List of NGSP Certified Methods

(updated 5/25, 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 ensure
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
Wiener HbA1c v.2 Immuno- May ‘25 630830, 627600 2.830 g/dL - Univ. of Missouri
Laboratorios Turbitest AA on assay 630870, HbA1c; 13.60 SRL#12
S.A.I.C. CMD 800i 630850, g/dL Hb
91.5*HbA1c/Hb 633350
+2.15
HbA1c v.2 Immuno- May ‘25 630830, 627600 2.830 g/dL - Univ. of Missouri
Turbitest AA on assay 630870, HbA1c; 13.60 SRL#12
CM 250 630850, g/dL Hb
91.5*HbA1c/Hb 633350
+2.15
HbA1c v.2 Immuno- May ‘25 630830, 627600 2.830 g/dL - Univ. of Missouri
Turbitest AA on assay 630870, HbA1c; 13.60 SRL#12
CMD 600i 630850, g/dL Hb
91.5*HbA1c/Hb 633350
+2.15
HbA1c v.2 Immuno- May ‘25 630830, 627600 2.830 g/dL - Univ. of Missouri
Turbitest AA on assay 630870, HbA1c; 13.60 SRL#12
CT 600i X1 630850, g/dL Hb
91.5*HbA1c/Hb 633350
+2.15
HbA1c v.2 Immuno- May ‘25 630830, 627600 2.830 g/dL - Univ. of Missouri
Turbitest AA on assay 630870, HbA1c; 13.60 SRL#12
CB 350i 630850, g/dL Hb
91.5*HbA1c/Hb 633350
+2.15
Sakae Corporation MEDIDAS Immuno- May ‘25 462502 24E20 4.7%, 7.1%, - ReCCS
HbA1c on A1c assay 10.3%, 14.2% ASRL#1
GEAR
MEDIDAS Immuno- May ‘25 462502 24E20 4.7%, 7.1%, - ReCCS
HbA1c on A1c assay 10.3%, 14.2% ASRL#1
iGear
MEDIDAS Immuno- May ‘25 462502 24E20 4.7%, 7.1%, - ReCCS
HbA1c on A1c assay 10.3%, 14.2% ASRL#1
iGear Quick
MEDIDAS Immuno- May ‘25 462502 24E20 4.7%, 7.1%, - ReCCS
HbA1c on iGear assay 10.3%, 14.2% ASRL#1
Pro
Abbott HbA1c Enzymatic May ‘25 67097UQ09, 67304UQ12, 5.52%, - Univ. of Missouri.
Diagnostics (Hemolysate) on 67097UQ09, 67304UQ12 12.52% SRL #12
Architect c4000 67097UQ09,
%NGSP=HbA1
c/Hb*91.48+2.1
52

1
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Abbott HbA1c (Whole Enzymatic May ‘25 67097UQ09, 67304UQ12, 5.52%, - Univ. of Missouri.
Diagnostics Blood) on 67097UQ09, 67304UQ12 12.52% SRL #12
Architect c4000 67097UQ09,
%NGSP=HbA1
c/Hb*91.48+2.1
52
HbA1c (Whole Enzymatic May ‘25 67097UQ09, 67304UQ12, 5.52%, - Univ. of Missouri.
Blood) on 67097UQ09, 67304UQ12 12.52% SRL #12
Architect c8000 67097UQ09,
%NGSP=HbA1
c/Hb*91.48+2.1
52
HbA1c Enzymatic May ‘25 67097UQ09, 67304UQ12, 5.52%, - Univ. of Missouri.
(Hemolysate) on 67097UQ09, 67304UQ12 12.52% SRL #12
Architect c8000 67097UQ09,
%NGSP=HbA1
c/Hb*91.48+2.1
52
HbA1c Enzymatic May ‘25 67097UQ09, 67304UQ12, 5.52%, - Univ. of Missouri.
(Hemolysate) on 67097UQ09, 67304UQ12 12.52% SRL #12
Alinity c 67097UQ09,
%NGSP=HbA1
c/Hb*91.48+2.1
52
HbA1c (Whole Enzymatic May ‘25 67097UQ09, 67304UQ12, 5.52%, - Univ. of Missouri.
Blood) on 67097UQ09, 67304UQ12 12.52% SRL #12
Alinity c 67097UQ09,
analyzer
%NGSP=HbA1
c/Hb*91.48+2.1
52
Siemens Atellica DCA Immuno- May ‘25 07330624, - - - Univ. of Missouri.
Healthcare assay 08640225, SRL #12
Diagnostics 08650225
DCA Vantage Immuno- May ‘25 0203035, - - - Univ. of Missouri.
assay 0204035, SRL #12
0871035
Zybio Inc. Immunofluoresc Immuno- May ‘25 550101 G20240901 0.36%, 3.10%, - Zhongshan Hospital
ence on EXR assay 4.73%, 8.84%, ASRL#3
110 12.94%
Immunofluoresc Immuno- May ‘25 550101 G20240901 0.36%, 3.10%, - Zhongshan Hospital
ence on EXR assay 4.73%, 8.84%, ASRL#3
120 12.94%
Immunofluoresc Immuno- May ‘25 550101 G20240901 0.36%, 3.10%, - Zhongshan Hospital
ence on Q8 Pro assay 4.73%, 8.84%, ASRL#3
12.94%
Immune Immuno- May ‘25 H250101 H250101 0.0%, 5.3%, - Zhongshan Hospital
turbidity on assay 6.8%, 10.5%, ASRL#3
EXC 200 14.8%
Immune Immuno- May ‘25 H250102 H250301 0.0%, 5.5%, - Zhongshan Hospital
turbidity on assay 6.8%, 10.6%, ASRL#3
EXC 400 14.7%
SD Biosensor, STANDARD F Immuno- May ‘25 6075B72AC - - - ReCCS
Inc. on F2400 assay ASRL#1
STANDARD F Immuno- May ‘25 6075B72AC - - - ReCCS
on F200 assay ASRL#1
Fujikura Kasei HbA1c-FW on Immuno- May ‘25 W24L121W W24F011D 5.0%, 8.4%, - ReCCS
Co., Ltd Hitachi 7180 assay 11.8%, 16.2% ASRL#1
HbA1c-FL on Immuno- May ‘25 W24K291FL W24A026FL 4.1%, 6.9%, - ReCCS
Hitachi 7180 assay 9.6%, 13.5% ASRL#1

2
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Fujikura Kasei HbA1c-FU on Immuno- May ‘25 W25A071U W25B051U 5.1%, 8.7%, - ReCCS
Co., Ltd TBA 120FR assay 12.0%, 15.8% ASRL#1
UMA Co., Ltd. Measure HbA1c Immuno- May ‘25 493AEC, 141AEC 0.0%, 6.3%, - ReCCS
II on Hitachi- assay 261AEB 8.6%, 13.3%, ASRL#1
7180 17.2%
GC Medis Corp. Boronate Boronate May ‘25 HM2364K051, - - - Univ. of Missouri.
Affinity Affinity HM2364K052, SRL #12
HM2364K05W
(LabonaCheck HM2364K151,
A1c HbA1c HM2364K152
Analyzer HM2364K15W
(Model: MH HM2365B071,
200) A1Card HM2365B072
HM2365B07W
HbA1c
Analyzer
Boronate Boronate May ‘25 HC2334K051, - - - Univ. of Missouri.
Affinity Affinity HC2334K052, SRL #12
HC2334K05W,
(CERA-STAT HC2334K151,
2000, QDx A1c HC2334K152,
Analyzer HC2334K15W,
HC2335B071,
HC2335B072,
HC2335B07W
Boronate Boronate May ‘25 HC4334K051, - - - Univ. of Missouri.
Affinity Affinity HC4334K052, SRL #12
HC4334K05W,
(CERA-STAT HC4334K151,
4000, Merilyzer HC4334K152,
Mericheck HC4334K15W,
Analyzer HC4335B071,
HC4335B072,
HC4335B07W
Sekisui Medical Norudia N Enzymatic May ‘25 216RJV, 229RLV 3.38 15.98 - ReCCS
Co., Ltd. HbA1c on 216RJV, µmol/L HbA1c; ASRL#1
Hitachi 7170 S 148RLV 100.8, 152.9
µmol/L Hb
(RE) Norudia N Enzymatic May ‘25 215RJV, 216RLV 4.92 22.17 - ReCCS
HbA1c on 215RJV, µmol/L HbA1c; ASRL#1
Hitachi 3500 148RLV 169.9, 225.1
µmol/L Hb
(RE) Norudia N Enzymatic May ‘25 HBA306RLV 216RLV 4.92 22.17 - ReCCS
HbA1c on TBA- , µmol/L HbA1c; ASRL#1
nx360 HBA306RLV 169.9, 225.1
, 148RLV µmol/L Hb
(RE) Norudia N Enzymatic May ‘25 215RJV, 226RLV 4.92 22.17 - ReCCS
HbA1c on 215RJV, µmol/L HbA1c; ASRL#1
Hitachi 7180 148RLV 169.9, 225.1
µmol/L Hb
HbA1c Auto Enzymatic May ‘25 211RJV, 216RLV 3.38 15.98 - ReCCS
TBA on TBA- 211RJV, µmol/L HbA1c; ASRL#1
120FR 148RLV 100.8, 152.9
µmol/L Hb
L-type Norudia Enzymatic May ‘25 307RJV, 215RLV 3.48 - ReCCS
N HbA1c on 307RJV, 15.43µmol/L ASRL#1
Hitachi LST006 148RLV HbA1c; 103.0,
147.2 µmol/L
Hb
L-type Norudia Enzymatic May ‘25 307RJV, 215RLV 3.48 - ReCCS
N HbA1c on 307RJV, 15.43µmol/L ASRL#1
Hitachi LST008 148RLV HbA1c; 103.0,
α 147.2 µmol/L
Hb
Norudia N Enzymatic May ‘25 216RJV, 229RLV 3.38 15.98 - ReCCS
HbA1c on JCA- 216RJV, µmol/L HbA1c; ASRL#1
BM9130 148RLV 100.8, 152.9
µmol/L Hb

3
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Sekisui Medical Norudia N Enzymatic May ‘25 216RJV, 229RLV 3.38 15.98 - ReCCS
Co., Ltd. HbA1c on 216RJV, µmol/L HbA1c; ASRL#1
EV800 148RLV 100.8, 152.9
µmol/L Hb
Norudia N Enzymatic May ‘25 216RJV, 229RLV 3.38 15.98 - ReCCS
HbA1c on 216RJV, µmol/L HbA1c; ASRL#1
Hitachi 3500 148RLV 100.8, 152.9
µmol/L Hb
Norudia N Enzymatic May ‘25 102RLV, 102RLV 3.27 15.25 - ReCCS
HbA1c II on 102RLV, µmol/L HbA1c; ASRL#1
JCA-BM9130 148RLV 97.2, 147.1
µmol/L Hb
Norudia N Enzymatic May ‘25 216RJV, 229RLV 3.38 15.98 - ReCCS
HbA1c on TBA- 216RJV, µmol/L HbA1c; ASRL#1
120FR 148RLV 100.8, 152.9
µmol/L Hb
Norudia N Enzymatic May ‘25 102RLV, 102RLV 3.27 15.25 - ReCCS
HbA1c II on 102RLV, µmol/L HbA1c; ASRL#1
Hitachi 3500 148RLV 97.2, 147.1
µmol/L Hb
Maccura Ion-exchange Ion- May ‘25 0724071 0724071 5.0%, 10.7% 2024050150 Zhongshan Hospital
Biotechnology HPLC on G exchange 7 ASRL#3
Co., Ltd. 01/G01 S HPLC
Anbio (Xiamen) AF System on Immuno- May ‘25 3017046, - - - Zhongshan Hospital
Biotechnology AF-100C assay 2024082202 ASRL#3
Co., Ltd.
Archem Sağlik HbA1c Immuno- May ‘25 601 060B 6.9%, 10.0%, - European Reference
Sanayi ve Ticaret Immunoturbidi assay 13.0%, 15.5% Lab ESRL #13
A.Ş. metric on
Mindray BS800
& BS800M
HbA1c Immuno- May ‘25 601 060B 6.9%, 10.0%, - European Reference
Immunoturbidi assay 13.0%, 15.5% Lab ESRL #13
metric on
Mindray
BS2000M
HbA1c Immuno- May ‘25 601 060B 5.4%, 8.3%, - European Reference
Immunoturbidi assay 10.5%, 15.5% Lab ESRL #13
metric on DxC
700 AU
HbA1c Immuno- May ‘25 601 060B 5.3%, 8.3%, - European Reference
Immunoturbidi assay 10.5%, 15.5% Lab ESRL #13
metric on
Olympus
AU5800
HbA1c Immuno- May ‘25 601 060B 5.3%, 8.3%, - European Reference
Immunoturbidi assay 10.5%, 15.5% Lab ESRL #13
metric on
Olympus
AU480
HbA1c Immuno- May ‘25 601 060B 6.3%, 8.5%, - European Reference
Immunoturbidi assay 11.1%, 15.5% Lab ESRL #13
metric Method
on Architect
c4000
HbA1c Immuno- May ‘25 601 060B 6.0%, 8.7%, - European Reference
Immunoturbidi assay 12.0%, 15.5% Lab ESRL #13
metric Method
on Architect
c8000

