Bio-Rad Laboratories I N F E C T I O U S D I S E A S E T E S T I N G

Monolisa™ HCV Ag-Ab ULTRA AssayPushing The Limits

Bio-Rad Laboratories

For further information, please contact the Bio-Rad office nearestyou or visit our website at www.bio-rad.com/diagnostics

ClinicalDiagnostics Group

Website www.bio-rad.com/diagnostics U.S. 1-800-2BIO-RAD Australia 61-2-9914-2800 Austria 43-1-877-8901 Belgium 32-9-385-5511 Brazil 5521-3237-9400 Canada 1-514-334-4372 China 86-21-64260808 Czech Republic 420-241-430-532 Denmark +45-4452-1000 Finland 358-9-804-22-00 France 33-1-47-95-60-00 Germany +49-(0)89-318-840 Greece 30-210-7774396 Hong Kong 852-2789-3300 Hungary 36-1-455-8800 India 91-124-4029300 Israel 972-3-9636050 Italy +39-02-216091 Japan 81-3-6361-6902 Korea 82-2-3473-4460 Mexico +52(55)5488-7670 The Netherlands +31-318-540666 New Zealand 64-9-415-2280 Norway 47-23-38-41-30 Poland 48-22-3319999 Portugal 351-21-472-7700 Russia 7-495-721-14-04 Singapore 65-6415-3188 South Africa 27-11-442-85-08 Spain 34-91-590-5200 Sweden 46-8-555-127-00 Switzerland 41-61-717-95-55 Thailand 662-651-8311 United Kingdom +44-(0)20-8328-2000

50 17157 Rev B 12/2007

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Monolisa™ HCV Ag-Ab ULTRA Assay

I N F E C T I O U S D I S E A S E T E S T I N G

Ordering InformationCatalog No. Description

72556 Monolisa™ HCV Ag-Ab ULTRA Assay ......................................................................................................... 96 tests72558 Monolisa™ HCV Ag-Ab ULTRA Assay ....................................................................................................... 480 tests

* Reactive samples after 30 minutes incubation

➊

➋

➌

• Microplate coated with: - Monoclonal Ab for HCV Ag detection - Recombinant protein and peptide for HCV Ab detection

• 100 μl of conjugate 1

• 50 μl of control or sample

• Incubate for 90 minutes at 37°C

• 100 μl of conjugate 2 • Incubate for 30 minutes at 37°C

Test Format Sample/Reagent Addition MonitoringColor of well BEFORE dispensing Color of well AFTER dispensing

WASH

READ at dual wavelength 450/620–700 nm

Anti-HCV capsidmonoclonalantibodies

Biotinylated anti-HCVcapsid monoclonal antibodies

WASH

• 80 μl of TMB substrate

• Incubate for 30 minutes in the dark at room temperature (18-30°C)

Peroxidase labeled streptavidine

* *

Mutated capsid peptide, recombinantprotein NS3 genotype 1 and 3,recombinant protein NS4

Peroxidase labeledantibodies to human IgG

• 100 μl of stopping solution

• Cut off = Mean pos. cont. (O.D. R4) /4

Sensitivity on Samples from Hospital LaboratoriesA total of 348 anti-HCV Ab positive samples (confirmed by immunoblot or PCR) mostly from chronically infectedpeople from 2 hospital laboratories were tested.

All of these 348 samples were reactive with Monolisa™ HCV Ag-Ab ULTRA assay giving a sensitivity of 100%

• High sensitivity: early HCV detection

• Dispense monitoring for all steps and OD norms in package insert

• Barcode on reagents

• Quality assurance: CE registered product

• Specific colored packaging for each marker

• Microplate and strip identification

Monolisa™ HCV Ag-Ab ULTRA Assay

Early HCV Exposure Detection70% reduction of the serologic HCV Ab negative Window PeriodA total of 35 commercially seroconversion panels, including subtype 1a, 1b, 2b, 3a, were tested by Monolisa™ HCV Ag-Ab ULTRA assay and by commercial EIA anti-HCV Ab assays. The serologic profile for one representative panel is shown below.

