List of NGSP Certified Methods

List of NGSP Certified Methods
(updated 9/16, 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
Green Cross
Medis Corp.
Boronate
Affinity
(LabonaCheck
A1c HbA1c
Analyzer
MH200,
A1Card
HbA1c
Analyzer
t
SD A1cCare
System
Quo-Test on
Quo-Test
Boronate
affinity
Sept ‘16
H06F1501,
H06F1502,
HM2SMO
EW
Immunoassay
Boronate
affinity
Sept ‘16
Quo-Lab on
Quo-Lab
SD Biosensor,
Inc.
EKF
Diagnostics
GmbH
Beckman
Coulter Ireland
Inc.
Column
Lot
-
Calibrator
Assigned
Value
-
A1C02160049
-
-
-
Sept ‘16
020332
-
-
-
Boronate
affinity
Sept ‘16
025235
-
-
-
HbA1c
B00389
Manual
Application
AU5800
Immunoassay
Sept ‘16
0025,
M504400
0025
-
HbA1c
B00389
Manual
Application
AU2700
Immunoassay
Sept ‘16
0025,
M504400
0025
HbA1c
B00389
Manual
Application
AU640
Immunoassay
Sept ‘16
0025,
M504400
0025
0.076, 0.288,
0.547, 1.037,
1.572
mmol/L
HbA1c; 8.10
mmol/L THb
0.076, 0.288,
0.547, 1.037,
1.572
mmol/L
HbA1c; 8.10
mmol/L THb
0.076, 0.288,
0.547, 1.037,
1.572
mmol/L
HbA1c; 8.10
mmol/L THb
1
-
Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9
ReCCS
ASRL#1
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
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Beckman
Coulter Ireland
Inc.
HbA1c
B00389
Manual
Application
AU680
Immunoassay
Sept ‘16
0025,
M504400
0025
HbA1c
B00389
Manual
Application
AU480
Immunoassay
Sept ‘16
0025,
M504400
0025
HbA1c
B00389
Manual
Application
AU400
Immunoassay
Sept ‘16
0025,
M504400
0025
%A1c on
Vitros 5,1 FS
Immunoassay
Sept ‘16
5423
3196, 3196
t
Immunoassay
Sept ‘16
5423
3196, 3196
t
%A1c on
Vitros 5600
Immunoassay
Sept ‘16
5423
3196, 3196
t
Enzymatic
Sept ‘16
137AFE,
137AFE
144AFF
t
Enzymatic
Sept ‘16
137AFE,
137AFE
144AFF
t
Enzymatic
Sept ‘16
137AFE,
137AFE
144AFF
Ortho Clinical
Diagnostics
%A1c on
Vitros 4600
Kyowa Medex
Co., Ltd.
MetaboLead
HbA1c on JCABM9130
MetaboLead
HbA1c on DMJACK
MetaboLead
HbA1c on
Hitachi-7180
2
Calibrator
Assigned
Value
0.076, 0.288,
0.547, 1.037,
1.572
mmol/L
HbA1c; 8.10
mmol/L THb
0.076, 0.288,
0.547, 1.037,
1.572
mmol/L
HbA1c; 8.10
mmol/L THb
0.076, 0.288,
0.547, 1.037,
1.572
mmol/L
HbA1c; 8.10
mmol/L THb
0.148, 0.879,
1.79, 4.047
g/dL HbA1c;
(-0.471),
3.335, 7.764,
16.697 g/dL
Hb
0.154, 0.865,
1.815, 3.938
g/dL HbA1c;
(-0.471),
3.335, 7.764,
16.697 g/dL
Hb
0.154, 0.865,
1.815, 3.938
g/dL HbA1c;
(-0.471),
3.335, 7.764,
16.697 g/dL
Hb
Column
Lot
2.51, 9.54
µmol/L
HbA1c; 83.2,
120.2 µmol/L
Hb
2.51, 9.54
µmol/L
HbA1c; 83.2,
120.2 µmol/L
Hb
2.51, 9.54
µmol/L
HbA1c; 83.2,
120.2 µmol/L
Hb
-
Secondary
Reference
Laboratory
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
-
Univ. of
Missouri.
SRL #9
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Kyowa Medex
Co., Ltd.
t MetaboLead
HbA1c on TBA120FR
Enzymatic
Sept ‘16
137AFE,
137AFE
144AFF
-
MetaboLead
HbA1c on
LABOSPECT
006
Enzymatic
Sept ‘16
137AFE,
137AFE
144AFF
JEOL Ltd.
t BM Test
HbA1c on JCABM 6010/C
Enzymatic
Sept ‘16
825RDN,
825RDN,
824RDN
909RLM
2.51, 9.54
µmol/L
HbA1c; 83.2,
120.2 µmol/L
Hb
2.51, 9.54
µmol/L
HbA1c; 83.2,
120.2 µmol/L
Hb
3.57, 14.1
µmol/L
HbA1c; 97.4,
147.9 µmol/L
Hb
Agappe
Diagnostics
Ltd.
tAgA1C
(Immunoturbidi
metric method)
on TBA 25 FR
Immunoassay
Sept ‘16
16060054,
15120076,
16060067
2606013626060139
tNephelometry
Immunoassay
Sept ‘16
16060054,
15120076,
16060067
2606013626060139
Immunoassay
Sept ‘16
16060054,
15120076,
16060067
Immunoassay
Sept ‘16
tAgA1C
(Immunoturbidi
metric method)
on Mispa
cLiNiA
tAgA1C
(Immunoturbidi
metric method)
on Mispa Nano
Immunoassay
tAgA1C
t
on Specific
Protein
Anallyzer Mispa
i2
tNephelometry
on cartridge
based Specific
Protein
Analyzer Mispa
i3
tAgA1C
(Immunoturbidi
metric method)
on Turbiquick
(Immunoturbidi
metric method)
on Biolis 24i
Samsung
Electronics
Tosoh
Corporation
Apex
Biotechnology
Corp.
