List of NGSP Certified Methods

(updated 3/21, listed by date certified)

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
Thermo Fisher HbA1c for Immuno- Mar ‘21 T892, T464 1.6072 - European
Scientific Oy Indiko, ref assay T780 mmol/L Reference Lab
981947, 981948 HbA1c; 8.830 ESRL #13
(91.5*HbA1c/Hb* mmol/L Hb
+2.15)
HbA1c for Immuno- Mar ‘21 T892, T464 1.6072 - European
Konelab, ref assay T780 mmol/L Reference Lab
981947, 981948 HbA1c; 8.830 ESRL #13
(91.5*HbA1c/Hb* mmol/L Hb
+2.15)
UMA Co., Ltd MEASURE Immuno- Mar ‘21 364AAA, 134AAA 0.0%, 5.4%, - ReCCS
217AAA
HbA1c II on assay 8.4%, 11.7%, ASRL#1
Hitachi 7180 15.2%
Fujikura Kasei HbA1c-FW on Immuno- Mar ‘21 W20K051W W20L011D 4.8%, 8.4%, - ReCCS
Co., Litd Hitachi 7180 assay 11.8%, 15.6% ASRL#1
HbA1c-F on Immuno- Mar ‘21 W20H041C W19H021C 4.6%, 8.6%, - ReCCS
Hitachi 7180 assay 12.2%, 16.4% ASRL#1
HbA1c-FL on Immuno- Mar ‘21 W20J151 W20L012F 4.3%, 6.9%, - ReCCS
Hitachi 7180 assay 9.6%, 13.3% ASRL#1
PTS Diagnostics A1CNOW+; Immuno- Mar ‘21 2003714 - - - Univ. of Missouri.
A1CNOW assay SRL #9
Selfcheck
Trinity Biotech Boronate Boronate Mar ‘21 10028, 10606, 11401, 5.6%, 10.5% 8069 Univ. of Missouri.
11508, 11575
Affinity HPLC affinity 11402 SRL #11
on ultra2 HPLC
Boronate Boronate Mar ‘21 11556, 10775, 11401, 5.5%, 10.4% 10131 Univ. of Missouri.
11508, 11575
Affinity HPLC affinity 11402 SRL #11
on Premier HPLC
Hb9210
t L type Norudia 122RJR,
Sekisui Medical Enzymatic Mar ‘21 116RIR 3.46, 14.95 - ReCCS
122RJR,
Co., Ltd. N HbA1c on 124RLR
µmol/L ASRL#1
Hitachi LST008 HbA1c; 101.2,
147.3 µmol/L
Hb
t 122RJR,
L type Norudia Enzymatic Mar ‘21 116RIR 3.33, 16.15 - ReCCS
122RJR,
N HbA1c on 124RLR
µmol/L ASRL#1
Hitachi LST006 HbA1c; 99.8,
144.4 µmol/L
Hb
t 123RJR,
Norudia N Enzymatic Mar ‘21 130RIR 3.33, 16.15 - ReCCS
123RJR,
HbA1c on 124RLR
µmol/L ASRL#1
Hitachi 7170S HbA1c; 99.8,
144.4 µmol/L
Hb
1
 List of NGSP Certified Methods (Updated 3/21, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
t 123RJR,
Sekisui Medical Norudia N Enzymatic Mar ‘21 130RIR 3.30, 16.07 - ReCCS
123RJR,
Co., Ltd. HbA1c on 124RLR
µmol/L ASRL#1
EV800 HbA1c; 99.4,
153.2 µmol/L
Hb
t Norudia N 123RJR,
Enzymatic Mar ‘21 130RIR 3.30, 16.07 - ReCCS
123RJR,
HbA1c on JCA- 124RLR
µmol/L ASRL#1
BM9130 HbA1c; 99.4,
153.2 µmol/L
Hb
t Norudia N 123RJR,
Enzymatic Mar ‘21 130RIR 3.30, 16.07 - ReCCS
123RJR,
HbA1c on TBA- 124RLR
µmol/L ASRL#1
120FR HbA1c; 99.4,
153.2 µmol/L
Hb
t 122RHR,
Norudia N Enzymatic Mar ‘21 130RIR 3.30, 16.07 - ReCCS
122RHR,
HbA1c on 124RLR
µmol/L ASRL#1
BioLis 30i HbA1c; 99.4,
153.2 µmol/L
Hb
t 123RJR,
Norudia N Enzymatic Mar ‘21 130RIR 3.30, 16.07 - ReCCS
123RJR,
HbA1c on 124RLR
µmol/L ASRL#1
Hitach 3500 HbA1c; 99.4,
153.2 µmol/L
Hb
t HBA202RLR,
(RE) Norudia Enzymatic Mar ‘21 110RIR 3.14, 16.22 - ReCCS
HBA202RLR,
N HbA1c on 124RLR
µmol/L ASRL#1
TBA-nx360 HbA1c; 99.6,
155.3 µmol/L
Hb
t 119RLR,
(RE) Norudia Enzymatic Mar ‘21 110RIR 3.14, 16.22 - ReCCS
119RLR,
N HbA1c on 124RLR
µmol/L ASRL#1
Hitachi 7180 HbA1c; 99.6,
155.3 µmol/L
Hb
t 119RLR,
(RE) Norudia Enzymatic Mar ‘21 110RIR 3.14, 16.22 - ReCCS
119RLR,
N HbA1c on 124RLR
µmol/L ASRL#1
Hitachi 3500 HbA1c; 99.6,
155.3 µmol/L
Hb
t 122RHR,
HbA1c Auto Enzymatic Mar ‘21 115RIR 3.30, 16.07 - ReCCS
122RHR,
TBA on TBA- 124RLR
µmol/L ASRL#1
120FR HbA1c; 99.4,
153.2 µmol/L
Hb
t 2011040008
RC-W FAST Ion- Mar ‘21 201016 5.06%, 2010080088 ReCCS
Mode exchange 11.08% ASRL#1
HPLC
t 2011040008
RC-W Variant Ion- Mar ‘21 201016 5.14%, 2010080090 ReCCS
Mode exchange 11.09% ASRL#1
HPLC
t 409AJL,
Hitachi Determiner L Immuno- Mar ‘21 404AJG 0.0%, 4.6%, - ReCCS
409AJL
Chemical HbA1c on DM- assay 6.8%, 9.7%, ASRL#1
Diagnostics JACK 13.1%
t Determiner L 409AJL,
Immuno- Mar ‘21 404AJG 0.0%, 4.5%, - ReCCS
409AJL
HbA1c on JCA- assay 6.8%, 9.6%, ASRL#1
BM9130 13.2%
t Determiner L 409AJL,
Immuno- Mar ‘21 405AJG 0.0%, 4.3%, - ReCCS
409AJL
HbA1c on assay 6.9%, 9.7%, ASRL#1
Hitachi 7180 13.3%

