List of NGSP Certified Methods

(updated 4/16, listed by date certified)

The NGSP has certified the following methods and reagents as having documented traceability to the
Diabetes Control and Complications Trial Reference Method. Manufacturers are awarded Certificates
of Traceability for successfully completing bias testing for specific methods, reagent lots, calibrator lots
and instrumentation used. Traceability to the DCCT applies only to results from fresh blood samples.
Analysis of processed (e.g. lyophilized) material may be subject to matrix effects and any comparisons to
the DCCT using results from processed specimens should be made with caution.
The NGSP recommends that manufacturers certify their methods each year; the certificate of
traceability expires after 1 year. During the year it is the responsibility of the manufacturer to insure
that the results of their method remain consistent over time throughout the year and between lots. It is
not the intent of the NGSP to certify each lot of reagents.
Manufacturer

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Nova
Biomedical

Allegro,
Immunoassay

Immunoassay

Apr 16

16022010

Boditech Med
Inc.

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

Immunoassay

Apr 16

AAMAA05F

502101

Immunoassay

Apr 16

6BC16006

16006

Immunoassay

Apr 16

PBC16005

Immunoassay

Apr 16

Boronate
affinity

Capillarys
HbA1c on
Capillarys 2
Flex Piercing

Getein
Biotech, Inc.

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

Calibrator
Assigned
Value
-

Column
Lot

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

ReCCS
ASRL#1

16006

5.25%,
10.55%

ReCCS
ASRL#1

YBC16006

16006

5.25%,
10.55%

ReCCS
ASRL#1

Apr 16

AP151208
05

ReCCS
ASRL#1

Capillary
Electrophoresis

Apr 16

14095/01,
20075/01,
12035/01

08045/01,
09045/01

35.5, 86.4
mmol/mol

European
Reference Lab
ESRL#10

Capillary
Electrophoresis

Apr 16

08065/01,
02094/80,
11055/01

07015/01,
08015/01

37.4, 85.8
mmol/mol

European
Reference Lab
ESRL#10

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

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

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

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Column
Lot

06115/01,
09115/01

Calibrator
Assigned
Value
36.8, 83.8
mmol/mol

Sebia

CAPI 3
HbA1c on
Capillarys 3

Capillary
Electrophoresis

Apr 16

14095/01,
20075/01,
12035/01

Immunoassay

Apr 16

174040,
174040.
174040,
169310

173490,
173500,
173510,
173520

0.49, 0.89,
1.65, 2.45
g/dL HbA1c;
13.7 g/dL Hb

Univ. of
Missouri.
SRL #9

Immunoassay

Apr 16

174040,
174040.
174040,
169310

173490,
173500,
173510,
173520

0.49, 0.89,
1.65, 2.45
g/dL HbA1c;
13.7 g/dL Hb

Univ. of
Missouri.
SRL #9

Immunoassay

Apr 16

174040,
174040.
174040,
169310

173490,
173500,
173510,
173520

0.49, 0.89,
1.65, 2.45
g/dL HbA1c;
13.7 g/dL Hb

Univ. of
Missouri.
SRL #9

Immunoassay

Apr 16

174040,
174040.
174040,
169310

173490,
173500,
173510,
173520

0.49, 0.89,
1.65, 2.45
g/dL HbA1c;
13.7 g/dL Hb

Univ. of
Missouri.
SRL #9

Immunoassay

Apr 16

174050,
174050.
174050,
169310

151007

2.883 g/dL
HbA1c;
12.31 g/dL
Hb

Univ. of
Missouri.
SRL #9

Immunoassay

Apr 16

174050,
174050.
174050,
169310

151007

2.883 g/dL
HbA1c;
12.31 g/dL
Hb

Univ. of
Missouri.
SRL #9

Immunoassay

Apr 16

174050,
174050.
174050,
169310

151007

2.883 g/dL
HbA1c;
12.31 g/dL
Hb

Univ. of
Missouri.
SRL #9

Immunoassay

Apr 16

174050,
174050.
174050,
169310

151007

2.883 g/dL
HbA1c;
12.31 g/dL
Hb

Univ. of
Missouri.
SRL #9

Immunoassay

Apr 16

QF51103,
RF51103,
SF50603

VF51103

0.0%, 4.3%,
6.8%, 9.6%,
13.3%

ReCCS
ASRL#1

Immunoassay

Apr 16

VF51103

ReCCS
ASRL#1

Apr 16

0.0%, 4.3%,
6.8%, 9.6%,
13.3%
0.0%, 4.3%,
6.8%, 9.6%,
13.3%

Immunoassay

QF51103,
RF51103,
SF50603
F9A005,
F9A005,
H2A003

ReCCS
ASRL#1

Secondary
Reference
Laboratory
European
Reference Lab
ESRL#10

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

Wiener
Laboratorios

tHbA1c
Turbitest AA on
CMD 800i X1
91.5*HbA1c/Hb
+ 2.15

HbA1c
Turbitest AA
on CT 600i
91.5*HbA1c/Hb
+ 2.15
t

HbA1c
Turbitest AA
on CM 250
91.5*HbA1c/Hb
+ 2.15
t

HbA1c
Turbitest AA
on CB 350i
91.5*HbA1c/Hb
+ 2.15
t

HbA1c v2
Turbitest AA
on CT600i
91.5*HbA1c/Hb
+ 2.15
t

HbA1c v2
Turbitest AA
on CM 250
91.5*HbA1c/Hb
+ 2.15
tHbA1c v2
Turbitest AA on
CMD 800i X1
91.5*HbA1c/Hb
+ 2.15
t

HbA1c v2
Turbitest AA
on CB 350i
91.5*HbA1c/Hb
+ 2.15

Fujirebio Inc.

Rapidia Auto
HbA1c-L on
BiOLis24i
Premium
t Rapidia Auto
HbA1c-L on
JCA-BM9130
t AU-Synchron
Reagent
HbA1c on
AU680

H1A005

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Fujirebio Inc.

Alere
Technologies
AS

Arkray, Inc.

