list of ngsp certified methods
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8/18/2019 List of NGSP Certified Methods
1/17
1
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
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
Nova
Biomedical
Allegro,
Immunoassay
Immuno-
assay
Apr ‘16 16022010 - - - Univ. of
Missouri.SRL #9
Boditech Med
Inc.
Immuno-assay
on AFIAS
HbA1c
Immuno-
assay
Apr ‘16 AAMAA05F 502101 5.1%, 8.1%,
10.8%,
13.5%
- ReCCS
ASRL#1
Getein
Biotech, Inc.
Colloidal Gold
on Getein
8600/8000
Immuno-
assay
Apr ‘16 6BC16006 16006 5.25%,
10.55%
- ReCCS
ASRL#1
Immunofluore
scence Assay
on Getein1600
Immuno-
assay
Apr ‘16 PBC16005 16006 5.25%,
10.55%
- ReCCS
ASRL#1
Immunofluore
scence Assayon Getein
1100
Immuno-
assay
Apr ‘16 YBC16006 16006 5.25%,
10.55%
- ReCCS
ASRL#1
Wuxi
Biohermes Bio
& MedicalTechnology
Co., Ltd.
Boronate
Affinity on
A1c EZ 2.0
Boronate
affinity
Apr ‘16 AP151208
05
- - - ReCCS
ASRL#1
Sebia
Capillarys
HbA1c on
Capillarys 2Flex Piercing
%NGSP=0.09148x [IFCC]
(mmol/mol) +2.152
Capillary
Electro-
phoresis
Apr ‘16 14095/01,
20075/01,
12035/01
08045/01,
09045/01
35.5, 86.4
mmol/mol
- European
Reference La
ESRL#10
Minicap
HbA1c%NGSP=0.09148
x [IFCC]
(mmol/mol) +
2.152
Capillary
Electro- phoresis
Apr ‘16 08065/01,
02094/80,11055/01
07015/01,
08015/01
37.4, 85.8
mmol/mol
- European
Reference LaESRL#10
-
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2/17
List of NGSP Certified Methods (Updated 4/16, listed by date certified)
2
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
Sebia CAPI 3
HbA1c on
Capillarys 3%NGSP=0.09148
x [IFCC]
(mmol/mol) +
2.152
Capillary
Electro-
phoresis
Apr ‘16 14095/01,
20075/01,
12035/01
06115/01,
09115/01
36.8, 83.8
mmol/mol
- European
Reference La
ESRL#10
Wiener
Laboratorios
tHbA1cTurbitest AA on
CMD 800i X191.5*HbA1c/Hb
+ 2.15
Immuno-
assay
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
tHbA1c
Turbitest AA
on CT 600i91.5*HbA1c/Hb
+ 2.15
Immuno-
assay
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
tHbA1c
Turbitest AA
on CM 250
91.5*HbA1c/Hb+ 2.15
Immuno-
assay
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
tHbA1c
Turbitest AA
on CB 350i91.5*HbA1c/Hb
+ 2.15
Immuno-
assay
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
tHbA1c v2
Turbitest AAon CT600i
91.5*HbA1c/Hb+ 2.15
Immuno-
assay
Apr ‘16 174050,
174050.174050,
169310
151007 2.883 g/dL
HbA1c;12.31 g/dL
Hb
- Univ. of
Missouri.SRL #9
tHbA1c v2
Turbitest AAon CM 25091.5*HbA1c/Hb
+ 2.15
Immuno-
assay
Apr ‘16 174050,
174050.174050,169310
151007 2.883 g/dL
HbA1c;12.31 g/dLHb
- Univ. of
Missouri.SRL #9
tHbA1c v2Turbitest AA on
CMD 800i X191.5*HbA1c/Hb
+ 2.15
Immuno-
assay
Apr ‘16 174050,
174050.
174050,
169310
151007 2.883 g/dL
HbA1c;
12.31 g/dL
Hb
- Univ. of
Missouri.
SRL #9
tHbA1c v2
Turbitest AA
on CB 350i91.5*HbA1c/Hb
+ 2.15
Immuno-
assay
Apr ‘16 174050,
174050.
174050,
169310
151007 2.883 g/dL
HbA1c;
12.31 g/dL
Hb
- Univ. of
Missouri.
SRL #9
Fujirebio Inc.
t
Rapidia AutoHbA1c-L on
BiOLis24i
Premium
Immuno-assay Apr ‘16 QF51103,RF51103,
SF50603
VF51103 0.0%, 4.3%,6.8%, 9.6%,
13.3%
- ReCCSASRL#1
t Rapidia Auto
HbA1c-L onJCA-BM9130
Immuno-
assay
Apr ‘16 QF51103,
RF51103,SF50603
VF51103 0.0%, 4.3%,
6.8%, 9.6%,13.3%
- ReCCS
ASRL#1
t AU-SynchronReagent
HbA1c on
AU680
Immuno-assay
Apr ‘16 F9A005,F9A005,
H2A003
H1A005 0.0%, 4.3%,6.8%, 9.6%,
13.3%
- ReCCSASRL#1
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3/17
List of NGSP Certified Methods (Updated 4/16, listed by date certified)
3
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
Fujirebio Inc. t Rapidia Auto
HbA1c-L on
AU680
Immuno-
assay
Apr ‘16 QF51103,
RF51103,
SF50603
VF51103 0.0%, 4.3%,
6.8%, 9.6%,
13.3%
- ReCCS
ASRL#1
t Rapidia Auto
HbA1c-L on
Hitachi 7170s
Immuno-
assay
Apr ‘16 QF51103,
RF51103,
NF50702
VF51103 0.0%, 4.3%,
6.8%, 9.6%,
13.3%
- ReCCS
ASRL#1
t Rapidia AutoHbA1c-L on
TBA-120FR
Immuno-assay
Apr ‘16 QF51103,RF51103,