2
 List of NGSP Certified Methods (Updated 3/21, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
t Determiner L 409AJL,
Hitachi Immuno- Mar ‘21 404AJG 0.0%, 4.5%, - ReCCS
409AJL
Chemical HbA1c on TBA- assay 6.8%, 9.6%, ASRL#1
Diagnostics 120FR 13.2%
t Determiner 409AJL,
Immuno- Mar ‘21 404AJG 0.0%, 4.5%, - ReCCS
409AJL
HbA1c on assay 6.8%, 9.6%, ASRL#1
FUNOTEC 13.2%
FC300
ELITech HbA1c Immuno- Mar ‘21 R200901, R190296, 5.1%, 8.4%, - European
R200902,
Clinical Systems (immunoturbidi assay R200903,
R190297, 11.6%, 16.1% Reference Lab
SAS metric assay) on A200672 R190298, ESRL#10
Selectra ProM R190299
HbA1c Immuno- Mar ‘21 R200901, R190296, 5.1%, 8.4%, - European
R200902,
(immunoturbidi assay R200903,
R190297, 11.6%, 16.1% Reference Lab
metric assay) on A200672 R190298, ESRL#10
Selectra ProS R190299
Green Cross Boronate Boronate Feb ‘21 HC4330H201, - - - Univ. of Missouri.
HC4330H202,
Medis Corp. Affinity on Affinity HC4330H20W
SRL #9
Cera-Stat 4000
(Merilyzer
Mericheck
Analyzer)
Boronate Boronate Feb ‘21 HC2330J071, - - - Univ. of Missouri.
HC2330J072,
Affinity on Affinity HC2330J07W
SRL #9
Cera-Stat 2000
(QDx A1c
Analyzer)
Boronate Boronate Feb ‘21 HM2360J071, - - - Univ. of Missouri.
HM2360J072,
Affinity Affinity HM2360J07W
SRL #9
LabonaCheck
A1c HbA1c
Analyzer
(Model:
MH200),
A1Card HbA1c
Analyzer
Shenzhen HPLC on LD- Ion- Feb ‘21 20200922, 20200102, 5.7%, 9.9% 20200922 ReCCS
Labnovation 500, LD-510, exchange 20200922, 20200102 ASRL#1
Technologies, LD-520 HPLC 20200922
Inc.
HPLC on LD- Ion- Feb ‘21 20200926, 20200102, 5.7%, 9.9% 3F32862 ReCCS
560, LD-561, exchange 20200926, 20200102 ASRL#1
LD-562 HPLC 20200926
HPLC on LD- Ion- Feb ‘21 20200926, 20200102, 5.7%, 9.9% 2F32593 ReCCS
600, LD-620 exchange 20200926, 20200102 ASRL#1
HPLC 20200926
Borate affinity Boronate Feb ‘21 20200930 20200102, 5.7%, 9.9% - ReCCS
on LD-100, LD- Affinity 20200102 ASRL#1
120, LD-160
Trinity Biotech Tri-stat 1 Boronate Feb ‘21 11357(2L) - - - Univ. of Missouri.
Affinity SRL #11
Tri-stat 2 Boronate Feb ‘21 11357(2L) - - - Univ. of Missouri.
Affinity SRL #11
Skyla Immunoassay Immuno- Feb ‘21 A1ZH20JS1 - - - ReCCS
Corporation on Skyla Hi assay ASRL#1
Hsinchu Science Analyzer
Park Branch
DxGen Corp Boronate Boronate Jan ‘21 CI0J1301R1, - - - Univ. of Missouri.
Affinity on Affinity C10JJ1301W1, SRL #9
C10J13001C1
Epithod HbA1c
(Ep.414-Epithod
AutoDx)