Immunoassay
on LabGEO
t
G11, Variant
Analysis Mode
(1.0 min),
HLC-723G11
Immunoagglut
ination on
Eclipse A1c
Secondary
Reference
Laboratory
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
5.70%,
9.80%,
13.60%,
16.20%
5.70%,
9.80%,
13.60%,
16.20%
-
European
Reference Lab
ESRL#10
-
European
Reference Lab
ESRL#10
2606013626060139
5.70%,
9.80%,
13.60%,
16.20%
-
European
Reference Lab
ESRL#10
36060123
2606013626060139
-
European
Reference Lab
ESRL#10
Sept ‘16
16060054,
15120076,
16060067
2606013626060139
5.70%,
9.80%,
13.60%,
16.20%
5.70%,
9.80%,
13.60%,
16.20%
-
European
Reference Lab
ESRL#10
Immunoassay
Sept ‘16
16060054,
15120076,
16060067
2606013626060139
-
European
Reference Lab
ESRL#10
Immunoassay
Sept ‘16
16060054,
15120076,
16060067
2606013626060139
-
European
Reference Lab
ESRL#10
Immunoassay
Ionexchange
HPLC
Sept ‘16
Q00CAH6S
-
6.00%,
10.10%,
14.10%,
16.40%
5.70%,
9.80%,
13.60%,
16.20%
-
-
Sept ‘16
B1-151B,
B1-251B,
B1-351B,
HW-25A
ZS5002
5.66%,
10.50%
B
ReCCS
ASRL#1
Univ. of
Missouri.
SRL #9
Immunoassay
Sept ‘16
S60501,
S60502,
S60503
-
-
-
3
ReCCS
ASRL#1
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Jiangsu
Audicom
Medical
Technology
Co., Ltd.
Ion-exchange
chromatography
on AC6601
HbA1c
Analyzer
Ionexchange
HPLC
Sept ‘16
160601-26,
160601-27
Alfa
Wassermann
Diagnostic
Technologies,
LLC
ACE HbA1c
Reagent on
ACE Alera
Clinical
Chemistry
System
ACE HbA1c
Reagent on
ACE Axcel
Clinical
Chemistry
System
t
HPLC Auto
A1c HA-8160
ADAMS
Immunoassay
Aug ‘16
160703-20,
160701-21,
160702-22,
160702-23,
160601-24
1769HA,
1770HA,
1772HA,
1688HA
366906
0.00, 0.45,
0.60, 0.80,
1.17, 1.89
g/dL HbA1c;
18.6 g/dL Hb
-
Univ. of
Missouri.
SRL #9
Immunoassay
Aug ‘16
1769HA,
1770HA,
1772HA,
1688HA
366906
0.00, 0.45,
0.60, 0.80,
1.17, 1.89
g/dL HbA1c;
18.6 g/dL Hb
-
Univ. of
Missouri.
SRL #9
Ionexchange
HPLC
Aug ‘16
201605,
201505,
201511,
201603
W20710502
A
201503
5.70%,
11.10%
4J035Y
European
Reference Lab
ESRL#10
-
-
-
ReCCS
ASRL#1
320
(2018/02),
5723A
(2018/02),
5723A
(2018/02),
417M
(2018/03)
160074,
160074,
160074
CAL63C
(2017/12)
5.1%, 7.8%,
11.1%,
15.1%
-
European
Reference Lab
ESRL#10
5CD010
0, 2.71, 4.00,
4.66, 6.41,
10.23
µmol/L
HbA1c;
12.54 g/dL
Hb
0%, 5.3%,
9.0%, 13.2%,
15.9%
-
Univ. of
Missouri.
SRL #9
-
European
Reference Lab
ESRL#9
A.Menarini
Diagnostics
Calibrator
Assigned
Value
5.8%, 12.1%
Column
Lot
160601-48
Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9
Guangzhou
Wondfo
Biotech Co.,
Ltd.
Spinreact
SAU
t Fluorescence
immunoassay on
Finecare FIA
Meter
Immunoassay
Aug ‘16
HbA1c (Latex
turbidimetry –
Direct method
%) on
SPIN640
Immunoassay
July ‘16
Siemens
Healthcare
Diagnostics
Inc.