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Rapidia Auto
HbA1c-L on
AU680
t Rapidia Auto
HbA1c-L on
Hitachi 7170s
t Rapidia Auto
HbA1c-L on
TBA-120FR
Afinion
HbA1c /
Afinion
AS100
Analyzer
Afinion
HbA1c Dx /
Afinion
AS100
Analyzer
t ADAMS A1c
HA-8160 VP
mode

Immunoassay

Apr 16

VF51103

Immunoassay

Apr 16

Immunoassay

Apr 16

Boronate
affinity

Apr 16

QF51103,
RF51103,
SF50603
QF51103,
RF51103,
NF50702
QF51103,
RF51103,
SF50603
10176087

Boronate
affinity

Apr 16

Ionexchange
HPLC

Apr 16

ADAMS A1c
HA-8160 TP
mode

Ionexchange
HPLC

Apr 16

ADAMS A1c
HA-8160
(Ver.1)

Ionexchange
HPLC

Apr 16

ADAMS A1c
HA-8160
(Ver.4)

Ionexchange
HPLC

Apr 16

ADAMS A1c
HA-8170

Ionexchange
HPLC

Apr 16

ADAMS A1c
HA-8180

Apr 16

ADAMS A1c
HA-8180V
Variant mode

Ionexchange
HPLC
Ionexchange
HPLC

ADAMS A1c
HA-8180V
Fast mode

Ionexchange
HPLC

Apr 16

ADAMS A1c
HA-8180T

Ionexchange
HPLC

Apr 16

Apr 16

Column
Lot

Calibrator
Assigned
Value
0.0%, 4.3%,
6.8%, 9.6%,
13.3%
0.0%, 4.3%,
6.8%, 9.6%,
13.3%
0.0%, 4.3%,
6.8%, 9.6%,
13.3%
-

10176087

15071731,
15061612,
15041033,
15120714
15071731,
15061612,
15121134,
15051535,
15120714
15091611,
15061612,
15062613,
15120714
15121757,
15082858,
15072759,
15111955
15121757,
15082858,
15072759,
15111955
6C1011,
6A1022,
5I1051
6C1011,
6A1022,
5D1401,
5I1051
6C1011,
6A1022,
5D1401,
5I1051
6C1011,
6A1022,
5E1601,
5I1051
3

VF51103

Secondary
Reference
Laboratory
ReCCS
ASRL#1

ReCCS
ASRL#1

ReCCS
ASRL#1

European
Reference Lab
ESRL #11

European
Reference Lab
ESRL #11

5D76;
S5001

5.2%, 10.7%;
5.2%, 10.7%

5H076Y

ReCCS
ASRL#1

5D76;
S5001

5.2%, 10.7%;
5.2%, 10.7%

5G041W

ReCCS
ASRL#1

5D76;
S5001

5.2%, 10.7%;
5.2%, 10.7%

5K001X

ReCCS
ASRL#1

5D82;
S5001

5.2%, 10.5%;
5.2%, 10.5%

5H051F

ReCCS
ASRL#1

5D82;
S5001

5.2%, 10.5%;
5.2%, 10.5%

5H291G

ReCCS
ASRL#1

CA85D53;
S5001

5.2%, 10.6%;
5.2%, 10.6%

5J001N

ReCCS
ASRL#1

CA85D51;
S5001

5.2%, 10.6%;
5.2%, 10.6%

5H101U

ReCCS
ASRL#1

CA85D51;
S5001

5.2%, 10.6%;
5.2%, 10.6%

5H101U

ReCCS
ASRL#1

CA85D51;
S5001

5.2%, 10.6%;
5.2%, 10.6%

5H007L

ReCCS
ASRL#1

VF51103

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Calibrator
Assigned
Value

Column
Lot

Arkray, Inc.

t ADAMS
HYBRID AH8290
t ADAMS A1c
HA-8181

Ionexchange
HPLC
Ionexchange
HPLC
Ionexchange
HPLC

Apr 16

CA85D53;
S5001

5.2%, 10.6%;
5.2%, 10.6%

5K401N

CA85D53;
S5001

5.2%, 10.6%;
5.2%, 10.6%

5J001N

ReCCS
ASRL#1

CA85D53;
S5001

5.2%, 10.6%;
5.2%, 10.6%

5G484N

ReCCS
ASRL#1

Enzymatic

Apr 16

6C1011,
6A1022,
5I1051
6C1011,
6A1022,
5I1051
6C1011,
6A1022,
5I1051
MFC03,
MFE03

CAC5C16

2.95, 7.31
mol/L HbA1c;
90.1, 96.9
mol/L Hb

ReCCS
ASRL#1

Enzymatic

Apr 16

MFC03,
MFE03

CAC5C16

2.95, 7.31
mol/L HbA1c;
90.1, 96.9
mol/L Hb

ReCCS
ASRL#1

Enzymatic

Apr 16

MFC03,
MFE03

CAC5C16

2.95, 7.31
mol/L HbA1c;
90.1, 96.9
mol/L Hb

ReCCS
ASRL#1

Enzymatic

Apr 16

MFC03,
MFE03

CAC5C16

2.95, 7.31
mol/L HbA1c;
90.1, 96.9
mol/L Hb

ReCCS
ASRL#1

Ionexchange
HPLC
Ionexchange
HPLC

Apr 16

6C1011,
6A1022,
151422255

C1L5D05;
S5001

5.2%, 10.6%;
5.2%, 10.6%

5K401N

ReCCS
ASRL#1

Apr 16

6C1011,
6A1022,
5D1401,
151422255

C1L5D06;
S5001

5.2%, 10.6%;
5.2%, 10.6%

5K194U

ReCCS
ASRL#1

Ionexchange
HPLC

Apr 16

6C1011,
6A1022,
5D1401,
151422255

C1L5D06;
S5001

5.2%, 10.6%;
5.2%, 10.6%

5K194U

ReCCS
ASRL#1

Ionexchange
HPLC
Immunoassay
Immunoassay

Apr 16

6C1011,
6A1022,
5I1051

CA85D53;
S5001

5.2%, 10.6%;
5.2%, 10.6%

5J001N

ReCCS
ASRL#1

Mar 16

MS1016001

Mar 16

270

5HD051 (15)

Mar 16

6040, 6047,
6107, 6133

6081, 6082

2.46, 3.54,
4.95, 6.76,
10.74
mol/L A1c;
11.74 g/dL
Hb
5.2%, 11.3%

ReCCS
ASRL#1
Univ. of
Missouri.
SRL #9

ADAMS
HYBRID AH8280
t CinQ HbA1c
on BioMajesty
JCA-BM6010

Apr 16

Apr 16

HbA1c%(NGSP)=0.
0915*HbA1c/Hb*10
00(IFCC)+2.15
t CinQ HbA1c
on TBA-120FR

HbA1c%(NGSP)=0.
0915*HbA1c/Hb*10
00(IFCC)+2.15
t

CinQ HbA1c
on JCABM9130

HbA1c%(NGSP)=0.
0915*HbA1c/Hb*10
00(IFCC)+2.15
t

CinQ HbA1c
on Hitachi
LABOSPECT
006

Secondary
Reference
Laboratory
ReCCS
ASRL#1

HbA1c%(NGSP)=0.
0915*HbA1c/Hb*10
00(IFCC)+2.15
t

ADAMS A1c
Lite HA-8380

ADAMS A1c
Lite HA8380V Fast
mode
t ADAMS A1c
Lite HA8380V Variant
mode
t ADAMS A1c
HA-8182
SD Biosensor,
Inc.
Siemens
Healthcare
Diagnostics