3
 List of NGSP Certified Methods (Updated 3/21, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
DxGen Corp Boronate Boronate Jan ‘21 CI0J1301R1, - - - Univ. of Missouri.
Affinity on Affinity C10JJ1301W1, SRL #9
C10J13001C1
Epithod 616
HbA1c (Ep.616-
Epithod 616)
Toyobo Co., HbA1c Enzymatic Jan ‘21 20A801, CAL78 5.50%, - ReCCS
Ltd. Enzymatic 20A802, 16.00% ASRL#1
method on 20A803
Hitachi 7180
HbA1c Enzymatic Jan ‘21 20A801, CAL78 5.50%, - ReCCS
Enzymatic 20A802, 16.00% ASRL#1
method on JCA- 20A803
BM9130
Human Ion-exchange Ion- Jan ‘21 H8SX20038 H8SX20037 5.30%, I02BSX20B0 Zhongshan
Gesellschaft für hplc on exchange 10.20% 6264 Hospital ASRL#2
Biochemica und HumaNex A1c HPLC
Diagnostica Variant
mbH
Suzhou Sepax Ion-exchange Ion- Jan ‘21 132E0F1, 906004-1, 5.30%, CP049 Zhongshan
Technology, HPLC on exchange 132E0F2, 906004-3 10.20% Hospital ASRL#2
Inc. GlyHb-100 HPLC 132E0F3,
132B97E
Ensayos y Fluorescence Immuno- Jan ‘21 F20714309A - - - ReCCS
Tamizajes de Immunoassay assay D ASRL#1
Mexico S.A. de on Finecare FIA
C.V. Meter
Guangzhou Fluorescence Immuno- Jan ‘21 F20714301A - - - ReCCS
Wondfo Biotech Immunoassay assay D ASRL#1
Co., Ltd. on Finecare FIA
Meter
Fluorescence Immuno- Jan ‘21 F20714301A - - - ReCCS
Immunoassay assay D ASRL#1
on Finecare FIA
Meter Plus
Nittobo Medical N-Assay LA Immuno- Jan ‘21 N902A J902A 0%, 4.6%, - ReCCS
Co., Ltd HbA1c Nittobo assay 8.5%, 11.9%, ASRL#1
on TBA-120FR 15.9%
Shenzhen Ion-exchange Ion- Jan ‘21 H8SX20038 H8SX20037 5.30%, I02BSX20B0 Zhongshan
Lifotronic HPLC on H8 exchange 10.20% 6262 Hospital ASRL#2
Technology Co., Hemoglobin HPLC
Ltd. Analyzer; also
sold by ASSEL
srl as AS8
Ion-exchange Ion- Jan ‘21 H9SX20033 H8SX20037 5.30%, I02BSX20B0 Zhongshan
HPLC on H9 exchange 10.20% 6265 Hospital ASRL#2
Hemoglobin HPLC
Analyzer; also
sold by ASSEL
srl as AS9
Lateral Flow Immuno- Jan ‘21 8520019 - - - Zhongshan
Immunoassay assay Hospital ASRL#2
on FA-160
Ion-exchange Ion- Jan ‘21 822046 G9N20011 5.20%, GH20040275 Zhongshan
HPLC on exchange 10.20% Hospital ASRL#2
GH900 and HPLC
GH900Plus
Hemoglobin
Analyzer
Nihon Kohden @Celltac Chemi Immuno- Jan ‘21 80501 CEN008 0.0%, 4.4%, - ReCCS
Corporation HbA1c N on assay 6.7%, 9.6%, ASRL#1
MEK-1303 12.9%

4
 List of NGSP Certified Methods (Updated 3/21, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Nihon Kohden @Celltac Chemi Immuno- Jan ‘21 80501 CEN008 0.0%, 4.4%, - ReCCS
Corporation HbA1c N on assay 6.7%, 9.6%, ASRL#1
CHM-4100 12.9%
@Celltac Chemi Immuno- Jan ‘21 20038 CEN009 0.0%, 4.4%, - ReCCS
HbA1c on assay 6.7%, 9.5%, ASRL#1
CHM-4100 12.9%
i-SENS Enzymatic on Enzymatic Jan ‘21 DGBMAD - - - ReCCS
A1Care ASRL#1
t Immunoassay
TaiDoc Immuno- Jan ‘21 20F103 832001 5.40%, - European
Technology on TD-4611 assay 11.60% Reference Lab
Corp. ESRL#13
t
Bio-Rad VARIANT II Ion- Jan ‘21 64350248, 64365796, 5.1%, 10.2% AB60425 Univ. of Missouri.
Laboratories Dual (A1c) exchange 64350249, 64365797 SRL #9
HPLC 64378419
t VARIANT II Ion- Jan ‘21 64350248, 64349618, 5.1%, 10.5% BB60425 Univ. of Missouri.
Dual exchange 64350249, 64349619 SRL #9
(A2/F/A1c) HPLC 64335682

