 9852 5.1%, 11.8% 10002 Univ. of Missouri.
10267, 8993
Affinity HPLC affinity SRL #11
on Premier HPLC
Hb9210
t L type Norudia 116RJQ,
Sekisui Medical Enzymatic Mar ‘20 112RIQ 3.46, 14.95 - ReCCS
116RJQ,
Co., Ltd. N HbA1c on 117RJQ
µmol/L ASRL#1
Hitachi LST008 HbA1c; 101.2,
147.3 µmol/L
Hb
t 116RJQ,
Sekisui Medical L type Norudia Enzymatic Mar ‘20 112RIQ 3.46, 14.95 - ReCCS
116RJQ,
Co., Ltd. N HbA1c on 117RJQ
µmol/L ASRL#1
Hitachi LST006 HbA1c; 101.2,
147.3 µmol/L
Hb
t 116RHQ,
Norudia N Enzymatic Mar ‘20 123RIQ 3.34, 15.18 - ReCCS
116RHQ,
HbA1c on 117RJQ
µmol/L ASRL#1
Hitachi 7170S HbA1c; 100.1,
156.9 µmol/L
Hb
t 116RHQ,
Norudia N Enzymatic Mar ‘20 123RIQ 3.34, 15.18 - ReCCS
116RHQ,
HbA1c on 117RJQ
µmol/L ASRL#1
EV800 HbA1c; 100.1,
156.9 µmol/L
Hb
t Norudia N 116RHQ,
Enzymatic Mar ‘20 123RIQ 3.34, 15.18 - ReCCS
116RHQ,
HbA1c on JCA- 117RJQ
µmol/L ASRL#1
BM9130 HbA1c; 100.1,
156.9 µmol/L
Hb
t 1902050025
Adams A1c Ion- Mar ‘20 1902040018 5.29%, 1005003319 ReCCS
mini exchange 11.28% ASRL#1
HPLC
t 1902050025
RC20 Ion- Mar ‘20 1902040018 5.29%, 180400222 ReCCS
exchange 11.28% ASRL#1
HPLC
t 116RHQ,
Norudia N Enzymatic Mar ‘20 123RIQ 3.34, 15.18 - ReCCS
116RHQ,
HbA1c on TBA- 117RJQ
µmol/L ASRL#1
120FR HbA1c; 100.1,
156.9 µmol/L
Hb
t 102RLQ,
(RE) Norudia Enzymatic Mar ‘20 105RIQ 3.36, 15.84 - ReCCS
102RLQ,
N HbA1c on 117RJQ
µmol/L ASRL#1
TBA-nx360 HbA1c; 106.1,
165.6 µmol/L
Hb

11
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
t 106RLQ,
(RE) Norudia Enzymatic Mar ‘20 105RIQ 3.36, 15.84 - ReCCS
106RLQ,
N HbA1c on 117RJQ
µmol/L ASRL#1
Hitachi 7180 HbA1c; 106.1,
165.6 µmol/L
Hb
t HbA1c Auto 116RHQ,
Enzymatic Mar ‘20 111RIQ 3.34, 15.18 - ReCCS
116RHQ,
TBA on TBA- 117RJQ
µmol/L ASRL#1
120FR HbA1c; 100.1,
156.9 µmol/L
Hb
t Norudia 191018, 191018
Enzymatic Mar ‘20 123RIQ 3.82, 16.74 - ReCCS
HbA1c II on µmol/L ASRL#1
JCA-BM9130 HbA1c; 104.6,
154.1 µmol/L
Hb
t 1907110001
RC-W FAST Ion- Mar ‘20 1906100001 5.41%, 1912160026 ReCCS
Mode exchange 11.06% ASRL#1
HPLC
t RC-W Variant Ion- 1907110001
Mar ‘20 1906100001 5.36%, 1912160026 ReCCS
Mode exchange 11.06% ASRL#1
HPLC
t 403AII, 403AII
Hitachi Determiner L Immuno- Mar ‘20 400AIJ 0.0%, 4.5%, - ReCCS
Chemical HbA1c on DM- assay 6.9%, 9.8%, ASRL#1
Diagnostics JACK 13.1%
t Determiner L 403AII, 403AII
Hitachi Immuno- Mar ‘20 400AIJ 0.0%, 4.5%, - ReCCS
Chemical HbA1c on JCA- assay 6.8%, 9.7%, ASRL#1
Diagnostics BM9130 13.2%
t Determiner L 403AII, 403AII
Immuno- Mar ‘20 401AIJ 0.0%, 4.3%, - ReCCS
HbA1c on assay 6.9%, 9.7%, ASRL#1
Hitachi 7180 13.3%
t Determiner L 403AII, 403AII
Immuno- Mar ‘20 400AIJ 0.0%, 4.5%, - ReCCS
HbA1c on TBA- assay 6.8%, 9.7%, ASRL#1
120FR 13.2%
t Determiner 403AII, 403AII
Immuno- Mar ‘20 400AIJ 0.0%, 4.5%, - ReCCS
HbA1c on assay 6.8%, 9.7%, ASRL#1
FUNOTEC 13.2%
FC300
Green Cross Boronate Boronate Feb ‘20 HC4339J11R1, - - - Univ. of Missouri.