SD MultiCare
System
Hemoglobin
A1c 3 (A1c 3)Automated
Pretreatment
on Advia 1800

Trinity
Biotech

GHb/HbA1c
HPLC
Boronate
Affinity on
PDQ

Boronate
affinity
HPLC

6018

Univ. of
Missouri.
SRL #3

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Trinity
Biotech

GHb/HbA1c
HPLC
Boronate
Affinity on
ultra2
GHb/HbA1c
HPLC
Boronate
Affinity on
Premier
Hb9210
t Autokit
HbA1c on
Hitachi 7170S

Boronate
affinity
HPLC

Mar 16

6040, 6047,
6115

Boronate
affinity
HPLC

Mar 16

Immunoassay

RC20

HbA1c
AUTO TBA
on TBA120FR

Wako Pure
Chemical
Industries, Ltd.

Column
Lot

6081, 6082

Calibrator
Assigned
Value
5.4%, 11.6%

6089, 6047,
6115, 6005

6081, 6082

5.3%, 11.6%

5919

Univ. of
Missouri.
SRL #3

Mar 16

YA003,
KE436

YA003

ReCCS
ASRL#1

Ionexchange
HPLC

Mar 16

1503240008

1509140008

0.49, 0.88,
1.65, 2.43
g/dL HbA1c;
14.0 g/dL Hb
5.56%,
11.30%

1509030122

ReCCS
ASRL#1

Enzymatic

Mar 16

855RHM,
856RHM,
807RHM

905RIM

ReCCS
ASRL#1

Enzymatic

Mar 16

807RIM,
807RIM,
806RLM

806RLM

ReCCS
ASRL#1

Enzymatic

Mar 16

807RIM,
807RIM,
806RLM

806RLM

ReCCS
ASRL#1

Enzymatic

Mar 16

855RHM,
856RHM,
847RJM

013RIM

ReCCS
ASRL#1

Norudia N
HbA1c on
EV800

Enzymatic

Mar 16

855RHM,
856RHM,
847RJM

013RIM

ReCCS
ASRL#1

Norudia N
HbA1c on
TBA-120FR

Enzymatic

Mar 16

855RHM,
856RHM,
847RJM

013RIM

ReCCS
ASRL#1

Enzymatic

Mar 16

855RHM,
856RHM,
847RJM

013RIM

ReCCS
ASRL#1

Ionexchange
HPLC

Mar 16

1106000315

1209000315

1006003415

ReCCS
ASRL#1

Sekisui
Medical Co.,
Ltd.

L type
Norudia N
HbA1c on
Hitachi
LST006
t L type
Norudia N
HbA1c on
Hitachi
LST008
t Norudia N
HbA1c on
Hitachi 7170S

Norudia N
HbA1c on
JCA-BM9130

RC20 on
Adams A1c
mini

3.83, 16.19
mol/L
HbA1c;
103.1, 154.7
mol/L Hb
3.62, 13.77
mol/L
HbA1c; 97.7,
137.0
mol/L Hb
3.62, 13.77
mol/L
HbA1c; 97.7,
137.0
mol/L Hb
3.83, 16.19
mol/L
HbA1c;
103.1, 154.7
mol/L Hb
3.83, 16.19
mol/L
HbA1c;
103.1, 154.7
mol/L Hb
3.83, 16.19
mol/L
HbA1c;
103.1, 154.7
mol/L Hb
3.83, 16.19
mol/L
HbA1c;
103.1, 154.7
mol/L Hb
5.56%,
11.30%

6018

Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #3

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Method/
Instrument

Kyowa Medex
Co., Ltd.

Nanjing
LAOLA
Electronic Co.,
Ltd.
Diazyme
Laboratories

Shanghai
Huizhong
Medical
Science and
Technology
Co. Ltd.

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Immunoassay

Mar 16

369AEK,
369AEL

507AEG

Immunoassay

Mar 16

391AEK,
391AEK

509AFA

Immunoassay

Mar 16

138AEI,
138AEI

310AEI

Immunoassay

Mar 16

138AEI,
138AEI

310AEI

Immunoassay

Mar 16

138AEI,
138AEI

310AEI

Immunoassay

Mar 16

138AEI,
138AEI

310AEI

Ionexchange
HPLC

Feb 16

15070110,
15070211,
15070312,
15070312

15070115,
15070125

Direct HbA1c
Assay on
Roche
Modular P800
(On-Board
Lysis)
MQ-6000
Glycated
Hemoglobin
Analyzer

Enzymatic

Jan 16

HAL01150,
HA101150,
HA201150

Human
Gesellschaft fur
Biochemica und
Diagnostica
mbH

HAS101150,
HAS201150

Ionexchange
HPLC

Jan 16

20150616B

MQ-2000PT
Glycated
Hemoglobin
Analyzer

Ionexchange
HPLC

Jan 16

Immuno-assay
on ichroma
Reader

Immunoassay

Immunoassay
on TD-4611

Determiner
HbA1c on
DM-JACK
t Determiner
HbA1c on
JCA-BM9130
t Determiner L
HbA1c on
DM-JACK
t Determiner L
HbA1c on
JCA-BM9130
t Determiner L
HbA1c on
Hitachi 7180
t Determiner L
HbA1c on
TBA-120FR
Ion-exchange
LPLC on JL760

Column
Lot
-

Secondary
Reference
Laboratory
ReCCS
ASRL#1

ReCCS
ASRL#1

ReCCS
ASRL#1

ReCCS
ASRL#1

ReCCS
ASRL#1

ReCCS
ASRL#1

20150610

Univ. of
Missouri.
SRL #9

6.2%, 12.3%

Univ. of
Minnesota
SRL#10

20151029

5.70%,
10.67%

6K15071301

Univ. of
Missouri.
SRL #9

PTHbA1c1
50 302H

20151029

5.42%,
10.62%

PTHbA1c15
0302H

Univ. of
Missouri.
SRL #9

Jan 16

AALYA55

502101

5.1%, 8.1%,
11.2%, 15.2%

ReCCS
ASRL#1

Immunoassay

Jan 16

15L103

415501-212

5.2%, 8.3%,
11.6%, 15.5%

Architect
HbA1c on
Architect i

Immunoassay

Jan 16

10445UP00

802905582

4.0%, 5.5%,
7.5%, 9.0%,
12.0%,14.5%

HumaMeter A1c

Boronate
Fluorescence
quenching

Jan 16

025196
2016-06

025196
2016-06

Barcode

European
Reference Lab
ESRL#9
European
Reference Lab
ESRL#12
European
Reference Lab
ESRL#10