Monolisa™ HCV Ag-Ab ULTRA Assay4th Generation Assay

Example of serological profile of HCV Seroconversion Panel BBI - 917

Window Period Reduction. Ranking on 35 Seroconversions in Days of Delay versus Nucleic Acid Testing

Genotyped HCV Positive Sample DetectionA total of 405 genotyped samples were tested: 133 genotyped from various origin and 272 genotyped from2 hospital laboratories.

405 genotyped samples tested

All these samples from different genotype were found positive: 100% sensitivity (405/405)

Number

Genotype

Number

Genotype

405

TOTAL

2,1444,2632,4303,564

12,401

,

Blood Bank Specificity

Example of serological profile of HCV Seroconversion Panel BBI - 917

Very low rate of repeat reactive samples. Specificity: 99.85%

Number

Genotype

Number

Genotype

405

TOTAL

2,1444,2632,4303,564

12,401

,

40 60 20 0

0

1

2

3

4

5

6

7

8

9

80 100 120 140 160

cut-off

HCV RNA detection + - - - - - - + ++

HCV Ab assay

HCV Ag assay Monolisa HCVAg-AbULTRA assay™

Among these 35 serocoversion panels, Monolisa™ HCV Ag-Ab ULTRA assay detects exposure to HCV at least17 days earlier than the other anti-HCV Ab assays tested: 70% reduction of the serologic HCV Ab negative Window Period with Nucleic Acid Testing (HCV RNA detection) as reference. Monolisa™ HCV Ag-Ab ULTRA assay is able to detect 126 out of 145 (87%) of HCV RNA positive/anti-HCV negative samples tested.

Rat

io: S

amp

le/c

ut-o

ff

Bleed date (Days)

8 12 4 0 16 20 24 Days

HCV Ab microplate assay: D

4.4

HCV Ab automated assay: A

4.4

24

HCV Ab microplate assay: F

HCV Ab automated assay: E

HCV Ab automated assay: C

21.6

22.8

say: D

22.9

24.9

2323

23.5

HCV Ab microplate assay: B

Monolisa HCVAg-Ab ULTRA

™

NAT

det

ectio

n si

ngle

uni

t

Average Day of Delay

Reduction of Anti-HCV Ab Negative Window Period70% reduction of the serologic HCV Ab negative Window Period

Easily Automatable, Robust and Secure

EIA for Detection of HCV Ag and HCV Ab

Bio-Rad Laboratories I N F E C T I O U S D I S E A S E T E S T I N G

Sensitivity on Samples from Hospital LaboratoriesA total of 348 anti-HCV Ab positive samples (confirmed by immunoblot or PCR) mostly from chronically infectedpeople from 2 hospital laboratories were tested.

All of these 348 samples were reactive with Monolisa™ HCV Ag-Ab ULTRA assay giving a sensitivity of 100%

• High sensitivity: early HCV detection

• Dispense monitoring for all steps and OD norms in package insert

• Barcode on reagents

• Quality assurance: CE registered product

• Specific colored packaging for each marker

• Microplate and strip identification

Monolisa™ HCV Ag-Ab ULTRA Assay

Early HCV Exposure Detection70% reduction of the serologic HCV Ab negative Window PeriodA total of 35 commercially seroconversion panels, including subtype 1a, 1b, 2b, 3a, were tested by Monolisa™ HCV Ag-Ab ULTRA assay and by commercial EIA anti-HCV Ab assays. The serologic profile for one representative panel is shown below.

Monolisa™ HCV Ag-Ab ULTRA Assay4th Generation Assay

Example of serological profile of HCV Seroconversion Panel BBI - 917

Window Period Reduction. Ranking on 35 Seroconversions in Days of Delay versus Nucleic Acid Testing

Genotyped HCV Positive Sample DetectionA total of 405 genotyped samples were tested: 133 genotyped from various origin and 272 genotyped from2 hospital laboratories.

