1. Healthcare

List of NGSP Certified Methods
(updated 2/15, 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
Home Access
Health Corp
Immunoassay
Feb ‘15
5066, 5957
0041A
Boronate
Affinity
Feb ‘15
H04L091,
H04L092,
HC233AP9EW
Boronate
Affinity
Feb ‘15
Boditech Med
Inc.
Red blood cellserum stripbased cassettes
on Beckman
AU640e
CERA-STAT
2000, also sold
as QDx A1c
Analyzer
CERA-STAT
4000, also sold
as Merilyzer
Mericheck
Analyzer
ichroma HbA1c
Test
Immunoassay
UMA Co., Ltd
Measure HbA1c
Ceragem
Medisys Inc.
TaiDoc
Technology
Corp.
Axis-Shield
Human GmbH
Calibrator
Assigned
Value
Column
Lot
-
0.019, 0.234,
0.416, 0.560,
0.977, 1.596
g/dL A1c; 21.1
g/dL Hb
-
-
Univ. of
Missouri.
SRL #9
H04L091,
H04L092,
HC433AP9EW
-
-
-
Univ. of
Missouri.
SRL #9
Jan ‘15
AAKYA03.1
ReCCS
ASRL#1
Jan ‘15
385ADK,
152ADK
-
ReCCS
ASRL#1
Measure HbA1c
II
Immunoassay
Jan ‘15
010ADK,
152ADK
-
ReCCS
ASRL#1
t
Immunoassay
on TD-4611
Immunoassay
Jan ‘15
14K117
415501-212
5.1%, 5.8%,
6.5%, 8.1%,
11.2%, 15.2%
0%, 4.3%,
8.3%, 11.5%,
15.3%
0%, 4.6%,
7.5%, 11.9%,
15.5%
5.2%, 8.3%,
11.6%, 15.5%
-
Immunoassay
130013A,
120355A,
415501A
114ADK
-
Architect
HbA1c on
Architect i
Immunoassay
Jan ‘15
10386UP00
802900732
4.0%, 5.5%,
7.5%, 9.0%,
12.0%,14.5%
-
HumaMeter A1c
Boronate
Fluorescence
quenching
Jan ‘15
025120
025120
Barcode
-
HumaNex A1c
Ionexchange
HPLC
Jan ‘15
140718F
7038
5.77%,
11.20%
-
European
Reference Lab
ESRL#9
European
Reference Lab
ESRL#12
European
Reference Lab
ESRL#10
European
Reference Lab
ESRL#10
1
113BDK
-
Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9
List of NGSP Certified Methods (Updated 2/15, listed by date certified)
Manufacturer
Method/
Instrument
Thermo Fisher
Scientific Oy
t
HbA1c for
Konelab, ref
981947,
Manual
hemolyzation,
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
European
Reference Lab
ESRL#9
Immunoassay
Jan ‘15
K694, K783
K553
1.502 mmol/L
HbA1c; 8.440
mmol/L Hb
-
Immunoassay
Jan ‘15
K694, K783
K553
1.483 mmol/L
HbA1c; 8.440
mmol/L Hb
-
European
Reference Lab
ESRL#9
Ionexchange
HPLC
Ionexchange
HPLC
Jan ‘15
64007684,
64007685,
64007215
64006671,
64006672
5.1%, 10.0%
XA20900
Univ. of Minn
SRL #10
Jan ‘15
64007684,
64007685,
64007215
64006669,
64006670
5.3%, 9.9%
XA20900
Univ. of Minn
SRL #10
Ionexchange
HPLC
Ionexchange
HPLC
Ionexchange
HPLC
Ionexchange
HPLC
Ionexchange
HPLC
Jan ‘15
AA40263,
AA40264,
AA40177
AA40151,
AA40152
5.6%, 10.2%
D22250P
Univ. of Minn
SRL #10
Jan ‘15
AA40261,
AA40262,
AA40354
AA40284,
AA40285
5.7%, 10.2%
A22250AJ
Univ. of Minn
SRL #10
Jan ‘15
64008379,
64008380,
64002753
64007325,
64007327
5.2%, 10.2%
S20170W
Univ. of Minn
SRL #10
Jan ‘15
64006950,
64006951,
64007016
64005919,
64005920
5.3%, 10.2%
LLV20170P
Univ. of Minn
SRL #10
Jan ‘15
64008184,
64007349,
64007016
64004700,
64004701
5.1%, 10.2%
11840AF
Univ. of Minn
SRL #10
Immunoassay
Jan ‘15
19362,
19497
E19/14
Immunoassay
Jan ‘15
19362,
19497
E19/14
Immunoassay
Jan ‘15
1974719749,
18878
19949,
19950,
19951,
19952
0.316, 1.040
g/dL HbA1c;
5.13, 15.2
g/dL Hb
0.390, 1.057
g/dL HbA1c;
6.30, 15.0
g/dL Hb
5.08%,
7.91%,
11.6%,
15.8%
Immunoassay
Jan ‘15
76, 18878
20628,
20629,
20630,
20631
5.05%,
6.60%,
10.3%,
14.2%
91.5*HbA1c/Hb
+2.15
t
HbA1c for
Indiko, ref
981947,
Manual
hemolyzation,
91.5*HbA1c/Hb
+2.15
Bio-Rad
Laboratories
t
VARIANT II
Dual (A1c)
t
VARIANT II
Dual
(A2/F/A1c)
D-10 Dual
A2/F/A1c
D-10 HbA1c
DiaSys
Diagnostic
Systems
GmbH
VARIANT II
TURBO
HbA1c
VARIANT II
TURBO Link
HbA1c
VARIANT II
TURBO
HbA1c Kit –
2.0
t
HbA1c net
FS, Reference
No. 1 3348 00,
on respons 910
t
HbA1c net
FS, Reference
No. 1 3348 00,
on Biomajesty
t
oneHbA1c
FS, Reference
No. 1 3329 00,
3 component
version on
Hitachi 917
t
oneHbA1c
FS, Reference
No. 1 3329 00,
on InnovaStar
2
-
European
Reference Lab
ESRL#10
-
European
Reference Lab
ESRL#10
-
European
Reference Lab
ESRL#10
-
European
Reference Lab
ESRL#10
List of NGSP Certified Methods (Updated 2/15, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Beckman
Coulter Ireland
Inc.