HumaStar
300SR

Immunoassay

Jan 16

517601
2016-12

15002/201706

0/5, 7/8, 9/11,

9/15, 2%

Boditech Med
Inc.
TaiDoc
Technology
Corp.
Axis-Shield

Calibrator
Assigned
Value
0.0%, 5.0%,
9.1%, 13.2%,
15.7%
0.0%, 5.0%,
9.0%, 13.2%,
15.8%
0.0%, 4.6%,
6.8%, 9.8%,
13.5%
0.0%, 4.3%,
6.8%, 9.7%,
13.5%
0.0%, 4.3%,
6.8%, 9.7%,
13.5%
0.0%, 4.3%,
6.8%, 9.7%,
13.5%
5.7%, 11.1%

European
Reference Lab
ESRL#10

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Calibrator
Assigned
Value

Column
Lot

Secondary
Reference
Laboratory
European
Reference Lab
ESRL#9

Thermo Fisher
Scientific Oy

t HbA1c for
Konelab, ref
981947,
Manual
hemolyzation,

Immunoassay

Jan 16

L986, L734

L246

1.533 mmol/L
HbA1c; 8.936
mmol/L Hb

Immunoassay

Jan 16

L986, L734

L246

1.533 mmol/L
HbA1c; 8.936
mmol/L Hb

European
Reference Lab
ESRL#9

Ionexchange
HPLC
Ionexchange
HPLC

Jan 16

64023628,
64023629,
64019494

64015994,
64015995

5.1%, 10.1%

FB20900

Univ. of Minn
SRL #10

Jan 16

64023628,
64023629,
64019494

64015998,
64015996

5.3%, 10.1%

FB20900

Univ. of Minn
SRL #10

Ionexchange
HPLC
Ionexchange
HPLC
Ionexchange
HPLC
Ionexchange
HPLC
Ionexchange
HPLC
Ionexchange
HPLC
Ionexchange
HPLC

Jan 16

AA50357,
AA50358,
AA50372

AA50315,
AA50316

10.2%, 5.3%

D40035H

Univ. of Minn
SRL #10

Jan 16

AA50354,
AA50355,
AA50208

AA50370,
AA50371

5.5%, 10.2%

A40035Q

Univ. of Minn
SRL #10

Jan 16

64025852,
64012157

64010672

5.84%, 9.12%

31037AG

Univ. of Minn
SRL #10

Jan 16

AA40128,
AA40129,
64028214

64026941,
64026942

5.4%, 10.5%

NU31453E

Univ. of Minn
SRL #10

Jan 16

64012978,
64012977,
64006957

64011685,
64011701

5.2%, 10.2%

S31342C

Univ. of Minn
SRL #10

Jan 16

64012980,
64011236,
64012201

64011680,
64011683

5.2%, 10.2%

LLV31342F

Univ. of Minn
SRL #10

Jan 16

64019508,
64014744,
64016867

64012445,
64012446

5.2%, 10.3%

31500U

Univ. of Minn
SRL #10

Ionexchange
HPLC

Jan 16

64019508,
64018314,
64016867

64012445,
64012446

5.2%, 10.3%

31500U

Univ. of Minn
SRL #10

Immunoassay

Dec 15

1845, 1845

18451,
18452,
18453,
18454,
18455

0.00, 0.48,
0.89, 1.62,
2.51 g/dL
HbA1c;
-1.38, 14.06
g/dL Hb

Univ. of
Missouri.
SRL #9

91.5*HbA1c/Hb
+2.15
t

HbA1c for
Indiko, ref
981947, on
Indiko Plus,
Manual
hemolyzation,
91.5*HbA1c/Hb
+2.15

Bio-Rad
Laboratories

VARIANT II
Dual (A1c)

VARIANT II
Dual
(A2/F/A1c)
D-10 Dual
A2/F/A1c
D-10 HbA1c

D-100 HbA1c

Variant II
HbA1c NU

Ortho Clinical
Diagnostics

VARIANT II
TURBO
HbA1c
VARIANT II
TURBO Link
HbA1c
VARIANT II
TURBO
HbA1c Kit
2.0
VARIANT II
TURBO
HbA1c Kit
2.0 (screen and
diagnosis)
Vitros d%A1c

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Shenzhen
Lifotronic
Technology
Co., Ltd

Ion-exchange
HPLC on GH900

Ionexchange
HPLC

Dec 15

821514

Ion-exchange
HPLC on H-9

Ionexchange
HPLC
Immunoassay

Dec 15

DiaSys
Diagnostic
Systems
GmbH

2015090801

Calibrator
Assigned
Value
5.6%, 12.5%

2015092204

841502

2015101201

5.2%, 11.2%

2015100901

ReCCS
ASRL#1

Dec 15

21506,
21507

E28/14

European
Reference Lab
ESRL#10

Immunoassay

Dec 15

21506,
21507

E28/14

European
Reference Lab
ESRL#10

Immunoassay

Dec 15

82, 20760

European
Reference Lab
ESRL#10

Immunoassay

Dec 15

2136921371,
20760

European
Reference Lab
ESRL#10

Ionexchange
HPLC
Boronate
Affinity

Dec 15

HBR-003,
HBR-003

21670,
21671,
21672,
21673
21479,
21480,
21481,
21482
B041538CM

0.380, 1.05
g/dL HbA1c;
5.6, 15.2
g/dL Hb
0.365, 0.940
g/dL HbA1c;
5.9, 14.8
g/dL Hb
4.99%,
6.72%,
10.4%,
13.2%
4.77%,
8.39%,
12.5%,
17.2%
5.54%,
11.59%

HBR-002

Dec 15

5850 (0y)

Immunoassay

Dec 15

1513111

Immunoassay

Dec 15

15125,
15059

15239

Dimension
Flex on RxL

Immunoassay

Dec 15

GC6167

GC6167

Dimension
Flex on ExL

Immunoassay

Dec 15

GC6167

GC6167

Cobas b 101
HbA1c

Immunoassay

Dec 15

528131-01

4.77%,
8.39%,
12.5%,
17.2%
0.16, 0.55,
1.05, 1.89,
2.53 g/dL
HbA1c;
11.88, 11.65
g/dL Hb
0.16, 0.55,
1.05, 1.89,
2.53 g/dL
HbA1c;
11.88, 11.65
g/dL Hb
-

Univ. of
Missouri.
SRL #9
Univ. of
Missouri.
SRL #9
Univ. of
Missouri.
SRL #9
Univ. of
Missouri.
SRL #9

Erba Lachema
s.r.o.

