List of NGSP Certified Methods

List of NGSP Certified Methods
(updated 12/22, 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
Erba Lachema ERBA Hb- Ion- Dec ‘22 B052204, B052204L1, 5.90%, B052204 Univ. of Missouri.
s.r.o. Vario/Hb-820 exchange B052204, B052204L2 12.50% SRL #9
B052204
HPLC
Lansion Fluorescence Immuno- Dec ‘22 0422218 - - - Zhongshan
Biotechnology Immunoassay assay Hospital ASRL#3
Co., Ltd. on LS-1100
Fluorescence Immuno- Dec ‘22 0422218 - - - Zhongshan
Immunoassay assay Hospital ASRL#3
on LS-2000
on LS-2100
on LS-4000
on LS-3000
Siemens Dimension A1C Immuno- Dec ‘22 GA3220 GA3220 0.12, 0.63, - Univ. of Missouri.
Healthcare on ExL System assay 1.15, 2.04, SRL #9
Diagnostics 2.78 g/dL
HbA1c; 13.69,
13.36 g/dL Hb
Dimension A1C Immuno- Dec ‘22 GA3220 GA3220 0.12, 0.63, - Univ. of Missouri.
on RxL System assay 1.15, 2.04, SRL #9
2.78 g/dL
HbA1c; 13.69,
13.36 g/dL Hb
Dimension A1C Immuno- Dec ‘22 GA3220 GA3220 0.12, 0.63, - Univ. of Missouri.
on Xpand assay 1.15, 2.04, SRL #9
System 2.78 g/dL
HbA1c; 13.69,
13.36 g/dL Hb
Roche Cobas HbA1c Immuno- Dec ‘22 133041-01 - - - Univ. of Missouri.
Diagnostics Test on cobas b assay SRL #9
International Ltd 101
Roche TQ HbA1c Gen. Immuno- Dec ‘22 629598, 559759 0.124, 0.318, - European
Diagnostics 3 Whole Blood assay 619985 0.630, 0.879, Reference Lab
on cobas c311 1.201, 1.716 ESRL#13
mmol/L HbA1c;
HbA1c/Hb*91.5
1.376, 7.423
+2.15 mmol/L Hb
1
List of NGSP Certified Methods (Updated 12/22, listed by date certified)
Value Laboratory
Roche TQ HbA1c Gen. Immuno- Dec ‘22 629582, 559759 0.158, 0.356, - European
Diagnostics 3 Whole Blood assay 657543, 0.670, 0.915, Reference Lab
on cobas c303 611695 1.253, 1.770 ESRL#13
mmol/L HbA1c;
HbA1c/Hb*91.5
1.45, 7.78
+2.15 mmol/L Hb
TQ HbA1c Gen. Immuno- Dec ‘22 629582, 559759 0.153, 0.347, - European
3 Hemolysate on assay 657543, 0.654, 0.894, Reference Lab
cobas c303 626453 1.224, 1.730 ESRL#13
mmol/L HbA1c;
HbA1c/Hb*91.5
1.45, 7.78
+2.15 mmol/L Hb
TQ HbA1c Gen. Immuno- Dec ‘22 625156, 559759 0.01545, - European
3 Whole Blood assay 657554 0.01030, Reference Lab
on Cobas c111 0.00736, ESRL#13
0.00515,
HbA1c/Hb*91.5
0.00258,
+2.15 0.00103 mmol/L
HbA1c;
0.07423,
0.04949,
0.03535,
0.02474,
0.01237,
0.00495 mmol/L
Hb
B&E Bio- HPLC on G20 Ion- Dec ‘22 H0025, NIM-RM- 5.0%, 10.0% 220963BZ14 Zhongshan
Technology Co., exchange H0026, 3626 645 Hospital ASRL#3
Ltd. HPLC H0027, (220106),
H0028 NIM-RM-
3625
(220106)
SuZhou Sepax Ion-exchange Ion- Dec ‘22 20220902, 111001, 4.99%, 9.49% 20220101 Zhongshan
Diagnostics Ltd. HPLC on exchange 20220902, 111001 Hospital ASRL#3
GlyHb-100 HPLC 20220902,
20220902,
Tascom Co., Enzymatic on Enzymatic Dec ‘22 00222J20 - - - Univ. of Missouri.
Ltd. SimplexTAS SRL #9
101
Horiba Medical HbA1c WB Immuno- Nov ‘22 2204101 2203201 0.00, 1.45, - European
Whole Blood – assay 3.29, 5.26, Reference Lab
Pentra C400 9.35, 13.60 ESRL #13
Y=(0.3379*X)+2. µmol/L
458 HbA1c; 68.29
µmol/L Hb
HbA1c WB Immuno- Nov ‘22 2204101 2203201 0.00, 1.51, - European
Hemolysate – assay 3.13, 4.88, Reference Lab
Pentra C400 8.48, 12.21 ESRL #13
Y=(0.3616*X)+2. µmol/L
323 HbA1c; 68.29
µmol/L Hb
Pointe Immuno- Nov ‘22 117401 111001 0%, 5.2%, - European
Hemoglobin assay 8.9%, 12.6%, Reference Lab
A1c – Pentra 15.6% ESRL #13
C200
Y=(1.037*X)+0.0
76
Pentra C200 10.52, 14.68 ESRL #13
Y=(0.2504*X)+2. µmol/L
136 HbA1c; 68.29
µmol/L Hb
2
Value Laboratory
Horiba Medical HbA1c WB Immuno- Nov ‘22 2204101 2203201 0.00, 2.24, - European
ABX Pentra 400 9.79, 14.66 ESRL #13
Y=(0.323*X)+1.8 µmol/L
24 HbA1c; 68.29
µmol/L Hb
Whole Blood – assay 3.71, 6.13, Reference Lab
ABX Pentra 400 10.49, 16.12 ESRL #13
Y=(0.3057*X)+2. µmol/L
358 HbA1c; 68.29
µmol/L Hb
Bioyong Matrix-Assisted MALDI- Nov ‘22 010310- 010311- 5.10%, 7.60%, - Zhongshan
Technologies Laser TOF MS 210901 210901 10.10% Hospital ASRL#3
Co., Ltd. Desorption 010311-
Ionization Time 210901
of Flight Mass 010311-
Spectrometry 210901
(MALDI-TOF
MS)
Wells Bio, Inc. Boronate Boronate Nov ‘22 BHB22F081 - - - ReCCS
Affinity on Affinity BHB22F281 ASRL#1
careSURE
Analyzer 100
Caretium Cation-exchange Ion- Nov ‘22 20220812 150573A, 5.10%, 20220926 Zhongshan
Medical chromatography exchange 150575A 10.20% Hospital ASRL#3
Instruments Co., on HbA1c HPLC
Limited Analyzer KH-
101
Cation-exchange Ion- Nov ‘22 20220820 150573A, 5.10%, P170995012 Zhongshan
chromatography exchange 150575A 10.20% Hospital ASRL#3
on HbA1c HPLC
Analyzer T9
OSANG Frontier and Boronate Nov ‘22 F22I06I19E - - - Univ. of Missouri.
Healthcare Co., HemoCue Affinity L SRL #9
Ltd. HbA1c 501
Clover A1c Plus Boronate Nov ‘22 B22G16G27 - - - Univ. of Missouri.
Affinity EL SRL #9
Clover A1c, Boronate Nov ‘22 A22I21I30E - - - Univ. of Missouri.
Clover A1c Self Affinity L SRL #9
and Checkart
Cover A1c Boronate Nov ‘22 B22H30I15 - - - Univ. of Missouri.
Expert Affinity EL SRL #9
Biosurfit, S.A. spinit HbA1c Boronate Nov ‘22 533_00 - - - European
test on spinit affinity Reference Lab
C17 ESRL#11
Everly B00389 HbA1c Immuno- Oct ‘22 M104559, 1057 0.174, 0.468, - Univ. of Missouri.