HbA1c
OSR6192
Manual
Application
AU480
Immunoassay
Dec ‘14
6188
0042
HbA1c
OSR6192
Manual
Application
AU640
Immunoassay
Dec ‘14
6188
0042
HbA1c
OSR6192
Manual
Application
AU680
Immunoassay
Dec ‘14
6188
0042
HbA1c
OSR6192
Manual
Application
AU2700
Immunoassay
Dec ‘14
6188
0042
Bio-Rad
Laboratories,
Inc.
Biokit
D-100 HbA1c
Ionexchange
HPLC
Immunoassay
Dec ‘14
64007916
Dec ‘14
64007917,
64007918,
64007919
B23326
Siemens
Healthcare
Diagnostics
Hemoglobin
A1c_3
(A1c_3) –
Automated
Pretreatment
on Advia
1650/1800
Cobas b 101
HbA1c
Immunoassay
Dec ‘14
190
4DD071
Immunoassay
Dec ‘14
420021-01
-
TQ HbA1c
Gen. 2 Cobas
Integra 400
(hemolysate)
Immunoassay
Dec ‘14
691274,
693275
175535
(std. 1-6)
Roche
Diagnostics
International
Ltd
Roche
Diagnostics
Quantex
HbA1c
HbA1c/Hb*91.5
+2.15
3
B23683
Calibrator
Assigned
Value
0.019, 0.143,
0.253, 0.333,
0.586, 0.964
mmol/L
HbA1c;
13.50
mmol/L THb
0.019, 0.143,
0.253, 0.333,
0.586, 0.964
mmol/L
HbA1c;
13.50
mmol/L THb
0.019, 0.143,
0.253, 0.333,
0.586, 0.964
mmol/L
HbA1c;
13.50
mmol/L THb
0.019, 0.143,
0.253, 0.333,
0.586, 0.964
mmol/L
HbA1c;
13.50
mmol/L THb
5.97%,
9.25%
Column
Lot
0, 0.11, 0.21,
0.31, 0.55,
0.86 mmol/L
2.42, 3.70,
4.76, 5.91,
9.37 µmol/L
HbA1c;
11.49 g/dL
tHb
-
Secondary
Reference
Laboratory
European
Reference Lab
ESRL#9
-
European
Reference Lab
ESRL#9
-
European
Reference Lab
ESRL#9
-
European
Reference Lab
ESRL#9
100303100362
Univ. of Minn
SRL #10
-
European
Reference Lab
ESRL#9
Univ. of
Missouri.
SRL #9
-
-
-
Univ. of
Missouri.
SRL #9
2.719, 1.627,
1.357, 0.542,
0.107, 0 g/dL
HbA1c;
12.386, 2.477
g/dL Hb
-
Univ. of
Missouri.
SRL #9
List of NGSP Certified Methods (Updated 2/15, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Roche
Diagnostics
TQ HbA1c
Gen. 2 Cobas
c111 (whole
blood)
Immunoassay
Dec ‘14
696556,
690814
178336
(std. 1-6)
Immunoassay
Dec ‘14
691274,
693275
175535
(std. 1-6)
Immunoassay
Dec ‘14
603033,
601319,
692236
175535
(std. 1-6)
Immunoassay
Dec ‘14
603033,
601319
175535
(std. 1-6)
Boronate
Affinity
Nov ‘14
F14F17F28
DL
Boronate
Affinity
Nov ‘14
Enzymatic
-
Univ. of
Missouri.
SRL #9
0.1142, 0.324,
0.617, 0.85,
1.153, 1.635,
mmol/L
HbA1c; 1.368,
7.38 mmol/L
Hb
0.13, 0.321,
0.628, 0.87,
1.186, 1.689,
mmol/L
HbA1c; 1.368,
7.38 mmol/L
Hb
-
Univ. of
Missouri.
SRL #9
-
Univ. of
Missouri.
SRL #9
-
-
-
C14G15H1
4DL
-
-
-
Nov ‘14
DAIOA
-
-
-
Univ. of
Missouri.
SRL #9
Univ. of
Missouri.
SRL #9
ReCCS
ASRL#1
Ionexchange
HPLC
Nov ‘14
20131209,
20131209,
20140321
PTHbA1c
130922E,
PTHbA1c
130922E
5.24%,
10.56%
20131209
ReCCS
ASRL#1
Enzymatic
Oct ‘14
Y4A896
-
-
-
ReCCS
ASRL#1
Immunoassay
Oct ‘14
14149,
13227
14125
-
Univ. of
Missouri.
SRL #9
Immunoassay
Oct ‘14
1402301
1400101
5.08%,
7.88%,
12.00%,
17.30%
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
HbA1c/Hb*91.5
+2.15
TQ HbA1c
Gen. 3 cobas
c311 (whole
blood)
HbA1c/Hb*91.5
+2.15
Infopia Co,
Ltd
i-SENS, Inc.
Labnovation
Technologies,
Inc.
Hitachi
Chemical Co.,
Ltd.
Medica Corp
HORIBA
Medical
Frontier and
HemoCue
HbA1c 501
Clover A1c,
Clover A1c
Self, Checkart
A1Care
HbA1c assay
(Enzymatic
method)
CationExchange
HPLC HbA1c
Analyzer LD500
Seratestum
A1C
HbA1c Latex
ImmunoAssay
on EasyRA
t
HbA1c WB
Whole Blood
Pentra C400
Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9
-
HbA1c/Hb*91.5
+2.15
TQ HbA1c
Gen. 3 (ME)
cobas c311
(hemolysate)
Column
Lot
0.02566,
0.01551,
0.01301,
0.00541,
0.00136, 0
g/dL HbA1c;
0.12302,
0.02438 g/dL
Hb
2.650, 1.586,
1.323, 0.528,
0.104, 0 g/dL
HbA1c;
12.386, 2.477
g/dL Hb
HbA1c/Hb*91.5
+2.15
TQ HbA1c
Gen. 2 Cobas
Integra 400
(whole blood)
Calibrator
Assigned
Value
Y=(0.47*X)+2.02
4
List of NGSP Certified Methods (Updated 2/15, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
HbA1c WB
Whole Blood
Pentra 400
Immunoassay
Oct ‘14
1402301
1400101
Immunoassay
Oct ‘14
1402301
1400101
Immunoassay
Oct ‘14
1402301
1400101
Immunoassay
Oct ‘14
1402301
1400101
Immunoassay
Sept ‘14
451405
Ionexchange
HPLC
Ionexchange
HPLC
Sept ‘14
64005855,
64005856,
64004945
A1-101X,
A1-201X,
1-301X,
HW-05Y
64005760,
64005762
JS4001
5.90%,
10.96%
Immunoassay
Sept ‘14
A1C02140010,
A1C02140011,
A1C02140012
-
Enzymatic
Sept ‘14
044614001
044614001
t
HORIBA
Medical
Y=(0.47*X)+2.02
t
HbA1c WB
Hemolysate
Pentra C400
Y=(0.43*X)+2.25
t
HbA1c WB
Hemolysate
Pentra 400
Y=(0.43*X)+2.25
t
HbA1c WB
Hemolysate
Pentra C200
Y=(0.36*X)+2.30
Sakae
Corporation
Bio-Rad
Laboratories,
Inc
Tosoh
Corporation
SD Biosensor,
Inc.