4
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Archem Sağlik HbA1c Immuno- May ‘25 601 060B 6.0%, 8.7%, - European Reference
Sanayi ve Ticaret Immunoturbidi assay 12.0%, 15.5% Lab ESRL #13
A.Ş. metric Method
on Alinity c
Ailex Technology Ion-exchange Ion- Apr ‘25 20231201AD1, ZS3003, 5.80, 10.49 IEC-237-950 Zhongshan Hospital
Group Co., Ltd. HPLC on AH- exchange 20231201AD2, ZS3004 ASRL#3
20231201YY3,
600 HPLC 20240801
tAU-
Fujirebio Inc. Immuno- Apr ‘25 F9A040, H1A041 0.0%, 4.2%, - ReCCS
SYNCHRON assay F9A040, 6.9%, 9.5%, ASRL#1
Reagent HbA1C H2A031 13.3%
on DxC700AU
t Rapidia Auto Immuno- Apr ‘25 QF40801, VF40302 0.0%, 4.2%, - ReCCS
HbA1c-L on assay RF40801, 6.9%, 9.5%, ASRL#1
BiOLis30i NF40301 13.3%
t Rapidia Auto Immuno- Apr ‘25 QF40801, VF40302 0.0%, 4.2%, - ReCCS
HbA1c-L on assay RF40801, 6.9%, 9.5%, ASRL#1
JCA-BM9130 NF40301 13.3%
t Rapidia Auto Immuno- Apr ‘25 QF40801, VF40302 0.0%, 4.2%, - ReCCS
HbA1c-L on assay RF40801, 6.9%, 9.5%, ASRL#1
DxC700AU NF40301 13.3%
t Rapidia Auto Immuno- Apr ‘25 QF40801, VF40302 0.0%, 4.2%, - ReCCS
HbA1c-L on assay RF40801, 6.9%, 9.5%, ASRL#1
Hitachi 7180 NF40301 13.3%
t Rapidia Auto Immuno- Apr ‘25 QF40801, VF40302 0.0%, 4.2%, - ReCCS
HbA1c-L on assay RF40801, 6.9%, 9.5%, ASRL#1
TBA-120FR NF40301 13.3%
Abbott Afinion HbA1c / Boronate Apr ‘25 10230191 - - - European Reference
Diagnostics Afinion AS100 affinity Lab ESRL #11
Technologies AS Analyzer
Afinion HbA1c Boronate Apr ‘25 10229900 - - - European Reference
Dx / affinity Lab ESRL #11
Afinion AS100
Analyzer
Afinion HbA1c Boronate Apr ‘25 10229900 - - - European Reference
Dx / affinity Lab ESRL #11
Afinion 2
Analyzer
Afinion HbA1c / Boronate Apr ‘25 10230191 - - - European Reference
Afinion 2 affinity Lab ESRL #11
Analyzer
t ADAMS A1c
Arkray, Inc. Ion- Apr ‘25 240522101, S4003 5.4%, 11.0% 4E501N ReCCS
HA-8180 exchange 240321102, ASRL#1
HPLC 240701105
t ADAMS A1c Ion- Apr ‘25 240522101, S4003 5.4%, 11.0% 4A401N ReCCS
HA-8181 exchange 240321102, ASRL#1
HPLC 240701105
t ADAMS A1c Ion- Apr ‘25 4K1002, S4002 5.3%, 10.8% 4D007N ReCCS
HA-8182 exchange 4K1002, ASRL#1
HPLC 4L1043
ADAMS A1c Ion- Apr ‘25 240522101, S4003 5.4%, 11.0% 4E252E ReCCS
HA-8180V exchange 240321102, ASRL#1
Variant mode HPLC 240715112,
240701105
t ADAMS A1c Ion- Apr ‘25 240522101, S4003 5.4%, 11.0% 4E252E ReCCS
HA-8180V exchange 240321102, ASRL#1
Fast mode HPLC 240715112,
240701105
t
ADAMS A1c Ion- Apr ‘25 240522101, S4003 5.4%, 11.0% 4E253E ReCCS
Lite HA-8380V exchange 240321102, ASRL#1
Fast mode HPLC 240514125,
240701105

5
 List of NGSP Certified Methods (Updated 5/25, 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
Arkray, Inc. Ion- Apr ‘25 240522101, S4003 5.4%, 11.0% 4E253E ReCCS
Lite HA-8380V exchange 240321102, ASRL#1
Variant mode HPLC 240514125,
240701105
tADAMS A1c Ion- Apr ‘25 240522101, S4003 5.4%, 11.0% 4E252V ReCCS
HA-8190V Fast exchange 240321102, ASRL#1
mode HPLC 240519365,
240701105
t ADAMS A1c Ion- Apr ‘25 240522101, S4003 5.4%, 11.0% 4E252V ReCCS
HA-8190V exchange 240321102, ASRL#1
Variant mode HPLC 240519365,
240701105
t
ADAMS A1c Ion- Apr ‘25 240522101, S4003 5.4%, 11.0% 4E502N ReCCS
Lite HA-8380 exchange 240321102, ASRL#1
HPLC 240514125,
240701105
t ADAMS A1c Ion- Apr ‘25 240522101, S4003 5.4%, 11.0% 4E001H ReCCS
HA-8180T exchange 240321102, ASRL#1
HPLC 240708144,
240701105
t ADAMS Ion- Apr ‘25 240522101, S4003 5.4%, 11.0% 4A402N ReCCS
HYBRID AH- exchange 240321102, ASRL#1
8290 HPLC 240701105
t CinQ HbA1c Enzymatic Apr ‘25 MFA49, CAC3L30 2.79, 7.43 - ReCCS
on JCA- MFE49 µmol/L ASRL#1
BM6010 HbA1c
HbA1c% (IFCC); 87.6,
(NGSP)=0.0915 97.9 µmol/L
*HbA1c/Hb*10 Hb
00(IFCC)+2.15
t CinQ HbA1c Enzymatic Apr ‘25 MFA49, CAC3L30 2.79, 7.43 - ReCCS
on JCA- MFE49 µmol/L ASRL#1
BM9130 HbA1c
HbA1c% (IFCC); 87.6,
(NGSP)=0.0915 97.9 µmol/L
*HbA1c/Hb*10 Hb
00(IFCC)+2.15
t CinQ HbA1c Enzymatic Apr ‘25 MFA49, CAC3L30 2.79, 7.43 - ReCCS
on JCA-ZS050 MFE49 µmol/L ASRL#1
HbA1c% HbA1c
(NGSP)=0.0915 (IFCC); 87.6,
*HbA1c/Hb*10 97.9 µmol/L
00(IFCC)+2.15 Hb
t CinQ HbA1c Enzymatic Apr ‘25 HLS51 CAC3L30 2.79, 7.43 - ReCCS
on µmol/L ASRL#1
LABOSPECT006 HbA1c
HbA1c% (IFCC); 87.6,
(NGSP)=0.0915 97.9 µmol/L
*HbA1c/Hb*10 Hb
00(IFCC)+2.15
t CinQ HbA1c Enzymatic Apr ‘25 MFA49, CAC3L30 2.79, 7.43 - ReCCS
on TBA-120FR MFE49 µmol/L ASRL#1
HbA1c% HbA1c
(NGSP)=0.0915 (IFCC); 87.6,
*HbA1c/Hb*10 97.9 µmol/L
00(IFCC)+2.15 Hb
@ The Lab 001 CE114M4A1
Capillary Apr ‘25 - - - ReCCS
Electroph ASRL#1
oresis
Adams A1C X Ion- Apr ‘25 KE05A101, S2004 5.4%, 10.7% KC04J3006 ReCCS
HA-8110 QM exchange KE15A101, ASRL#1
mode HPLC KE25B101,
KE35B101
6
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Arkray, Inc. Adams A1C X Ion- Apr ‘25 KE05A101, S2004 5.4%, 10.7% KC04J3006 ReCCS
HA-8110 STD exchange KE15A101, ASRL#1
mode HPLC KE25B101,
KE35B101
Chongqing Fluorescence Immuno- Apr ‘25 3920241101, - - - Zhongshan Hospital
Boshengte Dry Quantitative assay 1220241101 ASRL#3
Biomedical Immjunoassay
Technology Co., on Jet-iStar
Ltd. MAX
Fluorescence Immuno- Apr ‘25 3920241101, - - - Zhongshan Hospital
Dry Quantitative assay 1220241101 ASRL#3
Immjunoassay
on FIC-Q100
Guangzhou Immunofluoresc Immuno- Apr ‘25 525240720, - - - Zhongshan Hospital
Decheng ence Analyzer assay 525241029, ASRL#3
Biotechnology DC906A 525241230
Co., Ltd.
Immunofluoresc Immuno- Apr ‘25 525240720, - - - Zhongshan Hospital
ence Analyzer assay 525241029, ASRL#3
DC903A 525241230
DxGen Corp. Boronate Boronate Apr ‘25 C15A1402R1, - - - Univ. of Missouri.
affinity on Affinity C15A1402W1, SRL #12
C15A1402C1
AUTODX
HbA1c
Measuring
System (Ep.414,
Dx.HbA1c)
Boronate Boronate Apr ‘25 A14K0102R1, - - - Univ. of Missouri.
affinity on Affinity A14K0102R2, SRL #12
A14K0102R3,
AUTODX A14K0102C1
HbA1c OnePro
INCLIX PLUS
Measuring
System (Ep.414,
Dx.HbA1cA)
Boronate Boronate Apr ‘25 C15A1001R1, - - - Univ. of Missouri.
affinity on Affinity C15A1001W1, SRL #12
C15A1001C1,
Epithod 616
HbA1c
Measuring
Systsem
(Ep.616,
EP.616H)
Caretium Medical HbA1c Ion- Apr ‘25 20241107 20241105, 5.10%, 20250123 Zhongshan Hospital
Instruments Co., Analyzer KH- exchange 20241105 10.00% ASRL#3
Limited 101 HPLC
HbA1c Ion- Apr ‘25 20240906 20241105, 5.10%, P17099312 Zhongshan Hospital
Analyzer T9 exchange 20241105 10.00% ASRL#3
HPLC
LumiraDx LumiraDx Immuno- Mar ‘25 6001292, - - - European Reference
HbA1c Test assay 24005601 Lab ESRL #15
Labnovation HPLC on LD- Ion- Mar ‘25 TH48I027, TH48I016, 5.43%, TH48I027 ReCCS
Technologies, Inc. 500, LD-510, exchange TH48I027, TH48I016 10.89% ASRL#1
TH48I027
LD-520 HPLC
HPLC on LD- Ion- Mar ‘25 TH48U030, TH48I016, 5.4%, 10.5% C314469721 ReCCS
560, LD-561, exchange TH48U030, TH48I016 8 ASRL#1
TH48U030
LD-562 HPLC
HPLC on LD- Ion- Mar ‘25 TH48I001, TH48I016, 5.4%, 10.6% C314470721 ReCCS
600, LD-620 exchange TH48I001, TH48I016 8 ASRL#1
TH48I001
HPLC

7
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Labnovation Borate affinity Boronate Mar ‘25 TH48P030 TH48I016, 5.5%, 11.0% - ReCCS
Technologies, Inc. on LD-100, LD- Affinity TH48I016 ASRL#1
120, LD-160,
LD-180, LD-
190
Minaris Medical Determiner L Immuno- Mar ‘25 563ADI, 516ADJ 0.0%, 4.6%, - ReCCS
Co., Ltd. HbA1c DM- assay 563ADI 6.9%, 9.8%, ASRL#1
JACK 13.4%
Determiner L Immuno- Mar ‘25 563ADI, 516ADJ 0.0%, 4.5%, - ReCCS
HbA1c on JCA- assay 563ADI 6.9%, 9.8%, ASRL#1
BM9130 13.4%
Determiner L Immuno- Mar ‘25 563ADI, 516ADJ 0.0%, 4.5%, - ReCCS
HbA1c on TBA- assay 563ADI 6.9%, 9.8%, ASRL#1
120FR 13.4%
Determiner L Immuno- Mar ‘25 563ADI, 517ADJ 0.0%, 4.3%, - ReCCS
HbA1c on assay 563ADI 7.0%, 9.8%, ASRL#1
Hitachi-7180 13.4%
Thermo Fisher HbA1c for Immuno- Mar ‘25 XD56, XD61 XE53 1.5345mmol/L - European Reference
Scientific Oy Indiko, ref assay HbA1c; 9.050 Lab ESRL #13
981947, 981948 mmol/L Hb
(91.5*HbA1c/H
b*+2.15)
HbA1c for Immuno- Mar ‘25 XD56, XD61 XE53 1.5345mmol/L - European Reference
Konelab, ref assay HbA1c; 9.050 Lab ESRL #13
981947, 981948 mmol/L Hb
(91.5*HbA1c/H
b*+2.15)
PTS Diagnostics A1CNOW+; Immuno- Mar ‘25 2405206 - - - University of
A1CNOW assay Minnesota SRL#10
Selfcheck
Genrui Biotech Immunofluoresc Immuno- Feb ‘25 24112811 - - - Zhongshan Hospital
Inc. ence on assay ASRL#3
Quantitative
Immunoassay
Analyzer FA-50
Changsha HbA1c Immuno- Feb ‘25 42K1012 - - - Zhongshan Hospital
Sinocare Inc. Monitoring assay ASRL#3
System on PCH-
50
HbA1c Immuno- Feb ‘25 4A1025 - - - Zhongshan Hospital
Monitoring assay ASRL#3
System on PCH-
100
HbA1c Immuno- Feb ‘25 41P0914 - - - Zhongshan Hospital
Monitoring assay ASRL#3
System on
iCARE-1000
HbA1c Immuno- Feb ‘25 41P0914 - - - Zhongshan Hospital
Monitoring assay ASRL#3
System on
iCARE-2100
HbA1c Immuno- Feb ‘25 41P0914 - - - Zhongshan Hospital
Monitoring assay ASRL#3
System on
iCARE-2200
HbA1c Immuno- Feb ‘25 3102102 - - - Zhongshan Hospital
Monitoring assay ASRL#3
System on
A1CNow+