Diagnostics on AU680 with assay 1057 0.839, 1.492, SRL #9
red blood cell- 2.180 mmol/L
serum strip- HbA1c; 14.4
based cassettes mmol/L Hb
Beckman HbA1c B00389 Immuno- Oct ‘22 1058, 1058 0.079, 0.280, - European
Coulter Ireland Manual assay 472137 0.523, 0.919, Reference Lab
Inc. Application on 1.366 mmol/L ESRL #13
AU480 HbA1c; 8.87
mmol/L Hb
HbA1c B00389 Immuno- Oct ‘22 1058, 1058 0.079, 0.280, - European
Manual assay 472137 0.523, 0.919, Reference Lab
Application on 1.366 mmol/L ESRL #13
AU680 HbA1c; 8.87
mmol/L Hb
3
Value Laboratory
Beckman HbA1c B00389 Immuno- Oct ‘22 1058, 1058 0.079, 0.280, - European
Coulter Ireland Manual assay 472137 0.523, 0.919, Reference Lab
Inc. Application on 1.366 mmol/L ESRL #13
AU5800 HbA1c; 8.87
mmol/L Hb
HbA1c B00389 Immuno- Oct ‘22 1058, 1058 0.079, 0.280, - European
Manual assay 472137 0.523, 0.919, Reference Lab
DXC700 AU HbA1c; 8.87
mmol/L Hb
HbA1c B00389 Immuno- Oct ‘22 1058 1058 0.096, 0.283, - European
Online assay 0.537, 0.920, Reference Lab
DxC700 AU HbA1c; 8.87
mmol/L Hb
Jiangsu Ion-exchange Ion- Oct ‘22 220801-20, 220801-26, 5.80%, 220801-48 Univ. of Missouri.
Audicom chromatography exchange 220801-21, 220801-27 11.90% SRL #9
Medical on AC6601 HPLC 220801-22,
Technology Co., 220801-23,
Ltd. 220801-24
Changsha HbA1c Immuno- Oct ‘22 22K0419 - - - Zhongshan
Sinocare Inc. Monitoring assay Hospital ASRL#3
System on PCH-
50
HbA1c Immuno- Oct ‘22 21P0809 - - - Zhongshan
Monitoring assay Hospital ASRL#3
System on
iCARE-1000
System on
iCARE-2000
System on
iCARE-2100
System on
iCARE-2200
Guangzhou Immunofluoresc Immuno- Oct ‘22 062220201 - - - Zhongshan
Descheng ence Analyzer assay Hospital ASRL#3
Biotechnology CHF200
Co., Ltd.
Immunofluoresc Immuno- Oct ‘22 062220201 - - - Zhongshan
ence Analyzer assay Hospital ASRL#3
CHF600
Hunan Yonghe- Ion-exchange Ion- Oct ‘22 20220408, 20220805, 5.40%, 9.30% 20220408, Zhongshan
Sun HPLC on YH- exchange 20220723 20220805 20220723 Hospital ASRL#3
Biotechnology 30 HPLC
Co., Ltd.
Shenzhen High Ion- Oct ‘22 220707024, 929601-300, 5.60%, BZ14645 Zhongshan
Xilaiheng performance exchange 220707024, 929601-300 16.00% Hospital ASRL#3
Medical liquid HPLC 220707024,
Electronics Co., chromatograph 220707024,
Ltd. (HPLC) on
H600 Full-Auto
HbA1c
Analyzer
4
Value Laboratory
Shenzhen HbA1c (Time- Immuno- Oct ‘22 2205G101, - - - Zhongshan
Superbio resolved assay 2206G101, Hospital ASRL#3
Technology Co., Fluorescence 2206G102
Ltd Immunochromat
ographic Assay)
on EASY-11
ACON On Call Immuno- Oct ‘22 OGHB2060 - - - Zhongshan
Laboratories, MultiPro assay 001 Hospital ASRL#3
Inc. and Acon System—
Biotech HbA1c
(Hangzhou) Co.,
Ltd.
On Call A1c Immuno- Oct ‘22 gHb2050001 - - - Zhongshan
assay Hospital ASRL#3
VivaChek Fluorescence Immuno- Oct ‘22 SE2207043 - - - Zhongshan
on POCT
Analyzer
VIM01
Fluorescence Immuno- Oct ‘22 SE2206072 - - - Zhongshan
on POCT
Analyzer
VIM2000
Getein Biotech, Immunofluoresc Immuno- Oct ‘22 YBC221028 - - - Zhongshan
Inc. ence Assay on assay Hospital ASRL#3
Getein 1100
Immunofluoresc
ence
Quantitative
Analyzer
Immunofluoresc Immuno- Oct ‘22 P009221042 - - - Zhongshan
ence Assay on assay Hospital ASRL#3
Getein 1600
Immunofluoresc
ence
Quantitative
Analyzer
Immunofluoresc Immuno- Oct ‘22 A019220009 - - - Zhongshan
Getein 1180
Immunofluoresc
ence
Quantitative
Analyzer
Colloidal Gold Immuno- Oct ‘22 6BC220002 - - - Zhongshan
on assay Hospital ASRL#3
FIA8600/8000
Quantitative
Immunoassay
Analyzer
Immunofluoresc Immuno- Oct ‘22 EBC220004 - - - Zhongshan
Getein 208
Hand-held
Integrated
System
Ailex Ion-exchange Ion- Oct ‘22 211204AC1, ZS9003, 5.83%, 2112C-0093 Zhongshan
Technology HPLC on AH- exchange 211204AC2, ZS9003 10.53% Hospital ASRL#3
Group Co., Ltd. 600 HPLC 220101YY3,
20220105
5
Value Laboratory
JEOL Ltd. BM Test HbA1c Enzymatic Oct ‘22 861RDT, 935RCT, 3.01, 15.06 - ReCCS
on JCA- 862RDT, 935RCT µmol/L ASRL#1
BM6010/C 857RJT HbA1c; 101.8,
155.6 µmol/L
Hb
HORIBA Spotchem Immuno- Oct ‘22 2232JK037O WC0071 0.0, 24.2, 50.9, - ReCCS
Medical Banalyst HbA1c assay 83.0, 124.5 ASRL#1
on SI-3620 mmol/mol
Banalyst Ace Immuno- Oct ‘22 2232JK041A WC0071 0.0, 24.2, 50.9, - ReCCS
HbA1c on assay 83.0, 124.5 ASRL#1
Banalyst Ace mmol/mol
Spotchem Immuno- Oct ‘22 2232JK037O WC0071 0.0, 24.2, 50.9, - ReCCS
Banalyst HbA1c assay 83.0, 124.5 ASRL#1
on SI-3610 mmol/mol
Banalyst HbA1c Immuno- Oct ‘22 2232JK041A WC0071 0.0, 24.2, 50.9, - ReCCS
on Yumizen assay 83.0, 124.5 ASRL#1
M100 Banalyst mmol/mol
Xiamen Biotime Fluorescence Immuno- Oct ‘22 Y2206022 - - - Zhongshan
Biotechnology Immunoassay assay Hospital ASRL#3
Co., Ltd. on BIOT-YG-1
FIA Analyzer
Goldsite HbA1c on GSH- Ion- Sept’22 9101220421A1, 20220714A1 5.50%, - Zhongshan
91012220421A1,
Diagnostics Inc. 60 exchange 9103220421A1 11.50% Hospital ASRL#3
HPLC
HbA1c on A1c Boronate Sept’22 320003220722 320003220520, 5.50%, - Zhongshan
Go affinity 320003220520, 14.30% Hospital ASRL#3
HbA1c on GPP- Immuno- Sept’22 1072220707, 20220713, 5.50%, 8.90%, - Zhongshan
100 assay 1072220707, 20220713, 11.90%, Hospital ASRL#3
1072220707 20220713, 16.70%
20220713
HbA1c on Immuno- Sept’22 0572230517, 20220713, 5.50%, 8.90%, - Zhongshan
Aristo assay 0572230517, 20220713, 11.90%, Hospital ASRL#3
0572230517, 20220713, 16.70%
20220713
HbA1c on Immuno- Sept’22 0372230417, 20220713, 5.50%, 8.90%, - Zhongshan
Omlipo assay 0372230417, 20220713, 11.90%, Hospital ASRL#3
0372230417 20220713, 16.70%
20220713
Tosoh HLC-723GR01 Ion- Sept’22 AR-101X, JS1001 5.87%, A Univ. of Missouri.
Corporation Standard Long exchange AR-201X, 11.07% SRL #9
Mode HPLC R-301X,
HW-09H
HLC-723GR01 Ion- Sept’22 AR-101X, JS1001 5.87%, A Univ. of Missouri.
Standard Short exchange AR-201X, 11.07% SRL #9
Mode HPLC R-301X,
HW-09H
Ortho Clinical A1C1 on Vitros Enzymatic Sept’22 8731 3311 4.06%, 6.77%, - Univ. of Missouri.
Diagnostics XT 3400 13.47% SRL #9
A1C1 on Vitros Enzymatic Sept’22 8731 3311 3.96%, 6.43%, - Univ. of Missouri.