D-10 HbA1c Ion- Jan ‘21 AA90092, AA00118, 5.6%, 10.0% R90055B Univ. of Missouri.
(12000949) exchange AA90093, AA00119 SRL #9
HPLC AA00142
D-10 HbA1c Ion- Jan ‘21 AA00217, AA00135, 5.4%, 10.1% D90234A Univ. of Missouri.
exchange AA00218, AA00136 SRL #9
HPLC AA00142
D-100 HbA1c Ion- Jan ‘21 64357937, 64369590, 5.92%, 9.61% 90095BA Univ. of Missouri.
exchange 64326283, 64369590 SRL #9
HPLC 64348909
D-10 Dual Ion- Jan ‘21 AA00145, AA00273, 5.3%, 10.1% D90234A Univ. of Missouri.
A2/F/A1c exchange AA00146, AA00274 SRL #9
HPLC AA00142
Variant II Ion- Jan ‘21 64344932, 64337554, 5.4%, 10.2% NU70415R Univ. of Missouri.
HbA1c NU exchange 64344933, 64337556 SRL #9
HPLC 64345159
VARIANT II Ion- Jan ‘21 64344921, 64344158, 5.3%, 10.2% 90072A Univ. of Missouri.
TURBO HbA1c exchange 64344924, 64337544 SRL #9
Kit – 2.0 HPLC 64353338
(12000447)
VARIANT II Ion- Jan ‘21 64344921, 64344158, 5.3%, 10.2% 90072A Univ. of Missouri.
TURBO HbA1c exchange 64344924, 64337544 SRL #9
Kit – 2.0 HPLC 64353338
Archem HbA1c Immuno- Jan ’21 086 021 5.75%, 8.30%, - European
Diagnostic Immunotrubidi assay 11.30%, Reference Lab
metric on 15.50% ESRL#13
Architect c
HbA1c Immuno- Jan ’21 081 021 5.75%, 8.00%, - European
Immunotrubidi assay 11.00%, Reference Lab
metric on 15.50% ESRL#13
Olympus AU
Siemens Atellica DCA Immuno- Dec ‘20 90800920, - - - Univ. of Missouri.
Healthcare assay 90860920 SRL #9
Diagnostics
Shenzhen Enzymatic on Enzymatic Dec ‘20 852RHQ, 852RJQ 3.10, 13.3 - ReCCS
Mindray Bio- BS200E 849RHQ µmol/L ASRL#1
Medical HbA1c; 89.2,
Electronics Co., 141.0 µmol/L
Ltd. Hb
Enzymatic on Enzymatic Dec ‘20 852RHQ, 852RJQ 3.10, 13.3 - ReCCS
BS240 849RHQ µmol/L ASRL#1
HbA1c; 89.2,
141.0 µmol/L
Hb

5
 List of NGSP Certified Methods (Updated 3/21, 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 Dec ‘20 852RHQ, 852RJQ 3.10, 13.3 - ReCCS
Mindray Bio- BS240Pro 849RHQ µmol/L ASRL#1
Medical HbA1c; 89.2,
Electronics Co., 141.0 µmol/L
Ltd. Hb
Enzymatic on Enzymatic Dec ‘20 852RHQ, 852RJQ 3.10, 13.3 - ReCCS
BS360E 849RHQ µmol/L ASRL#1
HbA1c; 89.2,
141.0 µmol/L
Hb
Enzymatic on Enzymatic Dec ‘20 852RHQ, 852RJQ 3.10, 13.3 - ReCCS
BS380 849RHQ µmol/L ASRL#1
HbA1c; 89.2,
141.0 µmol/L
Hb
Enzymatic on Enzymatic Dec ‘20 852RHQ, 852RJQ 3.10, 13.3 - ReCCS
BS400 849RHQ µmol/L ASRL#1
HbA1c; 89.2,
141.0 µmol/L
Hb
Enzymatic on Enzymatic Dec ‘20 852RHQ, 852RJQ 3.10, 13.3 - ReCCS
BS460 849RHQ µmol/L ASRL#1
HbA1c; 89.2,
141.0 µmol/L
Hb
Enzymatic on Enzymatic Dec ‘20 852RHQ, 852RJQ 3.10, 13.3 - ReCCS
BS480 849RHQ µmol/L ASRL#1
HbA1c; 89.2,
141.0 µmol/L
Hb
Enzymatic on Enzymatic Dec ‘20 852RHQ, 852RJQ 3.10, 13.3 - ReCCS
BS800 & 849RHQ µmol/L ASRL#1
BS800M HbA1c; 89.2,
141.0 µmol/L
Hb
Enzymatic on Enzymatic Dec ‘20 852RHQ, 852RJQ 3.10, 13.3 - ReCCS
BS830 849RHQ µmol/L ASRL#1
HbA1c; 89.2,
141.0 µmol/L
Hb
Enzymatic on Enzymatic Dec ‘20 852RHQ, 852RJQ 3.10, 13.3 - ReCCS
BS2000 & 849RHQ µmol/L ASRL#1
2000M HbA1c; 89.2,
141.0 µmol/L
Hb
Ion-exchange Ion- Dec ‘20 2019121301, 813RIQ N, 5.39%, 9I152M ReCCS
HPLC on exchange 2020010801, 813RIQ H 10.95% ASRL#1
H50/H50P HPLC 2020010601
Dirui Industrial Whole Blood- Immuno- Dec ‘20 20200716, 20200716 0%, 5.3%, - Zhongshan
Co., Ltd. Latex assay 20200716, 6.9%, 10.8%, Hospital ASRL#2
Agglutination 20200716 14.5%
Method on CS-
T180
Whole Blood- Immuno- Dec ‘20 20200716, 20200716 0%, 5.3%, - Zhongshan
Latex assay 20200716, 6.9%, 10.8%, Hospital ASRL#2
Agglutination 20200716 14.5%
Method on CS-
480