8
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Changsha HbA1c Immuno- Feb ‘25 4060902 - - - Zhongshan Hospital
Sinocare Inc. Monitoring assay ASRL#3
System on
A1CNow Self
Check
Lansion Fluorescence Immuno- Feb ‘25 0422432 - - - Zhongshan Hospital
Biotechnology Immunoassay assay ASRL#3
Co., Ltd. on LS-1100 Dry
Fluorescence
Immunoassay
Analyzer
Fluorescence Immuno- Feb ‘25 0422432 - - - Zhongshan Hospital
Immunoassay assay ASRL#3
on LS-2100 Dry
Fluorescence
Immunoassay
Analyzer
Aspen Nephelometry Immuno- Feb ‘25 2024062202 - - - European Reference
Laboratories Pvt. on Aspen Neph assay Lab
Ltd. Plus ESRL#10
Fluorescence Immuno- Feb ‘25 F2071A908AD - - - European Reference
Immunoassay assay Lab
on Aspen FIA ESRL#10
Hunan Mindray Enzymatic on Enzymatic Feb ‘25 0446240061 0446240061 4.00, 16.2 - ReCCS
Medical Beckman µmol/L ASRL#1
Technology Co., Coulter AU5800 HbA1c; 91.7,
Ltd. 146 µmol/L
Hb
Enzymatic on Enzymatic Feb ‘25 0446240061 0446240061 4.00, 16.2 - ReCCS
Hitachi µmol/L ASRL#1
Labospect HbA1c; 91.7,
008AS 146 µmol/L
Hb
Enzymatic on Enzymatic Feb ‘25 0446240061 0446240061 4.51, 16.8 - ReCCS
Roche Cobas µmol/L ASRL#1
8000 c701 HbA1c; 88.0,
142 µmol/L
Hb
Shenzhen Enzymatic on Enzymatic Feb ‘25 045624002 155124006 4.00, 16.2 - ReCCS
Mindray Bio- BS-240 µmol/L ASRL#1
Medical HbA1c; 91.7,
Electronics Co., 146 µmol/L
Ltd. Hb
Enzymatic on Enzymatic Feb ‘25 045624002 155124006 4.00, 16.2 - ReCCS
BS-240Pro µmol/L ASRL#1
HbA1c; 91.7,
146 µmol/L
Hb
Enzymatic on Enzymatic Feb ‘25 045624002 155124006 4.00, 16.2 - ReCCS
BS-430 & BS- µmol/L ASRL#1
460 HbA1c; 91.7,
146 µmol/L
Hb
Enzymatic on Enzymatic Feb ‘25 045624002 155124006 4.20, 16.2 - ReCCS
BS-600M&BS- µmol/L ASRL#1
620M HbA1c; 91.7,
146 µmol/L
Hb

9
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Shenzhen Enzymatic on Enzymatic Feb ‘25 045624002 155124006 4.10, 16.2 - ReCCS
Mindray Bio- BS-830 µmol/L ASRL#1
Medical HbA1c; 91.7,
Electronics Co., 146 µmol/L
Ltd. Hb
Enzymatic on Enzymatic Feb ‘25 045624002 155124006 4.20, 16.4 - ReCCS
BS-1000M µmol/L ASRL#1
HbA1c; 93.4,
149 µmol/L
Hb
Enzymatic on Enzymatic Feb ‘25 045624002 155124006 4.10, 16.4 - ReCCS
BS-2000 & BS- µmol/L ASRL#1
2000M HbA1c; 93.1,
149 µmol/L
Hb
Enzymatic on Enzymatic Feb ‘25 045624002 155124006 4.10, 16.3 - ReCCS
BS-2800M µmol/L ASRL#1
HbA1c; 92.9,
149 µmol/L
Hb
Ion-exchange Ion- Feb ‘25 2023113051, 202403181 4.94%, 20240301 ReCCS
HPLC on H50 exchange 2023112751, 10.83% ASRL#1
2023120151
& H50P HPLC
Ion-exchange Ion- Feb ‘25 2024120601, 202403181 5.02%, 2024100902 ReCCS
HPLC on H120 exchange 2024090801, 10.92% ASRL#1
2024101201
& H120P HPLC
Shanghai Upper Immuno-assay Immuno- Feb ‘25 20240701, 20240801C 0.00%, 5.21%, - Zhongshan Hospital
Bio-tech Co., Ltd. on Ottoman- assay 20240701, 7.74%, ASRL#3
20240701
1000 11.73%,
14.08%
. N-Assay LA Immuno- Feb ‘25 G409A E409A 0%, 5.0%, - ReCCS
Nittobo Medical HbA1c Nittobo assay 8.3%, 11.7%, ASRL#1
Co., Ltd on TBA-120FR 15.9%
N-Assay LA Immuno- Feb ‘25 G409A E409A 0%, 5.0%, - ReCCS
HbA1c Nittobo assay 8.3%, 11.7%, ASRL#1
on BM9130 15.9%
N-Assay LA Immuno- Feb ‘25 G409A E409A 0%, 5.0%, - ReCCS
HbA1c Nittobo assay 8.3%, 11.7%, ASRL#1
on TBA c8000 15.9%
Shenzhen FA-160 Lateral Immuno- Feb ‘25 HBA2400600 - - - Zhongshan Hospital
Lifotronic Flow assay ASRL#3
Technology Co., Immunoassay
Ltd Analyzer
GH-900Plus Ion- Feb ‘25 GSX1240760 GSX1240090 5.40%, 9.70% I02FSX24B Zhongshan Hospital
HbA1c Analyser exchange 11934 ASRL#3
HPLC
H6 Hemoglobin Ion- Feb ‘25 GSX1240760 GSX1240090 5.40%, 9.70% I02FSX24B Zhongshan Hospital
Analyzer exchange 11934 ASRL#3
HPLC
H8 Hemoglobin Ion- Feb ‘25 8SX3240710 8SX3240080 5.50%, I02DSX24A Zhongshan Hospital
Analyzer exchange 10.30% 60565 ASRL#3
Also sold by Assel HPLC
srl as AS8
H9 Hemoglobin Ion- Feb ‘25 9SX3240320 9SX3240040 5.60%, I02BSX24A Zhongshan Hospital
Analyzer exchange 10.10% 60289 ASRL#3
Also sold by Assel HPLC
srl as AS9
H100 Ion- Feb ‘25 1SXA240030, 1SX1240020 5.38%, I02MSX24B Zhongshan Hospital
Hemoglobin exchange 1SXB240040, 10.08% 01295 ASRL#3
Analyzer HPLC 1SXC240030

10
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Shenzhen H100Plus Ion- Feb ‘25 SX1A240080, SX11240030 5.40%, 9.62% I02NSX24A Zhongshan Hospital
Lifotronic Hemoglobin exchange SX1B240010, 00830 ASRL#3
Technology Co., Analyzer HPLC SX1C240010
Ltd
Hb NEXT Ion- Feb ‘25 HASX240160, HNSX240050 5.50%, I02HSX24A Zhongshan Hospital
Hemoglobin exchange HBSX240030, 10.30% 04670 ASRL#3
HCSX240040
Analyzer HPLC

Trivitron Trivitron Ion- Feb ‘25 9SX240280 9SX3240020 5.30%, 9.90% I02BSX2485 Zhongshan Hospital
Healthcare Healthcare Nano exchange 7973 ASRL#3
H110 HPLC
Trivitron Ion- Feb ‘25 GSX1240420 GSX1240042 5.50%, I02FSX24A Zhongshan Hospital
Healthcare Nano exchange 10.10% 11655 ASRL#3
H5 HPLC
MDX Medtek HPLCline 100 Ion- Feb ‘25 H8SX240040 H8SX240031 5.50%, 9.70% I02DSX24A Zhongshan Hospital
Diagnostics Hemoglobin exchange 60575 ASRL#3
(Netherlands) Analyzer HPLC
B.V.
Human Ion-exchange Ion- Feb ‘25 HA1C24020 HA1C24040 5.50%, I02DSX24B Zhongshan Hospital
Gesellschaft für HPLC on exchange 10.00% 63170 ASRL#3
Biochemica und HumaNex A1c HPLC
Diagnostica mbH Variant
Q-Line Biotech Q-A1c H10 Ion- Feb ‘25 8SX3240620 8SX3240051 5.50%, 9.70% I02DSX24A Zhongshan Hospital
Private Limited Hemoglobin exchange 60595 ASRL#3
Analyzer HPLC
(HPLC)
SpeedBio India SpeedBio S8 Ion- Feb ‘25 8SX3240790 8SX3240059 5.50%, 9.70% I02DSX24A Zhongshan Hospital
Private Limited Analyzer exchange 60585 ASRL#3
HPLC
SpeedBio S9 Ion- Feb ‘25 9SX3230120 9SX3240030 5.40%, I02BSX24A Zhongshan Hospital
Analyzer exchange 10.00% 61640 ASRL#3
HPLC
Roche TQ HbA1c Gen Immuno- Jan ‘25 789172, 728053 0.071, 0.376, European Reference
Diagnostics IV Whole Blood assay 812070, 0.494, 0.697, Lab
809425
on Cobas c303 1.118, 1.660 ESRL#13
mmol/L
HbA1c; 1.64,
8.19 mmol/L
Hb
TQ HbA1c Gen Immuno- Jan ‘25 789172, 728053 0.048, 0.388, - European Reference
IV Hemolysate assay 812070, 0.520, 0.746, Lab
809425
on Cobas c303 1.215, 1.819 ESRL#13
mmol/L
HbA1c; 1.64,
8.19 mmol/L
Hb
TQ HbA1c Gen Immuno- Jan ‘25 789172, 728053 0.046, 0.371, - European Reference
IV Whole Blood assay 812070, 0.497, 0.712, Lab
809425
on Cobas c503 1.160, 1.737 ESRL#13
mmol/L
HbA1c; 1.64,
8.19 mmol/L
Hb
TQ HbA1c Gen Immuno- Jan ‘25 789172, 728053 0.048, 0.388, - European Reference
IV Hemolysate assay 812070, 0.520, 0.746, Lab
809425
on Cobas c503 1.215, 1.819 ESRL#13
mmol/L
HbA1c; 1.64,
8.19 mmol/L
Hb