XT 4600 13.28% SRL #9
XT 5600 13.28% SRL #9
XT 7600 13.47% SRL #9
Boditech Med HbA1c on Neo Immuno- Sept’22 AASBA06EX 111001 5.5%, 8%, - ReCCS
Inc. EZ POC assay 10.4%, 12.5% ASRL#1
HbA1c on QDx Immuno- Sept’22 AASCX07 111001 5.5%, 8%, - ReCCS
Instacheck assay 10.4%, 12.5% ASRL#1
HbA1c Neo on Immuno- Sept’22 AASBA06EX 111001 5.5%, 8%, - ReCCS
QDx Instacheck assay 10.4%, 12.5% ASRL#1
6
Value Laboratory
t Boronate-
EKF Boronate Sept ‘22 020708 - - - European
Diagnostics Affinity Quo- affinity Reference Lab
GmbH Test HbA1C ESRL #11
t Boronate- Boronate Sept ‘22 026094 - - - European
Affinity Quo- affinity Reference Lab
Lab HbA1C ESRL #11
t Boronate-
Human Boronate Sept ‘22 026099 - - - European
Gesellschaft Affinity affinity Reference Lab
fuer Biochemica HumaMeter ESRL #11
und Diagnostica HbA1c
mbH
tNephelometry
Agappe Immuno- Sept ‘22 42010176, 42020130, 5.80%, 9.30%, - European
Diagnostics Ltd. on Specific assay 42010177, 42020131, 13.60%, Reference Lab
Protein 11070081 42020132, 16.10% ESRL#10
Analyzer Mispa 42020133
i2
tNephelometry Immuno- Sept ‘22 42010176, 42020130, 5.80%, 9.30%, - European
on cartridge assay 42010177, 42020131, 13.60%, Reference Lab
based Specific 11070081 42020132, 16.10% ESRL#10
Protein 42020133
Analyzer Mispa
i3
tAgA1c Immuno- Sept ‘22 42010176, 42020130, 5.80%, 9.30%, - European
(Immunoturbidi assay 42010177, 42020131, 13.60%, Reference Lab
metric method) 11070081 42020132, 16.10% ESRL#10
on TMS 30i 42020133
on TBA-120FR 42020133
on TBA-25FR 42020133
on Mispa Viva 42020133
on Mispa Plus 42020133
on Mispa CCXL 42020133
on Mispa CX4 42020133
on Mispa CXL 42020133
Pro Plus
on Mispa CXL 42020133
Pro
7
Value Laboratory
tAgA1c
Agappe Immuno- Sept ‘22 42010176, 42020130, 5.80%, 9.30%, - European
Diagnostics Ltd. (Immunoturbidi assay 42010177, 42020131, 13.60%, Reference Lab
on Mispa Clinia 42020133
Plus
on BS 390 42020133
on Mispa Nano 42020133
on Mispa Nano 42020133
Plus
on Mispa Ace 42020133
Apex Immunoagglutin Immuno- Sept ‘22 AS2031 - - - ReCCS
Biotechnology ation on Eclipse assay ASRL#1
Corp. PLUS
Immunoagglutin Immuno- Sept ‘22 S20401 - - - ReCCS
ation on Eclipse assay ASRL#1
A1c
Minaris Medical MetaboLead Immuno- Sept ‘22 506ABE, 504ABC 2.60, 9.78 - ReCCS
Co., Ltd. HbA1c on DM- assay 506ABE µmol/L ASRL#1
JACK HbA1c; 84.4,
120.9 µmol/L
Hb
MetaboLead Immuno- Sept ‘22 506ABE, 504ABC 2.60, 9.78 - ReCCS
HbA1c on JCA- assay 506ABE µmol/L ASRL#1
BM9130 HbA1c; 84.4,
120.9 µmol/L
Hb
HbA1c on TBA- assay 506ABE µmol/L ASRL#1
120FR HbA1c; 84.4,
120.9 µmol/L
Hb
HbA1c on assay 506ABE µmol/L ASRL#1
Hitachi 7180 HbA1c; 84.4,
120.9 µmol/L
Hb
HbA1c on assay 506ABE µmol/L ASRL#1
LABOSPECT HbA1c; 84.4,
006 120.9 µmol/L
Hb
Furuno Electric Centronic Immuno- Sept ‘22 HF04221F1- 211501 0%, 5.7%, - ReCCS
Co. Ltd. HbA1c assay 206, 8.3%, 11.4%, ASRL#1
Turbidimetric HF04221F1- 15.5%
206,
immunoassay on
HF04221ALY
CA-800 -201
JW Bioscience Immuno assay Immuno- Aug ‘22 201 Cal201 5.6%, - ReCCS
on JCA- (JW reagent) 8.6%,11.9%, ASRL#1
assay
BM6010/C 15.5%
8
Value Laboratory
Human HumanNex A1c Ion- Aug ‘22 220509, 20211220, 5.69%, 220509 Univ. of Missouri.
Gesellschaft fur exchange 220509, 20211220 10.95% SRL #9
Biochemica und HPLC 220509
Diagnostica
mbH
Shanghai HPLC on MQ- Ion- Aug ‘22 PTHbA1c211 20210113, 5.71%, PTHbA1c21 Univ. of Missouri.
Medconn 2000PT 018F, 20210113 11.04% 1018F SRL #9
exchange
Medical PTHbA1c211
HPLC 018F,
Technology Co.
PTHbA1c211
Ltd (China) 018F,
HPLC on MQ- Ion- Aug ‘22 3K20211115C, 20220223, 5.74%, 3K20211115C Univ. of Missouri.
3000 3K20211115C, 20220223 11.02% SRL #9
exchange 3K20211115C
HPLC
HPLC on MQ- Ion- Aug ‘22 3K20211115C, 20220223, 5.74%, 3K20211115C Univ. of Missouri.
3000PT 3K20211115C, 20220223 11.02% SRL #9
exchange 3K20211115C
HPLC
HPLC on MQ- Ion- Aug ‘22 20220530K, 20211221, 5.39%, 20220530K Univ. of Missouri.
6000 exchange 20220530K, 20211221 10.72% SRL #9
HPLC 20220530K,
20220530K,
HPLC on MQ- 6KV20220223H, 6KV20220223H
Ion- Aug ‘22
6KV20220223H,
20210113, 5.56%, Univ. of Missouri.
8000 exchange 6KV20220223H, 20210113 10.88% SRL #9
6KV20220223H
HPLC
HPLC on MQ- Ion- Aug ‘22 6KV20211116F, 20210113, 5.51%, 6KV20211116F Univ. of Missouri.
6KV20211116F,
8000PT exchange 6KV20211116F,
20210113 10.72% SRL #9
HPLC 6KV20211116F
Shanghai Latex Immuno- Aug ‘22 02HbA1c21 211222 0.0%, 5.3%, - Univ. of Missouri.
Medconn agglutination on assay 0702 9.4%, 13.1%, SRL #9
Medical AU5800 17.0%
Technology Co.
Ltd (China)
Shinva Medical SGH-200 Ion- July ‘22 202201, 202201, 5.00%, 8.90% 220404 Zhongshan
Instrument Co., exchange 202201 202201 Hospital ASRL#3
Ltd. HPLC
Boditech Med HbA1c Neo on Immuno- July ‘22 AASCA04X 111001 5.5%, 8.0%, - ReCCS
Inc. AFIAS-1 assay 10.4%, 12.5% ASRL#1
HbA1c Neo on Immuno- July ‘22 AASCA04X 111001 5.5%, 8.0%, - ReCCS
AFIAS-3 assay 10.4%, 12.5% ASRL#1
HbA1c Neo on Immuno- July ‘22 AASBA06EX 111001 5.5%, 8.0%, - ReCCS
ichroma II assay 10.4%, 12.5% ASRL#1
ichroma III assay 10.4%, 12.5% ASRL#1
ichroma -50 assay 10.4%, 12.5% ASRL#1
PLUS
ichroma M3 assay 10.4%, 12.5% ASRL#1
ichroma Reader assay 10.4%, 12.5% ASRL#1
HbA1c on Immuno- July ‘22 AASAB84F 111001 5.5%, 8.0%, - ReCCS
9
Value Laboratory
Boditech Med HbA1c on Immuno- July ‘22 AASAB84F 111001 5.5%, 8.0%, - ReCCS
Inc. AFIAS-10 assay 10.4%, 12.5% ASRL#1
HbA1c on Immuno- July ‘22 AASCX07 111001 5.5%, 8.0%, - ReCCS
ichroma II assay 10.4%, 12.5% ASRL#1
ichroma III assay 10.4%, 12.5% ASRL#1
ichroma M3 assay 10.4%, 12.5% ASRL#1
ichroma -50 assay 10.4%, 12.5% ASRL#1
PLUS
ichroma Reader assay 10.4%, 12.5% ASRL#1
Instrumentation HbA1c Enzymatic July ‘22 I0622200 I0622201, 2.99, 15.76 - European
Laboratory Enzymatic I0622201 µmol/L Reference Lab
(Manual HbA1c; 102.8, ESRL#16
pretreatment) on 158.4 µmol/L
Ilab Taurus Hb
(%NGSP=HbA1c/T
Hb*91.48+2.152)
HbA1c Enzymatic July ‘22 I0622200 I0622201, 2.99, 15.76 - European
Enzymatic I0622201 µmol/L Reference Lab
(Manual HbA1c; 102.8, ESRL#16
Ilab Aries Hb
(%NGSP=HbA1c/T
Hb*91.48+2.152)
HbA1c Enzymatic July ‘22 I0622200 I0622201, 2.99, 15.76 - European
Enzymatic I0622201 µmol/L Reference Lab
(Automatic HbA1c; 102.8, ESRL#16
Ilab Taurus Hb
(%NGSP=HbA1c/T
Hb*91.48+2.152)
CareforU.Co.Ltd CareBuddy Boronate July ‘22 CDC122E09 - - - European
Multi/ Affinity Reference Lab
CareBuddy ESRL#10
HbA1c/ HUBI
DIA/ HUBI
A1c)
GC Medical Boronate Boronate July ‘22 R12D061K - - - Univ. of Missouri.