Mindray
t
Medidas
HbA1c on A1c
iGear
Variant II Dual
(A2/F/A1c)
0.5 min
Standard
Analysis Mode
on HLC723G11
t
SD A1cCare
System
t
Enzymatic on
BS-200E
Sept ‘14
STS010
t
Enzymatic on
BS-400
Enzymatic
Sept ‘14
044614001
044614001
t
Enzymatic on
BS-480
Enzymatic
Sept ‘14
044614001
044614001
5
Calibrator
Assigned
Value
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
0.0%, 4.9%,
8.9%, 12.5%,
13.9%
5.3%, 9.9%
Column
Lot
-
Secondary
Reference
Laboratory
European
Reference Lab
ESRL#10
-
European
Reference Lab
ESRL#10
-
European
Reference Lab
ESRL#10
-
European
Reference Lab
ESRL#10
-
ReCCS
ASRL#1
SA20900
Univ. of Minn
SRL #10
XA0001A
Univ. of
Missouri.
SRL #9
-
-
3.80, 16.00
µmol/L
HbA1c;
95.70, 150.40
µmol/L Hb
3.80, 16.00
µmol/L
HbA1c;
95.70, 150.40
µmol/L Hb
3.80, 16.00
µmol/L
HbA1c;
95.70, 150.40
µmol/L Hb
-
ReCCS
ASRL#1
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
List of NGSP Certified Methods (Updated 2/15, listed by date certified)
Manufacturer
Mindray
Quotient
Diagnostics
Limited
Wuxi
BioHermes
Bio & Medical
Technology
Co., Ltd.
Polymer
Technology
Systems, Inc.
(PTS)
Beckman
Coulter Ireland
Inc.
Ortho Clinical
Diagnostics
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Enzymatic on
BS-800/800M
Enzymatic
Sept ‘14
044614001
044614001
t
Enzymatic on
BS2000/2000M
Enzymatic
Sept ‘14
044614001
044614001
Quo-Test
HbA1c Test on
Quo-Test
Quo-Lab
HbA1c Test on
Quo-Lab
Boric Acid
Affinity
Chromatograp
hy on A1C EZ
Boronate
affinity
Sept ‘14
020202
Boronate
affinity
Sept ‘14
Boronate
affinity
A1CNow+,
A1CNow
Selfcheck
HbA1c
B00389
Manual
Application
AU2700
HbA1c
B00389
Manual
Application
AU640
HbA1c
B00389
Manual
Application
AU680
HbA1c
B00389
Manual
Application
AU480
d%A1c on
Vitros 5, 1FS
t
Column
Lot
-
Calibrator
Assigned
Value
3.80, 16.00
µmol/L
HbA1c;
95.70, 150.40
µmol/L Hb
3.80, 16.00
µmol/L
HbA1c;
95.70, 150.40
µmol/L Hb
-
025084
-
-
-
Sept ‘14
AP14072907,
ABA14061601,
ABB14061601
Y14030601
5.3%, 11.0%
-
Immunoassay
Sept ‘14
1407750
-
-
-
Univ. of
Missouri.
SRL #9
Immunoassay
Sept ‘14
0016,
M403186
0016
-
European
Reference Lab
ESRL #9
Immunoassay
Sept ‘14
0016,
M403186
0016
-
European
Reference Lab
ESRL #9
Immunoassay
Sept ‘14
0016,
M403186
0016
-
European
Reference Lab
ESRL #9
Immunoassay
Sept ‘14
0016,
M403186
0016
-
European
Reference Lab
ESRL #9
Immunoassay
Sept ‘14
1874
18741,
18742,
18743,
18744,
18745
0.093, 0.300,
0.559, 0.997,
1.48 mmol/L
HbA1c; 8.29
mmol/L THb
0.093, 0.300,
0.559, 0.997,
1.48 mmol/L
HbA1c; 8.29
mmol/L THb
0.093, 0.300,
0.559, 0.997,
1.48 mmol/L
HbA1c; 8.29
mmol/L THb
0.093, 0.300,
0.559, 0.997,
1.48 mmol/L
HbA1c; 8.29
mmol/L THb
0, 0.48, 0.89,
1.47, 2.15
g/dL HbA1c;
-0.71, 13.86
g/dL Hb
-
Univ. of
Missouri.
SRL #9
6
-
Secondary
Reference
Laboratory
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
European
Reference Lab
ESRL #11
European
Reference Lab
ESRL #11
Univ. of
Missouri.