A1c_3 on
Atellica CH
Analyzer
Immunoassay
July ‘16
MedTest
Pointe
Scientific,
HbA1c on
Beckman AU
400
t
Auto A1c
HA-8180V
ADAMS
Immunoassay
July ‘16
604003
609102
Ionexchange
HPLC
July ‘16
5L1201,
5L1211,
5L1501,
5K1222
201503
5.70%,
11.10%
3F014Q
European
Reference Lab
ESRL#10
Auto A1c
HA-8180T
ADAMS
Ionexchange
HPLC
July ‘16
201503
5.70%,
11.10%
5F006P
European
Reference Lab
ESRL#10
t
HPLC Auto
A1c on Premier
Hb-9210
Boronate
affinity
July ‘16
5JI201,
5JI1211,
5JI1701,
5I1221
5632, 5709,
5642, 5880
6201, 6202
5.90%,
12.10%
1731-5920
European
Reference Lab
ESRL#10
A.Menarini
Diagnostics
t
4
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Mindray
Enzymatic on
BS-460
Enzymatic
June ‘16
044616002
044616002
Enzymatic on
BS-240
Enzymatic
June ‘16
044616002
044616002
Immunoassay
June ‘16
451601
STS012
Immunoassay
June ‘16
451601
STS012
Immunoassay
June ‘16
608985,
614544,
137147
185997
Immunoassay
June ‘16
608985,
137147
185997
Immunoassay
June ‘16
620741,
614544,
116686
185948
Immunoassay
June ‘16
620741,
116686
185948
Immunoassay
June ‘16
125253,
138037,
614544
185997
Sakae
Corporation
Roche
Diagnostics
t
Medidas
HbA1c on A1c
GEAR
t
Medidas
HbA1c on A1c
iGEAR
TQ HbA1c
Gen. 2
hemolysate on
Cobas Integra
800
(HbA1c/Hb*91.5+
2.15)
TQ HbA1c
Gen. 2 whole
blood on
Cobas Integra
800
(HbA1c/Hb*91.5+
2.15)
TQ HbA1c
Gen. 3
hemolysate on
cobas c501/502
(HbA1c/Hb*91.5+
2.15)
Roche
Diagnostics
TQ HbA1c
Gen. 3 whole
blood on cobas
c501/502
(HbA1c/Hb*91.5+
2.15)
TQ HbA1c
Gen. 3
hemolysate on
cobas c513
(HbA1c/Hb*91.5+
2.15)
5
Calibrator
Assigned
Value
3.59, 15.73
µmol/L
HbA1c;
91.81, 140.3
µmol/L Hb
3.59, 15.73
µmol/L
HbA1c;
91.81, 140.3
µmol/L Hb
0.0%, 5.0%,
9.2%, 13.0%,
14.1%
0.0%, 5.0%,
9.2%, 13.0%,
14.1%
3.114, 1.839,
1.525, 0.571,
0.063, 0 g/dL
HbA1c;
12.069, 2.414
g/dL Hb
Column
Lot
0.02872,
0.01719,
0.01435,
0.00573,
0.00113, 0
g/dL HbA1c;
0.12069,
0.02414 g/dL
Hb
0.142, 0.341,
0.660, 0.915,
1.244, 1.771
mmol/L
HbA1c;
1.474, 7.949
mmol/L Hb
0.136, 0.338,
0.661, 0.919,
1.252, 1.786
mmol/L
HbA1c;
1.474, 7.949
mmol/L Hb
0.148, 0.352,
0.676, 0.930,
1.279, 1.811
mmol/L
HbA1c; 1.40,
7.54 mmol/L
Hb
-
Secondary
Reference
Laboratory
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
Univ. of
Missouri.
SRL #9
-
Univ. of
Missouri.
SRL #9
-
Univ. of
Missouri.
SRL #9
-
Univ. of
Missouri.
SRL #9
-
Univ. of
Missouri.
SRL #9
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
0.145, 0.352,
0.679, 0.935,
1.287, 1.825
mmol/L
HbA1c; 1.40,
7.54 mmol/L
Hb
5.66%,
10.50%
Column
Lot
Roche
Diagnostics
TQ HbA1c
Gen. 3 whole
blood on cobas
Immunoassay
June ‘16
125253,
138037
185997
Ionexchange
HPLC
June ‘16
K7-102A,
K7-204Y,
7-303A,
HW-25A
ZS5002
K
Univ. of
Missouri.
SRL #9
Ionexchange
HPLC
June ‘16
K7-102A,
K7-204Y,
7-303A,
HW-25A
JS5001
5.67%,
10.79%
K
Univ. of
Missouri.
SRL #9
Ionexchange
HPLC
June ‘16
G8-101A,
G8-201A,
8-303A,
HW-25A
ZS5002
5.66%,
10.50%
G
Univ. of
Missouri.
SRL #9
Ionexchange
HPLC
June ‘16
G8-101A,
G8-201A,
8-301A,
HW-25A
JS5001
5.67%,
10.79%
G
Univ. of
Missouri.
SRL #9
Ionexchange
HPLC
June ‘16
ZS5002
5.66%,
10.50%
C
Univ. of
Missouri.
SRL #9
G9 HbA1c,
HLC-723G9
Ionexchange
HPLC
June ‘16
JS5001
5.67%,
10.79%
C
Univ. of
Missouri.
SRL #9
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 ‘16
C9-101A,
C9-201A,
9-301A,
HW-25A
C9-101A,
C9-201A,
9-301A,
HW-25A
H8-101A,
H8-201A,
H8-301A,
HW-25A
ZS5002
5.66%,
10.50%
H
Univ. of
Missouri.
SRL #9
Ionexchange
HPLC
June ‘16
M7-109A,
M7-201Y,
M7-301Y,
HW-25A
ZS5002
5.66%,
10.50%
M
Univ. of
Missouri.
SRL #9
Ionexchange
HPLC
June ‘16
ZS5002
5.66%,
10.50%
A
Univ. of
Missouri.
SRL #9
Ionexchange
HPLC
June ‘16
AX-102B,
AX-202B,
AX-302B,
HX-02B
AX-102B,
AX-202B,
AX-302B,
HW-02B
JS5001
5.67%,
10.79%
A
Univ. of
Missouri.
SRL #9
c513
(HbA1c/Hb*91.5+
2.15)
Tosoh
Corporation
t
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
t
GX
HLC-723GX
6
-
Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Tosoh
Corporation
Siemens
Healthcare
Diagnostics
Mindray
ELITech
Clinical
Systems SAS
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
5.66%,
10.50%
Column
Lot
G11, Standard
Analysis Mode
(0.5 min),
HLC-723G11
t
G11, Standard
Analysis Mode
(0.5 min),
HLC-723G11
DCA 2000+
Ionexchange
HPLC
June ‘16
ZS5002
Ionexchange
HPLC
June ‘16
Immunoassay
June ‘16
A1-101Y,
A1-201Y,
1-301Y,
HW-25A
A1-101Y,
A1-201Y,
1-301Y,
HW-25A
0572036
JS5001
5.67%,
10.79%
A
Univ. of
Missouri.
SRL #9
-
-
-
0572036
-
-
-
Univ. of
Missouri.
SRL #9
Univ. of
Missouri.