HbA1c net FS,

Reference No.
1 3348 00,
respons910
HbA1c net FS,
Reference No.
1 3348 00,
Biomajesty
oneHbA1c FS,
Reference No.
1 3329 00,
InnovaStar
oneHbA1c FS,
Reference No.
1 3329 00,
Hitachi 917
ERBA HbVario

Trinity
Biotech

Tri-stat HbA1c
Assay

PTS
Diagnostics

A1CNow+;
A1CNow
SELFCHECK
HbA1c Latex
Immunoassay
on EasyRA

Medica
Corporation

Siemens
Healthcare
Diagnostics,
Inc.

Roche
Diagnostics
International
Ltd

Column
Lot

Secondary
Reference
Laboratory
ReCCS
ASRL#1

Univ. of
Missouri.
SRL #9

Univ. of
Missouri.
SRL #9

Univ. of
Missouri.
SRL #9

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Calibrator
Assigned
Value

Column
Lot

Roche
Diagnostics

TQ HbA1c
Gen. 2 Cobas
Integra 400
(hemolysate)

Immunoassay

Dec 15

604503,
617546,
610045

185997

2.868, 1.703,
1.415, 0.544,
0.078, 0 g/dL
HbA1c;
12.069, 2.414
g/dL Hb

Immunoassay

Dec 15

610611,
617543

183640

Univ. of
Missouri.
SRL #9

Immunoassay

Dec 15

604503,
617546

185997

Univ. of
Missouri.
SRL #9

Immunoassay

Dec 15

617092,
614514,
610045

185997

Univ. of
Missouri.
SRL #9

Immunoassay

Dec 15

617092,
614514

185997

Univ. of
Missouri.
SRL #9

Immunoassay

Dec 15

618064,
610071

185997

Univ. of
Missouri.
SRL #9

Immunoassay

Dec 15

618064,
610071,
610045

185997

0.02607,
0.01575,
0.01321,
0.00549,
0.00137, 0
g/dL HbA1c;
0.12052,
0.02386 g/dL
Hb
0.02796,
0.0166,
0.0138,
0.0053,
0.00076, 0
g/dL HbA1c;
0.12069,
0.02414 g/dL
Hb
0.145, 0.334,
0.639, 0.882,
1.196, 1.697
mmol/L
HbA1c; 1.35,
7.279 mmol/L
Hb
0.131, 0.326,
0.641, 0.891,
1.215, 1.733,
mmol/L
HbA1c; 1.35,
7.279 mmol/L
Hb
0.152, 0.357,
0.682, 0.936,
1.286, 1.82
mmol/L
HbA1c; 1.40,
7.54 mmol/L
Hb
0.154, 0.357,
0.679, 0.931,
1.278, 1.806
mmol/L
HbA1c; 1.40,
7.54 mmol/L
Hb

Univ. of
Missouri.
SRL #9

Boronate
Affinity

Nov 15

F15F02F16
DL

Boronate
Affinity

Nov 15

C15F22G0
6DL

Univ. of
Missouri.
SRL #9
Univ. of
Missouri.
SRL #9

HbA1c/Hb*91.5
+2.15

TQ HbA1c
Gen. 2 Cobas
c111 (whole
blood)
HbA1c/Hb*91.5
+2.15

TQ HbA1c
Gen. 2 Cobas
Integra 400
(whole blood)
HbA1c/Hb*91.5
+2.15

TQ HbA1c
Gen. 3 cobas
c311
(hemolysate)
HbA1c/Hb*91.5
+2.15

TQ HbA1c
Gen. 3 cobas
c311 (whole
blood)
HbA1c/Hb*91.5
+2.15

TQ HbA1c
Gen. 3 cobas
c513 (whole
blood)
HbA1c/Hb*91.5
+2.15

TQ HbA1c
Gen. 3 cobas
c513
(hemolysate)
HbA1c/Hb*91.5
+2.15

Infopia Co,
Ltd

Frontier and
HemoCue
HbA1c 501
Clover A1c,
Clover A1c
Self, Checkart

Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

i-SENS, Inc.

A1Care
HbA1c assay
(Enzymatic
method)
Ion-Exchange
HPLC on LD500

Enzymatic

Nov 15

DBJGA

Ionexchange
HPLC

Nov 15

20150623,
20150623,
20150623

Spotchem
Banalyst
HbA1c on SI3620
Axis-Shield
HbA1c kit on
AU400

Immunoassay

Oct 15

Immunoassay

Shenzhen
Labnovation
Technologies,
Inc.
ROHM Co.,
Ltd.

Axis-Shield

Archem
Diagnostic
Industry Ltd.
Arkray, Inc.

Hitachi
Chemical Co.,
Ltd.
HORIBA
Medical

Calibrator
Assigned
Value
-

Column
Lot

150609K

5.70%,
11.25%

20150506

ReCCS
ASRL#1

1533FD07
7O

WC0014

ReCCS
ASRL#1

Oct 15

802905118

802902331802902335

European
Reference Lab
ESRL#12

Immunoassay

Oct 15

AR957

806

European
Reference Lab
ESRL#9

Ionexchange
HPLC

Oct 15

S4002

4J101U

Univ. of
Missouri.
SRL #9

Ionexchange
HPLC

Oct 15

S4002

5.4%, 10.5%

4J101U

Univ. of
Missouri.
SRL #9

Ionexchange
HPLC

Oct 15

S4002

5.4%, 10.5%

4J206N

Seratestum
A1C

Enzymatic

Oct 15

5E1012,
5E1021,
4L1401,
4J1053
5E1012,
5E1021,
4L1401,
4J1053
5E1012,
5E1021,
4J1053
Y5C617

0.0, 24.0,
51.0, 82.8,
119.0
mmol/mol
0.00%,
4.40%,
7.00%,
9.90%,
13.30%
5.85%,
9.05%,
11.9%,
16.02%
5.4%, 10.5%

Univ. of
Missouri.
SRL #9
ReCCS
ASRL#1

HbA1c WB
Whole Blood
Pentra C400

Immunoassay

Oct 15

1504101

1501801

European
Reference Lab
ESRL#10

Immunoassay

Oct 15

1504101

1501801

European
Reference Lab
ESRL#10

Immunoassay

Oct 15

1504101

1501801

0.00, 1.60,
2.90, 4.20,
7.00, 10.80
mol/l
HbA1c;
68.29 mol/l
Hb
0.00, 1.60,
2.90, 4.20,
7.00, 10.80
mol/l
HbA1c;
68.29 mol/l
Hb
0.00, 1.60,
2.90, 4.20,
7.00, 10.80
mol/l
HbA1c;
68.29 mol/l
Hb