SF50603
VF51103 0.0%, 4.3%,6.8%, 9.6%,
13.3%
- ReCCSASRL#1
Alere
Technologies
AS
Afinion
HbA1c /
Afinion
AS100Analyzer
Boronate
affinity
Apr ‘16 10176087 - - - European
Reference La
ESRL #11
Afinion
HbA1c Dx /Afinion
AS100
Analyzer
Boronate
affinity
Apr ‘16 10176087 - - - European
Reference LaESRL #11
Arkray, Inc. t ADAMS A1cHA-8160 VP
mode
Ion-exchange
HPLC
Apr ‘16 15071731,15061612,
15041033,
15120714
5D76;S5001
5.2%, 10.7%;5.2%, 10.7%
5H076Y ReCCSASRL#1
t ADAMS A1c
HA-8160 TP
mode
Ion-
exchange
HPLC
Apr ‘16 15071731,
15061612,
15121134,
15051535,15120714
5D76;
S5001
5.2%, 10.7%;5.2%, 10.7%
5G041W ReCCS
ASRL#1
t ADAMS A1cHA-8160
(Ver.1)
Ion-exchange
HPLC
Apr ‘16 15091611,15061612,
15062613,
15120714
5D76;S5001
5.2%, 10.7%;
5.2%, 10.7%5K001X ReCCS
ASRL#1
t ADAMS A1c
HA-8160
(Ver.4)
Ion-
exchange
HPLC
Apr ‘16 15121757,
15082858,
15072759,15111955
5D82;
S5001
5.2%, 10.5%;5.2%, 10.5%
5H051F ReCCS
ASRL#1
t ADAMS A1cHA-8170
Ion-exchange
HPLC
Apr ‘16 15121757,15082858,
15072759,
15111955
5D82;S5001
5.2%, 10.5%;5.2%, 10.5%
5H291G ReCCSASRL#1
t ADAMS A1c
HA-8180
Ion-
exchangeHPLC
Apr ‘16 6C1011,
6A1022,5I1051
CA85D53;
S5001
5.2%, 10.6%;5.2%, 10.6%
5J001N ReCCS
ASRL#1
t ADAMS A1c
HA-8180VVariant mode
Ion-
exchangeHPLC
Apr ‘16 6C1011,
6A1022,5D1401,
5I1051
CA85D51;
S5001
5.2%, 10.6%;
5.2%, 10.6%5H101U ReCCS
ASRL#1
t ADAMS A1cHA-8180V
Fast mode
Ion-exchange
HPLC
Apr ‘16 6C1011,6A1022,
5D1401,5I1051
CA85D51;S5001
5.2%, 10.6%;5.2%, 10.6%
5H101U ReCCSASRL#1
t ADAMS A1cHA-8180T
Ion-exchange
HPLC
Apr ‘16 6C1011,6A1022,
5E1601,
5I1051
CA85D51;S5001
5.2%, 10.6%;5.2%, 10.6%
5H007L ReCCSASRL#1
-
8/18/2019 List of NGSP Certified Methods
4/17
List of NGSP Certified Methods (Updated 4/16, listed by date certified)
4
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
Arkray, Inc. t ADAMS
HYBRID AH-
8290
Ion-
exchange
HPLC
Apr ‘16 6C1011,
6A1022,
5I1051
CA85D53;
S5001
5.2%, 10.6%;5.2%, 10.6%
5K401N ReCCS
ASRL#1
t ADAMS A1c
HA-8181
Ion-
exchange
HPLC
Apr ‘16 6C1011,
6A1022,
5I1051
CA85D53;
S5001
5.2%, 10.6%;
5.2%, 10.6%5J001N ReCCS
ASRL#1
t ADAMSHYBRID AH-
8280
Ion-exchange
HPLC
Apr ‘16 6C1011,6A1022,
5I1051
CA85D53;S5001
5.2%, 10.6%;
5.2%, 10.6%5G484N ReCCS
ASRL#1
t CinQ HbA1con BioMajestyJCA-BM6010
HbA1c%(NGSP)=0.0915*HbA1c/Hb*10
00(IFCC)+2.15
Enzymatic Apr ‘16 MFC03,
MFE03
CAC5C16 2.95, 7.31µmol/L HbA1c;
90.1, 96.9
µmol/L Hb
- ReCCS
ASRL#1
t CinQ HbA1con TBA-120FRHbA1c%(NGSP)=0.0915*HbA1c/Hb*10
00(IFCC)+2.15
Enzymatic Apr ‘16 MFC03,MFE03
CAC5C16 2.95, 7.31µmol/L HbA1c;
90.1, 96.9
µmol/L Hb
- ReCCSASRL#1
t CinQ HbA1con JCA-BM9130
HbA1c%(NGSP)=0.0915*HbA1c/Hb*10
00(IFCC)+2.15
EnzymaticApr ‘16 MFC03,MFE03 CAC5C16
2.95, 7.31
µmol/L HbA1c;90.1, 96.9
µmol/L Hb
- ReCCSASRL#1
t CinQ HbA1con Hitachi
LABOSPECT
006HbA1c%(NGSP)=0.0915*HbA1c/Hb*10
00(IFCC)+2.15
Enzymatic Apr ‘16 MFC03,
MFE03
CAC5C16 2.95, 7.31µmol/L HbA1c;
90.1, 96.9
µmol/L Hb
- ReCCS
ASRL#1
t ADAMS A1cLite HA-8380
Ion-exchange
HPLC
Apr ‘16 6C1011,6A1022,
151422255
C1L5D05;S5001
5.2%, 10.6%;5.2%, 10.6%
5K401N ReCCSASRL#1
t ADAMS A1cLite HA-
8380V Fastmode
Ion-exchange
HPLC
Apr ‘16 6C1011,6A1022,5D1401,
151422255
C1L5D06;S5001
5.2%, 10.6%;5.2%, 10.6%
5K194U ReCCSASRL#1
t ADAMS A1cLite HA-
8380V Variant
mode
Ion-exchange
HPLC
Apr ‘16 6C1011,6A1022,5D1401,
151422255
C1L5D06;S5001
5.2%, 10.6%;5.2%, 10.6%
5K194U ReCCSASRL#1
t ADAMS A1c
HA-8182
Ion-
exchange
HPLC
Apr ‘16 6C1011,6A1022,
5I1051
CA85D53;S5001
5.2%, 10.6%;
5.2%, 10.6%
5J001N ReCCS
ASRL#1
SD Biosensor,
Inc.
SD MultiCare
System
Immuno-
assay
Mar ‘16 MS1016001 - - - ReCCS
ASRL#1
SiemensHealthcareDiagnostics
HemoglobinA1c 3 (A1c 3)-
Automated
Pretreatment
on Advia 1800
Immuno-assay
Mar ‘16 270 5HD051 (1-5)
2.46, 3.54,4.95, 6.76,
10.74
µmol/L A1c;
11.74 g/dL
Hb
- Univ. ofMissouri.SRL #9
Trinity
Biotech
GHb/HbA1c
HPLC
BoronateAffinity on
PDQ
Boronate
affinity
HPLC
Mar ‘16 6040, 6047,
6107, 6133
6081, 6082 5.2%, 11.3% 6018 Univ. of
Missouri.