6
 List of NGSP Certified Methods (Updated 3/21, 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- Dec ‘20 20200716, 20200716 0%, 5.3%, - Zhongshan
Co., Ltd. Latex assay 20200716, 6.9%, 10.8%, Hospital ASRL#2
Agglutination 20200716 14.5%
Method on CS-
680
Whole Blood- Immuno- Dec ‘20 20200716, 20200716 0%, 5.3%, - Zhongshan
Latex assay 20200716, 6.9%, 10.8%, Hospital ASRL#2
Agglutination 20200716 14.5%
Method on CS-
1200
Whole Blood- Immuno- Dec ‘20 20200716, 20200716 0%, 5.3%, - Zhongshan
Latex assay 20200716, 6.9%, 10.8%, Hospital ASRL#2
Agglutination 20200716 14.5%
Method on CS-
1300B
Latex Immuno- Dec ‘20 20200716, 20200716 0%, 5.3%, - Zhongshan
Agglutination assay 20200716, 6.9%, 10.8%, Hospital ASRL#2
Method on CS- 20200716 14.5%
6400
Roche Cobas HbA1c Immuno- Dec ‘20 019131-01 - - - Univ. of Missouri.
Diagnostics Test on cobas b assay SRL #9
International Ltd 101
Roche TQ HbA1c Gen. Immuno- Dec ‘20 452526, 410444 0.130, 0.334, - European
Diagnostics 3 Whole Blood assay 443461 0.661, 0.922, Reference Lab
on cobas c311 1.259, 1.799 ESRL#13
mmol/L HbA1c;
HbA1c/Hb*91.5
1.397, 7.532
+2.15 mmol/L Hb
TQ HbA1c Gen. Immuno- Dec ‘20 458125, 410444 0.0162, 0.0108, - European
3 Whole Blood assay 480067 0.00771, 0.0054, Reference Lab
on Cobas c111 0.0027, 0.00108 ESRL#13
mmol/L HbA1c;
HbA1c/Hb*91.5
0.07532,
+2.15 0.05021,
0.03587,
0.02511,
0.01255,
0.00502 mmol/L
Hb
Siemens Dimension Vista Immuno- Dec ‘20 20209BA 0GD045 0.11, 0.46, - Univ. of Missouri.
Healthineers A1C on Vista assay 0.87, 1.49, SRL #9
1500 2.06 g/dL
HbA1c; 12.79,
12.59 g/dL Hb
Dimension Vista Immuno- Dec ‘20 20209BA 0GD045 0.11, 0.46, - Univ. of Missouri.
A1C on Vista assay 0.87, 1.49, SRL #9
500 2.06 g/dL
HbA1c; 12.79,
12.59 g/dL Hb
Shenzhen Ultra- Boronate Boronate Dec ‘20 20082201 - - - Zhongshan
Diagnostics Affinity Affinity Hospital ASRL#2
Biotec. Co., Ltd. Chromatography
on Portable
Glycosylated
Hemoglobin
Analyzer H100
Siemens Dimension Immuno- Nov ‘20 GD1096 GD1096 0.11, 0.63, - Univ. of Missouri.
Healthcare Hemoglobin assay 1.18, 2.02, SRL #9
A1c (A1C) on 2.79 g/dL
Dimension EXL HbA1c; 13.4,
13.0 g/dL Hb

7
 List of NGSP Certified Methods (Updated 3/21, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Siemens Dimension Immuno- Nov ‘20 GD1096 GD1096 0.11, 0.63, - Univ. of Missouri.
Healthcare Hemoglobin assay 1.18, 2.02, SRL #9
A1c (A1C) on 2.79 g/dL
Dimension RxL HbA1c; 13.4,
13.0 g/dL Hb
Dimension Immuno- Nov ‘20 GD1096 GD1096 0.11, 0.63, - Univ. of Missouri.
Hemoglobin assay 1.18, 2.02, SRL #9
A1c (A1C) on 2.79 g/dL
Dimension HbA1c; 13.4,
Xpand 13.0 g/dL Hb
Aidian Oy, QuikRead go Immuno- Nov ‘20 KJ78, KJ97 - - - European
assay Reference Lab
ESRL#11
OSANG Frontier and Boronate Nov ‘20 F20G13G24EL - - - Univ. of Missouri.
Healthcare Co., HemoCue Affinity SRL #9
Ltd. HbA1c 501
Clover A1c Plus Boronate Nov ‘20 B20H12I07EL - - - Univ. of Missouri.
Affinity SRL #9
Clover A1c, Boronate Nov ‘20 A20H31I22EL - - - Univ. of Missouri.
Clover A1c Self Affinity SRL #9
and Checkart
Genrui Biotech Immunofluoresc Immuno- Nov ‘20 20080601 - - - ReCCS
Inc. ence on assay ASRL#1
Quantitative
Immunoassay
Analyzer FA50
Nephelometry Immuno- Nov ‘20 20200708 - - - ReCCS
on Specific assay ASRL#1
Protein
Analyzer PA120
Nephelometry Immuno- Nov ‘20 20200612 - - - ReCCS
on Specific assay ASRL#1
Protein
Analyzer PA200
Archem HbA1c Immuno- Nov ‘20 081 021 5.75%, 8.00%, - European
Diagnostic Immunoturbidi assay 11.00%, Reference Lab
metric on Dirui 15.50% ESRL#13
CS Series
Biochemistry
Systems
HbA1c Immuno- Nov ‘20 081 021 5.75%, 8.00%, - European
Immunoturbidi assay 11.00%, Reference Lab
metric on 15.50% ESRL#13
Mindray BS
Series
Biochemistry
Systems
Nittobo Medical N-Assay LA Immuno- Oct ‘20 N902A J902A 0%, 4.6%, - ReCCS
Co., LTD. HbA1c Nittobo assay 8.5%, 11.9%, ASRL#1
on BM9130 15.9%
N-Assay LA Immuno- Oct ‘20 N902A J902A 0%, 4.6%, - ReCCS
HbA1c Nittobo assay 8.5%, 11.9%, ASRL#1
on H7180 15.9%
N-Assay LA Immuno- Oct ‘20 N902A J902A 0%, 4.6%, - ReCCS
HbA1c Nittobo assay 8.5%, 11.9%, ASRL#1
on TBA c8000 15.9%
JEOL Ltd. BM Test HbA1c Enzymatic Oct ‘20 927RFR, 927RFR 3.19, 14.86 - ReCCS
on JCA- 927RFR, µmol/L ASRL#1
BM6010/C 846RLQ HbA1c; 99.9,
152.0 µmol/L
Hb