HC4339J11R2,
Medis Corp. Affinity on Affinity HC4339J11EW
SRL #9
Cera-Stat 4000
(Merilyzer
Mericheck
Analyzer)
Boronate Boronate Feb ‘20 HC2339K18R1, - - - Univ. of Missouri.
HC2339K18R2,
Affinity on Affinity HC2339K18EW
SRL #9
Cera-Stat 2000
(QDx A1c
Analyzer)
Boronate Boronate Feb ‘20 HM2339J23R1, - - - Univ. of Missouri.
HM2339J23R2,
Affinity Affinity HM2339J23EW,
SRL #9
LabonaCheck
A1c HbA1c
Analyzer
(Model:
MH200),
A1Card HbA1c
Analyzer
Shenzhen HPLC on LD- Ion- Feb ‘20 20190416 20190626, 5.6%, 9.2% - ReCCS
Labnovation 500, LD-510, exchange 20190626 ASRL#1
Technologies, LD-520 HPLC
Inc.

12
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
HPLC on LD- Ion- Feb ‘20 20190712 20190626, 5.7%, 9.2% - ReCCS
560, LD-561, exchange 20190626 ASRL#1
LD-562 HPLC
HPLC on LD- Ion- Feb ‘20 20190820 20190626, 5.6%, 9.2% - ReCCS
600, LD-620 exchange 20190626 ASRL#1
HPLC
Ark Diagnostics HPLC on Ion- Feb ‘20 190902-01, 19090116, 5.40%, COL190901 Zhongshan
Bangalore Pvt. CKKA1c exchange 190902-02, 19090126 11.40% Hospital ASRL#2
Ltd. HPLC 190902-03,
190902-04
Shenzhen Ion-exchange Ion- Jan ‘20 H8SE19027 H8SE19027 5.50%, I02DSE1970 ReCCS
Lifotronic HPLC on H8 exchange 10.00% 0001 ASRL#1
Technology Co., Hemoglobin HPLC
Ltd. Analyzer; also
sold by ASSEL
srl as AS8
Ion-exchange Ion- Jan ‘20 H8SE19027 H8SE19027 5.50%, I02DSE1970 ReCCS
HPLC on H9 exchange 10.00% 0002 ASRL#1
Hemoglobin HPLC
Analyzer; also
sold by ASSEL
srl as AS9
Lateral Flow Immuno- Jan ‘20 8519017 - - - ReCCS
Immunoassay assay ASRL#1
on FA-160
Shenzhen Ion-exchange Ion- Jan ‘20 821943 G9N19081 5.50%, GH19040275 ReCCS
Lifotronic HPLC on exchange 10.40% ASRL#1
Technology Co., GH900 and HPLC
Ltd. GH900Plus
Hemoglobin
Analyzer
Nihon Kohden @Celltac Chemi Immuno- Jan ‘20 89004 CEN008 0.0%, 4.4%, - ReCCS
Corporation HbA1c N on assay 6.7%, 9.6%, ASRL#1
MEK-1303 12.9%
@Celltac Chemi Immuno- Jan ‘20 89051 CEN008 0.0%, 4.3%, - ReCCS
HbA1c on assay 6.8%, 9.6%, ASRL#1
CHM-4100 12.9%
Biosurfit Spinit HbA1c Boronate Jan ‘20 427_01 - - - European
test Affinity Reference Lab
ESRL#11
i-SENS Enzymatic on Enzymatic Jan ‘20 DFBZAC - - - ReCCS
A1Care ASRL#1
Boditech Med Immuno-assay Immuno- Jan ‘20 AAPXE22 906004 5.5%, 7.5%, - ReCCS
Inc. on ichroma II assay 10.5%, 13.8% ASRL#1
t Immunoassay
TaiDoc Immuno- Jan ‘20 19I223 704101-122 5.5%, 7.9%, - European
Technology on TD-4611 assay 10.7%, 15.5% Reference Lab
Corp. ESRL#13
t
Bio-Rad VARIANT II Ion- Jan ‘20 64297955, 64287653, 5.3%, 10.4% VA60425 Univ. of Minn
Laboratories Dual (A1c) exchange 64297956, 64287656 Dual (A1c) SRL #10
HPLC 6492761
t VARIANT II Ion- Jan ‘20 64297955, 64287663, 5.1%, 10.4% VA60425 Univ. of Minn
Dual exchange 64297956, 64287664 Dual SRL #10
(A2/F/A1c) HPLC 64292761 (A2/F/A1c)

D-10 HbA1c Ion- Jan ‘20 AA90299, AA90242, 5.4%, 10.2% R70468R Univ. of Minn