SRL #9
DCA Vantage
Immunoassay
June ‘16
Ion-exchange
HPLC on
H50/H50P
Enzymatic on
BS-200E
Ionexchange
HPLC
May ‘16
2015120901,
141113B,
141212H
2015082901,
2015082901
5.47%,
11.67%
5I005M
ReCCS
ASRL#1
Enzymatic
May ‘16
044616002
044616002
-
ReCCS
ASRL#1
Enzymatic on
BS-380
Enzymatic
May ‘16
044616002
044616002
-
ReCCS
ASRL#1
Enzymatic on
BS-400
Enzymatic
May ‘16
044616002
044616002
-
ReCCS
ASRL#1
Enzymatic on
BS-480
Enzymatic
May ‘16
044616002
044616002
-
ReCCS
ASRL#1
Enzymatic on
BS-800 & BS800M
Enzymatic
May ‘16
044616002
044616002
-
ReCCS
ASRL#1
Enzymatic on
BS-2000 &
BS-2000M
Enzymatic
May ‘16
044616002
044616002
-
ReCCS
ASRL#1
HbA1c
(immunoturbid
imetric assay)
on Selectra
ProM
Immunoassay
May ‘16
R151436,
R151437,
R151435,
R160106
R160161,
R160162,
R160163,
R160164
3.59, 15.73
µmol/L
HbA1c;
91.81, 140.3
µmol/L Hb
3.59, 15.73
µmol/L
HbA1c;
91.81, 140.3
µmol/L Hb
3.59, 15.73
µmol/L
HbA1c;
91.81, 140.3
µmol/L Hb
3.59, 15.73
µmol/L
HbA1c;
91.81, 140.3
µmol/L Hb
3.59, 15.73
µmol/L
HbA1c;
91.81, 140.3
µmol/L Hb
3.59, 15.73
µmol/L
HbA1c;
91.81, 140.3
µmol/L Hb
5.0%, 7.7%,
11.2%,
15.3%
-
European
Reference Lab
ESRL#10
t
7
A
Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
ELITech
Clinical
Systems SAS
HbA1c
(immunoturbid
imetric assay)
on Selectra
ProS
B-analyst
HbA1c on Banalyst S1
NGSP=
0.0915*IFCC
+ 2.15
Spotchem
Banalyst
HbA1c on SI3610
NGSP=
0.0915*IFCC
+ 2.15
Banalyst Ace
HbA1c on
Banalyst Ace
NGSP=
0.0915*IFCC
+ 2.15
Uni Cel DxC
Syr on
HBA1C3
UniCel DxC
800
Nephelometry
on Specific
Protein
Analyzer
PA54/PA50
Nephelometry
on Fully-auto
Specific
Protein
Analyzer
PA120/PA200
HbA1c
(Hemolysate)
on Architect
c8000
Immunoassay
May ‘16
R151436,
R151437,
R151435,
R160106
R160161,
R160162,
R160163,
R160164
Immunoassay
May ‘16
1607FL258O
Immunoassay
May ‘16
Immunoassay
ROHM Co.,
Ltd
Beckman
Coulter, Inc.
Shenzhen
Genius
Electronics
Co., Ltd.
Abbott
Diagnostics
Calibrator
Assigned
Value
5.0%, 7.7%,
11.2%,
15.3%
Column
Lot
WC0014
0.0, 24.5,
51.3, 82.3,
118.0
mmol/mol
-
ReCCS
ASRL#1
1606FL055O
WC0014
0.0, 24.5,
51.3, 82.3,
118.0
mmol/mol
-
ReCCS
ASRL#1
May ‘16
1606FL054O
WC0014
0.0, 24.5,
51.3, 82.3,
118.0
mmol/mol
-
ReCCS
ASRL#1
Immunoassay
May ‘16
M512476
M512476
-
Univ. of
Missouri.
SRL #9
Immunoassay
May ‘16
20160316
-
0.158, 0.470,
0.897, 1.696,
2.705 g/dL
A1c3; 19.74
g/dL Hb3
-
-
ReCCS
ASRL#1
Immunoassay
May ‘16
20160318
-
-
-
ReCCS
ASRL#1
Enzymatic
May ‘16
47041UQ02,
47041UQ02,
47041UQ
47973UQ06,
47973UQ06
5.2%,
11.4%;
3.07, 14.83
µmol/L
HbA1c;
92.5, 146.6
µmol/L
THb
-
Univ. of
Missouri.
SRL #9
%NGSP=HbA1c/
Hb*91.48+2.152
8
-
Secondary
Reference
Laboratory
European
Reference Lab
ESRL#10
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Abbott
Diagnostics
HbA1c
(Hemolysate)
on Architect
c4000
Enzymatic
May ‘16
47041UQ02,
47041UQ02,
47041UQ
47973UQ06,
47973UQ06
-
Enzymatic
May ‘16
47041UQ02,
47041UQ02,
47041UQ
47973UQ06,
47973UQ06
Enzymatic
May ‘16
47041UQ02,
47041UQ02,
47041UQ
47973UQ06,
47973UQ06
5.2%,
11.4%;
3.07, 14.83
µmol/L
HbA1c;
92.5, 146.6
µmol/L
THb
5.2%,
11.4%;
3.07, 14.83
µmol/L
HbA1c;
92.5, 146.6
µmol/L
THb
5.2%,
11.4%;
3.07, 14.83
µmol/L
HbA1c;
92.5, 146.6
µmol/L
THb
Immunoassay
May ‘16
85040
CEN002
%NGSP=HbA1c/
Hb*91.48+2.152
HbA1c
(Whole Blood)
on Architect
c4000
%NGSP=HbA1c/
Hb*91.48+2.152
HbA1c
(Whole Blood)
on Architect
c8000
%NGSP=HbA1c/
Hb*91.48+2.152
Nihon Kohden
Corporation
Celltac Chemi
HbA1c on
CHM-4100
Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9
-
Univ. of
Missouri.
SRL #9
-
Univ. of
Missouri.
SRL #9
0.0%, 4.4%,
6.9%, 9.7%,
13.2%
-
ReCCS
ASRL#1
0.16, 0.62,
1.15, 1.99,
2.52 g/dL
HbA1c;
13.05, 12.40
g/dL THb
-
-
Univ. of
Missouri.