11
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Roche TQ HbA1c Gen Immuno- Jan ‘25 725180, 728053 0.047, 0.382, - European Reference
Diagnostics IV Whole Blood assay 809690, 0.512, 0.734, Lab
809704
on Cobas c513 1.196, 1.790 ESRL#13
mmol/L
HbA1c; 1.64,
8.19 mmol/L
Hb
TQ HbA1c Gen Immuno- Jan ‘25 725180, 728053 0.048, 0.388, - European Reference
IV Hemolysate assay 809690, 0.520, 0.746, Lab
809704
on Cobas c513 1.215, 1.819 ESRL#13
mmol/L
HbA1c; 1.64,
8.19 mmol/L
Hb
PWN Laboratory Beckman Immuno- Jan ‘25 1065 1065 0.169, 0.448, - Univ. of Missouri.
B00389 on assay 0.843, 1.484, SRL #12
AU680 using 2.270 g/dL
red blood cell- HbA1c;
serum strip- 14.335 g/dL
based cassettes Hb
SG Diagnostics Boronate Boronate Jan ‘25 ETSC24092406 - - - Zhongshan Hospital
1
Pte, Ltd. Affinity on SG Affinity ASRL#3
Diagnostics
HbA1c Analysis
System
Shijiazhuang Nepelometry on Immuno- Jan ‘25 FA241026 S03523-3 2.0%, 4.1%, - Zhongshan Hospital
Hipro HP-AFS/1 assay 6.1%, 8.2%, ASRL#3
Biotechnology Automatic 10.3%, 12.3%,
Co., Ltd. Immunoassay 14.4%
Analyzer
Xiamen Biotime Fluorescence Immuno- Jan ‘25 Y2409013 - - - Zhongshan Hospital
Biotechnology Immunoassay assay ASRL#3
Co., Ltd. on BIOT-YG-I
FIA Analyzer
Ion-Exchange Ion- Jan ‘25 H24070101 HJ24070101 5.20%, H24070101 Zhongshan Hospital
chromatography exchange 10.03% ASRL#3
on HLC-100 HPLC
Siemens Dimension A1C Immuno- Jan ‘25 GA5287 GA5287 0.11, 0.59, - Univ. of Missouri.
Healthineers on Dimension assay 1.15, 2.01, SRL #12
EXL System 2.88 g/dL
HbA1c; 14.10,
13.54 g/dL Hb
Dimension A1C Immuno- Jan ‘25 GA5287 GA5287 0.11, 0.59, - Univ. of Missouri.
on Dimension assay 1.15, 2.01, SRL #12
RXL System 2.88 g/dL
HbA1c; 14.10,
13.54 g/dL Hb
Dimension A1C Immuno- Jan ‘25 GA5287 GA5287 0.11, 0.59, - Univ. of Missouri.
on Dimension assay 1.15, 2.01, SRL #12
Xpand System 2.88 g/dL
HbA1c; 14.10,
13.54 g/dL Hb
Dimension Vista Immuno- Jan ‘25 24190BA 4GD033 0.11, 0.47, - Univ. of Missouri.
1500 assay 0.92, 1.56, SRL #12
2.23 g/dL
HbA1c; 13.36,
12.98 g/dL Hb
Dimension Vista Immuno- Jan ‘25 24190BA 4GD033 0.11, 0.47, - Univ. of Missouri.
500 assay 0.92, 1.56, SRL #12
2.23 g/dL
HbA1c; 13.36,
12.98 g/dL Hb

12
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Beckman Coulter HbA1c Immuno- Jan ‘25 M405414;, M405414 0.147, 0.453, - Univ. of Missouri.
Inc. Colorimetric assay M405414 0.854, 1.482, SRL #12
DxC 600 2.294 g/dL
Platform HbA1c; 19.79
%NGSP g/dL Hb
HbA1c=(A1c/H
b)*91.48+2.152
HbA1c Immuno- Jan ‘25 M405414;, M405414 0.147, 0.453, - Univ. of Missouri.
Colorimetric assay M405414 0.854, 1.482, SRL #12
DxC 800 2.294 g/dL
Platform HbA1c; 19.79
%NGSP g/dL Hb
HbA1c=(A1c/H
b)*91.48+2.152
HbA1c3 Immuno- Jan ‘25 M402242, M402242 0.138, 0.454, - Univ. of Missouri.
Colorimetric assay M402242 0.871, 1.526, SRL #12
DxC 800 2.408 g/dL
Platform HbA1c; 19.47
%NGSP g/dL Hb
HbA1c3=(A1c/
Hb)*91.48+2.15
2
HbA1c3 Immuno- Jan ‘25 M402242, M402242 0.138, 0.454, - Univ. of Missouri.
Colorimetric assay M402242 0.871, 1.526, SRL #12
DxC 600 2.408 g/dL
Platform HbA1c; 19.47
%NGSP g/dL Hb
HbA1c3=(A1c/
Hb)*91.48+2.15
2
EMPECS Medical ASUREQUAN Enzymatic Jan ‘25 BAIYB25L1AD - - - European Reference
Device Co., Ltd. Analyzer Lab
ESRL#17
Nihon Kohden Celltac Chemi Immuno- Jan ‘25 24048 CEN013 0.0%, 4.4%, - ReCCS
Corporation HbA1c N on assay 6.8%, 9.4%, ASRL#1
MEK-1303 12.6%
Celltac @+
Celltac Chemi Immuno- Jan ‘25 24030 CEN013 0.0%, 4.4%, - ReCCS
HbA1c on assay 6.7%, 9.4%, ASRL#1
CHM-4100 12.8%
Celltac Chemi Immuno- Jan ‘25 24048 CEN013 0.0%, 4.4%, - ReCCS
HbA1c N on assay 6.8%, 9.4%, ASRL#1
CHM-4100 12.6%
i-SENS Enzymatic on Enzymatic Jan ‘25 DKIEJD - - - ReCCS
A1Care ASRL#1
Analyzer
Guangzhou P60 Ion- Jan ‘25 B124501, ZS3002, 5.87%, D70005B Zhongshan Hospital
Wondfo Biotech exchange B224602, ZS3002 10.59% ASRL#3
W324601,
Co., Ltd. HPLC HW24701
TaiDoc Immunoassay Immuno- Jan ‘25 24G111 1130723, 5.7%, 11.1% - European Reference
Technology Corp. on TD-4611 assay 1130723 Lab
ESRL#13
Bio-Rad t VARIANT II Ion- Jan ‘25 64626161, 64614806, 5.5%, 10.4% LA00058 Univ. of Missouri.
Laboratories Dual (A1c) exchange 64626162, 64614807 SRL #12
64580659
HPLC
t VARIANT II Ion- Jan ‘25 64626161, 64628873, 5.4%, 10.6% LA00058 Univ. of Missouri.
Dual exchange 64626162, 64628875 SRL #12
64626153
(A2/F/A1c) HPLC

D-10 HbA1c Ion- Jan ‘25 AA40295, AA40373, 5.5%, 10.3% R30081A Univ. of Missouri.
(12000949) exchange AA40296, AA40374 SRL #12
AA40426
HPLC
13
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Bio-Rad D-10 HbA1c Ion- Jan ‘25 AA40439, AA40373, 5.5%, 10.3% D20022V Univ. of Missouri.
Laboratories exchange AA40440, AA40374 SRL #12
AA40380
HPLC
D-100 HbA1c Ion- Jan ‘25 64554229. 64627388, 6.14%, 8.97% 20371AP Univ. of Missouri.
exchange 64565464, 64627388 SRL #12
64618290
HPLC
D-10 Dual Ion- Jan ‘25 AA40346, AA40397, 5.5%, 10.1% D20022X Univ. of Missouri.
A2/F/A1c exchange AA40347, AA40398 SRL #12
AA30185
HPLC
Variant II Ion- Jan ‘25 AA40484, 64594149, 5.6%, 10.7% NU00061H Univ. of Missouri.
HbA1c NU exchange AA40485, 64594150 SRL #12
64614630
HPLC
VARIANT II Ion- Jan ‘25 64619067, 64614782, 5.2%, 10.6% 10256V Univ. of Missouri.
TURBO HbA1c exchange 64619068, 64614783 SRL #12
64631973
Kit – 2.0 HPLC
(12000447)
VARIANT II Ion- Jan ‘25 64619067, 64614782, 5.2%, 10.6% 10256V Univ. of Missouri.
TURBO HbA1c exchange 64619068, 64614783 SRL #12
64631973
Kit – 2.0 HPLC
Nanjing Poclight Hemoglobin Immuno- Jan ‘25 D240401ER2 240402, 5.10%, - Zhongshan Hospital
Biotechnology A1c (HbA1c) assay 240402 10.00% ASRL#3
Co., Ltd. Test Kit
(Homogeneous
Chemiluminesce
nce
Immunoassay)
on C5000
Aehealth Limited Immunofluoresc Immuno- Dec ‘24 2024101801 - - - Zhongshan Hospital
ence assay on assay ASRL#3
Lamuno Plus

Immunofluoresc Immuno- Dec ‘24 2024101801 - - - Zhongshan Hospital

ence assay on assay ASRL#3
Lamuno Pro

Immunofluoresc Immuno- Dec ‘24 2024101801 - - - Zhongshan Hospital

ence assay on assay ASRL#3
Lamuno X

Hunan Kangxin Glycated Immuno- Dec ‘24 1F18402, 1F18402 14.0%, 12.0%, - Zhongshan Hospital
Biotechnology Haemoglobin assay 1F18402, 10.0%, 8.0%, ASRL#3
Co., Ltd. Kit 1F18402 6.5%, 5.0%,
(Microfluidic 3.8%, 0.0%
Fluorescent
Immunoassay
on LYOFIA-I
Glycated Immuno- Dec ‘24 1F18402, 1F18402 14.0%, 12.0%, - Zhongshan Hospital
Haemoglobin assay 1F18402, 10.0%, 8.0%, ASRL#3
Kit 1F18402 6.5%, 5.0%,
(Microfluidic 3.8%, 0.0%
Fluorescent
Immunoassay
on LYOFIA8
Hunan Yonghe- Ion-exchange Ion- Dec ‘24 20240819, 20241014 5.30%, 9.70% 20240819, Zhongshan Hospital
Sun HPLC on YH- exchange 20241008 20241008 ASRL#3
Biotechnology 30 HPLC
Co., Ltd.
Ion-exchange Ion- Dec ‘24 20240530, 20241014 5.30%, 9.70% 20240530, Zhongshan Hospital
HPLC on YH- exchange 20240902 20240902 ASRL#3
60 HPLC

14
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
CareforU.Co.Ltd CareBuddy Boronate Dec ‘24 CDC124G18 - - - ReCCS
Multi/ Affinity ASRL#1
CareBuddy
HbA1c/
Conficare M1/
Conficare
HbA1c
Goldsite HbA1c on Immuno- Dec ‘24 0372250720, 20240401 6.10%, 8.70%, - Zhongshan Hospital
Diagnostics Inc. Omlipo assay 0372250720, 14.00%, ASRL#3
0372250720, 17.20%
HbA1c on A1c Boronate Dec ‘24 3200032408 3200032408 5.84%, 8.25% - Zhongshan Hospital
Go also sold by Affinity 14 14 ASRL#3
Laboratório de
Análises
Clínicas Labpoc
LTDA as Lab
Poc HbA1c –
LP5-HG
HbA1c on Immuno- Dec ‘24 0572250628, 20240401 6.10%, 8.70%, - Zhongshan Hospital
Aristo assay 0572250628, 14.00%, ASRL#3
0572250628 17.20%
HbA1c on GPP- Immuno- Dec ‘24 1072240722, 20240401 6.10%, 8.70%, - Zhongshan Hospital
100 assay 1072240722, 14.00%, ASRL#3
1072240722, 17.20%
HbA1c on GSH- Ion- Dec ‘24 9101240520 20240601 5.25%, - Zhongshan Hospital
60 exchange A1, 11.30% ASRL#3
HPLC 9102240520
A1,
9103240520
A1,
HbA1c on Immuno- Dec ‘24 0172240721, 20240401 6.10%, 8.70%, - Zhongshan Hospital
Nephstar assay 0172240721, 14.00%, ASRL#3
0172240721 17.20%
Roche Cobas HbA1c Immuno- Dec ‘24 41904I-01 - - - Univ. of Missouri.
Diagnostics Test on cobas b assay SRL #12
International Ltd 101
Roche TQ HbA1c Gen. Immuno- Dec ‘24 790123, 728053 0.131, 0.336, - European Reference
Diagnostics 3 on cobas c311 assay 812086, 0.666, 0.928, Lab
HbA1c/Hb*91.5 800321 1.269, 1.812 ESRL#13
+2.15 mmol/L
HbA1c; 1.424,
7.682 mmol/L
Hb
TQ HbA1c Gen. Immuno- Dec ‘24 782828, 728053 0.154, 0.371, - European Reference
3 Whole Blood assay 812070, 0.718, 0.987, Lab
on cobas c303 809425 1.359, 1.925 ESRL#13
HbA1c/Hb*91.5 mmol/L
+2.15 HbA1c; 1.50,
8.08 mmol/L
Hb
TQ HbA1c Gen. Immuno- Dec ‘24 782828, 728053 0.154, 0.369, - European Reference
3 Hemolysate on assay 812070, 0.712, 0.979, Lab
cobas c303 809425 1.348, 1.911 ESRL#13
HbA1c/Hb*91.5 mmol/L
+2.15 HbA1c; 1.49,
8.03 mmol/L
Hb