(12000949) exchange AA90300, AA90243 SRL #10
HPLC AA90220
D-10 HbA1c Ion- Jan ‘20 AA90258, AA90271, 5.3%, 10.1% A70468AK Univ. of Minn
exchange AA90259, AA90272 SRL #10
HPLC AA90004

13
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
D-100 HbA1c Ion- Jan ‘20 64298608, 64293212, 5.92%, 9.61% 90095AB Univ. of Minn
exchange 64301694, 64293212 SRL #10
HPLC 64303938
Variant II Ion- Jan ‘20 64284285, 64232925, 5.6%, 10.1% NU70415J Univ. of Minn
HbA1c NU exchange 64284286, 64232927 SRL #10
HPLC 64234894
VARIANT II Ion- Jan ‘20 64296652, 64287389, 5.2%, 10.2% 70234AJ Univ. of Minn
TURBO HbA1c exchange 64296654, 64287390 SRL #10
Kit – 2.0 HPLC 64297942
(12000447)
VARIANT II Ion- Jan ‘20 64296652, 64287389, 5.2%, 10.2% 70234AJ Univ. of Minn
TURBO HbA1c exchange 64296654, 64287390 SRL #10
Kit – 2.0 HPLC 64297942
Trinity Biotech Tri-stat 1 Boronate Jan ‘20 9329 (2I), - - - Univ. of Missouri.
HbA1c Assay Affinity 10069(2y) SRL #11
Tri-stat 2 Boronate Jan ‘20 10308 (2A) - - - Univ. of Missouri.
HbA1c Assay Affinity SRL #11
Skyla Immunoassay Immuno- Jan ‘20 A1ZH19103 - - - ReCCS
Corporation on Skyla Hi assay ASRL#1
Hsinchu Science Analyzer
Park Branch
Maccura Ion-exchange Ion- Jan ‘20 0919011 0919011 5.4%, 9.3% BZ168 Zhongshan
Biotechnology HPLC on exchange Hospital ASRL#2
Co., Ltd maccura G 01 HPLC
MedTestDx Pointe Scientific Immuno- Jan ’20 H7546 906004 5.0%, 7.7%, - European
on Biolis 24i assay 11.8%, 15.5% Reference Lab
ESRL#13
Pointe Scientific Immuno- Jan ’20 H7546:91280 906004 5.3%, 8.5%, - European
on AU400 assay 1/2020-10-31 12.5%, 15.5% Reference Lab
ESRL#13
SD Biosensor, Standard Immuno- Jan ’20 AC0219013 - - - ReCCS
Inc. A1cCare assay ASRL#1
Standard F on Immuno- Jan ’20 FHB10191004 - - - ReCCS
Standard F-100 assay 2 ASRL#1
Standard F on Immuno- Jan ’20 FHB1019100 - - - ReCCS
Standard F-200 assay 42 ASRL#1
Standard F on Immuno- Jan ’20 FHB10191004 - - - ReCCS
Standard F-2400 assay 2 ASRL#1
ELITech HbA1c Immuno- Jan ’20 R190864, R190296, 5.1%, 8.4%, - European
Clinical Systems (immunoturbiti assay R190865, R190297, 11.6%, 16.1% Reference Lab
SAS metric assay) on R190866, R190298, ESRL#13
A190377
Selectra ProM R190299
AA-PRO-ELserie-
HBAC-1.pdf
HbA1c Immuno- Jan ’20 R190864, R190296, 5.1%, 8.4%, - European
(immunoturbiti assay R190865, R190297, 11.6%, 16.1% Reference Lab
metric assay) on R190866, R190298, ESRL#13
A190377
Selectra ProS R190299
AA-PRO-ELserie-
HBAC-1.pdf
Archem HbA1c Immuno- Jan ’20 081 020 5.6%, 8.1%, - European
Diagnostic Immunotrubidi assay 11.2%, 15.5% Reference Lab
metric on ESRL#13
Architect c
DxGen Corp. Boronate Boronate Dec ‘19 C19J1601R1, - - - Univ. of Missouri.
affinity on Affinity C19J1601W1, SRL #9
Epithod 616 C19J16001C1
Boronate Boronate Dec ‘19 C19J1601R1, - - - Univ. of Missouri.