European
Reference Lab
ESRL#10

HbA1c Direct
Method (2
Reagents)
Immuno-assay
ADAMS A1c
Lite HA8380V Variant
mode
ADAMS A1c
Lite HA8380V Fast
mode
ADAMS A1c
Lite HA-8380

Y=(0.42*X)+2.25

HbA1c WB
Hemolysate
Pentra C400

Y=(0.43*X)+2.06

HbA1c WB
Hemolysate
Pentra C200

Y=(0.35*X)+2.24

10

Secondary
Reference
Laboratory
ReCCS
ASRL#1

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Column
Lot

Calibrator
Assigned
Value
0.00, 1.60,
2.90, 4.20,
7.00, 10.80
mol/l
HbA1c;
68.29 mol/l
Hb
0.00, 1.60,
2.90, 4.20,
7.00, 10.80
mol/l
HbA1c;
68.29 mol/l
Hb
-

HORIBA
Medical

t HbA1c WB
Whole Blood
ABX Pentra
400

Immunoassay

Oct 15

1504101

1501801

Immunoassay

Oct 15

1504101

1501801

Boronate
affinity

Sept 15

H05G2901,
H05G2902,
HM236GH
UEW

Immunoassay

Sept 15

A1C02150021

Enzymatic

Sept 15

044615006

044615006

Y=(0.43*X)+2.14

HbA1c WB
Hemolysate
Pentra 400

Y=(0.43*X)+1.98

Green Cross
Medis Corp.

SD Biosensor,
Inc.
Mindray

Boronate
Affinity
(LabonaCheck
A1c HbA1c
Analyzer,
A1Card
HbA1c
Analyzer
t
SD A1cCare
System
t Enzymatic on
BS-200E

Enzymatic on
BS-380

Enzymatic

Sept 15

044615006

044615006

Enzymatic on
BS-400

Enzymatic

Sept 15

044615006

044615006

Enzymatic on
BS-480

Enzymatic

Sept 15

044615006

044615006

Enzymatic on
BS-800/800M

Enzymatic

Sept 15

044615006

044615006

Enzymatic

Sept 15

044615006

044615006

Enzymatic on
BS2000/2000M

11

Secondary
Reference
Laboratory
European
Reference Lab
ESRL#10

European
Reference Lab
ESRL#10

Univ. of
Missouri.
SRL #9

3.36, 15.51
mol/L
HbA1c;
91.54, 147.07
mol/L Hb
3.36, 15.51
mol/L
HbA1c;
91.54, 147.07
mol/L Hb
3.36, 15.51
mol/L
HbA1c;
91.54, 147.07
mol/L Hb
3.36, 15.51
mol/L
HbA1c;
91.54, 147.07
mol/L Hb
3.36, 15.51
mol/L
HbA1c;
91.54, 147.07
mol/L Hb
3.36, 15.51
mol/L
HbA1c;
91.54, 147.07
mol/L Hb

ReCCS
ASRL#1
ReCCS
ASRL#1

ReCCS
ASRL#1

ReCCS
ASRL#1

ReCCS
ASRL#1

ReCCS
ASRL#1

ReCCS
ASRL#1

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Quotient
Diagnostics
Limited

Quo-Test on
Quo-Test

Boronate
affinity

Sept 15

020248

Quo-Lab on
Quo-Lab

Boronate
affinity

Sept 15

HbA1c
B00389
Manual
Application
AU5800

Immunoassay

HbA1c
B00389
Manual
Application
AU2700

Beckman
Coulter Ireland
Inc.

Ortho Clinical
Diagnostics

Column
Lot

Calibrator
Assigned
Value
-

025173

Sept 15

0020,
M405250

0020

Immunoassay

Sept 15

0020,
M405250

0020

HbA1c
B00389
Manual
Application
AU640

Immunoassay

Sept 15

0020,
M405250

0020

HbA1c
B00389
Manual
Application
AU680

Immunoassay

Sept 15

0020,
M405250

0020

HbA1c
B00389
Manual
Application
AU480

Immunoassay

Sept 15

0020,
M405250

0020

HbA1c
B00389
Manual
Application
AU400

Immunoassay

Sept 15

0020,
M405250

0020

%A1c on
Vitros 5,1 FS

Immunoassay

Sept 15

4386

3155

t
%A1c on
Vitros 4600

Immunoassay

Sept 15

4386

3155

0.094, 0.278,
0.515, 0.892,
1.427
mmol/L
HbA1c; 8.69
mmol/L THb
0.094, 0.278,
0.515, 0.892,
1.427
mmol/L
HbA1c; 8.69
mmol/L THb
0.094, 0.278,
0.515, 0.892,
1.427
mmol/L
HbA1c; 8.69
mmol/L THb
0.094, 0.278,
0.515, 0.892,
1.427
mmol/L
HbA1c; 8.69
mmol/L THb
0.094, 0.278,
0.515, 0.892,
1.427
mmol/L
HbA1c; 8.69
mmol/L THb
0.094, 0.278,
0.515, 0.892,
1.427
mmol/L
HbA1c; 8.69
mmol/L THb
0.219, 0.922,
1.886, 4.435
g/dL HbA1c;
-0.158,
3.692, 8.200,
17.296 g/dL
Hb
0.214, 0.927,
1.889, 4.407
g/dL HbA1c;
-0.158,
3.692, 8.200,
17.296 g/dL
Hb

12

Secondary
Reference
Laboratory
European
Reference Lab
ESRL #11
European
Reference Lab
ESRL #11
European
Reference Lab
ESRL #9

European
Reference Lab
ESRL #9

European
Reference Lab
ESRL #9

European
Reference Lab
ESRL #9

European
Reference Lab
ESRL #9

European
Reference Lab
ESRL #9

Univ. of
Missouri.
SRL #9

Univ. of
Missouri.
SRL #9

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Ortho Clinical
Diagnostics

t
%A1c on
Vitros 5600

Immunoassay

Sept 15

4386

3155

Kyowa Medex
Co., Ltd.

t MetaboLead
HbA1c on JCABM9130

Enzymatic

Sept 15

131AEE,
131AEE

135AEE

t MetaboLead
HbA1c on DMJACK

Enzymatic

Sept 15

131AEE,
131AEE

135AEE

MetaboLead
HbA1c on
Hitachi-7180

Enzymatic

Sept 15

131AEE,
131AEE

135AEE

t MetaboLead
HbA1c on TBA120FR

Enzymatic

Sept 15

131AEE,
131AEE

135AEE

JEOL Ltd.

t BM Test
HbA1c on JCABM 6010/C

Enzymatic

Sept 15

816RHL,
816RHL,
816RLL

914RIL

Beckman
Coulter, Inc.