15
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Roche TQ HbA1c Gen. Immuno- Dec ‘24 782821, 728053 0.139, 0.356, - European Reference
Diagnostics 3 on cobas c 501 assay 812086, 0.705, 0.983, Lab ESRL #13
/ c 502 800321 1.344, 1.920
(HbA1c/Hb*91. mmol/L
5+2.15) HbA1c; 1.424,
7.682 mmol/L
Hb
TQ HbA1c Gen. Immuno- Dec ‘24 782836, 728053 0.154, 0.369, - European Reference
3 Hemolysate on assay 812070, 0.712, 0.979, Lab ESRL #13
cobas c503 809425 1.348, 1.911
(HbA1c/Hb*91. mmol/L
5+2.15) HbA1c; 1.49,
8.03 mmol/L
Hb
TQ HbA1c Gen. Immuno- Dec ‘24 782836, 728053 0.154, 0.371, - European Reference
3 whole blood assay 812070, 0.718, 0.987, Lab ESRL #13
on cobas c503 809425 1.359, 1.925
(HbA1c/Hb*91. mmol/L
5+2.15) HbA1c; 1.50,
8.08 mmol/L
Hb
TQ HbA1c Gen. Immuno- Dec ‘24 782828, 728053 0.154, 0.371, - European Reference
3 whole blood assay 809690, 0.718, 0.987, Lab ESRL #13
on cobas c513 809704 1.359, 1.925
(HbA1c/Hb*91. mmol/L
5+2.15) HbA1c; 1.50,
8.08 mmol/L
Hb
TQ HbA1c Gen. Immuno- Dec ‘24 782828, 728053 0.154, 0.369, - European Reference
3 hemolysate on assay 809690, 0.712, 0.979, Lab ESRL #13
cobas c513 809704 1.348, 1.911
(HbA1c/Hb*91. mmol/L
5+2.15) HbA1c; 1.49,
8.03 mmol/L
Hb
Beckman Coulter HbA1c B00389 Immuno- Nov ‘24 1067, 1067 0.114, 0.278, - European Reference
Ireland Inc. Manual assay M310675 0.509, 0.893, Lab
Application on 1.326 mmol/L ESRL#13
AU480 HbA1c; 8.79
mmol/L Hb
HbA1c B00389 Immuno- Nov ‘24 1067, 1067 0.114, 0.278, - European Reference
Manual assay M310675 0.509, 0.893, Lab
Application on 1.326 mmol/L ESRL#13
AU680 HbA1c; 8.79
mmol/L Hb
HbA1c B00389 Immuno- Nov ‘24 1067, 1067 0.114, 0.278, - European Reference
Manual assay M310675 0.509, 0.893, Lab
Application on 1.326 mmol/L ESRL#13
AU5800 HbA1c; 8.79
mmol/L Hb
HbA1c B00389 Immuno- Nov ‘24 1067, 1067 0.114, 0.278, - European Reference
Manual assay M310675 0.509, 0.893, Lab
Application on 1.326 mmol/L ESRL#13
DxC700AU HbA1c; 8.79
mmol/L Hb
HbA1c Immuno- Nov ‘24 1067 1067 0.088, 0.275, - European Reference
Advanced assay 0.525, 0.895, Lab
B93009 Online 1.331 mmol/L ESRL#13
Application on HbA1c; 8.79
DxC500AU mmol/L Hb

16
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Beckman Coulter HbA1c Immuno- Nov ‘24 1067 1067 0.088, 0.275, - European Reference
Ireland Inc. Advanced assay 0.525, 0.895, Lab
B93009 Online 1.331 mmol/L ESRL#13
Application on HbA1c; 8.79
DxC700AU mmol/L Hb
Tosoh HLC-723GR01 Ion- Nov ‘24 XR-103X, ZB3020 5.88%, X Univ. of Missouri.
Corporation Variant Mode exchange XR-203X, 10.95% SRL #12
HPLC R351X,
HW-20M
Shenzen Drawray Fluorescence Immuno- Nov ‘24 20240801 34760 3.10%, 4.40%, - Zhongshan Hospital
Biotech Co., Ltd. Immunoassay assay 5.80%, 10.0%, ASRL#3
on UC100 15.3%, 19.5%
Fluorescence Immuno- Nov ‘24 20240801 34760 3.10%, 4.40%, - Zhongshan Hospital
Immunoassay assay 5.80%, 10.0%, ASRL#3
on UC1 15.3%, 19.5%
Fluorescence Immuno- Nov ‘24 20240801 34760 3.10%, 4.40%, - Zhongshan Hospital
Immunoassay assay 5.80%, 10.0%, ASRL#3
on UC10 15.3%, 19.5%
QuidelOrtho A1C1 on Vitros Enzymatic Nov ‘24 3185 3314 3.63%, 5.58%, - Univ. of Missouri.
4600 11.49% SRL #12
A1C1 on Vitros Enzymatic Nov ‘24 3185 3314 3.75%, 5.87%, - Univ. of Missouri.
XT 3400 11.74% SRL #12
A1C1 on Vitros Enzymatic Nov ‘24 3185 3314 3.63%, 5.58%, - Univ. of Missouri.
5600 11.49% SRL #12
A1C1 on Vitros Enzymatic Nov ‘24 3185 3314 3.75%, 5.87%, - Univ. of Missouri.
XT 7600 11.74% SRL #12
Getein Biotech, Immunofluoresc Immuno- Nov ‘24 YBC240087 - - - Zhongshan Hospital
Inc. ence Assay on assay ASRL#3
Getein 1100
Immunofluoresc Immuno- Nov ‘24 P009240060 - - - Zhongshan Hospital
ence Assay on assay ASRL#3
Getein 1600
Immunofluoresc Immuno- Nov ‘24 A019240080 - - - Zhongshan Hospital
ence Assay on assay ASRL#3
Getein 1180
Immunofluoresc Immuno- Nov ‘24 G009240005 - - - Zhongshan Hospital
ence Assay on assay ASRL#3
Getein 1200
Immunofluoresc Immuno- Nov ‘24 EBC240002W - - - Zhongshan Hospital
ence Assay on assay ASRL#3
Getein 208
Immunofluoresc Immuno- Nov ‘24 A019240050 - - - Zhongshan Hospital
ence Assay on assay ASRL#3
Getein 1160
Chemiluminesce Immuno- Nov ‘24 SBC24008 - - - Zhongshan Hospital
nce Assay on assay ASRL#3
MAGICL 6000
Chemiluminesce Immuno- Nov ‘24 SBC24012 - - - Zhongshan Hospital
nce Assay on assay ASRL#3
MAGICL 6000i
Chemiluminesce Immuno- Nov ‘24 SBC24010 - - - Zhongshan Hospital
nce Assay on assay ASRL#3
MAGICL 6200
ACON On Call Immuno- Nov ‘24 OGHB4030 - - - Zhongshan Hospital
Laboratories, Inc. MultiPro assay 002 ASRL#3
and Acon Biotech System—
(Hangzhou) Co., HbA1c
Ltd.
On Call A1c Immuno- Nov ‘24 gHb4060001 - - - Zhongshan Hospital
assay ASRL#3

17
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
ACON Fluorescent Immuno- Nov ‘24 FHB407500 - - - Zhongshan Hospital
Laboratories, Inc. Immunochromat assay 5 ASRL#3
and Acon Biotech ography on
(Hangzhou) Co., Fluorescent
Ltd. Immunoassay
Analyzer
OSANG Frontier and Boronate Nov ‘24 F24D23D30 - - - Univ. of Missouri.
Healthcare Co., HemoCue Affinity DL SRL #12
Ltd. HbA1c 501
Clover A1c Plus Boronate Nov ‘24 B24G28H08 - - - Univ. of Missouri.
Affinity EL SRL #12
Clover A1c, Boronate Nov ‘24 A24G17G22 - - - Univ. of Missouri.
Clover A1c Self Affinity EL SRL #12
and Checkart
Clover A1c Boronate Nov ‘24 E24C10C26 - - - Univ. of Missouri.
Expert Affinity EL SRL #12
Zhongfu Latex Immuno- Oct ‘24 24020101 24020101 0.0%, 4.3%, - Zhongshan Hospital
Bioengineering immunoturbidim assay 6.9%, 9.8%, ASRL#3
(Dalian) Co., Ltd. etric method on 13.4%
FUNOTEC FC-
100
Latex Immuno- Oct ‘24 24020101 24020101 0.0%, 4.3%, - Zhongshan Hospital
immunoturbidim assay 6.9%, 9.8%, ASRL#3
etric method on 13.4%
FUNOTEC FC-
300
Latex Immuno- Oct ‘24 24020101 24020101 0.0%, 4.3%, - Zhongshan Hospital
immunoturbidim assay 6.9%, 9.8%, ASRL#3
etric method on 13.4%
FUNOTEC FC-
800
Furuno Electric Centronic Immuno- Oct ‘24 HF04241G1 318612 0%, 5.6%, - ReCCS
Co., Ltd. HbA1c assay -407, 8.7%, 11.3%, ASRL#1
turbidimetric HF04241G1 15.3 %
immunoassay on -407,
CA-800 HF04231KL
Y-311
JEOL Ltd. BM Test HbA1c Enzymatic Oct ‘24 904RHU, 944RCV, 3.56, 15.86 - ReCCS
on JCA- 904RHU, 944RCV µmol/L ASRL#1
BM6010/C 870RHU HbA1c; 99.0,
153.8 µmol/L
Hb
HORIBA Ltd. Spotchem Immuno- Oct ‘24 2427KL098B WC0082 0.0, 25.6, 53.2, - ReCCS
Banalyst HbA1c assay 85.9, 126.2 ASRL#1
on SI-3620 mmol/mol
Banalyst Ace Immuno- Oct ‘24 2427KL098B WC0082 0.0, 25.6, 53.2, - ReCCS
HbA1c on assay 85.9, 126.2 ASRL#1
Banalyst Ace mmol/mol
Spotchem Immuno- Oct ‘24 2427KL098B WC0082 0.0, 25.6, 53.2, - ReCCS
Banalyst HbA1c assay 85.9, 126.2 ASRL#1
on SI-3610 mmol/mol
Banalyst HbA1c Immuno- Oct ‘24 2427KL098B WC0082 0.0, 25.6, 53.2, - ReCCS
on Yumizen assay 85.9, 126.2 ASRL#1
M100 Banalyst mmol/mol
Apex Immunoagglutin Immuno- Oct ‘24 AS4051 - - - ReCCS
Biotechnology -ation on Eclipse assay ASRL#1
Corp. PLUS Multi-
Purpose
Analyzer
Guangdong HbA1c on WS- Immuno- Oct ‘24 AA0042406 - - - Zhongshan Hospital
Wesail Biotech Si1500 assay 016 ASRL#3
Co., Ltd.
18
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Guangdong HbA1c on WS- Immuno- Oct ‘24 AA0042406 - - - Zhongshan Hospital
Wesail Biotech Mi6000 assay 016 ASRL#3
Co., Ltd.
HbA1c on WS- Immuno- Oct ‘24 AA0042406 - - - Zhongshan Hospital
Si1000 assay 016 ASRL#3
CKK Diagnostics Ion-exchange Ion- Oct ‘24 20240810, 20240730, 5.80%, 20240845(S Zhongshan Hospital
Bangalore Pvt. HPLC on exchange 20240811, 20240730 10.40% CXj-5) ASRL#3
Ltd. CKKA1c Pro HPLC 20240812,
20240813,
Ion-exchange Ion- Oct ‘24 20240715, 20240730, 5.80%, 20240831(F Zhongshan Hospital
HPLC on exchange 20240716, 20240730 10.40% 5116) ASRL#3
CKKA1c HPLC 20240717,
20240718
LLP “Aksel&A” Enzymatic assay Enzymatic Oct ‘24 230724 - - - ReCCS
(optical method) ASRL#1
Spectrophotome
try on Shyrai
A1c
VivaChek Biotech Fluorescence Immuno- Oct ‘24 E2407130 - - - Zhongshan Hospital
(Hangzhou) Co., Immunoassay assay ASRL#3
Ltd. on POCT
Analyzer
VIM1000
Fluorescence Immuno- Oct ‘24 E2407131 - - - Zhongshan Hospital
Immunoassay assay ASRL#3
on POCT
Analyzer
VIM1000 M6
Fluorescence Immuno- Oct ‘24 E2407132 - - - Zhongshan Hospital
Immunoassay assay ASRL#3
on POCT
Analyzer
VIM2000
Fluorescence Immuno- Oct ‘24 E2407133 - - - Zhongshan Hospital
Immunoassay assay ASRL#3
on POCT
Analyzer
VIM3000
Fluorescence Immuno- Oct ‘24 E2407134 - - - Zhongshan Hospital
Immunoassay assay ASRL#3
on
Multifunction
Meter
VIM220H
Guangdong Fapon Immuno assay Immuno- Sept ‘24 20231222, 20240718 0, 4.20%, - Zhongshan Hospital
Biotech Co., Ltd. on AU680 assay 20231222, 6.90%, 9.90%, ASRL#3
20231222 13.30%
Immuno assay Immuno- Sept ‘24 20231222, 20240718 0, 4.20%, - Zhongshan Hospital
on BS-480 assay 20231222, 6.90%, 9.90%, ASRL#3
20231222 13.30%
JW Bioscience Immuno assay Immuno- Sept ‘24 401 401 6.3%, 8.9%, - ReCCS
on JCA- assay 12.3%, 15.5% ASRL#1
BM6010/C
EKF Diagnostic Boronate- Boronate Sept ‘24 020835 - - - European Reference
GmbH Affinity Quo- affinity Lab ESRL #11
Test HbA1C
Boronate- Boronate Sept ‘24 026430 - - - European Reference
Affinity Quo- affinity Lab ESRL #11
Lab HbA1C