affinity on Affinity C19J1601W1, SRL #9
Epithod 414 C19J16001C1

14
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
DiaSys HbA1c net FS, Enzymatic Dec ‘19 26535, 27376, 0.418, 1.09 - European
Diagnostic on respons910 26536 27376 g/dL HbA1c; Reference Lab
Systems GmbH HbA1c/Hb*91.5 7.50, 14.8 ESRL#10
+2.15 g/dL Hb
HbA1c net FS, Enzymatic Dec ‘19 26535, 27376, 0.418, 1.09 - European
on JCA- 26536 27376 g/dL HbA1c; Reference Lab
BM6010/C 7.50, 14.8 ESRL#10
HbA1c/Hb*91.5 g/dL Hb
+2.15
HbA1c net FS, Enzymatic Dec ‘19 26535, 27376, 0.425, 1.21 - European
on Hitachi 917 26536 27376 g/dL HbA1c; Reference Lab
HbA1c/Hb*91.5 4.69, 15.0 ESRL#10
+2.15 g/dL Hb
oneHbA1c IS, Enzymatic Dec ‘19 113, 25676 26858, 34.3, 66.5, - European
InnovaStar 26859, 112, 166 Reference Lab
HbA1c/Hb*91.5 26860, mmol/mol ESRL#10
+2.15 26861
Roche Cobas HbA1c Immuno- Dec ‘19 928131-01 - - - Univ. of Missouri.
Diagnostics Test on cobas b assay SRL #9
International Ltd 101
Roche TQ HbA1c Gen. Immuno- Dec ‘19 401258, 319736 0.01726, - European
Diagnostics 3 Whole Blood assay 384400 0.01151, Reference Lab
on Cobas 0.00822, ESRL#13
0.00575,
Integra 400 Plus
0.00288,
HbA1c/Hb*91.5 0.00115 mmol/L
+2.15 HbA1c;
0.07833,
0.05222,
0.03730,
0.02611,
0.01306,
0.00522 mmol/L
Hb
TQ HbA1c Gen. Immuno- Dec ‘19 401258, 319736 0.130, 0.334, - European
3 Whole Blood assay 407157 0.661, 0.922, Reference Lab
on cobas c311 1.259, 1.799 ESRL#13
mmol/L HbA1c;
HbA1c/Hb*91.5
1.452, 7.833
+2.15 mmol/L Hb
TQ HbA1c Gen. Immuno- Dec ‘19 420814, 319736 0.0162, 0.0108, - European
3 Whole Blood assay 392151 0.00771, 0.0054, Reference Lab
on Cobas c111 0.0027, 0.00108 ESRL#13
mmol/L HbA1c;
HbA1c/Hb*91.5
0.07833,
+2.15 0.05222, 0.0373,
0.02611,
0.01306,
0.00522 mmol/L
Hb
TQ HbA1c Gen. Immuno- Dec ‘19 401258, 319736 1.744, 1.163, - European
3 Hemolysate on assay 384400, 0.830, 0.581, Reference Lab
Cobas Integra 416817 0.291, 0.116 ESRL#13
mmol/L HbA1c;
400 Plus
7.833, 5.222,
HbA1c/Hb*91.5 3.730, 2.611,
+2.15 1.306, 0.522
mmol/L Hb
Siemens Dimension Vista Immuno- Dec ‘19 19112BA 9DD078 0.13, 0.49, - Univ. of Missouri.
Healthineers A1C on Vista assay 0.92, 1.59, SRL #9
1500 2.38 g/dL
HbA1c; 11.91,
11.77 g/dL Hb

15
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Dimension Vista Immuno- Dec ‘19 19112BA 9DD078 0.13, 0.49, - Univ. of Missouri.
A1C on Vista assay 0.92, 1.59, SRL #9
500 2.38 g/dL
HbA1c; 11.91,
11.77 g/dL Hb
Bioanalytic Immunoassay Immuno- Dec ‘19 938729N, 828300N 5.8%, 8.8%, - European
(Diaclinica on AU 680 assay 938729N, 11.6%, 15.4% Reference Lab
Diagnostik 936903N ESRL#13
Kimya)
Siemens Dimension Immuno- Nov ‘19 GA9319 GA9319 0.10, 0.57, - Univ. of Missouri.
Healthcare Hemoglobin assay 1.06, 1.75, SRL #9
A1c (A1C) on 2.54 g/dL
Dimension EXL HbA1c; 12.29,
11.77 g/dL Hb
Dimension Immuno- Nov ‘19 GA9319 GA9319 0.10, 0.57, - Univ. of Missouri.
Hemoglobin assay 1.06, 1.75, SRL #9
A1c (A1C) on 2.54 g/dL
Dimension RxL HbA1c; 12.29,
11.77 g/dL Hb
Dimension Immuno- Nov ‘19 GA9319 GA9319 0.10, 0.57, - Univ. of Missouri.
Hemoglobin assay 1.06, 1.75, SRL #9
A1c (A1C) on 2.54 g/dL
Dimension HbA1c; 12.29,
Xpand 11.77 g/dL Hb
Siemens Dimension Vista Immuno- Nov ‘19 19196BA 9GD084 0.09, 0.56, - Univ. of Missouri.