8
 List of NGSP Certified Methods (Updated 3/21, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Beckman- HbA1c- Immuno- Oct ‘20 M001004 M001004, 0.167, 0.483, - Univ. of Missouri.
Coulter Inc. Colorimetric assay M001004, 0.889, 1.537, SRL #9
DxC600 M003043 2.316 g/dL
Platform HbA1c; 19.61
g/dL Hb
HbA1c- Immuno- Oct ‘20 M001004 M001004, 0.167, 0.483, - Univ. of Missouri.
Colorimetric assay M001004, 0.889, 1.537, SRL #9
DxC800 M003043 2.316 g/dL
Platform HbA1c; 19.61
g/dL Hb
HbA1c3- Immuno- Oct ‘20 M004002 M004002, 0.162, 0.466, - Univ. of Missouri.
Colorimetric assay M004002, 0.859, 1.470, SRL #9
DxC600 M008014 2.284 g/dL
Platform HbA1c; 19.59
g/dL Hb
HbA13c- Immuno- Oct ‘20 M004002 M004002, 0.162, 0.466, - Univ. of Missouri.
Colorimetric assay M004002, 0.859, 1.470, SRL #9
DxC800 M008014 2.284 g/dL
Platform HbA1c; 19.59
g/dL Hb
HORIBA Spotchem Immuno- Oct ‘20 2032HL067O WC0050 0.0, 25.6, 51.6, - ReCCS
Medical Banalyst HbA1c assay 83.3, 124.4 ASRL#1
on SI-3620 mmol/mol
Banalyst Ace Immuno- Oct ‘20 2032HL069A 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 ‘20 2032HL467O 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 ‘20 2032HL067O 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 ‘20 2032HL069A WC0050 0.0, 25.6, 51.6, - ReCCS
on Yumizen assay 83.3, 124.4 ASRL#1
M100 Banalyst mmol/mol
Hitachi MetaboLead Enzymatic Oct ‘20 406 AJC, 403AJD 2.40, 9.74 - ReCCS
Chemical HbA1c on JCA- 406AJC µmol/L ASRL#1
Diagnostics BM9130 HbA1c; 83.4,
Systems Co., 120.6 µmol/L
Ltd. Hb
MetaboLead Enzymatic Oct ‘20 406 AJC, 403AJD 2.40, 9.74 - ReCCS
HbA1c on DM- 406AJC µmol/L ASRL#1
JACK HbA1c; 83.4,
120.6 µmol/L
Hb
MetaboLead Enzymatic Oct ‘20 406 AJC, 403AJD 2.40, 9.74 - ReCCS
HbA1c on 406AJC µmol/L ASRL#1
Hitachi 7180 HbA1c; 83.4,
120.6 µmol/L
Hb
MetaboLead Enzymatic Oct ‘20 406 AJC, 403AJD 2.40, 9.74 - ReCCS
HbA1c on 406AJC µmol/L ASRL#1
LABOSPECT HbA1c; 83.4,
006 120.6 µmol/L
Hb
MetaboLead Enzymatic Oct ‘20 406 AJC, 403AJD 2.40, 9.74 - ReCCS
HbA1c on TBA- 406AJC µmol/L ASRL#1
120FR HbA1c; 83.4,
120.6 µmol/L
Hb

9
 List of NGSP Certified Methods (Updated 3/21, 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 Sept‘20 27949, 28429, 0.425, 1.12 - European
Diagnostic with onboard 28244 28429 g/dL HbA1c; Reference Lab
Systems GmbH hemolysis on 8.10, 15.2 ESRL#10
respons910 g/dL Hb
HbA1c (NGSP)
=0.0915xHbA1c
(IFCC)+2.15
HbA1c net FS Enzymatic Sept‘20 27949, 28429, 0.425, 1.12 - European
with onboard 28244 28429 g/dL HbA1c; Reference Lab
hemolysis on 8.10, 15.2 ESRL#10
JCA-BM6010/C g/dL Hb
HbA1c (NGSP)
=0.0915xHbA1c
(IFCC)+2.15
HbA1c net FS Enzymatic Sept‘20 27949, 27376, 0.425, 1.21 - European
with onboard 28244 27376 g/dL HbA1c; Reference Lab
hemolysis on 4.69, 15.0 ESRL#10
Sysmex BX- g/dL Hb
3010
HbA1c (NGSP)
=0.0915xHbA1c
(IFCC)+2.15
HbA1c net FS Enzymatic Sept‘20 27949, 28429, 0.465, 1.20 - European
with manual 28244 28429 g/dL HbA1c; Reference Lab
hemolysis on 5.02, 15.0 ESRL#10
Hitachi 917 g/dL Hb
HbA1c (NGSP)
=0.0915xHbA1c
(IFCC)+2.15
oneHbA1c IS on Enzymatic Sept‘20 119, 27517 28963, 30.8, 63.2, - European
InnovaStar 28964, 116, 151 Reference Lab
HbA1c (NGSP) 28965, mmol/mol ESRL#10
=0.0915xHbA1c 28966
(IFCC)+2.15
Hitado GmbH Super-ID Enzymatic Sept‘20 119, 27517 28963, 30.8, 63.2, - European
HbA1c on 28964, 116, 151 Reference Lab
SUPER ID 28965, mmol/mol ESRL#10
clinchem 28966
Dr. Müller HbA1c ID on Enzymatic Sept‘20 119, 27517 28963, 30.8, 63.2, - European
Gerätebau SUPER ID 28964, 116, 151 Reference Lab
GmbH clinchem 28965, mmol/mol ESRL#10
28966
Lansion Fluorescence Immuno- Sept ‘20 0012001 - - - Zhongshan
Biotechnology Immunoassay assay Hospital ASRL#2
Co., Ltd. on LS-1100
Erba Lachema ERBA Hb-Vario Ion- Sept ‘20 2003167, 190597A, 5.73%, 2003167 Univ. of Missouri.
s.r.o. exchange 2003167, 190598A 12.67% SRL #9
HPLC 2003167
Horiba Medical HbA1c WB Immuno- Sept ‘20 2000201 1900401 0.00, 1.80, - European
Hemolysate – assay 3.50, 4.74, Reference Lab
ABX Pentra 8.96, 13.20 ESRL #10
C200 µmol/L
(Y=(0.2867*X) HbA1c; 68.29
+2.471) µmol/L Hb
HbA1c WB Immuno- Sept ‘20 2000201 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=(0.3732*X) µmol/L
+2.461) HbA1c; 68.29
µmol/L Hb