SRL #3
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5/17
List of NGSP Certified Methods (Updated 4/16, listed by date certified)
5
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
Trinity
Biotech
GHb/HbA1c
HPLC
BoronateAffinity on
ultra2
Boronate
affinity
HPLC
Mar ‘16 6040, 6047,
6115
6081, 6082 5.4%, 11.6% 6018 Univ. of
Missouri.
SRL #3
GHb/HbA1cHPLC
Boronate
Affinity onPremier
Hb9210
Boronateaffinity
HPLC
Mar ‘16 6089, 6047,6115, 6005
6081, 6082 5.3%, 11.6% 5919 Univ. ofMissouri.
SRL #3
Wako Pure
Chemical
Industries, Ltd.
t Autokit
HbA1c on
Hitachi 7170S
Immuno-
assay
Mar ‘16 YA003,
KE436
YA003 0.49, 0.88,
1.65, 2.43
g/dL HbA1c;
14.0 g/dL Hb
- ReCCS
ASRL#1
Sekisui
Medical Co.,Ltd.
RC20 Ion-
exchangeHPLC
Mar ‘16 1503240008 1509140008 5.56%,
11.30%
1509030122 ReCCS
ASRL#1
t
HbA1cAUTO TBA
on TBA-
120FR
Enzymatic Mar ‘16 855RHM,856RHM,
807RHM
905RIM 3.83, 16.19µmol/L
HbA1c;
103.1, 154.7µmol/L Hb
- ReCCSASRL#1
t L type
Norudia NHbA1c on
Hitachi
LST006
Enzymatic Mar ‘16 807RIM,
807RIM,806RLM
806RLM 3.62, 13.77
µmol/LHbA1c; 97.7,
137.0
µmol/L Hb
- ReCCS
ASRL#1
t L type
Norudia NHbA1c on
HitachiLST008
Enzymatic Mar ‘16 807RIM,
807RIM,806RLM
806RLM 3.62, 13.77
µmol/LHbA1c; 97.7,
137.0µmol/L Hb
- ReCCS
ASRL#1
t Norudia N
HbA1c on
Hitachi 7170S
Enzymatic Mar ‘16 855RHM,
856RHM,
847RJM
013RIM 3.83, 16.19
µmol/L
HbA1c;
103.1, 154.7µmol/L Hb
- ReCCS
ASRL#1
t Norudia NHbA1c on
EV800
Enzymatic Mar ‘16 855RHM,856RHM,
847RJM
013RIM 3.83, 16.19µmol/L
HbA1c;
103.1, 154.7µmol/L Hb
- ReCCSASRL#1
t Norudia N
HbA1c onTBA-120FR
Enzymatic Mar ‘16 855RHM,
856RHM,847RJM
013RIM 3.83, 16.19
µmol/LHbA1c;
103.1, 154.7
µmol/L Hb
- ReCCS
ASRL#1
t Norudia N
HbA1c onJCA-BM9130
Enzymatic Mar ‘16 855RHM,
856RHM,847RJM
013RIM 3.83, 16.19
µmol/LHbA1c;
103.1, 154.7
µmol/L Hb
- ReCCS
ASRL#1
t RC20 on
Adams A1c
mini
Ion-
exchange
HPLC
Mar ‘16 1106000315 1209000315 5.56%,
11.30%
1006003415 ReCCS
ASRL#1
-
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List of NGSP Certified Methods (Updated 4/16, listed by date certified)
6
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
Kyowa Medex
Co., Ltd.
t Determiner
HbA1c on
DM-JACK
Immuno-
assay
Mar ‘16 369AEK,
369AEL
507AEG 0.0%, 5.0%,
9.1%, 13.2%,
15.7%
- ReCCS
ASRL#1
t Determiner
HbA1c on
JCA-BM9130
Immuno-
assay
Mar ‘16 391AEK,
391AEK
509AFA 0.0%, 5.0%,
9.0%, 13.2%,
15.8%
- ReCCS
ASRL#1
. t Determiner LHbA1c on
DM-JACK
Immuno-assay
Mar ‘16 138AEI,138AEI
310AEI 0.0%, 4.6%,6.8%, 9.8%,
13.5%
- ReCCSASRL#1
t Determiner L
HbA1c on
JCA-BM9130
Immuno-
assay
Mar ‘16 138AEI,
138AEI
310AEI 0.0%, 4.3%,
6.8%, 9.7%,
13.5%
- ReCCS
ASRL#1
t Determiner L
HbA1c on
Hitachi 7180
Immuno-
assay
Mar ‘16 138AEI,
138AEI
310AEI 0.0%, 4.3%,
6.8%, 9.7%,
13.5%
- ReCCS
ASRL#1
t Determiner L
HbA1c onTBA-120FR
Immuno-
assay
Mar ‘16 138AEI,
138AEI
310AEI 0.0%, 4.3%,
6.8%, 9.7%,13.5%
- ReCCS
ASRL#1
NanjingLAOLA
Electronic Co.,
Ltd.
Ion-exchangeLPLC on JL-
760
Ion-exchange
HPLC
Feb ‘16 15070110,15070211,15070312,15070312
15070115,15070125
5.7%, 11.1% 20150610 Univ. ofMissouri.
SRL #9
Diazyme
Laboratories
Direct HbA1c
Assay on
Roche
Modular P800(On-Board
Lysis)
Enzymatic Jan ‘16 HAL01150,HA101150,
HA201150
HAS101150,HAS201150
6.2%, 12.3% - Univ. of
Minnesota
SRL#10
Shanghai
HuizhongMedical
Science andTechnology
Co. Ltd.
MQ-6000
GlycatedHemoglobin
Analyzer
Ion-
exchangeHPLC
Jan ‘16 20150616B 20151029 5.70%,
10.67%
6K15071301 Univ. of
Missouri.SRL #9
MQ-2000PT
Glycated
HemoglobinAnalyzer
Ion-
exchange
HPLC
Jan ‘16 PTHbA1c1
50 302H
20151029 5.42%,
10.62%
PTHbA1c150302H
Univ. of
Missouri.
SRL #9
Boditech MedInc.