Healthcare Flex HbA1c assay 1.03, 1.76, SRL #9
Diagnostics, Inc. 2.44 g/dL
HbA1c; 13.93,
13.73 g/dL Hb
OSANG Frontier and Boronate Nov ‘19 F19H28I05EL - - - Univ. of Missouri.
Healthcare Co., HemoCue Affinity SRL #9
Ltd. HbA1c 501
Clover A1c, Boronate Nov ‘19 A19I04I16EL - - - Univ. of Missouri.
Clover A1c Self Affinity SRL #9
and Checkart
Clover A1c Plus Boronate Nov ‘19 B19G26H16EL - - - Univ. of Missouri.
Affinity SRL #9
Clover A1c, Boronate Nov ‘19 C19A23B19DL - - - Univ. of Missouri.
Clover A1c Self Affinity SRL #9
and Checkart
ACON On Call A1c Boronate Oct ‘19 201907233 - - - Zhongshan
Laboratories, affinity Hospital ASRL#2
Inc. and Acon
Biotech
(Hangzhou) Co.,
Ltd.
Sekisui HbA1c (Whole Immuno- Oct ‘19 53376, 53569 4.62%, - Univ. of Missouri.
Diagnostics Blood) on assay 53376, 12.01% SRL #9
SK500 53376
Boditech Med Immuno-assay Immuno- Oct ‘19 AAPFA88F 704101 4.9%, 7.3%, - ReCCS
Inc. on AFIAS-6 assay 9.5%, 12.0% ASRL#1
Immuno-assay Immuno- Oct ‘19 AAPFA88F 704101 4.9%, 7.3%, - ReCCS
on AFIAS-1 assay 9.5%, 12.0% ASRL#1
Beckman- UniCel DxC Immuno- Oct ‘19 M908026 M901001 0.183, 0.485, - Univ. of Missouri.
Coulter Inc. Synchron assay 0.864, 1.632, SRL #9
Systems 2.454 g/dL
HbA1c- on HbA1c; 18.28
DxC 800 g/dL Hb

16
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
UniCel DxC Immuno- Oct ‘19 M811015 M907003 0.152, 0.475, - Univ. of Missouri.
Synchron assay 0.885, 1.675, SRL #9
Systems 2.314 g/dL
HbA1c3 on HbA1c; 18.40
DxC 800 g/dL Hb
HORIBA, Ltd. Spotchem Immuno- Oct ‘19 1932HE498O WC0050 0.0, 25.6, 51.6, - ReCCS
Banalyst HbA1c assay 83.3, 124.4 ASRL#1
on SI-3620 mmol/mol
Banalyst Ace Immuno- Oct ‘19 1931HE001C WC0050 0.0, 25.6, 51.6, - ReCCS
HbA1c on assay 83.3, 124.4 ASRL#1
Banalyst Ace mmol/mol
B-analyst Immuno- Oct ‘19 1932HE098O WC0050 0.0, 25.6, 51.6, - ReCCS
HbA1c on B- assay 83.3, 124.4 ASRL#1
analyst S1 mmol/mol
Spotchem Immuno- Oct ‘19 1932HE498O WC0050 0.0, 25.6, 51.6, - ReCCS
Banalyst HbA1c assay 83.3, 124.4 ASRL#1
on SI-3610 mmol/mol
Banalyst HbA1c Immuno- Oct ‘19 1932HEH98A WC0050 0.0, 25.6, 51.6, - ReCCS
on Yumizen assay 83.3, 124.4 ASRL#1
mmol/mol
Caretium Cation-exchange Ion- Oct ‘19 20190611 20190611 5.10%, 20190507 ReCCS
Medical chromatography exchange 10.40% ASRL#1
Instruments Co., on HbA1c HPLC
Limited analyzer KH-
101
Shenzhen Enzymatic on Enzymatic Oct ‘19 045618002 155118003 3.10, - ReCCS
Mindray Bio- BS-200E 16.9µmol/L ASRL#1
Medical HbA1c; 96.0,
Electronics Co., 157 µmol/L
Ltd Hb
Enzymatic on Enzymatic Oct ‘19 045618002 155118003 3.10, - ReCCS
BS-240 16.9µmol/L ASRL#1
HbA1c; 96.0,
157 µmol/L
Hb
Enzymatic on Enzymatic Oct ‘19 045618002 155118003 3.10, - ReCCS
BS-240Pro 16.9µmol/L ASRL#1
HbA1c; 96.0,
157 µmol/L
Hb
Enzymatic on Enzymatic Oct ‘19 045618002 155118003 3.10, - ReCCS
BS-360E 16.9µmol/L ASRL#1
HbA1c; 96.0,
157 µmol/L
Hb
Enzymatic on Enzymatic Oct ‘19 045618002 155118003 3.10, - ReCCS
BS-380 16.9µmol/L ASRL#1
HbA1c; 96.0,
157 µmol/L
Hb
Enzymatic on Enzymatic Oct ‘19 045618002 155118003 3.10, - ReCCS
BS-400 16.9µmol/L ASRL#1
HbA1c; 96.0,
157 µmol/L
Hb
Enzymatic on Enzymatic Oct ‘19 045618002 155118003 3.10, - ReCCS