Science` Corp. Affinity on Affinity SRL #9
Greencare A1c
Boronate Boronate July ‘22 R12D061K - - - Univ. of Missouri.
Affinity on Affinity SRL #9
Arkray Pocket
Chem A1c
Advanced
Diasys India
QDx A1c
Advance
Medisys Hemo
G Smart
Analyzer
Wuxi Boronate Affinity Boronate July ‘22 CAP220301 - - - Zhongshan
Biohermes Bio on A1C EZ 2.0 Affinity 111 Hospital ASRL#3
& Medical Glycohemoglobi
Technology Co., n Analysis
Ltd. System
10
Value Laboratory
Wuxi Boronate Boronate July ‘22 EAZ220523 - - - Zhongshan
Biohermes Bio Affinity on Affinity 011 Hospital ASRL#3
& Medical A1cChek
Technology Co., Express
Ltd. Glycohemoglobi
n Analysis
System
Boronate Boronate July ‘22 CAV220606 - - - Zhongshan
Affinity on Affinity 011 Hospital ASRL#3
A1cChek Pro
Glycohemoglobi
n Analysis
System
Ion-exchange Ion- July ‘22 CHI2204270 CHW22021 5.03%, CHD224100 Zhongshan
HPLC on BH60 exchange 11AD 401 10.41% 22AD Hospital ASRL#3
Automatic HPLC
Glycohemoglobi
n Analysis
System
Boronate Boronate July ‘22 EAG220505 - - - Zhongshan
Affinity on Affinity 111 Hospital ASRL#3
GluCoA1c
Blood Glucose
and
Glycohemoglobi
n Analysis
System
Arkray Inc. CinQ HbA1c on Enzymatic June ‘22 MFA23, CAC0K25 2.73, 6.94 - ReCCS
JCA-ZS050 MFE22 µmol/L ASRL#1
HbA1c HbA1c; 95.3
HbA1c%(NGSP)=0 µmol/L Hb
.0915*HbA1c/Hb*1
000(IFCC)+2.15
CinQ HbA1c on Enzymatic June ‘22 MFA23, CAC0K25 2.73, 6.94 - ReCCS
JCA-BM9130 MFE22 µmol/L ASRL#1
HbA1c HbA1c; 95.3
.0915*HbA1c/Hb*1
000(IFCC)+2.15
CinQ HbA1c on Enzymatic June ‘22 HLS33 CAC0K25 2.73, 6.94 - ReCCS
LABOSPECT00 µmol/L ASRL#1
6 HbA1c; 95.3
HbA1c µmol/L Hb
HbA1c%(NGSP)=0
.0915*HbA1c/Hb*1
000(IFCC)+2.15
CinQ HbA1c on Enzymatic June ‘22 MFA23, CAC0K25 2.73, 6.94 - ReCCS
TBA-120FR MFE22 µmol/L ASRL#1
HbA1c HbA1c; 95.3
.0915*HbA1c/Hb*1
000(IFCC)+2.15
Sebia Capillarys Capillary June ‘22 28091/01, 05030/01, 35.8, 85.9 - European
HbA1c on Electro- 13010/01, 06030/01 mmol/mol Reference Lab
Capillarys 2 phoresis 23081/01 ESRL#10
Flex Piercing
%NGSP=0.0914
8 x [IFCC]
(mmol/mol) +
2.152
11
Value Laboratory
Sebia Minicap HbA1c Capillary June ‘22 06071/01, 15041/01, 36.5, 87.1 - European
%NGSP=0.0914 Electro- 12071/01, 16041/01 mmol/mol Reference Lab
8 x [IFCC] phoresis 15071/01 ESRL#10
(mmol/mol) +
2.152
CAPI 3 HbA1c Capillary June ‘22 08061/80, 15041/01, 36.5, 87.1 - European
on Capillarys 3 Electro- 30081/01, 16041/01 mmol/mol Reference Lab
%NGSP=0.0914 phoresis 24032/01 ESRL#10
8 x [IFCC]
(mmol/mol) +
2.152
Ortho Clinical %A1c on Vitros Immuno- June ‘22 9647 3132 0.169, 0.839, - Univ. of Missouri.
Diagnostics 5,1 FS assay 1.705, 3.786 SRL #9
g/dL HbA1c;
-0.695, 3.034,
7.385, 16.166
g/dL Hb
%A1c on Vitros Immuno- June ‘22 9647 3132 0.165, 0.843, - Univ. of Missouri.
4600 assay 1.719, 3.704 SRL #9
g/dL HbA1c;
-0.695, 3.034,
7.385, 16.166
g/dL Hb
5600 assay 1.719, 3.704 SRL #9
g/dL HbA1c;
-0.695, 3.034,
7.385, 16.166
g/dL Hb
7600 assay 1.719, 3.704 SRL #9
g/dL HbA1c;
-0.695, 3.034,
7.385, 16.166
g/dL Hb
Siemens DCA Vantage Immuno- June ‘22 0942032, - - - Univ. of Missouri.
Healthcare assay 0948032 SRL #9
Diagnostics
Roche TQ HbA1c Gen. Immuno- June ‘22 614165, 538206 0.130, 0.333, - European
Diagnostics 3 on cobas c 501 assay 592643 0.659, 0.919, Reference Lab
GmbH / c 502 1.257, 1.795 ESRL #13
(HbA1c/Hb*91. mmol/L
5+2.15) HbA1c; 1.379,
7.438 mmol/L
Hb
TQ HbA1c Gen. Immuno- June ‘22 567668, 538206 0.149, 0.340, - European
3 Hemolysate on assay 580773, 0.643, 0.880, Reference Lab
cobas c503 521990 1.206, 1.704 ESRL #13
5+2.15) HbA1c; 1.46,
7.83 mmol/L
Hb
3 whole blood assay 580773 0.659, 0.901, Reference Lab
on cobas c503 1.238, 1.750 ESRL #13
5+2.15) HbA1c; 1.46,
7.83 mmol/L
Hb
12
Value Laboratory
Roche TQ HbA1c Gen. Immuno- June ‘22 611967, 538206 0.149, 0.340, - European
Diagnostics 3 hemolysate on assay 521990, 0.642, 0.878, Reference Lab
GmbH cobas c513 587784 1.204, 1.701 ESRL #13
5+2.15) HbA1c; 1.46,
7.83 mmol/L
Hb
3 whole blood assay 587784 0.654, 0.893, Reference Lab
on cobas c513 1.225, 1.728 ESRL #13
5+2.15) HbA1c; 1.46,
7.83 mmol/L
Hb
Tosoh G8 HbA1c Ion- June ‘22 S8-105G, ZS0004 5.68%, S Univ. of Missouri.
Corporation Variant Analysis exchange S8-209G, 10.61% SRL #9
Mode Ver. 5.23 HPLC S8-308G,
(1.6 min), HLC- HW-34G
723G8
t G8 HbA1c Ion- June ‘22 R8-107G, ZS0004 5.68%, R Univ. of Missouri.
Standard exchange R8-205F, 8- 10.61% SRL #9
Analysis Mode HPLC 302F, HW-
Ver. 5.29 (1.0 34G
min) HLC-
723G8
t G9 HbA1c, Ion- June ‘22 E9-101G, JS1001 5.87%, E Univ. of Missouri.