19
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Human Boronate- Boronate Sept ‘24 0264301 - - - European Reference
Gesellschaft fuer Affinity affinity Lab ESRL #11
Biochemica und HumaMeter
Diagnostica mbH HbA1c
Agappe Nephelometry Immuno- Sept ‘24 42401331, 42305231, 5.60%, 9.80%, - European Reference
Diagnostics Ltd. on Specific assay 42401332, 42305232, 14.10%, Lab
Protein 12402036 42305233, 16.50% ESRL#17
Analyzer Mispa 42305234,
i2
Nephelometry Immuno- Sept ‘24 42401331, 42305231, 5.60%, 9.80%, - European Reference
on cartridge assay 42401332, 42305232, 14.10%, Lab
based Specific 12402036 42305233, 16.50% ESRL#17
Protein 42305234
Analyzer Mispa
i3
Nephelometry Immuno- Sept ‘24 42401331, 42305231, 5.60%, 9.80%, - European Reference
on cartridge assay 42401332, 42305232, 14.10%, Lab
based Specific 12402036 42305233, 16.50% ESRL#17
Protein 42305234
Analyzer Mispa
i2Plus
AgA1c Immuno- Sept ‘24 42401331, 42305231, 5.60%, 9.80%, - European Reference
(Immunoturbidi assay 42401332, 42305232, 14.10%, Lab
metric method) 12402036 42305233, 16.50% ESRL#17
on TMS 30i 42305234
AgA1c Immuno- Sept ‘24 42401331, 42305231, 5.70%, 9.70%, - European Reference
(Immunoturbidi assay 42401332, 42305232, 13.80%, Lab
metric method) 12402036 42305233, 16.80% ESRL#17
on TBA-120FR 42305234
AgA1c Immuno- Sept ‘24 42401331, 42305231, 5.70%, 9.70%, - European Reference
(Immunoturbidi assay 42401332, 42305232, 13.80%, Lab
metric method) 12402036 42305233, 16.80% ESRL#17
on Mispa Plus 42305234
AgA1c Immuno- Sept ‘24 42401331, 42305231, 6.20%, - European Reference
(Immunoturbidi assay 42401332, 42305232, 10.00%, Lab
metric method) 12402036 42305233, 15.20%, ESRL#17
on Mispa CCXL 42305234 18.00%
Agappe AgA1c Immuno- Sept ‘24 42401331, 42305231, 6.30%, 9.90%, - European Reference
Diagnostics Ltd. (Immunoturbidi assay 42401332, 42305232, 15.00%, Lab
metric method) 12402036 42305233, 18.00% ESRL#17
on Mispa CX4 42305234
AgA1c Immuno- Sept ‘24 42401331, 42305231, 5.60%, 9.60%, - European Reference
(Immunoturbidi assay 42401332, 42305232, 15.20%, Lab
metric method) 12402036 42305233, 18.00% ESRL#17
on Mispa CXL 42305234
Pro Plus
AgA1c Immuno- Sept ‘24 42401331, 42305231, 5.60%, 9.60%, - European Reference
(Immunoturbidi assay 42401332, 42305232, 15.50%, Lab
metric method) 12402036 42305233, 18.00% ESRL#17
on Mispa CXL 42305234
Pro
AgA1c Immuno- Sept ‘24 42401331, 42305231, 5.60%, 9.70%, - European Reference
(Immunoturbidi assay 42401332, 42305232, 14.50%, Lab
metric method) 12402036 42305233, 16.70% ESRL#17
on Mispa Nano 42305234
Plus
AgA1c Immuno- Sept ‘24 42401331, 42305231, 5.70%, 9.70%, - European Reference
(Immunoturbidi assay 42401332, 42305232, 13.80%, Lab
metric method) 12402036 42305233, 16.80% ESRL#17
on Mispa Viva 42305234

20
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Agappe AgA1c Immuno- Sept ‘24 42401331, 42305231, 5.90%, 9.90%, - European Reference
Diagnostics Ltd. (Immunoturbidi assay 42401332, 42305232, 14.90%, Lab
metric method) 12402036 42305233, 17.30% ESRL#17
on Mispa 42305234
Nano/Ace
AgA1c Immuno- Sept ‘24 42401331, 42305231, 5.60%, 9.50%, - European Reference
(Immunoturbidi assay 42401332, 42305232, 14.20%, Lab
metric method) 12402036 42305233, 16.60% ESRL#17
on BS 390 42305234
Minaris Medical MetaboLead Immuno- Sept ‘24 561ADC, 511ACL 2.44, - ReCCS
Co., Ltd. HbA1c on DM- assay 561ADC 9.32µmol/L ASRL#1
JACK HbA1c; 83.2,
120.0 µmol/L
Hb
MetaboLead Immuno- Sept ‘24 561ADC, 511ACL 2.44, - ReCCS
HbA1c on JCA- assay 561ADC 9.32µmol/L ASRL#1
BM9130 HbA1c; 83.2,
120.0 µmol/L
Hb
MetaboLead Immuno- Sept ‘24 561ADC, 511ACL 2.44, - ReCCS
HbA1c on TBA- assay 561ADC 9.32µmol/L ASRL#1
120FR HbA1c; 83.2,
120.0 µmol/L
Hb
MetaboLead Immuno- Sept ‘24 561ADC, 511ACL 2.44, - ReCCS
HbA1c on assay 561ADC 9.32µmol/L ASRL#1
Hitachi 7180 HbA1c; 83.2,
120.0 µmol/L
Hb
MetaboLead Immuno- Sept ‘24 561ADC, 511ACL 2.44, - ReCCS
HbA1c on assay 561ADC 9.32µmol/L ASRL#1
LABOSPECT HbA1c; 83.2,
006 120.0 µmol/L
Hb
Truth Truth-H80 Ion- Aug ‘24 B123901, 20240520, 5.66%, D50002B Zhongshan Hospital
Biotechnology exchange B223902, 20240520 11.24% ASRL#3
Co., Ltd. HPLC W323a03,
HW23a01
Truth-H80E Ion- Aug ‘24 B123901, 20240520, 5.66%, D50003B Zhongshan Hospital
exchange B223902, 20240520 11.24% ASRL#3
HPLC W323a03,
HW23a01
Shenzhen Borate affinity Boronate Aug ‘24 240408 - - - Zhongshan Hospital
Poweray chromatography Affinity ASRL#3
Biotechnology on PR303
Co., Ltd.
Borate affinity Boronate Aug ‘24 240408 - - - Zhongshan Hospital
chromatography Affinity ASRL#3
on PR606
Borate affinity Boronate Aug ‘24 240408 - - - Zhongshan Hospital
chromatography Affinity ASRL#3
on PR603
Human HumanNex A1c Ion- Aug ‘24 240603Q, 20230815, 5.86%, 240603Q Univ. of Missouri.
Gesellschaft fuer exchange 240603Q, 20230815 10.90% SRL #12
Biochemica und HPLC 240603Q
Diagnostica mbH

21
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Shanghai HPLC on MQ- Ion- Aug ‘24 PTHbA1c24 20240312, 5.36%, PTHbA1c24 Univ. of Missouri.
Medconn Medical 2000PT exchange 0318P, 20240312 11.04% 0318P SRL #12
Technology Co. HPLC PTHbA1c24
Ltd (China) 0318P,
PTHbA1c24
0318P
HPLC on MQ- Ion- Aug ‘24 3K20240123k 20240312, 5.52%, DZ2024012 Univ. of Missouri.
3000 exchange , 20240312 11.26% 3k SRL #12
HPLC 3K20240123k
,
3K20240123k
,
3K20240123k
,20240123k
HPLC on MQ- Ion- Aug ‘24 3K20240123k 20240109, 5.65%, DZ2024012 Univ. of Missouri.
3000PT exchange , 20240109 11.20% 3k SRL #12
HPLC 3K20240123k
,
3K20240123k
,
3K20240123k
,20240123k
HPLC on MQ- Ion- Aug ‘24 3K20240520 240510, 5.53%, DZ2024052 Univ. of Missouri.
4000 exchange H, 240510 10.72% 0H SRL #12
HPLC 3K20240520
H,
3K20240520
H,
3K20240520
H,
20240520H
HPLC on MQ- Ion- Aug ‘24 3K20240520 240510, 5.53%, DZ2024052 Univ. of Missouri.
4000PT exchange H, 240510 10.72% 0H SRL #12
HPLC 3K20240520
H,
3K20240520
H,
3K20240520
H,
20240520H
HPLC on MQ- Ion- Aug ‘24 20240226L, 20240312, 5.30%, 6K20240226 Univ. of Missouri.
6000 exchange 20240226L, 20240312 10.58% L SRL #12
HPLC 20240226L,
20240226L,
HPLC on MQ- Ion- Aug ‘24 6KV202403 20240312, 5.36%, 6K20240311 Univ. of Missouri.
8000 exchange 11N, 20240312 10.76% N SRL #12
HPLC 6KV202403
11N,
6KV202403
11N,
20240311N
Shanghai HPLC on MQ- Ion- Aug ‘24 6KV202405 20231115, 5.60%, DZ2024051 Univ. of Missouri.
Medconn Medical 8000PT exchange 16Y, 20231115 10.62% 6M SRL #12
Technology Co. HPLC 6KV202405
Ltd (China) 16Y,
6KV202405
16Y,
20240516Y
PT Darma Labora HPLC on Ion- Aug ‘24 PTHbA1c24 230529, 4.93%, PTHbA1c24 Univ. of Missouri.
Indonesia Vercentra MQ- exchange 0108O, 230529 10.02% 0108O SRL #12
2000DX HPLC PTHbA1c24
0108O,
PTHbA1c24
0108O
22
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Medicalsystem Latex enhanced Immuno- Aug ‘24 240607101 240514101 0%, 5.6%, - Zhongshan Hospital
Biotechnology immunoturbidim assay 8.4%, 10.6%, ASRL#3
Co., Ltd. etric method on 14.9%
Hitachi 7180
Latex enhanced Immuno- Aug ‘24 240607101 240514101 0%, 5.6%, - Zhongshan Hospital
immunoturbidim assay 8.4%, 10.6%, ASRL#3
etric method on 14.9%
Medicalsystem
Biotechnology
MS-1280
Latex enhanced Immuno- Aug ‘24 240607101 240514101 0%, 5.6%, - Zhongshan Hospital
immunoturbidim assay 8.4%, 10.6%, ASRL#3
etric method on 14.9%
Medicalsystem
Biotechnology
MS-8080
Shenzhen New Immunoassay Immuno- Aug ‘24 551240101, 551240101, 0.00%, 5.70%, - Zhongshan Hospital
Industries on Hitachi assay 551240101, 551240101, 9.05%, ASRL#3
Biomedical LABOSPECT 551240101 551240101, 12.58%,
Engineering Co., 008AS 551240101, 17.09%
Ltd (SNIBE) 551240101,
Immunoassay Immuno- Aug ‘24 551240101, 551240101, 0.00%, 5.70%, - Zhongshan Hospital
on SNIBE assay 551240101, 551240101, 9.05%, ASRL#3
Biossays C8 551240101 551240101, 12.58%,
551240101, 17.09%
551240101,
Immunoassay Immuno- Aug ‘24 551240101, 551240101, 0.00%, 5.70%, - Zhongshan Hospital
on Snibe assay 551240101, 551240101, 9.05%, ASRL#3
Biolumi CX8 551240101 551240101, 12.58%,
551240101, 17.09%
551240101,
Immunoassay Immuno- Aug ‘24 551240201, 551240201, 0.00%, 6.00%, - Zhongshan Hospital
on Snibe assay 551240201, 551240201, 9.36%, ASRL#3
Biossays 240 551240201 551240201, 13.90%,
Plus 551240201, 17.05%
551240201
Wuxi Biohermes Boronate Boronate July ‘24 CAP240402 - - - Zhongshan Hospital
Bio & Medical Affinity on A1C Affinity 021 ASRL#3
Technology Co., EZ 2.0
Ltd. Glycohemoglobi
n Analysis
System
Boronate Boronate July ‘24 EAZ240314 - - - Zhongshan Hospital
Affinity on Affinity 061 ASRL#3
A1cChek
Express
Glycohemoglobi
n Analysis
System
Boronate Boronate July ‘24 CAW24040 - - - Zhongshan Hospital
Affinity on Affinity 2031 ASRL#3
A1cChek Pro
Glycohemoglobi
n Analysis
System

