VARIANT II Hemoglobin - Bio- · PDF fileVARIANT™ II Hemoglobin Testing System Hemoglobin...

VARIANT™ II Hemoglobin Testing System

H e m o g l o b i n T e s T i n g Bio-Rad Laboratories H e m o g l o b i n T e s T i n g

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© 2011 Bio-Rad Laboratories, Inc. Printed in USA 05/11 DG11-0353 A-241

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Printed on recycled paper with soy-based inks

VARIANT™ II Hemoglobin Testing System For HbA1c

Unparalleled Support

Bio-Rad’s world class service and support team is backed by our decades-long leadership

in the fi eld of HbA1c testing. The VARIANT™ II System represents our continued commitment

to helping you be the difference for the patients who count on you.

Uncompromising Performance

VARIANT™ II System combines superior HbA1c

results, exceptional ease of use and powerful data

management in one powerful automated solution

offering HbA1c, β-thalassemia and dual assays.

Ordering InformationCatalog No. Description

270-2000 VARIANT™ II Hemoglobin Testing System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 unit

270-2101NU VARIANT™ II Hemoglobin A1c Program Reorder Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1000 tests

740 Lyphochek® Diabetes Control, Bilevel (3 each of 2 levels) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 x 0.5 mL

120 Lyphochek® Hemoglobin A1c Linearity Set, (1 each of 4 levels) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 x 0.5 mL

BC80 EQAS™ Hemoglobin Program (3 analytes) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 x 0.5 mL

196-2052 Hemoglobin Capillary Collection System (HCCS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 testsHbA1C reportable in patient sample with HbD trait

Superior HbA1c Accuracy• A1C accuracy in the presence of hemoglobins D, E, S or C

• A1C accuracy in the presence of carbamylated hemoglobin (CHb) and labile A1c (LA1c )

• Anchored to the IFCC Reference Method

• NGSP certifi ed and traceable to the Diabetes Control and Complications Trial (DCCT)

Patient DataSample ID: ADPatient ID:Name:Physician:Sex:DOB:

Comments:

Analysis DataAnalysis Performed: 06/21/2010 13:44:09Injection Number: 205Run Number: 24Rack ID:Tube Number: 3Report Generated: 04/07/2011 18:07:54Operator ID:

Peak Name NGSP % Area % Retention Time (min) Peak AreaA1a — 0.3 0.11 7427A1b — 1.8 0.30 52834F — 1.0 0.58 28918LA1c — 1.2 0.77 32890A1c 7.2* — 0.96 78247P3 — 1.8 1.53 82416P4 — 1.1 1.61 31547A0 — 47.1 1.75 1345160E,D — 43.0 1.89 1227588

*Values outside of expected range Total Area: 2,857,028

HbA1c (NGSP) = 7.2*%

Bio-Rad CDM SystemCDM 5.1 VII Instrument

Patient ReportV2_A1c_NU

20.0

17.5

15.0

12.5

10.0

7.5

5.0

2.5

0.00.0 0.5 1.0 1.5 2.0 2.5 3.0

0.11 0.

30

0.58

0.77

0.96

Time (min.)

%A

1c

1.53 1.

611.

751.

89

A1c

E,D — 43.0 1.89

quality results

Now with both IFCC (mmol/mol) and NGSP (%) HbA1c Values

HbA1C reportable in patient sample with HbE trait

HbA1C reportable in patient sample with CHb and LA1c(CHb is identified as the unknown peak between A1C and LA1c )

Analysis Performed: 06/21/2010 13:44:09Injection Number:

Report Generated:

Retention Time (min) 0.11 0.30 0.58 0.77 0.96 1.53 1.61 1.75

2.5

1.89

Patient DataSample ID: AEPatient ID:Name:Physician:Sex:DOB:

Comments:

Analysis DataAnalysis Performed: 06/21/2010 13:51:23Injection Number: 207Run Number: 24Rack ID: Tube Number: 5Report Generated: 04/08/2011 12:22:29Operator ID: YG-IFCC_DAY1

20.0

17.5

15.0

12.5

0.0

7.5

5.0

2.5

0.00.0 0.5 1.0 1.5 2.0 2.5 3.0

0.30

0.20

0.11

0.55

0.73

0.84

A1c

0.96

1.53

1.63

1.75

1.85

Time (min.)

%A

1c



Unknown

A1a

A1b

F

LA1c

Unknown

A1c

P3

P4

A0

E,D

—

—

—

—

—

—

37

—

—

—

—

—

—

—

—

—

—

5.6

—

—

—

—

0.3

0.7

0.9

0.6

0.3

0.8

—

2.5

2.7

53.4

35.6

0.11

0.20

0.30

0.55

0.73

0.84

0.96

1.53

1.63

1.75

1.85

6852

17722

23288

17159

7405

22534

62642

66287

70902

1428051

950966

HbA1c (IFCC) = 37 mmol/mol Total Area: 2,673,808

PeakName

IFCCmmol/mol

NGSP%

Area%

Retention Tim (min)

PeakArea

E,D — — 35.6 1.85 950966

LA1c

Unknown

—

—

—

—

0.3

0.8

0.73

0.84

7405

22534

DEAD ZONE(Grey area)

Bio-Rad Laboratories H e m o g l o b i n T e s T i n g

Your patients count on you. You can count on the VARIANT™ II System.