HLC-723G9, exchange E9-201G, 9- 11.07% SRL #9
Ver. 1.13 HPLC 301G, HW-
34G
G8 HbA1c Ion- June ‘22 S8-105G, ZS0004 5.68%, S Univ. of Missouri.
Variant Analysis exchange S8-209G, 10.61% SRL #9
Mode Ver. HPLC S8-308G,
5.24F (1.6 min), HW-34G
HLC-723G8
G8 HbA1c Ion- June ‘22 S8-105F, ZS0004 5.68%, S Univ. of Missouri.
Mode (1.6 min), HPLC S8-308G,
HLC-723G8 HW-34G
G8 HbA1c Ion- June ‘22 S8-105G, ZS0004 5.68%, S Univ. of Missouri.
Mode Ver.5.29 HPLC S8-308G,
(1.6 min), HLC- HW-34G
723G8
G7 HbA1c Ion- June ‘22 M7-101G, ZS0004 5.68%, M Univ. of Missouri.
Variant Analysis exchange M7-201G, 10.61% SRL #9
Mode (2.2 min), HPLC M7-301G,
HLC-723G7 HW-20G
t GX, Ver.1.24 Ion- June ‘22 BX-101G, ZS0004 5.68%, B Univ. of Missouri.
HLC-723GX exchange BX-201G, 10.61% SRL #9
HPLC BX-301G,
HW-23G
t G11, Standard Ion- June ‘22 H1-106G, ZB0030 5.88%, H Univ. of Missouri.
Analysis Mode exchange H1-201F, 1- 10.87% SRL #9
Ver.3.08 (0.5 HPLC 303G, HW-
min), HLC- 34G
723G11
t G11, Standard Ion- June ‘22 H1-106G, ZS0004 5.68%, H Univ. of Missouri.
Analysis Mode exchange H1-201F, 1- 10.61% SRL #9
Ver.3.08 (0.5 HPLC 303G, HW-
min), HLC- 34G
723G11
13
Value Laboratory
t G11, Variant
Tosoh Ion- June ‘22 G1-111G, ZS0004 5.68%, G Univ. of Missouri.
Corporation Analysis Mode exchange G1-204G, 10.61% SRL #9
Ver.3.08 (1.0 HPLC G1-301G,
min), HLC- HW-34G
723G11
t G11, Variant Ion- June ‘22 G1-111G, ZB0030 5.88%, G Univ. of Missouri.
Analysis Mode exchange G1-204G, 10.87% SRL #9
Ver.3.08 (1.0 HPLC G1-301G,
min), HLC- HW-34G
723G11
t G11, Variant Ion- June ‘22 G1-111G, ZS0004 5.68%, G Univ. of Missouri.
Analysis Mode exchange G1-204G, 10.61% SRL #9
Ver.3.05F2 (1.0 HPLC G1-301G,
min), HLC- HW-26G
723G11
Siemens Enzymatic Enzymatic June ‘22 260, 260, 1FS001, 3.46, 13.59 - Univ. of Missouri.
Healthcare Hemoglobin 260, 260 1FS001 µmol/L SRL #9
Diagnostics A1c (A1c_E) – HbA1c; 98.7,
Automated 148.6 µmol/L
Hb
Pretreatment
on Advia 1800
Enzymatic Enzymatic June ‘22 260, 260, 1FS001, 3.46, 13.59 - Univ. of Missouri.
Hemoglobin 260, 260 1FS001 µmol/L SRL #9
A1c (A1c_E) – HbA1c; 98.7,
Hb
Pretreatment
on Advia 2400
A1c (A1c_E) – HbA1c; 98.7,
Hb
Pretreatment
on Advia XPT
Enzymatic Enzymatic June ‘22 110360, 1HS003, 3.03, 15.18 - Univ. of Missouri.
Hemoglobin 110360, 1HS003 µmol/L SRL #9
A1c (A1c_E) – 110360, HbA1c; 96.1,
Automated 110360 148.0 µmol/L
Hb
Pretreatment
on Atellica CH
930
Enzymatic Enzymatic June ‘22 110360, 1HS003, 3.03, 15.18 - Univ. of Missouri.
Hemoglobin 110360, 1HS003 µmol/L SRL #9
A1c (A1c_E) – 110360, HbA1c; 96.1,
Automated 110360 148.0 µmol/L
Hb
Pretreatment
on Atellica CI
1900
A1c HbA1c; 98.7,
(A1c_EM) – 148.6 µmol/L
Hb
Manual
Pretreatment
on Advia 1800
14
Value Laboratory
Siemens Enzymatic Enzymatic June ‘22 260, 260, 1FS001, 3.46, 13.59 - Univ. of Missouri.
Healthcare Hemoglobin 260, 260 1FS001 µmol/L SRL #9
Diagnostics A1c HbA1c; 98.7,
(A1c_EM) – 148.6 µmol/L
Hb
Manual
Pretreatment
on Advia 2400
A1c HbA1c; 98.7,
(A1c_EM) – 148.6 µmol/L
Hb
Manual
Pretreatment
on Advia XPT
Nova Allegro, Immuno- May ‘22 22046005 - - - Univ. of Missouri
Biomedical Immunoassay assay SRL#9
Wiener HbA1c v.2 Immuno- May ‘22 479280, 478120 2.708 g/dL - Univ. of Missouri
Laboratorios Turbitest AA assay 479380, HbA1c; 13.82 SRL#9
S.A.I.C. on CMD 800i 479310, g/dL Hb
91.5*HbA1c/Hb+ 470680
2.15
HbA1c v.2 Immuno- May ‘22 479280, 478120 2.708 g/dL - Univ. of Missouri
Turbitest AA assay 479380, HbA1c; 13.82 SRL#9
on CM 250 479310, g/dL Hb
91.5*HbA1c/Hb+ 470680
2.15
on CT 600i 479310, g/dL Hb
91.5*HbA1c/Hb+ 470680
2.15
on CB 350i 479310, g/dL Hb
91.5*HbA1c/Hb+ 470680
2.15
Dirui Industrial Whole Blood- Immuno- May ‘22 20220114, 20220117 0%, 5.7%, - Zhongshan
Co., Ltd. Latex assay 20220114, 8.7%, 11.5%, Hospital ASRL#3
Agglutination 20220114 14.2%
Method on
CS-400
Whole Blood- Immuno- May ‘22 20220114, 20220117 0%, 5.7%, - Zhongshan
Latex assay 20220114, 8.7%, 11.5%, Hospital ASRL#3
Agglutination 20220114 14.2%
Method on
CS-T240 Plus
Sakae MEDIDAS Immuno- May ‘22 462203 20G17 4.7%, 7.1%, - ReCCS
Corporation HbA1c on A1c assay 10.2%, 13.9% ASRL#1
GEAR
MEDIDAS Immuno- May ‘22 462203 20G17 4.7%, 7.1%, - ReCCS
HbA1c on A1c assay 10.2%, 13.9% ASRL#1
iGear
MEDIDAS Immuno- May ‘22 462203 20G17 4.7%, 7.1%, - ReCCS
HbA1c on A1c assay 10.2%, 13.9% ASRL#1
iGear Quick
15
Value Laboratory
Abbott HbA1c Enzymatic May ‘22 61011UQ10, 60939UQ11 5.1%, 11.4% - Univ. of
Diagnostics (Hemolysate) 61011UQ10, Missouri.
on Architect 61011UQ10 SRL #9
c8000
%NGSP=HbA1c/
Hb*91.48+2.152
HbA1c Enzymatic May ‘22 61011UQ10, 60939UQ11 5.1%, 11.4% - Univ. of
(Hemolysate) 61011UQ10, Missouri.
c4000
%NGSP=HbA1c/
Hb*91.48+2.152
(Whole Blood) 61011UQ10, Missouri.
c4000
%NGSP=HbA1c/
Hb*91.48+2.152
c8000
%NGSP=HbA1c/
Hb*91.48+2.152
(Hemolysate) 61011UQ10, Missouri.