BS-460 16.9µmol/L ASRL#1
HbA1c; 96.0,
157 µmol/L
Hb

17
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Enzymatic on Enzymatic Oct ‘19 045618002 155118003 3.10, - ReCCS
BS-480 16.9µmol/L ASRL#1
HbA1c; 96.0,
157 µmol/L
Hb
Enzymatic on Enzymatic Oct ‘19 045618002 155118003 3.10, - ReCCS
BS-800 & BS- 16.9µmol/L ASRL#1
800M HbA1c; 96.0,
157 µmol/L
Hb
Enzymatic on Enzymatic Oct ‘19 045618002 155118003 3.10, - ReCCS
BS-830 16.9µmol/L ASRL#1
HbA1c; 96.0,
157 µmol/L
Hb
Enzymatic on Enzymatic Oct ‘19 045618002 155118003 3.10, - ReCCS
BS-2000 & BS- 16.9µmol/L ASRL#1
2000M HbA1c; 96.0,
157 µmol/L
Hb
Ion-exahange Ion- Oct ‘19 2018072601, 812RBQ N, 5.33%, 7I021M ReCCS
HPLC on exchange 2018091501, 812RBQ H 11.56% ASRL#1
H50/H50P HPLC 2018112201
Hitachi MetaboLead Enzymatic Oct ‘19 401AIE, 155AIA 2.46, 9.59 - ReCCS
Chemical HbA1c on JCA- 401AIE µmol/L ASRL#1
Diagnostics BM9130 HbA1c; 81.8,
Systems Co., 118.0 µmol/L
Ltd. Hb
MetaboLead Enzymatic Oct ‘19 401AIE, 155AIA 2.46, 9.59 - ReCCS
HbA1c on DM- 401AIE µmol/L ASRL#1
JACK HbA1c; 81.8,
118.0 µmol/L
Hb
MetaboLead Enzymatic Oct ‘19 401AIE, 155AIA 2.46, 9.59 - ReCCS
HbA1c on 401AIE µmol/L ASRL#1
Hitachi 7180 HbA1c; 81.8,
118.0 µmol/L
Hb
MetaboLead Enzymatic Oct ‘19 401AIE, 155AIA 2.46, 9.59 - ReCCS
HbA1c on 401AIE µmol/L ASRL#1
LABOSPECT HbA1c; 81.8,
006 118.0 µmol/L
Hb
MetaboLead Enzymatic Oct ‘19 401AIE, 155AIA 2.46, 9.59 - ReCCS
HbA1c on TBA- 401AIE µmol/L ASRL#1
120FR HbA1c; 81.8,
118.0 µmol/L
Hb
Beckman- UniCel DxC Immuno- Sept ‘19 M901002 M901002 0.183, 0.485, - Univ. of Missouri.
Coulter Inc. Synchron assay 0.864, 1.632, SRL #9
Systems 2.454 g/dL
HbA1c3 on HbA1c; 18.28
UniCel DxC 600 g/dL Hb
Jana Care, Inc. Aina HbA1c Boronate Sept ‘19 551 - - - Univ. of Missouri.
Monitoring affinity SRL #9
System 2
Hipro Nephelometry Immuno- Sept ‘19 FA190509 S3519-3 0.00%, 5.00%, - Zhongshan
Biotechnology on HP-AFS assay 7.40%, Hospital ASRL#2
Co., Ltd. 11.20%

18
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Horiba Medical HbA1c WB Immuno- Sept ‘19 1901901 1900401 0.00, 1.80, - European
Hemolysate – assay 3.51, 4.74, Reference Lab
ABX Pentra 8.96, 13.20 ESRL #10
C200 µmol/L
(Y=(0.328*X)+ HbA1c; 68.29
2.216) µmol/L Hb
HbA1c WB Immuno- Sept ‘19 1901901 1900401 0.00, 1.65, - European
Whole Blood – assay 3.37, 4.93, Reference Lab
ABX Pentra 400 8.87, 14.65 ESRL #10
(Y=(0.369*X)+ µmol/L
2.408) HbA1c; 68.29
µmol/L Hb
HbA1c WB Immuno- Sept ‘19 1901901 1900401 0.00, 2.03, - European
Hemolysate – assay 3.51, 4.84, Reference Lab
ABX Pentra 400 8.28, 13.32 ESRL #10
(Y=(0.419*X)+ µmol/L
1.61) HbA1c; 68.29
µmol/L Hb
HbA1c WB Immuno- Sept ‘19 1901901 1900401 0.00, 1.59, - European
Hemolysate – assay 3.13, 4.57, Reference Lab
Pentra C400 7.97, 12.72 ESRL #10
(Y=(0.42*X)+2. µmol/L
06) HbA1c; 68.29
µmol/L Hb
Horiba Medical HbA1c WB Immuno- Sept ‘19 1901901 1900401 0.00, 1.53, - European
Whole Blood – assay 3.28, 4.92, Reference Lab
Penta C400 8.78, 14.17 ESRL #10
(Y=(0.352*X)+ µmol/L
2.644) HbA1c; 68.29
µmol/L Hb
t Boronate-
EKF Boronate Sept ‘19 020531 - - - European
Diagnostics Affinity Quo- affinity Reference Lab