SRL #9
List of NGSP Certified Methods (Updated 2/15, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Ortho Clinical
Diagnostics
HbA1c on
Vitros 5, 1FS
Immunoassay
Sept ‘14
Not assigned
31
HbA1c on
Vitros 4600
Immunoassay
Sept ‘14
Not assigned
31
HbA1c on
Vitros 5600
Immunoassay
Sept ‘14
Not assigned
31
HB1C on
Dimension
Xpand
Immunoassay
Sept ‘14
GC5128
GC5128
HB1C on
Dimension
ExL
Immunoassay
Sept ‘14
GC5128
GC5128
HB1C on
Dimension
RxL RMS
Immunoassay
Sept ‘14
GC5128
GC5128
t
MetaboLead
HbA1c on JCABM9130
Enzymatic
Sept ‘14
124ADD,
124ADD
124ADF
t
MetaboLead
HbA1c on DMJACK
Enzymatic
Sept ‘14
124ADD,
124ADD
124ADF
Enzymatic
Sept ‘14
124ADD,
124ADD
124ADF
Siemens
Healthcare
Diagnostics
Kyowa Medex
Co., Ltd.
t
MetaboLead
HbA1c on
Hitachi-7180
7
Calibrator
Assigned
Value
0.147, 0.868,
1.792, 4.256
g/dL HbA1c;
-1.069,
2.678, 7.056,
16.059 g/dL
Hb
0.147, 0.855,
1.799, 4.349
g/dL HbA1c;
-1.069,
2.678, 7.056,
16.059 g/dL
Hb
0.147, 0.855,
1.799, 4.349
g/dL HbA1c;
-1.069,
2.678, 7.056,
16.059 g/dL
Hb
0.16, 0.70,
1.37, 2.25,
3.05 g/dL
HbA1c;
14.94, 14.56
g/dL Hb
0.16, 0.70,
1.37, 2.25,
3.05 g/dL
HbA1c;
14.94, 14.56
g/dL Hb
0.16, 0.70,
1.37, 2.25,
3.05 g/dL
HbA1c;
14.94, 14.56
g/dL Hb
Column
Lot
2.54, 10.04
µmol/L
HbA1c; 87.8,
126.6 µmol/L
Hb
2.54, 10.04
µmol/L
HbA1c; 87.8,
126.6 µmol/L
Hb
2.54, 10.04
µmol/L
HbA1c; 87.8,
126.6 µmol/L
Hb
-
Secondary
Reference
Laboratory
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
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
ReCCS
ASRL#1
List of NGSP Certified Methods (Updated 2/15, 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 ‘14
124ADD,
124ADD
124ADF
-
JEOL Ltd.
t
BM Test
HbA1c on JCABM 6010/C
Enzymatic
Sept ‘14
814RFL,
814RFL,
812RDL
903RFL
2.54, 10.04
µmol/L
HbA1c; 87.8,
126.6 µmol/L
Hb
3.39, 15.25
µmol/L
HbA1c, 97.5,
151.4 µmol/L
Hb
-
ReCCS
ASRL#1
Beckman
Coulter, Inc.
HBA1c on
UniCel DxC
800
Immunoassay
Sept ‘14
M401030,
M310008,
M405331,
M209413
M401030
-
Univ. of
Missouri.
SRL #9
t
Immuno assay
on AGA1C
Immunoassay
Sept ‘14
14050054,
14050055,
14050047
1604404100
0.171, 0.463,
0.840, 1.484,
2.328 g/dL
HbA1c;
19.240 g/dL
Hb
5.1%, 8.5%,
12.2% 15.8%
-
t
Immuno assay
on Mispa i2
Immunoassay
Sept ‘14
18284041,
18284041,
18064021
1604404100
5.1%, 8.5%,
12.2% 15.8%
-
t
Immuno assay
on Mispa i3
Immunoassay
Sept ‘14
18284041,
18284041,
18064021
1604404100
5.1%, 8.5%,
12.2% 15.8%
-
t
Immuno assay
on Mispa i4
Immunoassay
Sept ‘14
18284041,
18284041,
18064021
1604404100
5.1%, 8.5%,
12.2% 15.8%
-
Erba Mannheim
Hb-Vario
Ionexchange
HPLC
Immunoassay
Aug ‘14
HBR-001
HVC1-064,
HVC2-064
5.3%, 11.8%
HBR-001
Aug ‘14
802899453,
802899454,
802899955
0%, 4.2%,
6.9%, 9.7%,
13.1%
-
Immunoassay
Aug ‘14
W207E402
A
802899238,
802899239,
802899240,
802899241,
802899242
JCCAL-SC2
European
Reference Lab
ESRL#10
European
Reference Lab
ESRL#10
European
Reference Lab
ESRL#10
European
Reference Lab
ESRL#10
Univ. of
Missouri.
SRL #9
European
Reference Lab
ESRL#12
7.55%, 10.05%,
5.60%, 6.75%,
5.20%, 6.15%,
10.75%, 9.00%,
8.35%, 10.15%
-
ReCCS
ASRL#1
Immunoassay
Aug ‘14
S00107
BBC00009AL,
BBC00009AM,
BBC00009AH
4.4%, 6.2%,
9.7%
-
Ionexchange
HPLC
July ‘14
201302
5.8%, 10.6%
3F014Q
Ionexchange
HPLC
July ‘14
3C1201,
3F1211,
3D1501,
3D1221
201351,
201302,
201318,
201344
European
Reference Lab
ESRL#9
European
Reference Lab
ESRL#10
201302
5.8%, 10.6%
3I027Y
Agappe
Diagnostics
Ltd.
Erba
Diagnostics,
Inc
Axis-Shield
Guangzhou
Wondfo
Biotech Co.,
Ltd.
Apex
Biotechnology
Corp.
A.Menarini
Diagnostics
Axis-Shield
HbA1c kit on
Siemens Advia
2400
t
Fluorescence
immunoassay
t
Immunoagglutination
on Eclipse A1c
Auto A1c HA8180V
ADAMS
Auto A1c HA8160 ADAMS
8
Secondary
Reference
Laboratory
ReCCS
ASRL#1
European
Reference Lab
ESRL#10
List of NGSP Certified Methods (Updated 2/15, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Ceragem
Medisys Inc.