HBA1c on
UniCel DxC
800

Immunoassay

Sept 15

M505354,
M406277,
M506571,
M209413

M505354

Agappe
Diagnostics
Ltd.

tImmuno

Immunoassay

Sept 15

15060009,
15060010,
15020078

24120047,
24120048,
24120049,
24120050

tImmuno

Immunoassay

Sept 15

15060060,
15060010,
15020078

24120047,
24120048,
24120049,
24120050

tImmuno

assay
on Mispa i3

Immunoassay

Sept 15

15080027,
15060010,
15020078

24120047,
24120048,
24120049,
24120050

Cation-exchange
Chromatography
on HbA1c
Analyzer KH101
t Fluorescence
immunoassay on
Finecare FIA
Meter

Ionexchange
HPLC

Aug 15

20150102

Immunoassay

Aug 15

F207F602A

assay
on AGA1C

assay
on Mispa i2

Caretium
Medical
Instruments
Co., Limited
Guangzhou
Wondfo
Biotech Co.,
Ltd.

13

Calibrator
Assigned
Value
0.214, 0.927,
1.889, 4.407
g/dL HbA1c;
-0.158,
3.692, 8.200,
17.296 g/dL
Hb

Column
Lot

2.33, 9.38
mol/L
HbA1c; 82.8,
118.3 mol/L
Hb
2.33, 9.38
mol/L
HbA1c; 82.8,
118.3 mol/L
Hb
2.33, 9.38
mol/L
HbA1c; 82.8,
118.3 mol/L
Hb
2.33, 9.38
mol/L
HbA1c; 82.8,
118.3 mol/L
Hb
3.28, 15.53
mol/L
HbA1c, 92.9,
146.9 mol/L
Hb

ReCCS
ASRL#1

ReCCS
ASRL#1

ReCCS
ASRL#1

ReCCS
ASRL#1

ReCCS
ASRL#1

0.154, 0.451,
0.853, 1.582,
2.472 g/dL
HbA1c;
19.01 g/dL
Hb
4.70%,
7.60%,
12.00%,
15.70%
4.70%,
7.60%,
12.00%,
15.70%
4.70%,
7.60%,
12.00%,
15.70%

Univ. of
Missouri.
SRL #9

European
Reference Lab
ESRL#10

European
Reference Lab
ESRL#10

European
Reference Lab
ESRL#10

150573A,
150575A

5.2%, 11.10%

150210S

ReCCS
ASRL#1

ReCCS
ASRL#1

Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

A.Menarini
Diagnostics

t
Auto A1c
HA-8180V
ADAMS

Ionexchange
HPLC

July 15

201401

Auto A1c
HA-8160
ADAMS

Ionexchange
HPLC

July 15

5A1201,
4J1211,
4J1501,
5A1221
201468,
201404,
201412,
201435

t
HPLC Auto
A1c on Premier
Hb-9210

Boronate
affinity

July 15

Immunoassay

Samsung
Electronics
GuangDong
Unity
Biotechnology
Co., Ltd.
Zivak
Technologies

Jiangsu
Audicom
Medical
Technology
Co., Ltd.
Sakae
Corporation

Roche
Diagnostics

Calibrator
Assigned
Value
5.80%,
10.70%

Column
Lot

201401

5.80%,
10.70%

4J0354

European
Reference Lab
ESRL#10

4814, 5162,
5305, 4907

5211, 5212

5.70%,
11.40%

0870-5313

June 15

Q00CAG4N

JCCRM41
1-3

Boronate
affinity

June 15

HC14101N

HC14101N

Univ. of
Missouri.
SRL #9

HbA1c
HPLC kit on
HbA1c
Analyzer
t
Ion-exchange,
AC6601
HbA1c
Analyzer

Ionexchange
HPLC

June 15

R002201408
21,
R002201408
21,
R002201408
21
HB-1501,
HB-1501

5.0%, 5.6%,
7.3%, 9.4%,
12.0%
6.0%, 12.5%

European
Reference Lab
ESRL#10
ReCCS
ASRL#1

HB-1501

5.4%

HB-1501

European
Reference Lab
ESRL#10

Ionexchange
HPLC

June 15

150402-20,
150201-21,
150402-22,
150402-23,
150401-24

150101-26,
150101-27

5.7%, 12.0%

150401-48

Univ. of
Missouri.
SRL #9

t
Medidas
HbA1c on A1c
GEAR
t
Medidas
HbA1c on A1c
iGEAR
TQ HbA1c
Gen. 2
hemolysate on
Cobas Integra
800

Immunoassay

June 15

461503

STS011

ReCCS
ASRL#1

Immunoassay

June 15

461503

STS011

ReCCS
ASRL#1

Immunoassay

June 15

693374,
606814,
697646

180036

0.0%, 5.0%,
9.2%, 12.8%,
14.2%
0.0%, 5.0%,
9.2%, 12.8%,
14.2%
2.785, 1.667,
1.392, 0.557,
0.112, 0 g/dL
HbA1c;
12.931, 2.586
g/dL Hb

Univ. of
Missouri.
SRL #9

Immunoassay

June 15

693374,
697646

180036

0.02755,
0.01654,
0.01382,
0.00559,
0.00121, 0
g/dL HbA1c;
0.12931,
0.02586 g/dL
Hb

Univ. of
Missouri.
SRL #9

Immunoassay
on LabGEO
PT10

Boronic
Affinity
Chromatography
on HbA1c
analyzer

(HbA1c/Hb*91.5+
2.15)

TQ HbA1c
Gen. 2 whole
blood on
Cobas Integra
800
(HbA1c/Hb*91.5+
2.15)

14

3F014Q

Secondary
Reference
Laboratory
European
Reference Lab
ESRL#10

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Calibrator
Assigned
Value
0.152, 0.345,
0.654, 0.901,
1.220, 1.731
mmol/L
HbA1c;
1.437, 7.749
mmol/L Hb
0.142, 0.345,
0.674, 0.935,
1.273, 1.814
mmol/L
HbA1c;
1.437, 7.749
mmol/L Hb
5.76%,
10.76%

Column
Lot

Roche
Diagnostics

TQ HbA1c
Gen. 3
hemolysate on

Immunoassay

June 15

608283,
606814

180036

Immunoassay

June 15

608283,
604554

180036

Ionexchange
HPLC

June 15

K7-104W,
K7-203W,
7-303W,
HW-09Y

ZS4002

Ionexchange
HPLC

June 15

K7-104W,
K7-203W,
7-303W,
HW-09Y

JS4002

Ionexchange
HPLC

June 15

E8-106W,
E8-201W,
8-305W,
HW-09Y

Ionexchange
HPLC

June 15

Ionexchange
HPLC

June 15

G9 HbA1c,
HLC-723G9

Ionexchange
HPLC

June 15

G8 HbA1c
Variant
Analysis Mode
(1.6 min),
HLC-723G8
G7 HbA1c
Variant
Analysis Mode
(2.2 min),
HLC-723G7
t
GX
HLC-723GX