Immuno-assayon ichroma
Reader
Immuno-assay
Jan ‘16 AALYA55 502101 5.1%, 8.1%,11.2%, 15.2%
- ReCCSASRL#1
TaiDoc
TechnologyCorp.
t Immunoassay
on TD-4611 Immuno-
assay
Jan ‘16 15L103 415501-212 5.2%, 8.3%,11.6%, 15.5%
- European
Reference LaESRL#9
Axis-Shield ArchitectHbA1c onArchitect i
Immuno-
assay
Jan ‘16 10445UP00 802905582 4.0%, 5.5%,7.5%, 9.0%,12.0%,14.5%
- European
Reference LaESRL#12
HumanGesellschaft furBiochemica und
DiagnosticambH
HumaMeter A1c BoronateFluorescence
quenching
Jan ‘16 0251962016-06
0251962016-06
Barcode - EuropeanReference La
ESRL#10
HumaStar300SR
Immuno-
assay
Jan ‘16 5176012016-12
15002/2017-06
0/5, 7/8, 9/11,9/15, 2%
- European
Reference La
ESRL#10
-
8/18/2019 List of NGSP Certified Methods
7/17
List of NGSP Certified Methods (Updated 4/16, listed by date certified)
7
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
Thermo Fisher
Scientific Oy
t HbA1c for
Konelab, ref
981947,Manual
hemolyzation,
91.5*HbA1c/Hb+2.15
Immuno-
assay
Jan ‘16 L986, L734 L246 1.533 mmol/LHbA1c; 8.936mmol/L Hb
- European
Reference La
ESRL#9
t HbA1c for
Indiko, ref981947, on
Indiko Plus,
Manual
hemolyzation,91.5*HbA1c/Hb
+2.15
Immuno-
assay
Jan ‘16 L986, L734 L246 1.533 mmol/LHbA1c; 8.936mmol/L Hb
- European
Reference LaESRL#9
Bio-Rad
Laboratories
t VARIANT II
Dual (A1c)
Ion-
exchange
HPLC
Jan ‘16 64023628,64023629,64019494
64015994,
64015995
5.1%, 10.1% FB20900 Univ. of Minn
SRL #10
t VARIANT II
Dual
(A2/F/A1c)
Ion-
exchange
HPLC
Jan ‘16 64023628,
64023629,64019494
64015998,
64015996
5.3%, 10.1% FB20900 Univ. of Minn
SRL #10
D-10 DualA2/F/A1c
Ion-exchange
HPLC
Jan ‘16 AA50357,AA50358,AA50372
AA50315,AA50316
10.2%, 5.3% D40035H Univ. of MinnSRL #10
D-10 HbA1c Ion-
exchange
HPLC
Jan ‘16 AA50354,AA50355,AA50208
AA50370,
AA50371
5.5%, 10.2% A40035Q Univ. of Minn
SRL #10
D-100 HbA1c Ion-
exchange
HPLC
Jan ‘16 64025852,64012157
64010672 5.84%, 9.12% 31037AG Univ. of Minn
SRL #10
Variant II
HbA1c NU
Ion-
exchangeHPLC
Jan ‘16 AA40128,
AA40129,64028214
64026941,
64026942
5.4%, 10.5% NU31453E Univ. of Minn
SRL #10
VARIANT IITURBO
HbA1c
Ion-exchange
HPLC
Jan ‘16 64012978,64012977,64006957
64011685,
64011701
5.2%, 10.2% S31342C Univ. of MinnSRL #10
VARIANT II
TURBO Link
HbA1c
Ion-
exchange
HPLC
Jan ‘16 64012980,64011236,
64012201
64011680,64011683
5.2%, 10.2% LLV31342F Univ. of Minn
SRL #10
VARIANT II
TURBO
HbA1c Kit –2.0
Ion-
exchange
HPLC
Jan ‘16 64019508,64014744,64016867
64012445,64012446
5.2%, 10.3% 31500U Univ. of Minn
SRL #10
VARIANT II
TURBOHbA1c Kit –
2.0 (screen and
diagnosis)
Ion-
exchangeHPLC
Jan ‘16 64019508,
64018314,64016867
64012445,
64012446
5.2%, 10.3% 31500U Univ. of Minn
SRL #10
Ortho Clinical
Diagnostics
Vitros d%A1c Immuno-
assay
Dec ‘15 1845, 1845 18451,18452,18453,
18454,18455
0.00, 0.48,
0.89, 1.62,2.51 g/dL
HbA1c;
-1.38, 14.06g/dL Hb
- Univ. of
Missouri.SRL #9
-
8/18/2019 List of NGSP Certified Methods
8/17
List of NGSP Certified Methods (Updated 4/16, listed by date certified)
8
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
Shenzhen
Lifotronic
TechnologyCo., Ltd
Ion-exchange
HPLC on GH-
900
Ion-
exchange
HPLC
Dec ‘15 821514 2015090801 5.6%, 12.5% 2015092204 ReCCS
ASRL#1
Ion-exchange
HPLC on H-9
Ion-
exchangeHPLC
Dec ‘15 841502 2015101201 5.2%, 11.2% 2015100901 ReCCS
ASRL#1
DiaSys
Diagnostic
SystemsGmbH
HbA1c net FS,
Reference No.
1 3348 00,respons910
Immuno-
assay
Dec ‘15 21506,
21507
E28/14 0.380, 1.05
g/dL HbA1c;
5.6, 15.2g/dL Hb
- European
Reference La
ESRL#10
HbA1c net FS,
Reference No.1 3348 00,
Biomajesty
Immuno-
assay
Dec ‘15 21506,
21507
E28/14 0.365, 0.940
g/dL HbA1c;5.9, 14.8
g/dL Hb
- European
Reference LaESRL#10
oneHbA1c FS,Reference No.
1 3329 00,
InnovaStar
Immuno-assay
Dec ‘15 82, 20760 21670,21671,
21672,
21673
4.99%,6.72%,
10.4%,
13.2%
- EuropeanReference La
ESRL#10
oneHbA1c FS,Reference No.
1 3329 00,
Hitachi 917
Immuno-assay
Dec ‘15 21369-21371,
20760
21479,21480,
21481,
21482
4.77%,8.39%,
12.5%,
17.2%
- EuropeanReference La
ESRL#10
Erba Lachema
s.r.o.
ERBA Hb-
Vario
Ion-
exchange
HPLC
Dec ‘15 HBR-003,
HBR-003
B041538-
CM
5.54%,
11.59%
HBR-002 Univ. of
Missouri.
SRL #9
Trinity
Biotech
Tri-stat HbA1c
Assay
Boronate
Affinity
Dec ‘15 5850 (0y) - - - Univ. of
Missouri.
SRL #9
PTSDiagnostics
A1CNow+;A1CNow
SELFCHECK
Immuno-assay
Dec ‘15 1513111 - - - Univ. ofMissouri.
SRL #9Medica
CorporationHbA1c LatexImmunoassay
on EasyRA
Immuno-assay
Dec ‘15 15125,15059
15239 4.77%,8.39%,
12.5%,
17.2%
- Univ. ofMissouri.