GmbH Test HbA1c ESRL #11
t Boronate- Boronate Sept ‘19 025624 - - - European
Affinity Quo- affinity Reference Lab
Lab HbA1c ESRL #11
t Boronate-
Human Boronate Sept ‘19 025623 - - - European
Gesellschaft Affinity affinity Reference Lab
fuer Biochemica HumaMeter ESRL #11
und Diagnostica HbA1c
mbH
Beckman HbA1c B00389 Immuno- Sept ‘19 1045, 1045 0.069, 0.275, - European
Coulter Ireland Manual assay M811080 0.513, 0.943, Reference Lab
Inc. Application 1.431 mmol/L ESRL #13
AU5800 HbA1c; 7.87
mmol/L Hb
HbA1c B00389 Immuno- Sept ‘19 1045, 1045 0.069, 0.275, - European
Manual assay M811080 0.513, 0.943, Reference Lab
Application 1.431 mmol/L ESRL #13
AU2700 HbA1c; 7.87
mmol/L Hb
HbA1c B00389 Immuno- Sept ‘19 1045, 1045 0.069, 0.275, - European
Manual assay M811080 0.513, 0.943, Reference Lab
Application 1.431 mmol/L ESRL #13
AU680 HbA1c; 7.87
mmol/L Hb
HbA1c B00389 Immuno- Sept ‘19 1045, 1045 0.069, 0.275, - European
Manual assay M811080 0.513, 0.943, Reference Lab
Application 1.431 mmol/L ESRL #13
AU480 HbA1c; 7.87
mmol/L Hb

19
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
HbA1c B00389 Immuno- Sept ‘19 1045, 1045 0.069, 0.275, - European
Manual assay M811080 0.513, 0.943, Reference Lab
Application 1.431 mmol/L ESRL #13
DxC 700 AU HbA1c; 7.87
mmol/L Hb
t BM Test
JEOL Ltd. Enzymatic Sept ‘19 842RBQ, 920RIP, 3.32, 15.57 - ReCCS
HbA1c on JCA- 843RBQ, 920RIP µmol/L ASRL#1
BM 6010/C 843RFQ HbA1c;
102.30, 153.20
µmol/L Hb
tAgA1C
Agappe Immuno- Sept ‘19 19040026, 29030137, 5.8%, 9.8%, - European
Diagnostics Ltd. (Immunoturbidi assay 19040027, 29030139, 13.3%, 16.8% Reference Lab
metric method) 18030046 29030140, ESRL#10
on TBA 25 FR 29030142
tAgA1C Immuno- Sept ‘19 19040026, 29030137, 5.8%, 9.8%, - European
(Immunoturbidi assay 19040027, 29030139, 13.3%, 16.8% Reference Lab
metric method) 18030046 29030140, ESRL#10
on TBA 120 FR 29030142
tHbA1c Immuno- Sept ‘19 19040026, 29030137, 6.3%, 10.6%, - European
(Immunoturbidi assay 19040027, 29030139, 14.0%, 16.8% Reference Lab
metric method) 18030046 29030140, ESRL#10
on Turbiquick 29030142
tAgA1C
Agappe Immuno- Sept ‘19 19040026, 29030137, 6.3%, 10.6%, - European
Diagnostics Ltd. (Immunoturbidi assay 19040027, 29030139, 14.0%, 16.8% Reference Lab
metric method) 18030046 29030140, ESRL#10
on Mispa Nano 29030142
tAgA1C Immuno- Sept ‘19 19040026, 29030137, 5.8%, 9.8%, - European
(Immunoturbidi assay 19040027, 29030139, 13.3%, 16.8% Reference Lab
metric method) 18030046 29030140, ESRL#10
on Mispa Nano 29030142
Plus
tAgA1C Immuno- Sept ‘19 19040026, 29030137, 5.8%, 9.8%, - European
(Immunoturbidi assay 19040027, 29030139, 13.3%, 16.8% Reference Lab
metric method) 18030046 29030140, ESRL#10
on Mispa Clinia 29030142
tAgA1C
. Immuno- Sept ‘19 19040026, 29030137, 5.8%, 9.8%, - European
(Immunoturbidi assay 19040027, 29030139, 13.3%, 16.8% Reference Lab
metric method) 18030046 29030140, ESRL#10
on Mispa Clinia 29030142
Plus
tAgA1C Immuno- Sept ‘19 19040026, 29030137, 6.3%, 10.6%, - European
(Immunoturbidi assay 19040027, 29030139, 14.0%, 16.8% Reference Lab
metric method) 18030046 29030140, ESRL#10