on Alinity c 61011UQ10 SRL #9
%NGSP=HbA1c/
Hb*91.48+2.152
on Alinity c 61011UQ10 SRL #9
analyzer
%NGSP=HbA1c/
Hb*91.48+2.152
Sekisui Medical Norudia N Enzymatic Apr ‘22 129RJS, 205 RLS 3.41, 14.91 - ReCCS
Co., Ltd. HbA1c on 129RJS, µmol/L HbA1c; ASRL#1
Hitachi 7170 S 130RLS 104.0, 153.4
µmol/L Hb
(RE) Norudia N Enzymatic Apr ‘22 128RLS, 204 RLS 5.16, 22.53 - ReCCS
HbA1c on 129RJS, µmol/L HbA1c; ASRL#1
Hitachi 3500 130RLS 169.0, 236.1
µmol/L Hb
(RE) Norudia N Enzymatic Apr ‘22 HBA208RJS, 204 RLS 5.16, 22.53 - ReCCS
HbA1c on TBA- HBA208RJS, µmol/L HbA1c; ASRL#1
nx360 130RLS 169.0, 236.1
µmol/L Hb
(RE) Norudia N Enzymatic Apr ‘22 129RJS, 204 RLS 5.16, 22.53 - ReCCS
Hitachi 7180 130RLS 169.0, 236.1
µmol/L Hb
HbA1c Auto Enzymatic Apr ‘22 129RJS(T), 205 RLS 3.41, 14.91 - ReCCS
TBA on TBA- 129RJS(T), µmol/L HbA1c; ASRL#1
120FR 130RLS 104.0, 153.4
µmol/L Hb
L type Norudia Enzymatic Apr ‘22 128RLS, 203 RLS 3.52, 14.78 - ReCCS
N HbA1c on 128RLS, µmol/L HbA1c; ASRL#1
Hitachi LST006 130RLS 106.9, 148.8
µmol/L Hb
16
Value Laboratory
Sekisui Medical L type Norudia Enzymatic Apr ‘22 128RLS, 203 RLS 3.52, 14.78 - ReCCS
Co., Ltd. N HbA1c on 128RLS, µmol/L HbA1c; ASRL#1
Hitachi LST008 130RLS 106.9, 148.8
µmol/L Hb
Norudia N Enzymatic Apr ‘22 129RJS, 205 RLS 3.41, 14.91 - ReCCS
HbA1c on JCA- 129RJS, µmol/L HbA1c; ASRL#1
BM9130 130RLS 104.0, 153.4
µmol/L Hb
Norudia N Enzymatic Apr ‘22 130RLS, 205 RLS 3.41, 14.91 - ReCCS
HbA1c on 130RLS, µmol/L HbA1c; ASRL#1
EV800 130RLS 104.0, 153.4
µmol/L Hb
HbA1c on 130RLS, µmol/L HbA1c; ASRL#1
Hitachi 3500 130RLS 104.0, 153.4
µmol/L Hb
Norudia N Enzymatic Apr ‘22 129RJS, 205 RLS 3.41, 14.91 - ReCCS
SK300 130RLS 104.0, 153.4
µmol/L Hb
HbA1c on TBA- 130RLS, µmol/L HbA1c; ASRL#1
120FR 130RLS 104.0, 153.4
µmol/L Hb
RC-W FAST Enzymatic Apr ‘22 2107160005 201016 5.04%, 11.49% - ReCCS
Mode ASRL#1
RC-W Enzymatic Apr ‘22 2107160005 201016 5.07%, 11.44% - ReCCS
VARIANT ASRL#1
Mode
Toyobo Co., Toyobo HbA1c Enzymatic Apr ‘22 211027LB, CAL82 5.34%, - ReCCS
Ltd. Direct on 220127R1, 15.95% ASRL#1
Hitachi 7180 211213R2
Toyobo HbA1c Enzymatic Apr ‘22 211027LB, CAL82 5.41%, - ReCCS
Direct on JCA- 220127R1, 16.07% ASRL#1
BM9130 211213R2
SD Biosensor, Standard A1cC Immuno- Apr ‘22 4012C81AC - - - ReCCS
Inc. on Standard assay ASRL#1
A1cCare
Standard F on Immuno- Apr ‘22 6072CN6AC - - - ReCCS
Standard F100 assay ASRL#1
MultiCare Immuno- Apr ‘22 4022B53AC - - - ReCCS
assay ASRL#1
Ensayos y Fluorescence Immuno- Apr ‘22 F20715901 - - - ReCCS
Tamizajes de Immunoassay assay AD ASRL#1
Mexico S.A. de on Finecare FIA
C.V. Meter
Fluorescence Immuno- Apr ‘22 F20715901 - - - ReCCS
Immunoassay assay AD ASRL#1
on Finecare FIA
Meter Plus
Guangzhou Fluorescence Immuno- Apr ‘22 F20716B07 - - - ReCCS
Wondfo Biotech Immunoassay assay AD ASRL#1
Co., Ltd. on Finecare FIA
Meter
Fluorescence Immuno- Apr ‘22 F20716B07 - - - ReCCS
on Finecare FIA
Meter Plus
17
Value Laboratory
Guangzhou Fluorescence Immuno- Apr ‘22 F20716B07 - - - ReCCS
Wondfo Biotech Immunoassay assay AD ASRL#1
Co., Ltd. on Finecare FIA
Meter II Plus SE
Fluorescence Immuno- Apr ‘22 F20716B07 - - - ReCCS
on Finecare FIA
Meter III Plus
tAU-
Fujirebio Inc. Immuno- Apr ‘22 QF10501, VF10401 0.0%, 4.2%, - ReCCS
SYNCHRON assay RF10501, 6.8%, 9.6%, ASRL#1
Reagent HbA1C SF10101 13.2%
on DxC700AU
t Rapidia Auto Immuno- Apr ‘22 QF10501, VF10401 0.0%, 4.2%, - ReCCS
HbA1c-L on assay RF10501, 6.8%, 9.6%, ASRL#1
BiOLis24i SF10101 13.2%
Premium
JCA-BM9130 SF10101 13.2%
AU680 SF10101 13.2%
Hitachi 7180 SF10101 13.2%
TBA-120FR SF10101 13.2%
Abbott Afinion HbA1c / Boronate Apr ‘22 10215344 - - - European
Diagnostics Afinion AS100 affinity Reference Lab
Technologies Analyzer ESRL #11
AS
Afinion HbA1c Boronate Apr ‘22 10214123 - - - European
Dx / affinity Reference Lab
Afinion AS100 ESRL #11
Analyzer
Afinion HbA1c Boronate Apr ‘22 10214123 - - - European
Dx / affinity Reference Lab
Afinion 2 ESRL #11
Analyzer
Afinion HbA1c / Boronate Apr ‘22 10215344 - - - European
Afinion 2 affinity Reference Lab
Analyzer ESRL #11
t ADAMS A1c
Arkray, Inc. Ion- Apr ‘22 21072131, S1003 5.3%, 10.6% 16013Y ReCCS
HA-8160 VP exchange 21021212, ASRL#1
mode HPLC 22012733,
21042814
t ADAMS A1c Ion- Apr ‘22 21072131, S1003 5.3%, 10.6% 2A001W ReCCS
HA-8160 TP exchange 22021812, ASRL#1
mode HPLC 21031134,
21020535,
21042814
t ADAMS A1c Ion- Apr ‘22 21080557, S1003 5.2%, 10.4% 1C011S ReCCS
HA-8160 exchange 21082058, ASRL#1
(Ver.4) HPLC 21090159,
21102955
t ADAMS A1c Ion- Apr ‘22 21080557, S1003 5.2%, 10.4% 1C0016 ReCCS
HPLC 21090159,
21102955
18
Value Laboratory
t
Arkray, Inc. ADAMS A1c Ion- Apr ‘22 210804101, S1003 5.3%, 10.5% 1C601N ReCCS
HPLC 211018105
t ADAMS A1c Ion- Apr ‘22 210804101, S1003 5.3%, 10.5% 1C601N ReCCS
HPLC 211018105
t ADAMS A1c Ion- Apr ‘22 2A1001, CA81G07 5.3%, 10.7% 1E401N ReCCS
HA-8182 exchange 1J1022, ASRL#1
HPLC 1L1042
ADAMS A1c Ion- Apr ‘22 210804101, S1003 5.3%, 10.5% 1C210U ReCCS
HA-8180V exchange 210802102, ASRL#1
Variant mode HPLC 210729140,
211018105
t ADAMS A1c Ion- Apr ‘22 210804101, S1003 5.3%, 10.7% 1C210U ReCCS
Fast mode HPLC 210729140,
211018105
t ADAMS A1c Ion- Apr ‘22 210804101, S1003 5.3%, 10.5% 1C209V ReCCS
Lite HA-8380V exchange 210802102, ASRL#1
211018105
Lite HA-8380V exchange 210802102, ASRL#1
211018105
HA-8190V Fast exchange 210802102, ASRL#1
mode HPLC 210806364,
211018105
211018105
tADAMS A1c Ion- Apr ‘22 210804101, S1003 5.3%, 10.5% 1C602N ReCCS
Lite HA-8380 exchange 210802102, ASRL#1
HPLC 211018105
t ADAMS A1c Ion- Apr ‘22 210804101, S1003 5.3%, 10.5% 1C021L ReCCS
HA-8180T exchange 210802102, ASRL#1
HPLC 210217160,
211018105
t ADAMS Ion- Apr ‘22 210804101, S1003 5.3%, 10.5% 1C601N ReCCS
HYBRID AH- exchange 210802102, ASRL#1
8290 HPLC 211018105
tCinQ HbA1c Enzymatic Apr ‘22 MFA23, CACOK25 2.73, 6.94 - ReCCS
on JCA- MFE22 µmol/L ASRL#1
BM6010 HbA1c
HbA1c%(NGSP (IFCC), 95.3
)=0.0915*HbA1 µmol/L Hb
c/Hb*1000(IFC (IFCC)
C)+2.15
@ The Lab 001
Capillary Apr ‘22 CE112A2A1 - - - ReCCS
HbA1c%(NGSP)= Electroph ASRL#1
0.0915*HbA1c/Hb oresis
*1000(IFCC)+2.1
5
Siemens Dimension Vista Immuno- Apr ‘22 21144BB 1ED032 0.16, 0.50, - Univ. of Missouri.