SRL #9
Siemens
Healthcare
Diagnostics,Inc.
Dimension
Flex on RxL
Immuno-
assay
Dec ‘15 GC6167 GC6167 0.16, 0.55,
1.05, 1.89,
2.53 g/dLHbA1c;
11.88, 11.65
g/dL Hb
- Univ. of
Missouri.
SRL #9
Dimension
Flex on ExL
Immuno-
assay
Dec ‘15 GC6167 GC6167 0.16, 0.55,
1.05, 1.89,
2.53 g/dLHbA1c;
11.88, 11.65
g/dL Hb
- Univ. of
Missouri.
SRL #9
Roche
DiagnosticsInternational
Ltd
Cobas b 101
HbA1c
Immuno-
assay
Dec ‘15 528131-01 - - - Univ. of
Missouri.SRL #9
-
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9/17
List of NGSP Certified Methods (Updated 4/16, listed by date certified)
9
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
Roche
Diagnostics
TQ HbA1c
Gen. 2 Cobas
Integra 400(hemolysate)
HbA1c/Hb*91.5
+2.15
Immuno-
assay
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
- Univ. of
Missouri.
SRL #9
TQ HbA1c
Gen. 2 Cobas
c111 (whole blood)
HbA1c/Hb*91.5+2.15
Immuno-
assay
Dec ‘15 610611,
617543
183640 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
TQ HbA1c
Gen. 2 Cobas
Integra 400(whole blood)HbA1c/Hb*91.5
+2.15
Immuno-
assay
Dec ‘15 604503,
617546
185997 0.02796,0.0166,0.0138,
0.0053,0.00076, 0
g/dL HbA1c;0.12069,
0.02414 g/dLHb
- Univ. of
Missouri.
SRL #9
TQ HbA1c
Gen. 3 cobas
c311(hemolysate)
HbA1c/Hb*91.5+2.15
Immuno-
assay
Dec ‘15 617092,
614514,
610045
185997 0.145, 0.334,0.639, 0.882,1.196, 1.697
mmol/L
HbA1c; 1.35,7.279 mmol/L
Hb
- Univ. of
Missouri.
SRL #9
TQ HbA1cGen. 3 cobas
c311 (whole
blood)HbA1c/Hb*91.5
+2.15
Immuno-assay
Dec ‘15 617092,614514
185997 0.131, 0.326,0.641, 0.891,
1.215, 1.733,mmol/L
HbA1c; 1.35,7.279 mmol/L
Hb
- Univ. ofMissouri.
SRL #9
TQ HbA1cGen. 3 cobas
c513 (whole
blood)HbA1c/Hb*91.5
+2.15
Immuno-assay
Dec ‘15 618064,610071
185997 0.152, 0.357,0.682, 0.936,1.286, 1.82
mmol/LHbA1c; 1.40,
7.54 mmol/LHb
- Univ. ofMissouri.
SRL #9
TQ HbA1c
Gen. 3 cobas
c513(hemolysate)
HbA1c/Hb*91.5+2.15
Immuno-
assay
Dec ‘15 618064,
610071,
610045
185997 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
Infopia Co,
Ltd
Frontier and
HemoCue
HbA1c 501
Boronate
Affinity
Nov ‘15 F15F02F16
DL
- - - Univ. of
Missouri.
SRL #9
Clover A1c,
Clover A1c
Self, Checkart
Boronate
Affinity
Nov ‘15 C15F22G0
6DL
- - - Univ. of
Missouri.
SRL #9
-
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List of NGSP Certified Methods (Updated 4/16, listed by date certified)
10
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
i-SENS, Inc. A1Care
HbA1c assay
(Enzymaticmethod)
Enzymatic Nov ‘15 DBJGA - - - ReCCS
ASRL#1
Shenzhen
LabnovationTechnologies,
Inc.
Ion-Exchange
HPLC on LD-500
Ion-
exchangeHPLC
Nov ‘15 20150623,
20150623,20150623
150609K 5.70%,
11.25%
20150506 ReCCS
ASRL#1
ROHM Co.,
Ltd.
Spotchem
BanalystHbA1c on SI-
3620
Immuno-
assay
Oct ‘15 1533FD07
7O
WC0014 0.0, 24.0,
51.0, 82.8,119.0
mmol/mol
- ReCCS
ASRL#1
Axis-Shield Axis-ShieldHbA1c kit on
AU400
Immuno-assay
Oct ‘15 802905118 802902331-802902335
0.00%,4.40%,
7.00%,
9.90%,
13.30%
- EuropeanReference La
ESRL#12
Archem
DiagnosticIndustry Ltd.
HbA1c Direct
Method (2Reagents)
Immuno-assay
Immuno-
assay
Oct ‘15 AR957 806 5.85%,
9.05%,11.9%,
16.02%
- European
Reference LaESRL#9
Arkray, Inc. ADAMS A1c
Lite HA-
8380V Variant
mode
Ion-
exchange
HPLC
Oct ‘15 5E1012,
5E1021,
4L1401,
4J1053
S4002 5.4%, 10.5% 4J101U Univ. of
Missouri.
SRL #9
ADAMS A1c
Lite HA-8380V Fast
mode
Ion-
exchangeHPLC
Oct ‘15 5E1012,
5E1021,4L1401,
4J1053
S4002 5.4%, 10.5% 4J101U Univ. of
Missouri.SRL #9
ADAMS A1c
Lite HA-8380
Ion-
exchange
HPLC
Oct ‘15 5E1012,
5E1021,
4J1053
S4002 5.4%, 10.5% 4J206N Univ. of
Missouri.
SRL #9Hitachi
Chemical Co.,
Ltd.