Boronate
Affinity on
LabonaCheck
A1c HbA1c
Analyzer
Boronate
affinity
July ‘14
H04F101,
H04F102,
HM236
ARJEW
-
Siemens
Healthcare
Diagnostics
Hemoglobin
A1c 3 (A1c 3)
– Automated
Pretreatment
on Advia
1650/1800
Muligent on
Architect
c16000
HbA1c=HbA1
c/THb*1003+(0.2*THb)
Muligent on
Architect
c8000
HbA1c=HbA1
c/THb*1003+(0.2*THb)
Muligent on
Architect
c4000
HbA1c=HbA1
c/THb*1003+(0.2*THb)
t
Medidas
HbA1c on A1c
GEAR
TQ HbA1c
Gen. 2
hemolysate on
Cobas Integra
800
Immunoassay
June ‘14
140
3LD168
Immunoassay
June ‘14
39694UN13
451785
Immunoassay
June ‘14
39694UN13
Immunoassay
June ‘14
Immunoassay
Thermo Fisher
Diagnostics
Sakae
Corporation
Roche
Diagnostics
Calibrator
Assigned
Value
-
Column
Lot
2.74, 3.68,
4.85, 6.20
µmol/L
hbA1c;
12.41, 11.71
g/dL Hb
0.00, 0.391,
0.664, 0.857,
1.231, 1.830
g/dL hbA1c;
18.0 g/dL Hb
-
Univ. of
Missouri.
SRL #9
-
Univ. of
Missouri.
SRL #9
451785
0.00, 0.391,
0.664, 0.857,
1.231, 1.830
g/dL hbA1c;
18.0 g/dL Hb
-
Univ. of
Missouri.
SRL #9
39694UN13
451785
0.00, 0.391,
0.664, 0.857,
1.231, 1.830
g/dL hbA1c;
18.0 g/dL Hb
-
Univ. of
Missouri.
SRL #9
June ‘14
461401
STS010
-
ReCCS
ASRL#1
Immunoassay
June ‘14
680508,
682129,
694569
171434
(Std. 1-6)
0.0%, 4.9%,
8.9%, 12.5%,
13.9%
3.034, 1.788,
1.482, 0.55,
0.054, 0 g/dL
HbA1c;
11.968, 2.394
g/dL Hb
-
Univ. of
Missouri.
SRL #9
Immunoassay
June ‘14
680508,
694569
171434
(Std. 1-6)
0.0287,
0.01709,
0.01424,
0.00556,
0.00094, 0
g/dL HbA1c;
0.11968,
0.02394 g/dL
Hb
-
Univ. of
Missouri.
SRL #9
(HbA1c/Hb*91.5+
2.15)
TQ HbA1c
Gen. 2 whole
blood on
Cobas Integra
800
(HbA1c/Hb*91.5+
2.15)
9
-
Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9
List of NGSP Certified Methods (Updated 2/15, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Roche
Diagnostics
TQ HbA1c
Gen. 3
hemolysate on
Immunoassay
June ‘14
687516,
682129,
696499
171434
(Std. 1-6)
Immunoassay
June ‘14
687516,
696499
171434
(Std. 1-6)
Ionexchange
HPLC
June ‘14
K7-104W,
K7-203W,
7-303W,
HW-14W
ZS3002
Ionexchange
HPLC
June ‘14
K7-104W,
K7-203W,
7-303W,
HW-14W
JS3001
Ionexchange
HPLC
June ‘14
E8-107T,
E8-204T,
8-303T,
HW-14W
Ionexchange
HPLC
June ‘14
Ionexchange
HPLC
June ‘14
G9 HbA1c,
HLC-723G9
Ionexchange
HPLC
June ‘14
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 ‘14
Ionexchange
HPLC
Ionexchange
HPLC
cobas c501/502
(HbA1c/Hb*91.5+
2.15)
TQ HbA1c
Gen. 3 whole
blood on cobas
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
Univ. of
Missouri.
SRL #9
K
Univ. of
Missouri.
SRL #9
5.75%,
10.78%
K
Univ. of
Missouri.
SRL #9
ZS3002
5.83%,
11.00%
E
Univ. of
Missouri.
SRL #9
E8-107T,
E8-204T,
8-303T,
HW-14W
JS3001
5.75%,
10.78%
E
Univ. of
Missouri.
SRL #9
A9-103T,
A9-202T,
9-302T,
HW-19T
A9-103T,
A9-202T,
9-302T,
HW-19T
F8-101W,
F8-201W,
F8-301W,
HW-14W
ZS3002
5.83%,
11.00%
A
Univ. of
Missouri.
SRL #9
JS3001
5.75%,
10.78%
A
Univ. of
Missouri.
SRL #9
ZS3002
5.83%,
11.00%
F
Univ. of
Missouri.
SRL #9
June ‘14
H7-107W,
H7-202W,
H7-303T,
HW-14W
ZS3002
5.83%,
11.00%
H
Univ. of
Missouri.
SRL #9
June ‘14
AX-103W,
AX-203W,
AX-303W,
HW-14W
ZS3002
5.83%,
11.00%
A
Univ. of
Missouri.
SRL #9
c501/502
t
Column
Lot
-
(HbA1c/Hb*91.5+
2.15)
Tosoh
Corporation
Calibrator
Assigned
Value
0.147, 0.344,
0.659, 0.911,
1.236, 1.757
mmol/L
HbA1c;
1.337, 7.209
mmol/L Hb
0.145, 0.345,
0.666, 0.922,
1.253, 1.782
mmol/L
HbA1c;
1.337, 7.209
mmol/L Hb
5.83%,
11.00%
10
List of NGSP Certified Methods (Updated 2/15, listed by date certified)
Manufacturer
Method/
Instrument
t
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
5.75%,
10.78%
Column
Lot
-
-
-
-
-
-
5.4%, 8.4%,
11.4%,
15.8%
6.3%, 11.7%
-
Tosoh
Corporation
GX
HLC-723GX
Ionexchange
HPLC
June ‘14
Siemens
Healthcare
Diagnostics
DCA 2000+
Immunoassay
June ‘14
AX-103W,
AX-203W,
AX-303W,
HW-14W
0785034
DCA Vantage
Immunoassay
June ‘14
0785034
Direct HbA1c
on CLC720
Immunoassay
May ‘14
10245,
10245
LPLC (Low
Pressure Liquid
Chromatography)
LPLC
May ‘14
2013102801
Ionexchange
HPLC
May ‘14
4A1012,
3J1022,
4C1052
CA83G30,
CA83G34,
CA83G35,
S3003
5.4%, 10.3%;
5.4%, 10.3%;
5.4%, 10.3%;
5.4%, 10.3%
Enzymatic
May ‘14
45065UQ01,
45065UQ01,
45065UQ
44599UQ08
Enzymatic
May ‘14
45065UQ01,
45065UQ01,
45065UQ
Enzymatic
May ‘14
Enzymatic
Carolina
Liquid
Chemistries
Shenzhen
Lifotronic
Technology
Co., Ltd.