SRL #9
-
Univ. of
Missouri.
SRL #9
ReCCS
ASRL#1
(NGSP(%)=1.02*
JDS(%)+0.25)
Siemens
Healthcare
Diagnostics
Inc.
Dimension
Flex HB1C on
Dimension
Xpand
Immunoassay
May ‘16
BA6293
BA6293
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
Immunoassay
Apr ‘16
AAMAA05F
502101
Immunoassay
Apr ‘16
6BC16006
16006
Immunoassay
Apr ‘16
PBC16005
Immunoassay
Apr ‘16
YBC16006
Getein
Biotech, Inc.
9
5.1%, 8.1%,
10.8%,
13.5%
5.25%,
10.55%
-
-
ReCCS
ASRL#1
16006
5.25%,
10.55%
-
ReCCS
ASRL#1
16006
5.25%,
10.55%
-
ReCCS
ASRL#1
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Column
Lot
-
Calibrator
Assigned
Value
-
Wuxi
Biohermes Bio
& Medical
Technology
Co., Ltd.
Sebia
Boronate
Affinity on
A1c EZ 2.0
Boronate
affinity
Apr ‘16
AP151208
05
Capillarys
HbA1c on
Capillarys 2
Flex Piercing
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
Capillary
Electrophoresis
Apr ‘16
14095/01,
20075/01,
12035/01
06115/01,
09115/01
36.8, 83.8
mmol/mol
-
European
Reference Lab
ESRL#10
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
-
Secondary
Reference
Laboratory
ReCCS
ASRL#1
%NGSP=0.09148
x [IFCC]
(mmol/mol) +
2.152
Minicap
HbA1c
%NGSP=0.09148
x [IFCC]
(mmol/mol) +
2.152
CAPI 3
HbA1c on
Capillarys 3
%NGSP=0.09148
x [IFCC]
(mmol/mol) +
2.152
Wiener
Laboratorios
tHbA1c
Turbitest AA on
CMD 800i X1
91.5*HbA1c/Hb
+ 2.15
t
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
10
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Wiener
Laboratorios
tHbA1c v2
Turbitest AA on
CMD 800i X1
91.5*HbA1c/Hb
+ 2.15
Immunoassay
Apr ‘16
174050,
174050.
174050,
169310
151007
Immunoassay
Apr ‘16
174050,
174050.
174050,
169310
151007
Immunoassay
Apr ‘16
QF51103,
RF51103,
SF50603
Immunoassay
Apr ‘16
Immunoassay
Apr ‘16
Immunoassay
Apr ‘16
Immunoassay
Apr ‘16
Immunoassay
Apr ‘16
Boronate
affinity
t
HbA1c v2
Turbitest AA
on CB 350i
Calibrator
Assigned
Value
2.883 g/dL
HbA1c;
12.31 g/dL
Hb
Column
Lot
2.883 g/dL
HbA1c;
12.31 g/dL
Hb
-
Univ. of
Missouri.
SRL #9
VF51103
0.0%, 4.3%,
6.8%, 9.6%,
13.3%
-
ReCCS
ASRL#1
QF51103,
RF51103,
SF50603
F9A005,
F9A005,
H2A003
VF51103
0.0%, 4.3%,
6.8%, 9.6%,
13.3%
0.0%, 4.3%,
6.8%, 9.6%,
13.3%
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
VF51103
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
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%
-
-
Apr ‘16
QF51103,
RF51103,
SF50603
QF51103,
RF51103,
NF50702
QF51103,
RF51103,
SF50603
10176087
-
European
Reference Lab
ESRL #11
Boronate
affinity
Apr ‘16
10176087
-
-
-
European
Reference Lab
ESRL #11
Ionexchange
HPLC
Apr ‘16
15071731,
15061612,
15041033,
15120714
15071731,
15061612,
15121134,
15051535,
15120714
15091611,
15061612,
15062613,
15120714
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
91.5*HbA1c/Hb
+ 2.15
Fujirebio Inc.
Alere
Technologies
AS
Arkray, Inc.
t
Rapidia Auto
HbA1c-L on
BiOLis24i
Premium
t Rapidia Auto
HbA1c-L on
JCA-BM9130
t AU-Synchron
Reagent
HbA1c on
AU680
t 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
t
ADAMS A1c
HA-8160 TP
mode
Ionexchange
HPLC
Apr ‘16
t
ADAMS A1c
HA-8160
(Ver.1)
Ionexchange
HPLC
Apr ‘16
11
H1A005
VF51103
VF51103
-
Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Arkray, Inc.