Seratestum
A1C
Enzymatic Oct ‘15 Y5C617 - - - ReCCS
ASRL#1
HORIBA
Medical
t HbA1c WB
Whole Blood
Pentra C400Y=(0.42*X)+2.25
Immuno-
assay
Oct ‘15 1504101 1501801 0.00, 1.60,
2.90, 4.20,
7.00, 10.80µmol/l
HbA1c;
68.29 µmol/l
Hb
- European
Reference La
ESRL#10
t HbA1c WB
Hemolysate
Pentra C400Y=(0.43*X)+2.06
Immuno-
assay
Oct ‘15 1504101 1501801 0.00, 1.60,
2.90, 4.20,
7.00, 10.80µmol/l
HbA1c;68.29 µmol/l
Hb
- European
Reference La
ESRL#10
t HbA1c WBHemolysate
Pentra C200Y=(0.35*X)+2.24
Immuno-assay
Oct ‘15 1504101 1501801 0.00, 1.60,2.90, 4.20,
7.00, 10.80
µmol/l
HbA1c;68.29 µmol/l
Hb
- EuropeanReference La
ESRL#10
-
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List of NGSP Certified Methods (Updated 4/16, listed by date certified)
11
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
HORIBA
Medical
t HbA1c WB
Whole Blood
ABX Pentra400
Y=(0.43*X)+2.14
Immuno-
assay
Oct ‘15 1504101 1501801 0.00, 1.60,
2.90, 4.20,
7.00, 10.80µmol/l
HbA1c;
68.29 µmol/lHb
- European
Reference La
ESRL#10
t HbA1c WB
HemolysatePentra 400
Y=(0.43*X)+1.98
Immuno-
assay
Oct ‘15 1504101 1501801 0.00, 1.60,
2.90, 4.20,7.00, 10.80
µmol/l
HbA1c;
68.29 µmol/lHb
- European
Reference LaESRL#10
Green CrossMedis Corp.
BoronateAffinity
(LabonaCheck
A1c HbA1c
Analyzer,A1Card
HbA1c
Analyzer
Boronateaffinity
Sept ‘15 H05G2901,H05G2902,
HM236GH
UEW
- - - Univ. ofMissouri.
SRL #9
SD Biosensor,
Inc.
t SD A1cCare
System
Immuno-
assay
Sept ‘15 A1C02150021 - - - ReCCS
ASRL#1
Mindray t Enzymatic on
BS-200E
Enzymatic Sept ‘15 044615006 044615006 3.36, 15.51
µmol/L
HbA1c;
91.54, 147.07µmol/L Hb
- ReCCS
ASRL#1
t Enzymatic onBS-380
Enzymatic Sept ‘15 044615006 044615006 3.36, 15.51µmol/L
HbA1c;
91.54, 147.07
µmol/L Hb
- ReCCSASRL#1
t Enzymatic on
BS-400
Enzymatic Sept ‘15 044615006 044615006 3.36, 15.51
µmol/L
HbA1c;91.54, 147.07
µmol/L Hb
- ReCCS
ASRL#1
t Enzymatic onBS-480
Enzymatic Sept ‘15 044615006 044615006 3.36, 15.51µmol/L
HbA1c;
91.54, 147.07
µmol/L Hb
- ReCCSASRL#1
t Enzymatic on
BS-800/800M
Enzymatic Sept ‘15 044615006 044615006 3.36, 15.51
µmol/LHbA1c;
91.54, 147.07
µmol/L Hb
- ReCCS
ASRL#1
t Enzymatic on
BS-
2000/2000M
Enzymatic Sept ‘15 044615006 044615006 3.36, 15.51
µmol/L
HbA1c;91.54, 147.07
µmol/L Hb
- ReCCS
ASRL#1
-
8/18/2019 List of NGSP Certified Methods
12/17
List of NGSP Certified Methods (Updated 4/16, listed by date certified)
12
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
Quotient
Diagnostics
Limited
Quo-Test on
Quo-Test
Boronate
affinity
Sept ‘15 020248 - - - European
Reference La
ESRL #11
Quo-Lab on
Quo-Lab
Boronate
affinity
Sept ‘15 025173 - - - European
Reference La
ESRL #11Beckman
Coulter Ireland
Inc.
HbA1c
B00389
ManualApplication
AU5800
Immuno-
assay
Sept ‘15 0020,M405250
0020 0.094, 0.278,
0.515, 0.892,
1.427mmol/L
HbA1c; 8.69
mmol/L THb
- European
Reference La
ESRL #9
HbA1c
B00389
Manual
ApplicationAU2700
Immuno-
assay
Sept ‘15 0020,M405250
0020 0.094, 0.278,
0.515, 0.892,
1.427
mmol/LHbA1c; 8.69
mmol/L THb
- European
Reference La
ESRL #9
HbA1cB00389
Manual
ApplicationAU640
Immuno-assay Sept ‘150020,M405250 0020 0.094, 0.278,0.515, 0.892,
1.427
mmol/LHbA1c; 8.69
mmol/L THb
- EuropeanReference La
ESRL #9
HbA1cB00389
Manual
Application
AU680
Immuno-assay
Sept ‘15 0020,M405250
0020 0.094, 0.278,0.515, 0.892,
1.427
mmol/L
HbA1c; 8.69mmol/L THb
- EuropeanReference La
ESRL #9
HbA1cB00389
Manual
Application
AU480
Immuno-assay
Sept ‘15 0020,M405250
0020 0.094, 0.278,0.515, 0.892,
1.427
mmol/L
HbA1c; 8.69
mmol/L THb
- EuropeanReference La
ESRL #9
HbA1cB00389
Manual
Application
AU400
Immuno-assay
Sept ‘15 0020,M405250
0020 0.094, 0.278,0.515, 0.892,
1.427
mmol/L
HbA1c; 8.69
mmol/L THb
- EuropeanReference La
ESRL #9
Ortho ClinicalDiagnostics
%A1c onVitros 5,1 FS
Immuno-assay
Sept ‘15 4386 3155 0.219, 0.922,1.886, 4.435
g/dL HbA1c;
-0.158,3.692, 8.200,
17.296 g/dLHb
- Univ. ofMissouri.
SRL #9
t %A1c onVitros 4600
Immuno-assay
Sept ‘15 4386 3155 0.214, 0.927,1.889, 4.407
g/dL HbA1c;
-0.158,
3.692, 8.200,
17.296 g/dLHb
- Univ. ofMissouri.
SRL #9
-
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List of NGSP Certified Methods (Updated 4/16, listed by date certified)
13
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
Ortho Clinical
Diagnostics
t %A1c on
Vitros 5600
Immuno-
assay
Sept ‘15 4386 3155 0.214, 0.927,
1.889, 4.407
g/dL HbA1c;
-0.158,3.692, 8.200,
17.296 g/dLHb
- Univ. of
Missouri.