Exceptional Ease of Use• Fullyautomatedoperationsavestimeandlabor

• Built-inqualitycontrolmanagementsimplifiesquality

assurance compliance

• Reagentssuppliedinconvenientkitformat

• Readilyviewablereagentlevelsintransparentbufferbottles

• Primarytubesamplingwithcappiercingeliminates

manual sample handling

• Positivesampletrackingeliminatessamplemisidentification

• STATcapability

• Batchsamplingandcontinuousfeedingofferflexibilityinworkflow

• Easy-to-useonlinetoolsforQC,instrumentsupport,

remote education and communication services

• HemoglobinCapillaryCollectionSystem(HCCS)allowsremote

fingerstick sample collection to support outreach programs


Quality patient care is at the heart of what you do. And VARIANT™ II System

enables you to be the difference for the patients who count on you most—

delivering the best chemistry on the market for exceptionally accurate results.

The VARIANT™ IIHemoglobinTestingSystemisflexible,efficientanduses

gold-standard,highperformanceliquidchromatography(HPLC)todeliver

exceptionally precise HbA1c values in the presence of hemoglobin variants

and other interfering substances.

SuperiorHbA1c Accuracy

ExceptionalEase of Use

PowerfulData Management

Every patient deserves quality results. You deserve ease of use.

Powerful Data Management• Resultsandchromatogramscaptured

and archived by Bio-Rad’s Clinical Data

Management™ (CDM) software

• CDM™ interfaces with your laboratory information

system for optimal data management

• Advanceddiagnostics,useralertsandprompts

reduce costs and training time































Comments:







20.0

17.5

15.0

12.5

10.0

7.5

5.0

2.5

0.00.0 0.5 1.0 1.5 2.0 2.5 3.0

0.11 0.

30

0.58

0.77

0.96

Time (min.)

%A

1c

1.53 1.

611.

751.

89

A1c

E,D — 43.0 1.89

quality results





Report Generated:


2.5

1.89


Comments:


20.0

17.5

15.0

12.5

0.0

7.5

5.0

2.5

0.00.0 0.5 1.0 1.5 2.0 2.5 3.0

0.30

0.20

0.11

0.55

0.73

0.84

A1c

0.96

1.53

1.63

1.75

1.85

Time (min.)

%A

1c



Unknown

A1a

A1b

F

LA1c

Unknown

A1c

P3

P4

A0

E,D

—

—

—

—

—

—

37

—

—

—

—

—

—

—

—

—

—

5.6

—

—

—

—

0.3

0.7

0.9

0.6

0.3

0.8

—

2.5

2.7

53.4

35.6

0.11

0.20

0.30

0.55

0.73

0.84

0.96

1.53

1.63

1.75

1.85

6852

17722

23288

17159

7405

22534

62642

66287

70902

1428051

950966


PeakName

IFCCmmol/mol

NGSP%

Area%

Retention Tim (min)

PeakArea

E,D — — 35.6 1.85 950966

LA1c

Unknown

—

—

—

—

0.3

0.8

0.73

0.84

7405

22534


Bio-Rad Laboratories H e m o g l o b i n T e s T i n g

Your patients count on you. You can count on the VARIANT™ II System.

Exceptional Ease of Use• Fullyautomatedoperationsavestimeandlabor

• Built-inqualitycontrolmanagementsimplifiesquality

assurance compliance

• Reagentssuppliedinconvenientkitformat

• Readilyviewablereagentlevelsintransparentbufferbottles

• Primarytubesamplingwithcappiercingeliminates

manual sample handling

• Positivesampletrackingeliminatessamplemisidentification

• STATcapability

• Batchsamplingandcontinuousfeedingofferflexibilityinworkflow

• Easy-to-useonlinetoolsforQC,instrumentsupport,

remote education and communication services

• HemoglobinCapillaryCollectionSystem(HCCS)allowsremote

fingerstick sample collection to support outreach programs


Quality patient care is at the heart of what you do. And VARIANT™ II System

enables you to be the difference for the patients who count on you most—

delivering the best chemistry on the market for exceptionally accurate results.

The VARIANT™ IIHemoglobinTestingSystemisflexible,efficientanduses

gold-standard,highperformanceliquidchromatography(HPLC)todeliver

exceptionally precise HbA1c values in the presence of hemoglobin variants

and other interfering substances.

SuperiorHbA1c Accuracy

ExceptionalEase of Use

PowerfulData Management

Every patient deserves quality results. You deserve ease of use.

Powerful Data Management• Resultsandchromatogramscaptured

and archived by Bio-Rad’s Clinical Data

Management™ (CDM) software

• CDM™ interfaces with your laboratory information

system for optimal data management

• Advanceddiagnostics,useralertsandprompts

reduce costs and training time































Comments:







20.0

17.5

15.0

12.5

10.0

7.5

5.0

2.5

0.00.0 0.5 1.0 1.5 2.0 2.5 3.0

0.11 0.

30

0.58

0.77

0.96

Time (min.)

%A

1c

1.53 1.

611.

751.

89

A1c

E,D — 43.0 1.89

quality results





Report Generated:


2.5

1.89


Comments:


20.0

17.5

15.0

12.5

0.0

7.5

5.0

2.5

0.00.0 0.5 1.0 1.5 2.0 2.5 3.0

0.30

0.20

0.11

0.55

0.73

0.84

A1c

0.96

1.53

1.63

1.75

1.85

Time (min.)

%A

1c



Unknown

A1a

A1b

F

LA1c

Unknown

A1c

P3

P4

A0

E,D

—

—

—

—

—

—

37

—

—

—

—

—

—

—

—

—

—

5.6

—

—

—

—

0.3

0.7

0.9

0.6

0.3

0.8

—

2.5

2.7

53.4

35.6

0.11

0.20

0.30

0.55

0.73

0.84

0.96

1.53

1.63

1.75

1.85

6852

17722

23288

17159

7405

22534

62642

66287

70902

1428051

950966


PeakName

IFCCmmol/mol

NGSP%

Area%

Retention Tim (min)

PeakArea

E,D — — 35.6 1.85 950966

LA1c

Unknown

—

—

—

—

0.3

0.8

0.73

0.84

7405

22534


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