23
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Wuxi Biohermes Boronate Boronate July ‘24 EAG240318 - - - Zhongshan Hospital
Bio & Medical Affinity on Affinity 121 ASRL#3
Technology Co., GluCoA1c
Ltd. Blood Glucose
and
Glycohemoglobi
n Analysis
System
Ion-exchange Ion- July ‘24 CHI2404150 CHW240317 4.95%, CHD244100 Zhongshan Hospital
HPLC on GH60 exchange 11AQ 001 10.14% 17AQ ASRL#3
Automatic HPLC
Glycohemoglobi
n Analysis
System
Boditech Med Inc. Immuno-assay Immuno- July ‘24 AAUBA93X 211501A 5.4%, 7.8%, - ReCCS
on AFIAS-1 assay 11.0%, 14.9% ASRL#1
Neo Cartridge
Immuno-assay Immuno- July ‘24 AAUBA93X 211501A 5.4%, 7.8%, - ReCCS
on AFIAS-3 assay 11.0%, 14.9% ASRL#1
Neo Cartridge
Immuno-assay Immuno- July ‘24 AAUBA93X 211501A 5.4%, 7.8%, - ReCCS
on AFIAS-6 assay 11.0%, 14.9% ASRL#1
Neo Cartridge
Immuno-assay Immuno- July ‘24 AAUBA93X 211501A 5.4%, 7.8%, - ReCCS
on AFIAS-10 assay 11.0%, 14.9% ASRL#1
Neo Cartridge
Immuno-assay Immuno- July ‘24 AAUBC01EX 211501A 5.4%, 7.8%, - ReCCS
on ichroma II assay 11.0%, 14.9% ASRL#1
Neo Cartridge
Immuno-assay Immuno- July ‘24 AAUBC01EX 211501A 5.4%, 7.8%, - ReCCS
on ichroma III assay 11.0%, 14.9% ASRL#1
Neo Cartridge
Immuno-assay Immuno- July ‘24 AAUBC01EX 211501A 5.4%, 7.8%, - ReCCS
on ichroma -50 assay 11.0%, 14.9% ASRL#1
PLUS Neo
Cartridge
Immuno-assay Immuno- July ‘24 AAUBC01EX 211501A 5.4%, 7.8%, - ReCCS
on ichroma M3 assay 11.0%, 14.9% ASRL#1
Neo Cartridge
Immuno-assay Immuno- July ‘24 AAUBC01EX 211501A 5.4%, 7.8%, - ReCCS
on ichroma assay 11.0%, 14.9% ASRL#1
Reader Neo
Cartridge
Immuno-assay Immuno- July ‘24 AAUBC01EX 211501A 5.4%, 7.8%, - ReCCS
on QDx assay 11.0%, 14.9% ASRL#1
Instacheck
Neo Cartridge
Immuno-assay Immuno- July ‘24 AAUBC01EX 211501A 5.4%, 7.8%, - ReCCS
on EZ POC assay 11.0%, 14.9% ASRL#1
Neo Cartridge
Immuno-assay Immuno- July ‘24 AAUAC39F 211501A 5.4%, 7.8%, - ReCCS
on AFIAS-1 assay 11.0%, 14.9% ASRL#1
Immuno-assay Immuno- July ‘24 AAUAC39F 211501A 5.4%, 7.8%, - ReCCS
on AFIAS-3 assay 11.0%, 14.9% ASRL#1
Immuno-assay Immuno- July ‘24 AAUAC39F 211501A 5.4%, 7.8%, - ReCCS
on AFIAS-6 assay 11.0%, 14.9% ASRL#1
Immuno-assay Immuno- July ‘24 AAUAC39F 211501A 5.4%, 7.8%, - ReCCS
on AFIAS-10 assay 11.0%, 14.9% ASRL#1
Immuno-assay Immuno- July ‘24 AAUAL02 211501A 5.4%, 7.8%, - ReCCS
on EZ POC assay 11.0%, 14.9% ASRL#1

24
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Boditech Med Inc. Immuno-assay Immuno- July ‘24 AAUAL02 211501A 5.4%, 7.8%, - ReCCS
on ichroma II assay 11.0%, 14.9% ASRL#1
Immuno-assay Immuno- July ‘23 AAUAL02 211501A 5.4%, 7.8%, - ReCCS
on ichroma III assay 11.0%, 14.9% ASRL#1
Immuno-assay Immuno- July ‘23 AAUAL02 211501A 5.4%, 7.8%, - ReCCS
on ichroma M3 assay 11.0%, 14.9% ASRL#1
Immuno-assay Immuno- July ‘23 AAUAL02 211501A 5.4%, 7.8%, - ReCCS
on ichroma assay 11.0%, 14.9% ASRL#1
Reader
Immuno-assay Immuno- July ‘23 AAUAL02 211501A 5.4%, 7.8%, - ReCCS
on ichroma -50 assay 11.0%, 14.9% ASRL#1
PLUS
Immuno-assay Immuno- July ‘23 AAUAL02 211501A 5.4%, 7.8%, - ReCCS
on QDx assay 11.0%, 14.9% ASRL#1
Instacheck
Shenzhen High Ion- July ‘24 231030024, 211501-115 5.50%, 240226 Zhongshan Hospital
Xilaiheng Medical performance exchange 231030024, 15.50% ASRL#3
Electronics Co., liquid HPLC 231030024,
Ltd. chromatography 231030024
(HPLC) on
H600 Full-Auto
HbA1c
Analyzer
B&E Bio- High pressure Ion- July ‘24 H0069, NIM-RM- 5.1%, 10.1% 240122DG0 Zhongshan Hospital
Technology Co., ion-exchange exchange H0070, 3626(240204), 09 ASRL#3
Ltd. liquid HPLC H0071, NIM-RM-
3625(240204),
chromatography H0072
(HPLC) on G20
High pressure Ion- July ‘24 H0069, NIM-RM- 5.1%, 10.1% 230615BZ14 Zhongshan Hospital
ion-exchange exchange H0070, 3626(240204), 6X ASRL#3
liquid HPLC H0071, NIM-RM-
3625(240204),
chromatography H0072
(HPLC) on G21
High pressure Ion- July ‘24 H0069, NIM-RM- 5.1%, 10.1% 231149DG0 Zhongshan Hospital
ion-exchange exchange H0070, 3626(240204), 09K ASRL#3
liquid HPLC H0071, NIM-RM-
3625(240204),
chromatography H0072
(HPLC) on
G21+
Instrumentation HbA1c Enzymatic July ‘24 I0424169 10524191 3.66, 15.13 - European Reference
Laboratory Enzymatic µmol/L Lab
(Manual HbA1c; 97.2, ESRL#16
pretreatment) on 146.3 µmol/L
Ilab Taurus Hb
(%NGSP=HbA1
c/THb*91.48+2.
152)
HbA1c Enzymatic July ‘24 I0424169 10524191 3.66, 15.13 - European Reference
Enzymatic µmol/L Lab
(Manual HbA1c; 97.2, ESRL#16
pretreatment) on 146.3 µmol/L
Ilab Aries Hb
(%NGSP=HbA1
c/THb*91.48+2.
152)

25
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Instrumentation HbA1c Enzymatic July ‘24 I0424169 10524191 3.66, 15.13 - European Reference
Laboratory Enzymatic µmol/L Lab
(Automatic HbA1c; 97.2, ESRL#16
pretreatment) on 146.3 µmol/L
Ilab Taurus Hb
(%NGSP=HbA1
c/THb*91.48+2.
152)
GC Medical Boronate Affinity Boronate July ‘24 R14C151 - - - Univ. of Missouri.
Science` Corp. on DiaSys India Affinity SRL #12
QDx A1c
Advance
Boronate Affinity Boronate July ‘24 R14C151 - - - Univ. of Missouri.
on Arkray Pocket Affinity SRL #12
Chem A1c
Advanced
Boronate Affinity Boronate July ‘24 R14C151 - - - Univ. of Missouri.
on Medisys Hemo Affinity SRL #12
G Smart
Boronate Affinity Boronate July ‘24 R14C151 - - - Univ. of Missouri.
on DiaSys respons Affinity SRL #12
A1c
Boronate Affinity Boronate July ‘24 R14C151 - - - Univ. of Missouri.
on GREENCARE Affinity SRL #12
A1c
Med Trust Boronate Boronate July ‘24 EAR240201 - - - Zhongshan Hospital
Handelsges.m.b.H Affinity on Affinity 141 ASRL#3
Wellion BONA
HbA1c Analysis
System
Boronate Boronate July ‘24 EAZ240314 - - - Zhongshan Hospital
Affinity on Affinity 061 ASRL#3
Wellion
CLEVER
HbA1c Analysis
System
Randox HbA1c_II on Immuno- July ‘24 001RDHA, 2472HA, 0.0000%, - Univ. of Missouri.
Laboratories Ltd RX Daytona assay 002RDHA, 2473HA, 0.0458%, SRL #12
Plus 007RDHA 2474HA, 0.0877%,
2475HA, 0.1217%,
2476HA, 0.1466%
Dirui Industrial Whole Blood- Immuno- July ‘24 20240304, 20240415 0, 5.9%, 7.7%, - Zhongshan Hospital
Co., Ltd. Latex assay 20240304, 12.3%, 17.1% ASRL#3
Agglututination 20240304,
Method on CS-
T180
Whole Blood- Immuno- July ‘24 20240304, 20240415 0, 5.9%, 7.7%, - Zhongshan Hospital
Latex assay 20240304, 12.3%, 17.1% ASRL#3
Agglutination 20240304,
Method on CS-
T240Plus
Whole Blood- Immuno- July ‘24 20240304, 20240415 0, 5.9%, 7.7%, - Zhongshan Hospital
Latex assay 20240304, 12.3%, 17.1% ASRL#3
Agglutination 20240304,
Method on CS-
400
Whole Blood- Immuno- July ‘24 20240304, 20240415 0, 5.9%, 7.7%, - Zhongshan Hospital
Latex assay 20240304, 12.3%, 17.1% ASRL#3
Agglutination 20240304,
Method on CS-
480
Whole Blood- Immuno- July ‘24 20240304, 20240415 0, 5.9%, 7.7%, - Zhongshan Hospital
Latex assay 20240304, 12.3%, 17.1% ASRL#3
Agglutination 20240304,
Method on CS-
680

26
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Dirui Industrial Whole Blood- Immuno- July ‘24 20240304, 20240415 0, 5.9%, 7.7%, - Zhongshan Hospital
Co., Ltd. Latex assay 20240304, 12.3%, 17.1% ASRL#3
Agglutination 20240304,
Method on CS-
1200
Whole Blood- Immuno- July ‘24 20240304, 20240415 0, 5.9%, 7.7%, - Zhongshan Hospital
Latex assay 20240304, 12.3%, 17.1% ASRL#3
Agglutination 20240304,
Method on CS-
1300B
Latex Immuno- July ‘24 20240304, 20240415 0, 5.9%, 7.7%, - Zhongshan Hospital
Agglutination assay 20240304, 12.3%, 17.1% ASRL#3
Method on CS- 20240304,
1600
Latex Immuno- July ‘24 20240304, 20240415 0, 5.9%, 7.7%, - Zhongshan Hospital
Agglutination assay 20240304, 12.3%, 17.1% ASRL#3
Method on CS- 20240304,
2000
Nanjing RealMind Chemiluminesce Immuno- July ‘24 23112101, 231121011, 6.91%, - Zhongshan Hospital
Biotech Co., Ltd. nce assay 23112101 231121012 13.03% ASRL#3
Immunoassay
(CLIA) on
MCL60
Chemiluminesce
nce analyzer
Trinity Biotech Boronate Boronate July ‘24 13550, 15601, 5.2%, 10.6% 14992 Univ. of Missouri.
Affinity HPLC Affinity 14978, 15602 SRL #11
on Premier 15120,
Hb9210 New 14593
Calibration
Boronate Boronate July ‘24 14169, 15601, 5.10%, 14992 Univ. of Missouri.
Affinity HPLC Affinity 14978, 15602 10.48% SRL #11
on Premier 15120,
Hb9210 – 14938
Buffer A Plus
Horiba Medical Pointe Immuno- June ‘24 322201 211501 5.4%, 8.4%, - European Reference
Hemoglobin assay 12.2%, 15.6% Lab ESRL #13
A1c – Hba1c% -
ABX Pentra 400
Y=(1.297X)-
1.11
Pointe Immuno- June ‘24 322201 211501 0%, 5%, 7.9%, - European Reference
Hemoglobin assay 11.8%, 15.2% Lab ESRL #13
A1c - Pentra
C200
Y=(1.15X)-0.68
Pointe Immuno- June ‘24 322201 211501 5.4%, 8.4%, - European Reference
Hemoglobin assay 12.2%, 15.6% Lab ESRL #13
A1c – Hba1c% -
Pentra C400
Y=(1.193X)-
0.60
Pointe Immuno- June ‘24 322201 211501 5.4%, 8.4%, - European Reference
Hemoglobin assay 12.2%, 15.6% Lab ESRL #13
A1c –
Hba1c%H-
ABX Pentra 400
Y=(1.3X)-1.08