SRL #9
Kyowa Medex
Co., Ltd.
t MetaboLeadHbA1c on JCA-
BM9130
Enzymatic Sept ‘15 131AEE,131AEE
135AEE 2.33, 9.38µmol/L
HbA1c; 82.8,118.3 µmol/L
Hb
- ReCCS
ASRL#1
t MetaboLeadHbA1c on DM-
JACK
Enzymatic Sept ‘15 131AEE,131AEE
135AEE 2.33, 9.38µmol/L
HbA1c; 82.8,
118.3 µmol/LHb
- ReCCS
ASRL#1
t MetaboLeadHbA1c on
Hitachi-7180
Enzymatic Sept ‘15 131AEE,131AEE
135AEE 2.33, 9.38µmol/L
HbA1c; 82.8,
118.3 µmol/LHb
- ReCCS
ASRL#1
t MetaboLeadHbA1c on TBA-
120FR
Enzymatic Sept ‘15 131AEE,131AEE
135AEE 2.33, 9.38µmol/L
HbA1c; 82.8,118.3 µmol/L
Hb
- ReCCS
ASRL#1
JEOL Ltd. t BM TestHbA1c on JCA-
BM 6010/C
Enzymatic Sept ‘15 816RHL,816RHL,
816RLL
914RIL 3.28, 15.53µmol/L
HbA1c, 92.9,146.9 µmol/L
Hb
- ReCCS
ASRL#1
Beckman
Coulter, Inc.
HBA1c on
UniCel DxC
800
Immuno-
assay
Sept ‘15 M505354,M406277,
M506571,
M209413
M505354 0.154, 0.451,
0.853, 1.582,
2.472 g/dLHbA1c;
19.01 g/dL
Hb
- Univ. of
Missouri.
SRL #9
AgappeDiagnostics
Ltd.
tImmuno assayon AGA1C
Immuno-assay
Sept ‘15 15060009,15060010,
15020078
24120047,24120048,
24120049,24120050
4.70%,7.60%,
12.00%,
15.70%
- EuropeanReference La
ESRL#10
tImmuno assayon Mispa i2
Immuno-
assay
Sept ‘15 15060060,15060010,15020078
24120047,24120048,24120049,
24120050
4.70%,
7.60%,
12.00%,15.70%
- European
Reference La
ESRL#10
tImmuno assay
on Mispa i3
Immuno-
assay
Sept ‘15 15080027,
15060010,15020078
24120047,
24120048,24120049,24120050
4.70%,
7.60%,12.00%,
15.70%
- European
Reference LaESRL#10
Caretium
Medical
InstrumentsCo., Limited
Cation-exchangeChromatography
on HbA1c
Analyzer KH-101
Ion-
exchange
HPLC
Aug ‘15 20150102 150573A,150575A
5.2%, 11.10% 150210S ReCCS
ASRL#1
Guangzhou
Wondfo
Biotech Co.,Ltd.
t Fluorescenceimmunoassay on
Finecare FIA
Meter
Immuno-
assay
Aug ‘15 F207F602A - - - ReCCS
ASRL#1
-
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14/17
List of NGSP Certified Methods (Updated 4/16, listed by date certified)
14
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
A.Menarini
Diagnostics
tAuto A1c
HA-8180V
ADAMS
Ion-
exchange
HPLC
July ‘15 5A1201,
4J1211,
4J1501,
5A1221
201401 5.80%,
10.70%
3F014Q European
Reference La
ESRL#10
tAuto A1c
HA-8160ADAMS
Ion-
exchangeHPLC
July ‘15 201468,
201404,201412,
201435
201401 5.80%,
10.70%
4J0354 European
Reference LaESRL#10
tHPLC AutoA1c on Premier
Hb-9210
Boronateaffinity
July ‘15 4814, 5162,5305, 4907
5211, 5212 5.70%,11.40%
0870-5313 EuropeanReference La
ESRL#10
Samsung
Electronics
t Immunoassay
on LabGEO
PT10
Immuno-
assay
June ‘15 Q00CAG4N JCCRM41
1-3
5.0%, 5.6%,
7.3%, 9.4%,
12.0%
- ReCCS
ASRL#1
GuangDong
UnityBiotechnology
Co., Ltd.
t BoronicAffinity
Chromatographyon HbA1canalyzer
Boronate
affinity
June ‘15 R00220140821,
R00220140821,
R002201408
21
HC14101N 6.0%, 12.5% HC14101N Univ. of
Missouri.SRL #9
Zivak
Technologies
@ HbA1c
HPLC kit onHbA1c
Analyzer
Ion-
exchangeHPLC
June ‘15 HB-1501,HB-1501
HB-1501 5.4% HB-1501 European
Reference LaESRL#10
Jiangsu
Audicom
Medical
Technology
Co., Ltd.
t Ion-exchange,
AC6601
HbA1c
Analyzer
Ion-
exchange
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
Sakae
Corporation
t Medidas
HbA1c on A1cGEAR
Immuno-
assay
June ‘15 461503 STS011 0.0%, 5.0%,
9.2%, 12.8%,14.2%
- ReCCS
ASRL#1
t MedidasHbA1c on A1c
iGEAR
Immuno-assay
June ‘15 461503 STS011 0.0%, 5.0%,9.2%, 12.8%,
14.2%
- ReCCSASRL#1
Roche
Diagnostics
TQ HbA1c
Gen. 2hemolysate on
Cobas Integra
800(HbA1c/Hb*91.5+
2.15)
Immuno-
assay
June ‘15 693374,
606814,697646
180036 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
TQ HbA1cGen. 2 whole
blood on
Cobas Integra
800(HbA1c/Hb*91.5+
2.15)
Immuno-assay
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. ofMissouri.
SRL #9
-
8/18/2019 List of NGSP Certified Methods
15/17
List of NGSP Certified Methods (Updated 4/16, listed by date certified)
15
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
Roche
Diagnostics
TQ HbA1c
Gen. 3
hemolysate oncobas c501/502(HbA1c/Hb*91.5+
2.15)
Immuno-
assay
June ‘15 608283,606814
180036 0.152, 0.345,
0.654, 0.901,
1.220, 1.731
mmol/LHbA1c;
1.437, 7.749mmol/L Hb
- Univ. of
Missouri.
SRL #9
TQ HbA1c
Gen. 3 whole
blood on cobasc501/502
(HbA1c/Hb*91.5+
2.15)
Immuno-
assay
June ‘15 608283,604554
180036 0.142, 0.345,
0.674, 0.935,
1.273, 1.814
mmol/LHbA1c;
1.437, 7.749
mmol/L Hb
- Univ. of
Missouri.
SRL #9
Tosoh
Corporation
t G7 HbA1c
Standard
Analysis Mode(1.2 min)
HLC-723G7
Ion-
exchange
HPLC
June ‘15 K7-104W,
K7-203W,
7-303W,HW-09Y
ZS4002 5.76%,
10.76%
K Univ. of
Missouri.
SRL #9
t G7 HbA1c
Standard
Analysis Mode
(1.2 min)
HLC-723G7
Ion-
exchange
HPLC
June ‘15 K7-104W,
K7-203W,
7-303W,
HW-09Y
JS4002 5.86%,
10.97%
K Univ. of
Missouri.