Arkray, Inc.
Abbott
Laboratories
on GH-900
HbA1c
Analyzer
ADAMS
HYBRID AH8290
t
HbA1c
(Hemolysate)
on Architect
c8000
JS3001
A1479
2013102801
A
2013102801
Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9
Univ. of
Missouri.
SRL #9
Univ. of
Missouri.
SRL #9
Univ. of
Missouri.
SRL #9
ReCCS
ASRL#1
4C201N
Univ. of
Missouri.
SRL #9
5.3%,
11.6%
-
Univ. of
Missouri.
SRL #9
44599UQ08
5.3%,
11.6%
-
Univ. of
Missouri.
SRL #9
45065UQ01,
45065UQ01,
45065UQ
44599UQ08
5.3%,
11.6%
-
Univ. of
Missouri.
SRL #9
May ‘14
45065UQ01,
45065UQ01,
45065UQ
44599UQ08
5.3%,
11.6%
-
Univ. of
Missouri.
SRL #9
Immunoassay
May ‘14
83130
CEN001
0.0%, 4.4%,
6.9%, 9.7%,
13.3%
-
ReCCS
ASRL#1
Immunoassay
Apr ‘14
13308BA
3LD001
0.10, 0.59,
1.14, 1.87,
2.67 g/dL
HbA1c; 15.19,
14.89 g/dL Hb
-
Univ. of
Missouri.
SRL #9
%NGSP=HbA1c/
Hb*91.48+2.152
t
HbA1c
(Whole Blood)
on Architect
c8000
%NGSP=HbA1c/
Hb*91.48+2.152
t
HbA1c
(Hemolysate)
on Architect
c4000
%NGSP=HbA1c/
Hb*91.48+2.152
t
HbA1c
(Whole Blood)
on Architect
c4000
%NGSP=HbA1c/
Hb*91.48+2.152
Nihon Kohden
Corporation
Celltac Chemi
HbA1c on
CHM-4100
(NGSP(%)=1.02*
JDS(%)+0.25)
Siemens
Healthcare
Diagnostics
Dimension Vista
11
List of NGSP Certified Methods (Updated 2/15, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Beckman
Coulter, Inc.
HbA1c3 (Whole
Blood) on
UniCel DxC
Immunoassay
Apr ‘14
Arkray, Inc.
t
ADAMS A1c
HA-8160 VP
mode
Ionexchange
HPLC
Apr ‘14
t
ADAMS A1c
HA-8160 TP
mode
Ionexchange
HPLC
Apr ‘14
t
ADAMS A1c
HA-8160
(Ver.1)
Ionexchange
HPLC
Apr ‘14
t
ADAMS A1c
HA-8160
(Ver.4)
Ionexchange
HPLC
Apr ‘14
t
ADAMS A1c
HA-8170
Ionexchange
HPLC
Apr ‘14
t
ADAMS A1c
HA-8180
Ionexchange
HPLC
Apr ‘14
t
ADAMS A1c
HA-8180V
Variant mode
Ionexchange
HPLC
Apr ‘14
t
ADAMS A1c
HA-8180V
Fast mode
Ionexchange
HPLC
Apr ‘14
t
ADAMS A1c
HA-8180T
Ionexchange
HPLC
Apr ‘14
t
ADAMS
HYBRID AH8280
Ionexchange
HPLC
Apr ‘14
t
ADAMS A1c
HA-8181
Ionexchange
HPLC
Apr ‘14
4A1012,
3J1022,
3K1051
t
Enzymatic
Apr ‘14
MFV06,
MFQ06
CinQ HbA1c
on JCA-BM8
HbA1c%=0.09148
IFCC(mmol/mol)*
1000+2.152
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
M402134,
M402275
M402134
-
13111531,
13092512,
13032633,
13051314
13111531,
13092512,
13071934,
13042535,
13091335
13051711,
13092512,
13041213,
13051314
13051657,
13080158,
13101859,
13112755
13051657,
13080158,
13101859,
13112755
4A1012,
3J1022,
3K1051
3G72;
S3003
0.171, 0.463,
0.840, 1.484,
2.328 g/dL
HbA1c; 19.24
g/dL Hb
5.4%, 10.4%;
5.4%, 10.4%
3G72;
S3003
4A1012,
3J1022,
3G1401,
3K1051
4A1012,
3J1022,
3G1401,
3K1051
4A1012,
3J1022,
3I1601,
3K1051
4A1012,
3J1022,
3I1301
12
Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9
3L091Y
Univ. of
Missouri.
SRL #9
5.4%, 10.4%;
5.4%, 10.4%
3IW-1AR
Univ. of
Missouri.
SRL #9
3G72;
S3003
5.4%, 10.4%;
5.4%, 10.4%
3L001X
Univ. of
Missouri.
SRL #9
3G70,
3G71,
3G72;
S3003
3G70,
3G71,
3G72;
S3003
CA83G30,
CA83G34,
CA83G35,
S3003
CA83G30,
CA83G34,
CA83G35,
S3003
CA83G30,
CA83G34,
CA83G35,
S3003
CA83G30,
CA83G34,
CA83G35,
S3003
CA83G30,
CA83G34,
CA83G35,
S3003
CA83G30,
CA83G34,
CA83G35,
S3003
CAE4C33,
131201
5.3%, 10.3%;
5.3%, 10.3%;
5.3%, 10.3%;
5.3%, 10.3%
3L171F
Univ. of
Missouri.
SRL #9
5.3%, 10.3%;
5.3%, 10.3%;
5.3%, 10.3%;
5.3%, 10.3%
3L041G
Univ. of
Missouri.
SRL #9
5.4%, 10.3%;
5.4%, 10.3%;
5.4%, 10.3%;
5.4%, 10.3%
3L202N
Univ. of
Missouri.
SRL #9
5.4%, 10.3%;
5.4%, 10.3%;
5.4%, 10.3%;
5.4%, 10.3%
3L046U
Univ. of
Missouri.
SRL #9
5.4%, 10.3%;
5.4%, 10.3%;
5.4%, 10.3%;
5.4%, 10.3%
3L046U
Univ. of
Missouri.