Healthcare A1C on assay 0.90, 1.59,2.17 SRL #9
Diagnostics Dimension Vista g/dL hbA1c;
500 13.01, 12.52
g/dL Hb
19
Value Laboratory
Siemens Dimension Vista Immuno- Apr ‘22 21187BA 1GD001 0.14, 0.52, - Univ. of Missouri.
Healthcare A1C on assay 0.96, 1.60, SRL #9
Diagnostics Dimension Vista 2.18 g/dL
1500 HbA1c; 12.57,
12.07 g/dL Hb
Archem Seğlik Derect Method Immuno- Mar ‘22 083 023 5.5%, 7.3%, - European
Sanayi ve on Mindray assay 11.3%, 15.5% Reference Lab
Ticaret A.S. BS800 & ESRL #13
BS800M
Derect Method Immuno- Mar ‘22 083 023 5.5%, 7.3%, - European
on Olympus assay 11.3%, 15.5% Reference Lab
AU5800 ESRL #13
Immunoturbidi Immuno- Mar ‘22 083 023 5.5%, 7.3%, - European
metric Method assay 11.3%, 15.5% Reference Lab
on Alinity c ESRL #13
Immunoturbidi Immuno- Mar ‘22 088 023 5.7%, 7.7%, - European
metric Method assay 11.7%, 15.5% Reference Lab
on Architect ESRL #13
c8000
Shenzhen HPLC on LD- Ion- Mar ‘22 20211028, 20211020, 5.6%, 9.5% 20211028 ReCCS
Labnovation 500, LD-510, exchange 20211028, 20211020 ASRL#1
Technologies, LD-520 HPLC 20211028
Inc.
HPLC on LD- Ion- Mar ‘22 20211204, 20211020, 5.6%, 9.6% 8F50867 ReCCS
560, LD-561, exchange 20211204, 20211020 ASRL#1
LD-562 HPLC 20211204
HPLC on LD- Ion- Mar ‘22 20211126, 20211020, 5.5%, 9.5% 9F50695 ReCCS
600, LD-620 exchange 20211126, 20211020 ASRL#1
HPLC 20211126
Borate affinity Boronate Mar ‘22 20211230 20211020, 5.8%, 9.9% - ReCCS
on LD-100, LD- Affinity 20211020 ASRL#1
120, LD-160
Minaris Medical Determiner L Immuno- Mar ‘22 504AAL, 504AAK 0.0%, 4.4%, - ReCCS
Co., Ltd. HbA1c on assay 504AAL 6.8%, 9.7%, ASRL#1
FUNOTEC FC- 13.1%
300
Determiner L Immuno- Mar ‘22 504AAL, 504AAK 0.0%, 4.4%, - ReCCS
HbA1c DM- assay 504AAL 6.8%, 9.7%, ASRL#1
JACK 13.0%
HbA1c on JCA- assay 504AAL 6.8%, 9.7%, ASRL#1
BM9130 13.1%
HbA1c on TBA- assay 504AAL 6.8%, 9.7%, ASRL#1
120FR 13.1%
HbA1c on assay 504AAL 6.9%, 9.7%, ASRL#1
Hitachi-7180 13.1%
Thermo Fisher HbA1c for Immuno- Mar ‘22 U911, U443 U386 1.5638 - European
Scientific Oy Indiko, ref assay mmol/L Reference Lab
981947, 981948 HbA1c; 8.781 ESRL #13
(91.5*HbA1c/Hb* mmol/L Hb
+2.15)
HbA1c for Immuno- Mar ‘22 U911, U443 U386 1.5638 - European
Konelab, ref assay mmol/L Reference Lab
981947, 981948 HbA1c; 8.781 ESRL #13
(91.5*HbA1c/Hb* mmol/L Hb
+2.15)
UMA Co., Ltd MEASURE Immuno- Mar ‘22 396ABA, 134ABB 0.0%, 5.4%, - ReCCS
HbA1c II on assay 228ABA 8.4%, 11.7%, ASRL#1
Hitachi 7180 15.2%
20
Value Laboratory
Fujikura Kasei HbA1c-FW on Immuno- Mar ‘22 W22A201W W21L011D 5.0%, 8.5%, - ReCCS
Co., Litd Hitachi 7180 assay 11.9%, 15.9% ASRL#1
HbA1c-F on Immuno- Mar ‘22 W21G152C W21A011D 4.8%, 8.80%, - ReCCS
Hitachi 7180 assay 12.2%, 16.4% ASRL#1
HbA1c-FL on Immuno- Mar ‘22 W22A011L W22A141L 4.5%, 6.9%, - ReCCS
Hitachi 7180 assay 9.4%, 13.3% ASRL#1
PTS Diagnostics A1CNOW+; Immuno- Mar ‘22 2115818 - - - Univ. of Missouri.
A1CNOW assay SRL #9
Selfcheck
Trinity Biotech Boronate Boronate Mar ‘22 12064, 12951, 5.1%, 12.3% 12702 Univ. of Missouri.
Affinity HPLC affinity 12414, 12952 SRL #11
on Premier HPLC 12410,
Hb9210 12238
Tri-stat 1 Boronate Mar ‘22 11812(2S) - - - Univ. of Missouri.
Affinity SRL #11
Tri-stat 2 Boronate Mar ‘22 11812(2S) - - - Univ. of Missouri.
Affinity SRL #11
Green Cross Boronate Boronate Feb ‘22 HC4331J061, - - - Univ. of Missouri.
Medis Corp. Affinity on Affinity HC4331J062, SRL #9
Cera-Stat 4000 HC4331J06W
(Merilyzer
Mericheck
Analyzer)
Boronate Boronate Feb ‘22 HC2331J061, - - - Univ. of Missouri.
Affinity on Affinity HC2331J062, SRL #9
Cera-Stat 2000 HC2331J06W
(QDx A1c
Analyzer)
Boronate Boronate Feb ‘22 HM2361J061, - - - Univ. of Missouri.
Affinity Affinity HM2361J062, SRL #9
LabonaCheck HM2361J06W
A1c HbA1c
Analyzer
(Model:
MH200),
A1Card HbA1c
Analyzer
Skyla Immunoassay Immuno- Feb ‘22 A1ZH21JK1 - - - ReCCS
Corporation on Skyla Hi assay ASRL#1
Hsinchu Science Analyzer
Park Branch
DxGen Corp. Boronate Boronate Feb ‘22 C11K0301R1, - - - Univ. of Missouri.
affinity on Affinity C11K0301W1 SRL #9
Epithod 616, ,
C11K0301C1
616H
Boronate Boronate Feb ‘22 C11K1502R1, - - - Univ. of Missouri.
affinity on Affinity C11K1502W1 SRL #9
Epithod 414, ,
C11K1502C1
Dx.HbA1c
GuangDong Turbidimetric Immuno- Feb ‘22 3920211001 3920211001L, 8.2%, 10.9% - Zhongshan
Uniten inhibition assay 3920211001H Hospital ASRL#2
Biotechnology immuno assay
Co., Ltd. on Mindray BS-
450
Suzhou Borui HPLC on CM- Ion- Jan ‘22 2820211013 3020210720 5.1%, 10.4% G7111038 Zhongshan
Sunga Medical C1 Glycosylated exchange Hospital ASRL#2
Technology Co., Hemoglobin HPLC
Ltd. Analyzer
21
Value Laboratory
Beckman HbA1c3 Immuno- Jan ‘22 M107745, M107745 0.197, 0.455, - Univ. of Missouri.