SRL #9
t G8 HbA1cStandard
Analysis Mode
(1.0 min)
HLC-723G8
Ion-exchange
HPLC
June ‘15 E8-106W,E8-201W,
8-305W,
HW-09Y
ZS4002 5.76%,10.76%
E Univ. ofMissouri.
SRL #9
t G8 HbA1c
Standard
Analysis Mode(1.0 min),
HLC-723G8
Ion-
exchange
HPLC
June ‘15 E8-106W,
E8-201W,
8-305W,HW-09Y
JS4002 5.86%,
10.97%
E Univ. of
Missouri.
SRL #9
t G9 HbA1c,
HLC-723G9
Ion-
exchangeHPLC
June ‘15 B9-101W,
B9-201Y,9-301A,
HW-14W
ZS4002 5.76%,
10.76%
B Univ. of
Missouri.SRL #9
t G9 HbA1c,
HLC-723G9
Ion-
exchange
HPLC
June ‘15 B9-101W,
B9-201Y,
9-301A,
HW-14W
JS4002 5.86%,
10.97%
B Univ. of
Missouri.
SRL #9
G8 HbA1cVariant
Analysis Mode
(1.6 min),HLC-723G8
Ion-exchange
HPLC
June ‘15 F8-101W,F8-201W,
F8-301W,
HW-09Y
ZS4002 5.76%,10.76%
F Univ. ofMissouri.
SRL #9
G7 HbA1c
Variant
Analysis Mode(2.2 min),
HLC-723G7
Ion-
exchange
HPLC
June ‘15 M7-101Y,
M7-201Y,
M7-301Y,HW-09Y
ZS4002 5.76%,
10.76%
M Univ. of
Missouri.
SRL #9
t GX
HLC-723GX
Ion-
exchangeHPLC
June ‘15 AX-101W,
AX-201Y,AX-301Y,
HW-09W
ZS4002 5.76%,
10.76%
A Univ. of
Missouri.SRL #9
-
8/18/2019 List of NGSP Certified Methods
16/17
List of NGSP Certified Methods (Updated 4/16, listed by date certified)
16
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
Tosoh
Corporation
t GX
HLC-723GX
Ion-
exchange
HPLC
June ‘15 AX-101W,
AX-201Y,
AX-301Y,
HW-09W
JS4002 5.86%,
10.97%
A Univ. of
Missouri.
SRL #9
t G11, Standard
Analysis Mode(0.5 min),
HLC-723G11
Ion-
exchangeHPLC
June ‘15 A1-101Y,
A1-201Y,1-301Y,
HW-09Y
ZS4002 5.76%,
10.76%
A Univ. of
Missouri.SRL #9
t G11, StandardAnalysis Mode
(0.5 min),
HLC-723G11
Ion-exchange
HPLC
June ‘15 A1-101Y,A1-201Y,
1-301Y,
HW-09Y
JS4002 5.86%,10.97%
A Univ. ofMissouri.
SRL #9
Siemens
Healthcare
Diagnostics
DCA 2000+ Immuno-
assay
June ‘15 0912035 - - - Univ. of
Missouri.
SRL #9
DCA Vantage Immuno-
assay
June ‘15 0912035 - - - Univ. of
Missouri.
SRL #9
Mindray Ion-exchange
HPLC on
H50/H50P
Ion-
exchange
HPLC
May ‘15 2014081101,2014081201,2014071501
20141201 5.5%, 11.8% 140908 ReCCS
ASRL#1
Siemens
HealthcareDiagnostics
Inc.
Dimension
Vista FlexHbA1c on
Vista 1500
Immuno-
assay
May ‘15 14300BA 4KD063 0.13, 0.52,
0.92, 1.59,2.28 g/dL
HbA1c;
12.48, 12.25
g/dL Hb
- Univ. of
Missouri.SRL #9
Beckman
Coulter, Inc.
Uni Cel DxC
Syr on UniCel
DxC 800
Immuno-
assay
May ‘15 M407102 M410001 0.144, 0.460,
0.869, 1.503,
2.372 g/dL
A1c3; 19.09g/dL Hb3
- Univ. of
Missouri.
SRL #9
Shenzhen
GeniusElectronics
Co., Ltd.
Nephelometry
on SpecificProtein
Analyzer
PA54/PA50
Immuno-
assay
May ‘15 20150228 - - - ReCCS
ASRL#1
Abbott
Diagnostics
HbA1c
(Hemolysate)
on Architect
c8000%NGSP=HbA1c/
Hb*91.48+2.152
Enzymatic May ‘15 46208UQ07,46208UQ07,
46208UQ
46700UQ10 3.10, 16.15
µmol/L
HbA1c; 98,
150.1
µmol/L Hb
- Univ. of
Missouri.
SRL #9
HbA1c
(Whole Blood)on Architect
c8000%NGSP=HbA1c/
Hb*91.48+2.152
Enzymatic May ‘15 46208UQ07,
46208UQ07,46208UQ
46700UQ10 3.10, 16.15
µmol/LHbA1c; 98,
150.1
µmol/L Hb
- Univ. of
Missouri.SRL #9
HbA1c
(Hemolysate)
on Architect
c4000%NGSP=HbA1c/Hb*91.48+2.152
Enzymatic May ‘15 46208UQ07,46208UQ07,
46208UQ
46700UQ10 3.10, 16.15
µmol/L
HbA1c; 98,
150.1
µmol/L Hb
- Univ. of
Missouri.
SRL #9
-
8/18/2019 List of NGSP Certified Methods
17/17
List of NGSP Certified Methods (Updated 4/16, listed by date certified)
17
Manufacturer Method/
Instrument
Method
Type
Date
Certified
Reagent
Lot
Calibrator
Lot
Calibrator
Assigned
Value
Column
Lot
Secondary
Reference
Laboratory
Abbott
Diagnostics
HbA1c
(Whole Blood)
on Architectc4000
%NGSP=HbA1c/Hb*91.48+2.152
Enzymatic May ‘15 46208UQ07,46208UQ07,
46208UQ
46700UQ10 3.10, 16.15
µmol/L
HbA1c; 98,
150.1
µmol/L Hb
- Univ. of
Missouri.
SRL #9
Nihon Kohden
Corporation
Celltac Chemi
HbA1c on
CHM-4100(NGSP(%)=1.02*
JDS(%)+0.25)
Immuno-
assay
May ‘15 85002 CEN001 0.0%, 4.4%,
6.9%, 9.7%,
13.3%
- ReCCS
ASRL#1
t Method is not available in the US@ Method is not currently available
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