SRL #9
5.4%, 10.3%;
5.4%, 10.3%;
5.4%, 10.3%;
5.4%, 10.3%
3L005L
Univ. of
Missouri.
SRL #9
5.4%, 10.3%;
5.4%, 10.3%;
5.4%, 10.3%;
5.4%, 10.3%
4AN-1AR
Univ. of
Missouri.
SRL #9
5.4%, 10.3%;
5.4%, 10.3%;
5.4%, 10.3%;
5.4%, 10.3%
3KN-1AR
Univ. of
Missouri.
SRL #9
2.48, 7.08
µmol/L HbA1c
(IFCC), 88.3,
94.7 µmol/L Hb;
2.48, 7.08
µmol/L HbA1c
(IFCC), 88.3,
94.7 µmol/L Hb
-
Univ. of
Missouri.
SRL #9
List of NGSP Certified Methods (Updated 2/15, listed by date certified)
Manufacturer
Arkray, Inc.
Method/
Instrument
t
CinQ HbA1c
on JCABM9130
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
2.47, 6.99
µmol/L
HbA1c;
85.1, 93.2
µmol/L Hb
2.47, 6.99
µmol/L
HbA1c;
85.1, 93.2
µmol/L Hb
Column
Lot
Enzymatic
Apr ‘14
MFV05,
MFQ05
CAC3J14,
CAC3J14
Enzymatic
Apr ‘14
MFV05,
MFQ05
CAC3J14,
CAC3J14
-
Univ. of
Missouri.
SRL #9
Capillary
Electrophoresis
Apr ‘14
16043/20,
03043/01,
03073/01
27033/01,
28033/01
35.2, 86.8
mmol/mol
-
European
Reference Lab
ESRL#10
Capillary
Electrophoresis
Apr ‘14
29073/01,
24073/01,
09073/01
27033/01,
28033/01
35.2, 86.8
mmol/mol
-
European
Reference Lab
ESRL#10
Capillary
Electrophoresis
Immunoassay
Apr ‘14
04093/01,
05093/01
34.8, 84.9
mmol/mol
-
Apr ‘14
25113/80,
10123/01,
17103/01
124740
124740
0.50, 0.93,
1.59, 2.31
g/dL HbA1c;
12.9 g/dL Hb
-
European
Reference Lab
ESRL#10
Univ. of
Missouri.
SRL #9
Immunoassay
Apr ‘14
124740
124740
0.50, 0.93,
1.59, 2.31
g/dL HbA1c;
12.9 g/dL Hb
-
Univ. of
Missouri.
SRL #9
Immunoassay
Apr ‘14
124740
124740
0.50, 0.93,
1.59, 2.31
g/dL HbA1c;
12.9 g/dL Hb
-
Univ. of
Missouri.
SRL #9
Immunoassay
Apr ‘14
124740
124740
0.50, 0.93,
1.59, 2.31
g/dL HbA1c;
12.9 g/dL Hb
-
Univ. of
Missouri.
SRL #9
Immunoassay
Apr ‘14
1407EK268O
30601
0.0, 27.0,
50.0, 82.0,
115.0
mmol/mol
-
ReCCS
ASRL#1
Immunoassay
Apr ‘14
1407EK468O
30601
0.0, 27.1,
51.8, 85.5,
120.7
mmol/mol
-
ReCCS
ASRL#1
HbA1c%=0.0915
IFCC(mmol/mol)*
1000+2.152
t
CinQ HbA1c
on Hitachi
LABOSPECT
006
HbA1c%=0.0915
IFCC(mmol/mol)*
1000+2.152
Sebia
Capillarys
HbA1c on
Capillarys 2
Flex Piercing
-
Secondary
Reference
Laboratory
Univ. of
Missouri.
SRL #9
%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
Wiener
Laboratorios
t
HbA1c
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 400i
ROHM Co.,
Ltd.
91.5*HbA1c/Hb
+ 2.15
t
Banalyst Ace
HbA1c on
Banalyst Ace
NGSP=0.0981*
IFCC+1.95
t
B-analyst
HbA1c on BAnalyst S1
NGSP=0.0915*
IFCC+2.15
13
List of NGSP Certified Methods (Updated 2/15, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
ROHM Co.,
Ltd.
t
Spotchem
Banalyst HbA1c
on Spotchem
Banalyst SI3610
NGSP=0.0981*
IFCC+1.95
Immunoassay
Apr ‘14
1407EK068O
30601
t
Immunoassay
Apr ‘14
QF31106,
RF31106,
NF31203
Immunoassay
Apr ‘14
QF31106,
RF31106,
NF31203
Boronate
affinity
Apr ‘14
10163186
Boronate
affinity
Apr ‘14
Boronate
affinity
TFB, Inc.
Rapidia Auto
HbA1c-L on
BiOLis24i
Premium
Calibrator
Lot
Calibrator
Assigned
Value
0.0, 27.0,
50.0, 82.0,
115.0
mmol/mol
Column
Lot
VF40100
0.0%, 4.3%,
7.0%, 9.9%,
13.5%
-
ReCCS
ASRL#1
VF40100
0.0%, 4.3%,
7.0%, 9.9%,
13.5%
-
ReCCS
ASRL#1
-
-
-
European
Reference Lab
ESRL #11
-
-
-
Mar ‘14
10158008,
10163829,
10167396
4295
-
-
-
Boronate
affinity
HPLC
Mar ‘14
4638, 4342
4311, 4312
6.0%, 10.4%
PPE-08044060
European
Reference Lab
ESRL #11
Univ. of
Missouri.
SRL #3
Univ. of
Missouri.
SRL #3
Boronate
affinity
HPLC
Mar ‘14
4638, 4342
4311, 4312
5.9%, 10.1%
PPE-01634584
Univ. of
Missouri.
SRL #3
Boronate
affinity
HPLC
Mar ‘14
4638, 4342
4311, 4312
6.0%, 10.4%
PPE-01304388
Univ. of
Missouri.
SRL #3
Boronate
affinity
HPLC
Mar ‘14
4373, 4453
4311, 4312
6.0%, 10.3%
4404-1308
Univ. of
Missouri.