Coulter Inc. Colorimetric assay M107745, 0.843, 1.481, SRL #9
DxC600 M109385 2.164 g/dL
Platform HbA1c; 19.19
g/dL Hb
HbA1c3 Immuno- Jan ‘22 M107745, M107745 0.197, 0.455, - Univ. of Missouri.
Colorimetric assay M107745, 0.843, 1.481, SRL #9
DxC800 M109385 2.164 g/dL
g/dL Hb
HbA1c Immuno- Jan ‘22 M110467, M110467 0.197, 0.455, - Univ. of Missouri.
DxC800 M110580 2.164 g/dL
g/dL Hb
HbA1c Immuno- Jan ‘22 M110467, M110467 0.197, 0.455, - Univ. of Missouri.
DxC600 M110580 2.164 g/dL
g/dL Hb
EMPECS ASUREQUAN Enzymatic Jan ‘22 BAIVHI2P1A - - - European
Medical Device Analyzer Reference Lab
Co., Ltd. ESRL#13
Nittobo Medical N-Assay LA Immuno- Jan ‘22 H104A N004A 0%, 4.9%, - ReCCS
Co., Ltd HbA1c Nittobo assay 8.6%, 12.0%, ASRL#1
on TBA-120FR 15.8%
N-Assay LA Immuno- Jan ‘22 H104A N004A 0%, 4.9%, - ReCCS
HbA1c Nittobo assay 8.6%, 12.0%, ASRL#1
on BM9130 15.8%
on H-7180 15.8%
on TBA c8000 15.8%
Shenzhen Ion-exchange Ion- Jan ‘22 H8SX21026 H8SX210121 5.40%, 9.80% I02DSX21B Zhongshan
Lifotronic HPLC on H8 exchange 23415 Hospital ASRL#2
Technology Co., Hemoglobin HPLC
Ltd. Analyzer; also
sold by ASSEL
srl as AS8
Ion-exchange Ion- Jan ‘22 H9SX21025 H8SX210124 5.60%, I02BSX21B2 Zhongshan
HPLC on H9 exchange 10.20% 2780 Hospital ASRL#2
Hemoglobin HPLC
Analyzer; also
sold by ASSEL
srl as AS9
Lateral Flow Immuno- Jan ‘22 8521089 - - - Zhongshan
on FA-160
Ion-exchange Ion- Jan ‘22 822152 G9N21033 5.40%, GH21B51345 Zhongshan
HPLC on exchange 10.10% Hospital ASRL#2
GH900 and HPLC
GH900Plus
Hemoglobin
Analyzer
Ion-exchange Ion- Jan ‘22 H8SX21026 H8SX210121 5.40%, 9.80% I02DSX21B2 Zhongshan
HPLC on exchange 3422 Hospital ASRL#2
Benesphera A10 HPLC
Hemoglobin
Analyzer
22
Value Laboratory
Shenzhen Ion-exchange Ion- Jan ‘22 HASX210040 HNSX210010 5.35%, 9.64% I02HSX21B0 Zhongshan
Lifotronic HPLC on exchange 1223 Hospital ASRL#2
Technology Co., H100/H100Plus HPLC
Ltd. Hemoglobin
Analyzer
Ion-exchange Ion- Jan ‘22 HASX210040 HNSX210010 5.35%, 9.64% I02HSX21A0 Zhongshan
HPLC on Hb exchange 0209 Hospital ASRL#2
NEXT HPLC
Hemoglobin
Analyzer
Ion-exchange Ion- Jan ‘22 H6SX21022 H6SX210120 5.50%, 9.90% I02FSX21B1 Zhongshan
HPLC on exchange 5753 Hospital ASRL#2
LifeDx HBPro HPLC
Hemoglobin
Analyzer
HPLC on Nano exchange 3418 Hospital ASRL#2
H5 HbA1c HPLC
Analyzer
Ion-exchange Ion- Jan ‘22 H9SX21025 H9SX210124 5.60%, I02BSX21B2 Zhongshan
HPLC on Nano exchange 10.20% 2781 Hospital ASRL#2
H110 HPLC
Hemoglobin
Analyzer
HPLC on Z-Hb exchange 3423 Hospital ASRL#2
Confirm HPLC
Automated
Hemoglobin
Analyzer
Ion-exchange Ion- Jan ‘22 H6SX21022 H6SX210120 5.50%, 9.90% I02FSX21B1 Zhongshan
HPLC on H6 exchange 5748 Hospital ASRL#2
Hemoglobin HPLC
Analyzer
MDX Medtek Ion-exchange Ion- Jan ‘22 21026MDXH 210121MDX 5.40%, 9.80% 0021MDXHL Zhongshan
Diagnostics HPLC on exchange R HC Hospital ASRL#2
(Netherlands) HPLCline 100 HPLC
B.V.
Human Ion-exchange Ion- Jan ‘22 HA1C21026 HA1C210121 5.40%, 9.80% I02DSX21B2 Zhongshan
Gesellschaft für HPLC on exchange 3416 Hospital ASRL#2
Biochemica und HumaNex A1c HPLC
Diagnostica Variant
mbH
Nihon Kohden @Celltac Chemi Immuno- Jan ‘22 21013 CEN010 0.0%, 4.4%, - ReCCS
Corporation HbA1c N on assay 6.7%, 9.5%, ASRL#1
MEK-1303 12.7%
@Celltac Chemi Immuno- Jan ‘22 21013 CEN010 0.0%, 4.4%, - ReCCS
HbA1c N on assay 6.7%, 9.5%, ASRL#1
CHM-4100 12.7%
@Celltac Chemi Immuno- Jan ‘22 21048 CEN010 0.0%, 4.5%, - ReCCS
HbA1c on assay 6.7%, 9.5%, ASRL#1
CHM-4100 12.8%
i-SENS Enzymatic on Enzymatic Jan ‘22 DHHWAC - - - ReCCS
A1Care (also ASRL#1
sold as Rapic L)
TaiDoc Immunoassay Immuno- Jan ‘22 21C112 130AAA 5.80%, 9.20%, - European
Technology on TD-4611 assay 12.50%, Reference Lab
Corp. 18.60% ESRL#13
t
Bio-Rad VARIANT II Ion- Jan ‘22 64431428, 64429485, 5.3%, 10.6% GB60425 Univ. of Missouri.
Laboratories Dual (A1c) exchange 64431429, 64429486 SRL #9
HPLC 64404588
23
Value Laboratory
t
Bio-Rad VARIANT II Ion- Jan ‘22 64431428, 64427344, 5.0%, 10.5% GB60425 Univ. of Missouri.
Laboratories Dual exchange 64431429, 64429484 SRL #9
(A2/F/A1c) HPLC 64404588
D-10 HbA1c Ion- Jan ‘22 AA10352, AA10364, 5.4%, 10.5% R90055D Univ. of Missouri.
(12000949) exchange AA10353, AA10365 SRL #9
HPLC AA10298
D-10 HbA1c Ion- Jan ‘22 AA00217, AA10364, 5.4%, 10.5% D90234L Univ. of Missouri.
exchange AA00218, AA10365 SRL #9
HPLC AA10298
D-100 HbA1c Ion- Jan ‘22 64435373, 64433569, 5.92%, 9.61% 00054AC Univ. of Missouri.
exchange 64326283, 64433569 SRL #9
HPLC 64421818
D-10 Dual Ion- Jan ‘22 AA10296, AA10254, 5.5%, 10.4% D90234L Univ. of Missouri.
A2/F/A1c exchange AA10297, AA10255 SRL #9
HPLC AA10132
Variant II Ion- Jan ‘22 64357163, 64434242, 5.5%, 10.0% NU70415AA Univ. of Missouri.
HbA1c NU exchange 64357164, 64434243 SRL #9
HPLC 64345159
VARIANT II Ion- Jan ‘22 64434717, 64430709, 5.4%, 10.1% 90072AA Univ. of Missouri.
TURBO HbA1c exchange 64435395, 64430710 SRL #9
Kit – 2.0 HPLC 64419776
(12000447)
VARIANT II Ion- Jan ‘22 64434717, 64430709, 5.4%, 10.1% 90072AA Univ. of Missouri.
TURBO HbA1c exchange 64435395, 64430710 SRL #9
Kit – 2.0 HPLC 64419776
*
Method certification has been delayed due to coronavirus and/or other shipping issues.
@
Method is not currently available
24

List of NGSP Certified Methods - 2022

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List of NGSP Certified Methods - 2022

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(updated 12/22, listed by date certified)

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