10
 List of NGSP Certified Methods (Updated 3/21, 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 ‘20 2000201 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 ‘20 2000201 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
HbA1c WB Immuno- Sept ‘20 2000201 1900401 0.00, 1.53, - European
Whole Blood – assay 3.28, 4.92, Reference Lab
Penta C400 8.78, 14.17 ESRL #10
(Y=(0.3784*X) µmol/L
+2.517) HbA1c; 68.29
µmol/L Hb
HbA1C – Immuno- Sept ‘20 55841 55842, 0.00, 3.25, - European
YUMIZEN assay 56499 15.25 µmol/L Reference Lab
C1200 HbA1c; 98.0, ESRL #10
(Y=(97.74*X)+ 154.2 µmol/L
1.937) Hb
t Boronate-
EKF Boronate Sept ‘20 020588 - - - European
Diagnostics Affinity Quo- affinity Reference Lab
GmbH Test HbA1C ESRL #11
t Boronate- Boronate Sept ‘20 025770 - - - European
Affinity Quo- affinity Reference Lab
Lab HbA1C ESRL #11
t Boronate-
Human Boronate Sept ‘20 025774 - - - European
Gesellschaft Affinity affinity Reference Lab
fuer Biochemica HumaMeter ESRL #11
und Diagnostica HbA1c
mbH
tAgA1C
Agappe Immuno- Sept ‘20 19040026, 29030137, 5.80%, 9.80%, - European
Diagnostics Ltd. (Immunoturbidi assay 19040027, 29030139, 13.30%, Reference Lab
metric method) 18030046 29030140, 16.80% ESRL#10
on TBA 25 FR 29030142
tAgA1C Immuno- Sept ‘20 40020039, 29090579, 5.60%, - European
(Immunoturbidi assay 40020040, 29090580, 10.30%, Reference Lab
metric method) 10060001 29090581, 14.20%, ESRL#10
on TBA 120 FR 29090582 16.00%
tHbA1c Immuno- Sept ‘20 40020039, 29090579, 5.60%, - European
(Immunoturbidi assay 40020040, 29090580, 10.30%, Reference Lab
metric method) 10060001 29090581, 14.20%, ESRL#10
on Turbiquick 29090582 16.00%
tAgA1C Immuno- Sept ‘20 40020039, 29090579, 5.60%, - European
(Immunoturbidi assay 40020040, 29090580, 10.30%, Reference Lab
metric method) 10060001 29090581, 14.20%, ESRL#10
on Mispa Nano 29090582 16.00%
tAgA1C Immuno- Sept ‘20 40020039, 29090579, 5.60%, - European
(Immunoturbidi assay 40020040, 29090580, 10.30%, Reference Lab
metric method) 10060001 29090581, 14.20%, ESRL#10
on Mispa Nano 29090582 16.00%
Plus
tAgA1C Immuno- Sept ‘20 40020039, 29090579, 5.60%, - European
(Immunoturbidi assay 40020040, 29090580, 10.30%, Reference Lab
metric method) 10060001 29090581, 14.20%, ESRL#10
on Mispa Clinia 29090582 16.00%