27
 List of NGSP Certified Methods (Updated 5/25, 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 Pointe Immuno- June ‘24 322201 211501 5.4%, 8.4%, - European Reference
Hemoglobin assay 12.2%, 15.6% Lab ESRL #13
A1c –
Hba1c%H -
Pentra C400
Y=(1.279X)-
0.98
Sebia Capillarys Capillary June ‘24 04102/01, 08042/01, 36.0, 84.8 - European Reference
HbA1c on Electro- 13092/01, 11042/01 mmol/mol Lab
Capillarys 2 phoresis 30082/01 ESRL#17
Flex Piercing
%NGSP=0.0914
8 x [IFCC]
(mmol/mol) +
2.152
Minicap HbA1c Capillary June ‘24 27033/01, 07092/01, 35.5, 84.4 - European Reference
on Minicap Electro- 21083/01, 08092/01 mmol/mol Lab
Flex-Piercing phoresis 28112/01 ESRL#17
%NGSP=0.0914
8 x [IFCC]
(mmol/mol) +
2.152
CAPI 3 HbA1c Capillary June ‘24 18073/01, 08042/01, 36.0, 84.8 - European Reference
on Capillarys 3 Electro- 25082/01, 11042/01 mmol/mol Lab
%NGSP=0.0914 phoresis 02013/01 ESRL#17
8 x [IFCC]
(mmol/mol) +
2.152
QuidelOrtho %A1c on Vitros Immuno- June ‘24 2363 3113 0.099, 0.839, - Univ. of Missouri.
4600 assay 1.733, 3.905 SRL #12
g/dL HbA1c;
(-0.788),
3.122, 7.637,
16.735 g/dL
Hb
%A1c on Vitros Immuno- June ‘24 2363 3113 0.099, 0.839, - Univ. of Missouri.
5600 assay 1.733, 3.905 SRL #12
g/dL HbA1c;
(-0.788),
3.122, 7.637,
16.735 g/dL
Hb
%A1c on Vitros Immuno- June ‘24 2363 3113 0.099, 0.839, - Univ. of Missouri.
7600 assay 1.733, 3.905 SRL #12
g/dL HbA1c;
(-0.788),
3.122, 7.637,
16.735 g/dL
Hb
Roche TQ HbA1c Gen. Immuno- June ‘24 765161, 701814 0.130, 0.335, - European Reference
Diagnostics 3 on cobas c 501 assay 763862, 0.664, 0.926, Lab ESRL #13
GmbH / c 502 781136 1.265, 1.807
(HbA1c/Hb*91. mmol/L
5+2.15) HbA1c; 1.38,
7.42 mmol/L
Hb

28
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Roche TQ HbA1c Gen. Immuno- June ‘24 733771, 701814 0.153, 0.346, - European Reference
Diagnostics 3 Hemolysate on assay 773156, 0.654, 0.893, Lab ESRL #13
GmbH cobas c503 765741 1.223, 1.729
(HbA1c/Hb*91. mmol/L
5+2.15) HbA1c; 1.46,
7.84 mmol/L
Hb
TQ HbA1c Gen. Immuno- June ‘24 733771, 701814 0.154, 0.353, - European Reference
3 whole blood assay 773156, 0.669, 0.915, Lab ESRL #13
on cobas c503 765741 1.255, 1.774
(HbA1c/Hb*91. mmol/L
5+2.15) HbA1c; 1.46,
7.84 mmol/L
Hb
TQ HbA1c Gen. Immuno- June ‘24 733769, 701814 0.154, 0.353, - European Reference
3 whole blood assay 756498, 0.669, 0.915, Lab ESRL #13
on cobas c513 758478 1.255, 1.774
(HbA1c/Hb*91. mmol/L
5+2.15) HbA1c; 1.46,
7.84 mmol/L
Hb
TQ HbA1c Gen. Immuno- June ‘24 733769, 701814 0.153, 0.346, - European Reference
3 hemolysate on assay 756498, 0.654, 0.893, Lab ESRL #13
cobas c513 758478 1.223, 1.729
(HbA1c/Hb*91. mmol/L
5+2.15) HbA1c; 1.46,
7.84 mmol/L
Hb
Tosoh G8 HbA1c Ion- June ‘24 T8-101K, ZS3002 5.87%, T Univ. of Missouri.
Corporation Variant Analysis exchange T8-203K, 10.59% SRL #12
Mode Ver. HPLC T8-301K,
5.24F (1.6 min), HW-43K
HLC-723G8
G8 HbA1c Ion- June ‘24 T8-101K, ZS3002 5.87%, T Univ. of Missouri.
Variant Analysis exchange T8-203K, 10.59% SRL #12
Mode Ver.5.30 HPLC T8-301K,
(1.6 min), HLC- HW-43K
723G8,
G8 HbA1c Ion- June ‘24 T8-101K, GB3010 5.86%, T Univ. of Missouri.
Variant Analysis exchange T8-203K, 10.86% SRL #12
Mode (1.6 min), HPLC T8-301K,
HLC-723G8, HW-43K
G8 HbA1c Ion- June ‘24 T8-101K, ZS3002 5.87%, T Univ. of Missouri.
Variant Analysis exchange T8-203K, 10.59% SRL #12
Mode (1.6 min), HPLC T8-301K,
HLC-723G8 HW-43K
G8 HbA1c Ion- June ‘24 R8-104K, ZS3002 5.87%, R Univ. of Missouri.
Standard exchange R8-204K, 8- 10.59% SRL #12
Analysis Mode HPLC 301K, HW-
(1.0 min), HLC- 43K
723G8
G8 HbA1c Ion- June ‘24 R8-104K, GB3010 5.86%, R Univ. of Missouri.
Standard exchange R8-204K, 8- 10.86% SRL #12
Analysis Mode HPLC 301K, HW-
(1.0 min), HLC- 43K
723G8
G9 HbA1c, Ion- June ‘24 E9-103K, JS3001 5.86%, E Univ. of Missouri.
HLC-723G9 exchange E9-201K, 9- 10.93% SRL #12
HPLC 302K, HW-
43K

29
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Tosoh t GX, HLC- Ion- June ‘24 CX-101H, ZS3002 5.87%, C Univ. of Missouri.
Corporation 723GX exchange CX-201H, 10.59% SRL #12
HPLC CX-301H,
HW-17K
t GX, HLC- Ion- June ‘24 CX-101H, GB3010 5.86%, C Univ. of Missouri.
723GX exchange CX-201H, 10.86% SRL #12
HPLC CX-301H,
HW-17K
t G11, Standard Ion- June ‘24 S1-101K, ZS3002 5.87%, S Univ. of Missouri.
Analysis Mode exchange S1-201K, 1- 10.59% SRL #12
(0.5 min), HLC- HPLC 303K, HW-
723G11 43K
t G11, Standard Ion- June ‘24 S1-101K, ZB3040 5.94%, S Univ. of Missouri.
Analysis Mode exchange S1-201K, 1- 11.10% SRL #12
(0.5 min), HLC- HPLC 303K, HW-
723G11 43K
t G11, Variant Ion- June ‘24 R1-101K, ZS3002 5.87%, R Univ. of Missouri.
Analysis Mode exchange R1-201K, 10.59% SRL #12
(1.0 min), HLC- HPLC R1-301K,
723G11 HW-43K
t G11, Variant Ion- June ‘24 R1-101K, ZB3040 5.94%, R Univ. of Missouri.
Analysis Mode exchange R1-201K, 11.10% SRL #12
(1.0 min), HLC- HPLC R1-301K,
723G11 HW-43K
t GR01, Ion- June ‘24 AR-101H, ZB3040 5.94%, A Univ. of Missouri.
Standard Short exchange AR-201H, 11.10% SRL #12
Mode, HLC- HPLC R301H,
723GR01 HW-43K
t GR01, Ion- June ‘24 AR-101H, ZB3040 5.94%, A Univ. of Missouri.
Standard Long exchange AR-201H, 11.10% SRL #12
Mode, HLC- HPLC R301H,
723GR01 HW-43K
t GR01, Ion- June ‘24 AR-101H, ZB3040 5.94%, R Univ. of Missouri.
Standard Long exchange AR-201H, 11.10% SRL #12
Mode, HLC- HPLC R301H,
723GR01 HW-43K
t GR01, Ion- June ‘24 AR-101H, JS3001 5.84%, A Univ. of Missouri.
Standard Short exchange AR-201H, 10.93% SRL #12
Mode, HLC- HPLC R301H,
723GR01 HW-43K
Siemens Enzymatic Enzymatic June ‘24 370, 370, 4AS001, 3.32, 16.47 - Univ. of Missouri.
Healthcare Hemoglobin 370, 370 4AS001 µmol/L SRL #12
Diagnostics A1c (A1c_E) – HbA1c; 99.6,
Automated 156.4 µmol/L
Pretreatment on Hb
Advia 1800
Enzymatic Enzymatic June ‘24 370, 370, 4AS001, 3.32, 16.47 - Univ. of Missouri.
Hemoglobin 370, 370 4AS001 µmol/L SRL #12
A1c (A1c_E) – HbA1c; 99.6,
Automated 156.4 µmol/L
Pretreatment on Hb
Advia 2400
Enzymatic Enzymatic June ‘24 370, 370, 4AS001, 3.32, 16.47 - Univ. of Missouri.
Hemoglobin 370, 370 4AS001 µmol/L SRL #12
A1c (A1c_E) – HbA1c; 99.6,
Automated 156.4 µmol/L
Pretreatment on Hb
Advia XPT

30
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Siemens Enzymatic Enzymatic June ‘24 140090, 4AS001, 3.32, 16.47 - Univ. of Missouri.
Healthcare Hemoglobin 140090, 4AS001 µmol/L SRL #12
Diagnostics A1c (A1c_E) – 140090, HbA1c; 99.6,
Automated 140090 156.4 µmol/L
Pretreatment on Hb
Atellica CH 930
Enzymatic Enzymatic June ‘24 140090, 4AS001, 3.32, 16.47 - Univ. of Missouri.
Hemoglobin 140090, 4AS001 µmol/L SRL #12
A1c (A1c_E) – 140090, HbA1c; 99.6,
Automated 140090 156.4 µmol/L
Pretreatment on Hb
Atellica CI
Enzymatic Enzymatic June ‘24 370, 370, 4AS001, 3.32, 16.47 - Univ. of Missouri.
Hemoglobin 370, 370 4AS001 µmol/L SRL #12
A1c (A1c_EM) HbA1c; 99.6,
– Manual 156.4 µmol/L
Pretreatment on Hb
Advia 1800
Enzymatic Enzymatic June ‘24 370, 370, 4AS001, 3.32, 16.47 - Univ. of Missouri.
Hemoglobin 370, 370 4AS001 µmol/L SRL #12
A1c (A1c_EM) HbA1c; 99.6,
– Manual 156.4 µmol/L
Pretreatment on Hb
Advia 2400
Enzymatic Enzymatic June ‘24 370, 370, 4AS001, 3.32, 16.47 - Univ. of Missouri.
Hemoglobin 370, 370 4AS001 µmol/L SRL #12
A1c (A1c_EM) HbA1c; 99.6,
– Manual 156.4 µmol/L
Pretreatment on Hb
Advia XPT
Bioantibody Immunofluorens Immuno- June ‘24 A0142401 - - - Zhongshan Hospital
Biotechnology ence Assay on assay ASRL#3
Co., Ltd. Handheld
Biochemical
Immunoassay
Analyzer
BK120
AEHEALTH Ion-Exchange Ion- June ‘24 20240304 20231224, 5.30%, 240320(EJ0 Zhongshan Hospital
LIMITED HPLC on exchange 20231224 10.60% 15) ASRL#3
Hemoglobin HPLC
analyzer
(Chromatograph
y)Model:
Laffinite II
Shenzhen Ultra- Boronate Boronate June ‘24 24032201 - - - Zhongshan Hospital
Diagnostics Affinity affinity ASRL#3
Biotec. Co., Ltd. Chromatography
on Portable
Glycosylated
Hemoglobin
Analyzer H100
Ensayos y Fluorescence Immuno- June ‘24 F2071950B - - - ReCCS
Tamizajes de Immunoassay assay AD ASRL#1
México, S.A. de on Finecare FIA
C.V. Meter Plus
Fluorescence Immuno- June ‘24 F2071950B - - - ReCCS
Immunoassay assay AD ASRL#1
on Finecare FIA
Meter

31
 List of NGSP Certified Methods (Updated 5/25, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Guangzhou Fluorescence Immuno- June ‘24 F20719909A - - - ReCCS
Wondfo Biotech Immunoassay assay D ASRL#1
Co., Ltd. on Finecare FIA
Meter Plus
Fluorescence Immuno- June ‘24 F20719909A - - - ReCCS
Immunoassay assay D ASRL#1
on Finecare FIA
Meter
Fluorescence Immuno- June ‘24 F20719909A - - - ReCCS
Immunoassay assay D ASRL#1
on Finecare FIA
II Plus SE
Fluorescence Immuno- June ‘24 F20719909A - - - ReCCS
Immunoassay assay D ASRL#1
on Finecare FIA
Meter III Plus
@
Method is not currently available

32