List of NGSP Certified Methods

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


2/17

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

2


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


3/17


3


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


4/17


4


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


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


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


5/17


5


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


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


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


6/17


6


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


7/17


7


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


8/17


8


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%


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


9/17


9


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


10/17


10


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%


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


ESRL#10


11/17


11


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


12/17


12


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


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


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


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


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


13/17


13


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


135AEE 2.33, 9.38µmol/L

HbA1c; 82.8,

118.3 µmol/LHb

- ReCCS

ASRL#1

t MetaboLeadHbA1c on

Hitachi-7180


135AEE 2.33, 9.38µmol/L

HbA1c; 82.8,

118.3 µmol/LHb

- ReCCS

ASRL#1

t MetaboLeadHbA1c on TBA-

120FR


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%


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


14/17


14


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


15/17


15


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


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


16/17


16


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


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


46208UQ

46700UQ10 3.10, 16.15

µmol/L

HbA1c; 98,

150.1

µmol/L Hb

- Univ. of

Missouri.

SRL #9


17/17


17


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


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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List of NGSP Certified Methods

Documents