11
 List of NGSP Certified Methods (Updated 3/21, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
tAgA1C
Agappe Immuno- Sept ‘20 40020039, 29090579, 5.60%, - European
Diagnostics (Immunoturbidi assay 40020040, 29090580, 10.30%, Reference Lab
Ltd.. metric method) 10060001 29090581, 14.20%, ESRL#10
on Mispa Clinia 29090582 16.00%
Plus
tAgA1C Immuno- Sept ‘20 40020039, 29090579, 5.60%, - European
(Immunoturbidi assay 40020040, 29090580, 10.30%, Reference Lab
metric method) 10060001 29090581, 14.20%, ESRL#10
on Mispa Ace 29090582 16.00%
tNephelometry Immuno- Sept ‘20 40020039, 29090579, 5.60%, - European
on Specific assay 40020040, 29090580, 10.30%, Reference Lab
Protein 10060001 29090581, 14.20%, ESRL#10
Analyzer Mispa 29090582 16.00%
i2
tNephelometry Immuno- Sept ‘20 40020039, 29090579, 5.60%, - European
on cartridge assay 40020040, 29090580, 10.30%, Reference Lab
based Specific 10060001 29090581, 14.20%, ESRL#10
Protein 29090582 16.00%
Analyzer Mispa
i3
tAgA1C Immuno- Sept ‘20 40020039, 29090579, 5.60%, - European
(Immunoturbidi assay 40020040, 29090580, 10.30%, Reference Lab
metric method) 10060001 29090581, 14.20%, ESRL#10
on TMS 30i 29090582 16.00%
tAgA1C Immuno- Sept ‘20 40020039, 29090579, 5.60%, - European
(Immunoturbidi assay 40020040, 29090580, 10.30%, Reference Lab
metric method) 10060001 29090581, 14.20%, ESRL#10
on Mispa Viva 29090582 16.00%
tAgA1C Immuno- Sept ‘20 40020039, 29090579, 5.60%, - European
(Immunoturbidi assay 40020040, 29090580, 10.30%, Reference Lab
metric method) 10060001 29090581, 14.20%, ESRL#10
on Mispa CCXL 29090582 16.00%
tAgA1C Immuno- Sept ‘20 40020039, 29090579, 5.60%, - European
(Immunoturbidi assay 40020040, 29090580, 10.30%, Reference Lab
metric method) 10060001 29090581, 14.20%, ESRL#10
on Mispa CX4 29090582 16.00%
tAgA1C
. Immuno- Sept ‘20 40020039, 29090579, 5.60%, - European
(Immunoturbidi assay 40020040, 29090580, 10.30%, Reference Lab
metric method) 10060001 29090581, 14.20%, ESRL#10
on Mispa CXL 29090582 16.00%
Pro
tAgA1C Immuno- Sept ‘20 40020039, 29090579, 5.60%, - European
(Immunoturbidi assay 40020040, 29090580, 10.30%, Reference Lab
metric method) 10060001 29090581, 14.20%, ESRL#10
on BS 390 29090582 16.00%
Apex Immunoagglutin Immuno- Sept ‘20 S00402 - - - ReCCS
Biotechnology ation on Eclipse assay ASRL#1
Corp. A1c
MED TRUST Boronate Boronate Aug ‘20 EAR200302 - - - Zhongshan
Handelsges.m.b. Affinity on affinity 02 Hospital ASRL#2
H. Wellion BONA
HbA1c
Boronate Boronate Aug ‘20 EAZ200218 - - - Zhongshan
Affinity on affinity 03 Hospital ASRL#2
Wellion
CLEVER
HbA1c
Diazyme Roche Modular Enzymatic Aug’20 HAL05190, HAS103190, 5.60%, - Univ. of Minn
Laboratories, P HA105190, HAS203190 10.70% SRL #10
Inc. HA205190
Sugentech Immunoassay Immuno- Aug ‘20 HBAT20003 - - - ReCCS
on INCLIX assay ASRL#1
12
 List of NGSP Certified Methods (Updated 3/21, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
Beckman HbA1c Immuno- Aug ‘20 1049, 1049 0.096, 0.288, - European
Coulter Ireland Advanced assay M911090 0.540, 1.000, Reference Lab
Inc. B93009 Online 1.468 mmol/L ESRL#13
Application on HbA1c; 8.85
DxC700 AU mmol/L Hb
HbA1c Immuno- Aug ‘20 1049, 1049 0.090, 0.291, - European
Advanced assay M911090 0.543, 1.012, Reference Lab
B93009 Manual 1.497 mmol/L ESRL#13
Application on HbA1c; 8.85
DxC700 AU mmol/L Hb
HbA1c Immuno- Aug ‘20 1049, 1049 0.090, 0.291, - European
Advanced assay M911090 0.543, 1.012, Reference Lab
B93009 Manual 1.497 mmol/L ESRL#13
Application on HbA1c; 8.85
AU680 mmol/L Hb
HbA1c Immuno- Aug ‘20 1049, 1049 0.090, 0.291, - European
Advanced assay M911090 0.543, 1.012, Reference Lab
B93009 Manual 1.497 mmol/L ESRL#13
Application on HbA1c; 8.85
AU5800 mmol/L Hb
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)

13
 List of NGSP Certified Methods (Updated 3/21, 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

14
 List of NGSP Certified Methods (Updated 3/21, 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

15
 List of NGSP Certified Methods (Updated 3/21, 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 ‘20 382581, 348467 0.153, 0.358, - European
Diagnostics 3 whole blood assay 461472 0.682, 0.934, Reference Lab
GmbH 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

16
 List of NGSP Certified Methods (Updated 3/21, 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,
Tosoh Standard Ion- June ‘20 F1-101E, ZS9002 5.84%, F Univ. of Missouri.
Corporation 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
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%
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
HbA1c Enzymatic May ‘20 55739UQ06, 55353UQ05, 5.30%, - Univ. of
(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

17
 List of NGSP Certified Methods (Updated 3/21, 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 Enzymatic May ‘20 55739UQ06, 55353UQ05, 5.30%, - Univ. of
Diagnostics (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
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
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 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

18
 List of NGSP Certified Methods (Updated 3/21, 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 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 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
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 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%

19
 List of NGSP Certified Methods (Updated 3/21, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
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
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 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

20
 List of NGSP Certified Methods (Updated 3/21, listed by date certified)
Manufacturer Method/ Method Date Reagent Lot Calibrator Calibrator Column Secondary
Instrument Type Certified Lot Assigned Lot Reference
Value Laboratory
t
Arkray, Inc 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
tADAMS 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)
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 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
*
Method certification has been delayed due to coronavirus and/or other shipping issues. 
@
Method is not currently available
21