SRL #3
Immunoassay
Mar ‘14
AR237,
AR240
AR237
0.49, 0.87,
1.50, 2.32
g/dL HbA1c;
12.8 g/dL Hb
-
ReCCS
ASRL#1
-
Secondary
Reference
Laboratory
ReCCS
ASRL#1
NGSP(%)=1.02
X JDS(%) +
0.25
t
Rapidia Auto
HbA1c-L on
AU680
NGSP(%)=1.02
X JDS(%) +
0.25
Axis-Shield
PoC AS
Trinity
Biotech
Wako Pure
Chemical
Industries, Ltd.
Afinion
HbA1c /
Afinion
AS100
Analyzer
NycoCard /
NycoCard
Reader II
TriSTAT
GHb/HbA1c
HPLC
Boronate
Affinity on
CLC385
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
14
List of NGSP Certified Methods (Updated 2/15, listed by date certified)
Manufacturer
Wako Pure
Chemical
Industries, Ltd.
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
t
Immunoassay
Mar ‘14
AR237,
AR240
AR237
t
Autokit
HbA1c on
TBA-c16000
Immunoassay
Mar ‘14
AR237,
AR240
AR237
RC20
Ionexchange
HPLC
Mar ‘14
131031
130617L,
130617H
t
HbA1c
AUTO TBA
on TBA120FR
Enzymatic
Mar ‘14
802RJK
901RJK
t
Enzymatic
Mar ‘14
801RLK,
801RLK,
801RAL
801RAL
Enzymatic
Mar ‘14
801RLK,
801RLK,
801RAL
801RAL
Enzymatic
Mar ‘14
841RJK,
844RJK,
834RJK
003RJK
Norudia N
HbA1c on
EV800
Enzymatic
Mar ‘14
841RJK,
844RJK,
834RJK
003RJK
t
Norudia N
HbA1c on
TBA-120FR
Enzymatic
Mar ‘14
841RJK,
844RJK,
834RJK
003RJK
t
Norudia N
HbA1c on
JCA-BM9130
Enzymatic
Mar ‘14
841RJK,
844RJK,
834RJK
003RJK
t
Immunoassay
Mar ‘14
QF31106,
RF31106,
NF31203
VF40100
Autokit
HbA1c on
JCA-BM6050
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
t
TFB, Inc.
Rapidia Auto
HbA1c-L on
TBA-120FR
NGSP(%)=1.02
X JDS(%) +
0.25
15
Calibrator
Assigned
Value
0.49, 0.87,
1.50, 2.32
g/dL HbA1c;
12.8 g/dL Hb
0.49, 0.87,
1.50, 2.32
g/dL HbA1c;
12.8 g/dL Hb
5.37%,
10.94%
3.33, 15.29
µmol/L
HbA1c; 98.1,
153.0
µmol/L Hb
3.00,
15.24µmol/L
HbA1c;
100.3, 144.2
µmol/L Hb
3.00,
15.24µmol/L
HbA1c;
100.3, 144.2
µmol/L Hb
3.33, 15.29
µmol/L
HbA1c; 98.1,
153.0
µmol/L Hb
3.33, 15.29
µmol/L
HbA1c; 98.1,
153.0
µmol/L Hb
3.33, 15.29
µmol/L
HbA1c; 98.1,
153.0
µmol/L Hb
3.33, 15.29
µmol/L
HbA1c; 98.1,
153.0
µmol/L Hb
0.0%, 4.3%,
7.0%, 9.9%,
13.5%
Column
Lot
-
Secondary
Reference
Laboratory
ReCCS
ASRL#1
-
ReCCS
ASRL#1
2013103023
ReCCS
ASRL#1
-
ReCCS
ASRL#1
-
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 2/15, listed by date certified)
Manufacturer
Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Rapidia Auto
HbA1c-L on
Hitachi 7170s
Immunoassay
Mar ‘14
QF31106,
RF31106,
NF31203
VF40100
Immunoassay
Mar ‘14
QF31106,
RF31106,
NF31203
Determiner
ImmunoHbA1c on
assay
DM-JACK
t
Determiner
ImmunoHbA1c on
assay
JCA-BM9130
t
Determiner
ImmunoHbA1c on
assay
Hitachi 7180
t
.
Determiner L ImmunoHbA1c on
assay
DM-JACK
t
Determiner L ImmunoHbA1c on
assay
JCA-BM9130
Determiner L
ImmunoHbA1c on
assay
Hitachi 7180
t
Determiner L ImmunoHbA1c on
assay
TBA-120FR
t
Method is not available in the US
@
Method is not currently available
Mar ‘14
TFB, Inc.
t
Calibrator
Assigned
Value
0.0%, 4.3%,
7.0%, 9.9%,
13.5%
Column
Lot
VF40100
0.0%, 4.3%,
7.0%, 9.9%,
13.5%
-
ReCCS
ASRL#1
360ACH,
360ACJ
504ACI
-
ReCCS
ASRL#1
Mar ‘14
382ACH,
382ACJ
504ACI
-
ReCCS
ASRL#1
Mar ‘14
382ACH,
382ACJ
504ACI
-
ReCCS
ASRL#1
Mar ‘14
130ACI,
130ACI
306ACH
-
ReCCS
ASRL#1
Mar ‘14
130ACI,
130ACI
306ACH
-
ReCCS
ASRL#1
Mar ‘14
130ACI,
130ACI
306ACH
-
ReCCS
ASRL#1
Mar ‘14
130ACI,
130ACI
306ACH
0.0%, 4.9%,
8.8%, 12.9%,
15.8%
0.0%, 4.9%,
8.8%, 12.9%,
15.8%
0.0%, 4.9%,
8.8%, 12.9%,
15.8%
0.0%, 4.7%,
6.9%, 10.1%,
13.7%
0.0%, 4.4%,
7.0%, 10.1%,
13.7%
0.0%, 4.4%,
7.0%, 10.1%,
13.7%
0.0%, 4.4%,
7.0%, 10.1%,
13.7%
-
ReCCS
ASRL#1
-
Secondary
Reference
Laboratory
ReCCS
ASRL#1
NGSP(%)=1.02
X JDS(%) +
0.25
t
Rapidia Auto
HbA1c-L on
JCA-BM9130
NGSP(%)=1.02
X JDS(%) +
0.25
Kyowa Medex
Co., Ltd.
t
16