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
t
ADAMS A1c
HA-8160
(Ver.4)
Ionexchange
HPLC
Apr ‘16
5D82;
S5001
5.2%, 10.5%;
5.2%, 10.5%
5H051F
t
ADAMS A1c
HA-8170
Ionexchange
HPLC
Apr ‘16
5D82;
S5001
5.2%, 10.5%;
5.2%, 10.5%
5H291G
ReCCS
ASRL#1
t
ADAMS A1c
HA-8180
Apr ‘16
CA85D53;
S5001
5.2%, 10.6%;
5.2%, 10.6%
5J001N
ReCCS
ASRL#1
t
ADAMS A1c
HA-8180V
Variant mode
Ionexchange
HPLC
Ionexchange
HPLC
CA85D51;
S5001
5.2%, 10.6%;
5.2%, 10.6%
5H101U
ReCCS
ASRL#1
t
ADAMS A1c
HA-8180V
Fast mode
Ionexchange
HPLC
Apr ‘16
CA85D51;
S5001
5.2%, 10.6%;
5.2%, 10.6%
5H101U
ReCCS
ASRL#1
t
ADAMS A1c
HA-8180T
Ionexchange
HPLC
Apr ‘16
CA85D51;
S5001
5.2%, 10.6%;
5.2%, 10.6%
5H007L
ReCCS
ASRL#1
Ionexchange
HPLC
Ionexchange
HPLC
Ionexchange
HPLC
Apr ‘16
CA85D53;
S5001
5.2%, 10.6%;
5.2%, 10.6%
5K401N
ReCCS
ASRL#1
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
15121757,
15082858,
15072759,
15111955
15121757,
15082858,
15072759,
15111955
6C1011,
6A1022,
5I1051
6C1011,
6A1022,
5D1401,
5I1051
6C1011,
6A1022,
5D1401,
5I1051
6C1011,
6A1022,
5E1601,
5I1051
6C1011,
6A1022,
5I1051
6C1011,
6A1022,
5I1051
6C1011,
6A1022,
5I1051
MFC03,
MFE03
CAC5C16
2.95, 7.31
µmol/L HbA1c;
90.1, 96.9
µmol/L Hb
-
ReCCS
ASRL#1
Enzymatic
Apr ‘16
MFC03,
MFE03
CAC5C16
2.95, 7.31
µmol/L HbA1c;
90.1, 96.9
µmol/L Hb
-
ReCCS
ASRL#1
Enzymatic
Apr ‘16
MFC03,
MFE03
CAC5C16
2.95, 7.31
µmol/L HbA1c;
90.1, 96.9
µmol/L Hb
-
ReCCS
ASRL#1
Enzymatic
Apr ‘16
MFC03,
MFE03
CAC5C16
2.95, 7.31
µmol/L HbA1c;
90.1, 96.9
µmol/L Hb
-
ReCCS
ASRL#1
Ionexchange
HPLC
Apr ‘16
6C1011,
6A1022,
151422255
C1L5D05;
S5001
5.2%, 10.6%;
5.2%, 10.6%
5K401N
ReCCS
ASRL#1
t
ADAMS
HYBRID AH8290
t ADAMS A1c
HA-8181
t ADAMS
HYBRID AH8280
t
CinQ HbA1c
on BioMajesty
JCA-BM6010
Apr ‘16
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
12
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Arkray, Inc
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Column
Lot
C1L5D06;
S5001
Calibrator
Assigned
Value
5.2%, 10.6%;
5.2%, 10.6%
ADAMS A1c
Lite HA8380V Fast
mode
t ADAMS A1c
Lite HA8380V Variant
mode
t ADAMS A1c
HA-8182
Ionexchange
HPLC
Apr ‘16
6C1011,
6A1022,
5D1401,
151422255
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)
-
Boronate
affinity
HPLC
Mar ‘16
6040, 6047,
6107, 6133
6081, 6082
2.46, 3.54,
4.95, 6.76,
10.74
µmol/L A1c;
11.74 g/dL
Hb
5.2%, 11.3%
ReCCS
ASRL#1
Univ. of
Missouri.
SRL #9
6018
Univ. of
Missouri.
SRL #3
Boronate
affinity
HPLC
Mar ‘16
6040, 6047,
6115
6081, 6082
5.4%, 11.6%
6018
Univ. of
Missouri.
SRL #3
Boronate
affinity
HPLC
Mar ‘16
6089, 6047,
6115, 6005
6081, 6082
5.3%, 11.6%
5919
Univ. of
Missouri.
SRL #3
Immunoassay
Mar ‘16
YA003,
KE436
YA003
-
ReCCS
ASRL#1
RC20
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
t
HbA1c
AUTO TBA
on TBA120FR
Enzymatic
Mar ‘16
855RHM,
856RHM,
807RHM
905RIM
-
ReCCS
ASRL#1
t
Enzymatic
Mar ‘16
807RIM,
807RIM,
806RLM
806RLM
-
ReCCS
ASRL#1
t
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
GHb/HbA1c
HPLC
Boronate
Affinity on
ultra2
GHb/HbA1c
HPLC
Boronate
Affinity on
Premier
Hb9210
t Autokit
HbA1c on
Hitachi 7170S
Wako Pure
Chemical
Industries, Ltd.
Sekisui
Medical Co.,
Ltd.
L type
Norudia N
HbA1c on
Hitachi
LST006
13
3.83, 16.19
µmol/L
HbA1c;
103.1, 154.7
µmol/L Hb
3.62, 13.77
µmol/L
HbA1c; 97.7,
137.0
µmol/L Hb
5K194U
Secondary
Reference
Laboratory
ReCCS
ASRL#1
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Sekisui
Medical Co.,
Ltd.
t L type
Norudia N
HbA1c on
Hitachi
LST008
t Norudia N
HbA1c on
Hitachi 7170S
Enzymatic
Mar ‘16
807RIM,
807RIM,
806RLM
806RLM
Enzymatic
Mar ‘16
855RHM,
856RHM,
847RJM
013RIM
Norudia N
HbA1c on
EV800
Enzymatic
Mar ‘16
855RHM,
856RHM,
847RJM
013RIM
t
Norudia N
HbA1c on
TBA-120FR
Enzymatic
Mar ‘16
855RHM,
856RHM,
847RJM
013RIM
t
Norudia N
HbA1c on
JCA-BM9130
Enzymatic
Mar ‘16
855RHM,
856RHM,
847RJM
013RIM
t RC20 on
Adams A1c
mini
t 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
Boronate
Affinity on
Cera-Stat 4000
(Merilyzer
Mericheck
Analyzer)
Ionexchange
HPLC
Immunoassay
Mar ‘16
1106000315
1209000315
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
Boronate
Affinity
Feb ‘16
H05E071,
H05E72,
HC433GDG
EW
-
t
Kyowa Medex
Co., Ltd.
.
Green Cross
Medis Corp.