on Mispa Ace 29030142
tNephelometry Immuno- Sept ‘19 19040026, 29030137, 5.8%, 9.8%, - European
on Specific assay 19040027, 29030139, 13.3%, 16.8% Reference Lab
Protein 18030046 29030140, ESRL#10
Analyzer Mispa 29030142
i2
tNephelometry Immuno- Sept ‘19 19040026, 29030137, 5.8%, 9.8%, - European
on cartridge assay 19040027, 29030139, 13.3%, 16.8% Reference Lab
based Specific 18030046 29030140, ESRL#10
Protein 29030142
Analyzer Mispa
i3
tAgA1C Immuno- Sept ‘19 19040026, 29030137, 5.8%, 9.8%, - European
(Immunoturbidi assay 19040027, 29030139, 13.3%, 16.8% Reference Lab
metric method) 18030046 29030140, ESRL#10
on TMS 30i 29030142

20
 List of NGSP Certified Methods (Updated 6/20, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
tAgA1C Immuno- Sept ‘19 19040026, 29030137, 5.8%, 9.8%, - European
(Immunoturbidi assay 19040027, 29030139, 13.3%, 16.8% Reference Lab
metric method) 18030046 29030140, ESRL#10
on Mispa VIVA 29030142
tAgA1C Immuno- Sept ‘19 19040026, 29030137, 6.3%, 10.6%, - European
(Immunoturbidi assay 19040027, 29030139, 14.0%, 16.8% Reference Lab
metric method) 18030046 29030140, ESRL#10
on Mispa CCXL 29030142
tAgA1C Immuno- Sept ‘19 19040026, 29030137, 5.8%, 9.8%, - European
(Immunoturbidi assay 19040027, 29030139, 13.3%, 16.8% Reference Lab
metric method) 18030046 29030140, ESRL#10
on Mispa CX4 29030142
tAgA1C
. Immuno- Sept ‘19 19040026, 29030137, 5.8%, 9.8%, - European
(Immunoturbidi assay 19040027, 29030139, 13.3%, 16.8% Reference Lab
metric method) 18030046 29030140, ESRL#10
on Mispa CXL 29030142
Pro
tAgA1C Immuno- Sept ‘19 19040026, 29030137, 5.8%, 9.8%, - European
(Immunoturbidi assay 19040027, 29030139, 13.3%, 16.8% Reference Lab
metric method) 18030046 29030140, ESRL#10
on BS 390 29030142
Apex Immunoagglutin Immuno- Sept ‘19 S81103 - - - ReCCS
Biotechnology ation on Eclipse assay ASRL#1
Corp. A1c
Medisensor. Boronate Boronate Sept ‘19 BHC0001, BHB19F101 5.00%, 9.00% - ReCCS
INC. Affinity on Affinity BHC0002 ASRL#1
careSURE
Analyzer 100,
CareU analyzer
100
Erba Lachema Hb-Vario Ion- Aug ‘19 1904054, 170220A, 5.99%, 1904054 Univ. of Missouri.
s.r.o. exchange 1904054, 170221A 11.84% SRL #9
HPLC 1904054
Guangzhou Fluorescence on Immuno- Aug ‘19 W20713402A - - - ReCCS
Wondfo Biotech Finecare FIA assay ASRL#1
Co., Ltd. Meter Plus
Fluorescence on Immuno- Aug ‘19 W20713402A - - - ReCCS
Finecare FIA assay ASRL#1
Meter
Sugentech Immunoassay Immuno- Aug ‘19 HBAT19001 - - - ReCCS
on INCLIX assay ASRL#1
Sakae Medidas HbA1c Immuno- Aug ‘19 451812, STS009 0.0%, 4.5%, - ReCCS
Corporation on A1c iGear assay 461901, 6.9%, 10.0%, ASRL#1
Quick 461903 13.7%
Medidas HbA1c Immuno- Aug ‘19 451812, STS009 0.0%, 4.5%, - ReCCS
on A1c iGear assay 461901, 6.9%, 10.0%, ASRL#1
461903 13.7%
Beckman HbA1c Immuno- Aug ‘19 1045, 1045 0.093, 0.279, - European
Coulter Ireland Advanced assay M811080 0.522, 0.984, Reference Lab
Inc. B93009 Online 1.442 mmol/L ESRL#13
Application on HbA1c; 7.87
DxC 700 AU mmol/L Hb
*
Method certification has been delayed due to coronavirus and/or other shipping issues.
@
Method is not currently available

21