Ionexchange
HPLC

June 15

Ionexchange
HPLC

Ionexchange
HPLC

cobas c501/502
(HbA1c/Hb*91.5+
2.15)

TQ HbA1c
Gen. 3 whole
blood on cobas

Univ. of
Missouri.
SRL #9

Univ. of
Missouri.
SRL #9

5.86%,
10.97%

Univ. of
Missouri.
SRL #9

ZS4002

5.76%,
10.76%

Univ. of
Missouri.
SRL #9

E8-106W,
E8-201W,
8-305W,
HW-09Y

JS4002

5.86%,
10.97%

Univ. of
Missouri.
SRL #9

B9-101W,
B9-201Y,
9-301A,
HW-14W
B9-101W,
B9-201Y,
9-301A,
HW-14W
F8-101W,
F8-201W,
F8-301W,
HW-09Y

ZS4002

5.76%,
10.76%

Univ. of
Missouri.
SRL #9

JS4002

5.86%,
10.97%

Univ. of
Missouri.
SRL #9

ZS4002

5.76%,
10.76%

Univ. of
Missouri.
SRL #9

June 15

M7-101Y,
M7-201Y,
M7-301Y,
HW-09Y

ZS4002

5.76%,
10.76%

Univ. of
Missouri.
SRL #9

June 15

AX-101W,
AX-201Y,
AX-301Y,
HW-09W

ZS4002

5.76%,
10.76%

Univ. of
Missouri.
SRL #9

c501/502
(HbA1c/Hb*91.5+
2.15)

Tosoh
Corporation

G7 HbA1c
Standard
Analysis Mode
(1.2 min)
HLC-723G7
t
G7 HbA1c
Standard
Analysis Mode
(1.2 min)
HLC-723G7
t
G8 HbA1c
Standard
Analysis Mode
(1.0 min)
HLC-723G8
t
G8 HbA1c
Standard
Analysis Mode
(1.0 min),
HLC-723G8
t
G9 HbA1c,
HLC-723G9
t

Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9

15

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Tosoh
Corporation

t
GX
HLC-723GX

Ionexchange
HPLC

June 15

JS4002

G11, Standard
Analysis Mode
(0.5 min),
HLC-723G11
t
G11, Standard
Analysis Mode
(0.5 min),
HLC-723G11
DCA 2000+

Ionexchange
HPLC

June 15

Ionexchange
HPLC

June 15

Immunoassay

June 15

AX-101W,
AX-201Y,
AX-301Y,
HW-09W
A1-101Y,
A1-201Y,
1-301Y,
HW-09Y
A1-101Y,
A1-201Y,
1-301Y,
HW-09Y
0912035

DCA Vantage

Immunoassay

June 15

Ion-exchange
HPLC on
H50/H50P
Dimension
Vista Flex
HbA1c on
Vista 1500

Ionexchange
HPLC
Immunoassay

Beckman
Coulter, Inc.

Uni Cel DxC

Syr on UniCel
DxC 800

Shenzhen
Genius
Electronics
Co., Ltd.

Nephelometry
on Specific
Protein
Analyzer
PA54/PA50
HbA1c
(Hemolysate)
on Architect
c8000

Siemens
Healthcare
Diagnostics

Mindray

Siemens
Healthcare
Diagnostics
Inc.

Abbott
Diagnostics

Calibrator
Assigned
Value
5.86%,
10.97%

Column
Lot

ZS4002

5.76%,
10.76%

Univ. of
Missouri.
SRL #9

JS4002

5.86%,
10.97%

Univ. of
Missouri.
SRL #9

0912035

Univ. of
Missouri.
SRL #9
Univ. of
Missouri.
SRL #9

May 15

2014081101,
2014081201,
2014071501

20141201

5.5%, 11.8%

140908

ReCCS
ASRL#1

May 15

14300BA

4KD063

Univ. of
Missouri.
SRL #9

Immunoassay

May 15

M407102

M410001

Univ. of
Missouri.
SRL #9

Immunoassay

May 15

20150228

0.13, 0.52,
0.92, 1.59,
2.28 g/dL
HbA1c;
12.48, 12.25
g/dL Hb
0.144, 0.460,
0.869, 1.503,
2.372 g/dL
A1c3; 19.09
g/dL Hb3
-

ReCCS
ASRL#1

Enzymatic

May 15

46208UQ07,
46208UQ07,
46208UQ

46700UQ10

Univ. of
Missouri.
SRL #9

Enzymatic

May 15

46208UQ07,
46208UQ07,
46208UQ

46700UQ10

Univ. of
Missouri.
SRL #9

Enzymatic

May 15

46208UQ07,
46208UQ07,
46208UQ

46700UQ10

3.10, 16.15
mol/L
HbA1c; 98,
150.1
mol/L Hb
3.10, 16.15
mol/L
HbA1c; 98,
150.1
mol/L Hb
3.10, 16.15
mol/L
HbA1c; 98,
150.1
mol/L Hb

Univ. of
Missouri.
SRL #9

%NGSP=HbA1c/
Hb*91.48+2.152

HbA1c
(Whole Blood)
on Architect
c8000
%NGSP=HbA1c/
Hb*91.48+2.152

HbA1c
(Hemolysate)
on Architect
c4000
%NGSP=HbA1c/
Hb*91.48+2.152

16

Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9

List of NGSP Certified Methods (Updated 4/16, listed by date certified)

Manufacturer

Method/
Instrument

Method
Type

Date
Certified

Reagent
Lot

Calibrator
Lot

Calibrator
Assigned
Value

Column
Lot

Abbott
Diagnostics

HbA1c
(Whole Blood)
on Architect
c4000

Enzymatic

May 15

46208UQ07,
46208UQ07,
46208UQ

46700UQ10

3.10, 16.15
mol/L
HbA1c; 98,
150.1
mol/L Hb

Immunoassay

May 15

85002

CEN001

0.0%, 4.4%,
6.9%, 9.7%,
13.3%

%NGSP=HbA1c/
Hb*91.48+2.152

Nihon Kohden
Corporation

Celltac Chemi
HbA1c on
CHM-4100
(NGSP(%)=1.02*
JDS(%)+0.25)

t
@

Method is not available in the US

Method is not currently available

17

Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9

ReCCS
ASRL#1