14
Calibrator
Assigned
Value
3.62, 13.77
µmol/L
HbA1c; 97.7,
137.0
µmol/L Hb
3.83, 16.19
µmol/L
HbA1c;
103.1, 154.7
µmol/L Hb
3.83, 16.19
µmol/L
HbA1c;
103.1, 154.7
µmol/L Hb
3.83, 16.19
µmol/L
HbA1c;
103.1, 154.7
µmol/L Hb
3.83, 16.19
µmol/L
HbA1c;
103.1, 154.7
µmol/L Hb
5.56%,
11.30%
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%
-
Column
Lot
-
Secondary
Reference
Laboratory
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
1006003415
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
Univ. of
Missouri.
SRL #9
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Green Cross
Medis Corp.
Boronate
Affinity on
Cera-Stat 2000
(QDx A1c
Analyzer)
Ion-exchange
LPLC on JL760
Boronate
Affinity
Feb ‘16
H05G221,
H05G222,
HM233GHQ
EW
-
Ionexchange
HPLC
Feb ‘16
15070110,
15070211,
15070312,
15070312
Direct HbA1c
Assay on
Roche
Modular P800
(On-Board
Lysis)
MQ-6000
Glycated
Hemoglobin
Analyzer
Enzymatic
Jan ‘16
Ionexchange
HPLC
MQ-2000PT
Glycated
Hemoglobin
Analyzer
Nanjing
LAOLA
Electronic Co.,
Ltd.
Diazyme
Laboratories
Shanghai
Huizhong
Medical
Science and
Technology
Co. Ltd.
Calibrator
Assigned
Value
-
Column
Lot
15070115,
15070125
5.7%, 11.1%
20150610
Univ. of
Missouri.
SRL #9
HAL01150,
HA101150,
HA201150
HAS101150,
HAS201150
6.2%, 12.3%
-
Univ. of
Minnesota
SRL#10
Jan ‘16
20150616B
20151029
5.70%,
10.67%
6K15071301
Univ. of
Missouri.
SRL #9
Ionexchange
HPLC
Jan ‘16
PTHbA1c1
50 302H
20151029
5.42%,
10.62%
PTHbA1c15
0302H
Univ. of
Missouri.
SRL #9
Immuno-assay
on ichroma
Reader
Immunoassay
Jan ‘16
AALYA55
502101
5.1%, 8.1%,
11.2%, 15.2%
-
ReCCS
ASRL#1
Immunoassay
on TD-4611
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%
-
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
-
Boditech Med
Inc.
TaiDoc
Technology
Corp.
Axis-Shield
Human
Gesellschaft fur
Biochemica und
Diagnostica
mbH
Thermo Fisher
Scientific Oy
t
t
-
Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9
European
Reference Lab
ESRL#10
European
Reference Lab
ESRL#9
91.5*HbA1c/Hb
+2.15
t
HbA1c for
Indiko, ref
981947, on
Indiko Plus,
Manual
hemolyzation,
91.5*HbA1c/Hb
+2.15
15
European
Reference Lab
ESRL#9
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Bio-Rad
Laboratories
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
t
VARIANT II
Dual (A1c)
Jan ‘16
64023628,
64023629,
64019494
64015994,
64015995
5.1%, 10.1%
FB20900
t
VARIANT II
Dual
(A2/F/A1c)
Ionexchange
HPLC
Ionexchange
HPLC
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
-
Univ. of
Missouri.
SRL #9
Ion-exchange
HPLC on GH900
Ionexchange
HPLC
Dec ‘15
821514
2015090801
0.00, 0.48,
0.89, 1.62,
2.51 g/dL
HbA1c;
-1.38, 14.06
g/dL Hb
5.6%, 12.5%
2015092204
ReCCS
ASRL#1
Ion-exchange
HPLC on H-9
Ionexchange
HPLC
Immunoassay
Dec ‘15
841502
2015101201
5.2%, 11.2%
2015100901
ReCCS
ASRL#1
Dec ‘15
21506,
21507
E28/14
-
European
Reference Lab
ESRL#10
Dec ‘15
21506,
21507
E28/14
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
-
European
Reference Lab
ESRL#10
D-10 Dual
A2/F/A1c
D-10 HbA1c
D-100 HbA1c
Variant II
HbA1c NU
Ortho Clinical
Diagnostics
Shenzhen
Lifotronic
Technology
Co., Ltd
DiaSys
Diagnostic
Systems
GmbH
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
HbA1c net FS,
Reference No.
1 3348 00,
respons910
HbA1c net FS,
Reference No.
1 3348 00,
Biomajesty
Immunoassay
16
Secondary
Reference
Laboratory
Univ. of Minn
SRL #10
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
DiaSys
Diagnostic
Systems
GmbH
Immunoassay
Dec ‘15
82, 20760
Immunoassay
Dec ‘15
2136921371,
20760
Erba Lachema
s.r.o.
oneHbA1c FS,
Reference No.
1 3329 00,
InnovaStar
oneHbA1c FS,
Reference No.
1 3329 00,
Hitachi 917
ERBA HbVario
Dec ‘15
HBR-003,
HBR-003
Trinity
Biotech
Tri-stat HbA1c
Assay
Ionexchange
HPLC
Boronate
Affinity
21670,
21671,
21672,
21673
21479,
21480,
21481,
21482
B041538CM
Calibrator
Assigned
Value
4.99%,
6.72%,
10.4%,
13.2%
4.77%,
8.39%,
12.5%,
17.2%
5.54%,
11.59%
Dec ‘15
5850 (0y)
-
-
-
PTS
Diagnostics
A1CNow+;
A1CNow
SELFCHECK
HbA1c Latex
Immunoassay
on EasyRA
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
-
TQ HbA1c
Gen. 2 Cobas
Integra 400
(hemolysate)
Immunoassay
Dec ‘15
604503,
617546,
610045
185997
Immunoassay
Dec ‘15
610611,
617543
183640
Medica
Corporation
Siemens
Healthcare
Diagnostics,
Inc.
Roche
Diagnostics
International
Ltd
Roche
Diagnostics
HbA1c/Hb*91.5
+2.15
TQ HbA1c
Gen. 2 Cobas
c111 (whole
blood)
HbA1c/Hb*91.5
+2.15
17
Column
Lot
-
Secondary
Reference
Laboratory
European
Reference Lab
ESRL#10
-
European
Reference Lab
ESRL#10
HBR-002
Univ. of
Missouri.
SRL #9
Univ. of
Missouri.
SRL #9
Univ. of
Missouri.
SRL #9
Univ. of
Missouri.
SRL #9
-
Univ. of
Missouri.
SRL #9
-
Univ. of
Missouri.
SRL #9
-
Univ. of
Missouri.
SRL #9
2.868, 1.703,
1.415, 0.544,
0.078, 0 g/dL
HbA1c;
12.069, 2.414
g/dL Hb
-
Univ. of
Missouri.
SRL #9
0.02607,
0.01575,
0.01321,
0.00549,
0.00137, 0
g/dL HbA1c;
0.12052,
0.02386 g/dL
Hb
-
Univ. of
Missouri.
SRL #9
List of NGSP Certified Methods (Updated 9/16, 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
(whole blood)
Immunoassay
Dec ‘15
604503,
617546
185997
-
Immunoassay
Dec ‘15
617092,
614514,
610045
185997
Immunoassay
Dec ‘15
617092,
614514
185997
Immunoassay
Dec ‘15
618064,
610071
185997
Immunoassay
Dec ‘15
618064,
610071,
610045
185997
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
Boronate
Affinity
Nov ‘15
F15F02F16
DL
-
Boronate
Affinity
Nov ‘15
C15F22G0
6DL
Enzymatic
Nov ‘15
Ionexchange
HPLC
HbA1c/Hb*91.5
+2.15
TQ HbA1c
Gen. 3 cobas
c311
(hemolysate)
-
Univ. of
Missouri.
SRL #9
-
Univ. of
Missouri.
SRL #9
-
Univ. of
Missouri.
SRL #9
-
Univ. of
Missouri.
SRL #9
-
-
-
-
-
DBJGA
-
-
-
Univ. of
Missouri.
SRL #9
Univ. of
Missouri.
SRL #9
ReCCS
ASRL#1
Nov ‘15
20150623,
20150623,
20150623
150609K
5.70%,
11.25%
20150506
ReCCS
ASRL#1
Immunoassay
Oct ‘15
1533FD07
7O
WC0014
-
ReCCS
ASRL#1
Immunoassay
Oct ‘15
802905118
802902331802902335
0.0, 24.0,
51.0, 82.8,
119.0
mmol/mol
0.00%,
4.40%,
7.00%,
9.90%,
13.30%
-
European
Reference Lab
ESRL#12
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
i-SENS, Inc.
Shenzhen
Labnovation
Technologies,
Inc.
ROHM Co.,
Ltd.
Axis-Shield
Frontier and
HemoCue
HbA1c 501
Clover A1c,
Clover A1c
Self, Checkart
A1Care
HbA1c assay
(Enzymatic
method)
Ion-Exchange
HPLC on LD500
Spotchem
Banalyst
HbA1c on SI3620
Axis-Shield
HbA1c kit on
AU400
Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9
18
List of NGSP Certified Methods (Updated 9/16, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Archem
Diagnostic
Industry Ltd.
HbA1c Direct
Method (2
Reagents)
Immuno-assay
ADAMS A1c
Lite HA8380V Variant
mode
ADAMS A1c
Lite HA8380V Fast
mode
ADAMS A1c
Lite HA-8380
Immunoassay
Oct ‘15
AR957
806
Ionexchange
HPLC
Oct ‘15
Ionexchange
HPLC
Oct ‘15
Ionexchange
HPLC
Oct ‘15
Seratestum
A1C
Enzymatic
Oct ‘15
5E1012,
5E1021,
4L1401,
4J1053
5E1012,
5E1021,
4L1401,
4J1053
5E1012,
5E1021,
4J1053
Y5C617
HbA1c WB
Whole Blood
Pentra C400
Immunoassay
Oct ‘15
Immunoassay
Arkray, Inc.
Hitachi
Chemical Co.,
Ltd.
HORIBA
Medical
t
Column
Lot
S4002
Calibrator
Assigned
Value
5.85%,
9.05%,
11.9%,
16.02%
5.4%, 10.5%
4J101U
Univ. of
Missouri.
SRL #9
S4002
5.4%, 10.5%
4J101U
Univ. of
Missouri.
SRL #9
S4002
5.4%, 10.5%
4J206N
-
-
-
Univ. of
Missouri.
SRL #9
ReCCS
ASRL#1
1504101
1501801
-
European
Reference Lab
ESRL#10
Oct ‘15
1504101
1501801
-
European
Reference Lab
ESRL#10
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
µmol/l
HbA1c;
68.29 µmol/l
Hb
0.00, 1.60,
2.90, 4.20,
7.00, 10.80
µmol/l
HbA1c;
68.29 µmol/l
Hb
0.00, 1.60,
2.90, 4.20,
7.00, 10.80
µmol/l
HbA1c;
68.29 µmol/l
Hb
0.00, 1.60,
2.90, 4.20,
7.00, 10.80
µmol/l
HbA1c;
68.29 µmol/l
Hb
0.00, 1.60,
2.90, 4.20,
7.00, 10.80
µmol/l
HbA1c;
68.29 µmol/l
Hb
-
European
Reference Lab
ESRL#10
Y=(0.42*X)+2.25
t
HbA1c WB
Hemolysate
Pentra C400
Y=(0.43*X)+2.06
t
HbA1c WB
Hemolysate
Pentra C200
Y=(0.35*X)+2.24
t
HbA1c WB
Whole Blood
ABX Pentra
400
Y=(0.43*X)+2.14
t
HbA1c WB
Hemolysate
Pentra 400
Y=(0.43*X)+1.98
t
@
Method is not available in the US
Method is not currently available
19
-
Secondary
Reference
Laboratory
European
Reference Lab
ESRL#9