405 genotyped samples tested

All these samples from different genotype were found positive: 100% sensitivity (405/405)

Number

Genotype

Number

Genotype

405

TOTAL

2,1444,2632,4303,564

12,401

,

Blood Bank Specificity

Example of serological profile of HCV Seroconversion Panel BBI - 917

Very low rate of repeat reactive samples. Specificity: 99.85%

Number

Genotype

Number

Genotype

405

TOTAL

2,1444,2632,4303,564

12,401

,

40 60 20 0

0

1

2

3

4

5

6

7

8

9

80 100 120 140 160

cut-off

HCV RNA detection + - - - - - - + ++

HCV Ab assay

HCV Ag assay Monolisa HCVAg-AbULTRA assay™

Among these 35 serocoversion panels, Monolisa™ HCV Ag-Ab ULTRA assay detects exposure to HCV at least17 days earlier than the other anti-HCV Ab assays tested: 70% reduction of the serologic HCV Ab negative Window Period with Nucleic Acid Testing (HCV RNA detection) as reference. Monolisa™ HCV Ag-Ab ULTRA assay is able to detect 126 out of 145 (87%) of HCV RNA positive/anti-HCV negative samples tested.

Rat

io: S

amp

le/c

ut-o

ff

Bleed date (Days)

8 12 4 0 16 20 24 Days

HCV Ab microplate assay: D

4.4

HCV Ab automated assay: A

4.4

24

HCV Ab microplate assay: F

HCV Ab automated assay: E

HCV Ab automated assay: C

21.6

22.8

say: D

22.9

24.9

2323

23.5

HCV Ab microplate assay: B

Monolisa HCVAg-Ab ULTRA

™

NAT

det

ectio

n si

ngle

uni

t

Average Day of Delay

Reduction of Anti-HCV Ab Negative Window Period70% reduction of the serologic HCV Ab negative Window Period

Easily Automatable, Robust and Secure

EIA for Detection of HCV Ag and HCV Ab

Bio-Rad Laboratories I N F E C T I O U S D I S E A S E T E S T I N G

Bio-Rad Laboratories I N F E C T I O U S D I S E A S E T E S T I N G

Monolisa™ HCV Ag-Ab ULTRA AssayPushing The Limits

Bio-Rad Laboratories

For further information, please contact the Bio-Rad office nearestyou or visit our website at www.bio-rad.com/diagnostics

ClinicalDiagnostics Group

Website www.bio-rad.com/diagnostics U.S. 1-800-2BIO-RAD Australia 61-2-9914-2800 Austria 43-1-877-8901 Belgium 32-9-385-5511 Brazil 5521-3237-9400 Canada 1-514-334-4372 China 86-21-64260808 Czech Republic 420-241-430-532 Denmark +45-4452-1000 Finland 358-9-804-22-00 France 33-1-47-95-60-00 Germany +49-(0)89-318-840 Greece 30-210-7774396 Hong Kong 852-2789-3300 Hungary 36-1-455-8800 India 91-124-4029300 Israel 972-3-9636050 Italy +39-02-216091 Japan 81-3-6361-6902 Korea 82-2-3473-4460 Mexico +52(55)5488-7670 The Netherlands +31-318-540666 New Zealand 64-9-415-2280 Norway 47-23-38-41-30 Poland 48-22-3319999 Portugal 351-21-472-7700 Russia 7-495-721-14-04 Singapore 65-6415-3188 South Africa 27-11-442-85-08 Spain 34-91-590-5200 Sweden 46-8-555-127-00 Switzerland 41-61-717-95-55 Thailand 662-651-8311 United Kingdom +44-(0)20-8328-2000

50 17157 Rev B 12/2007

Bio

-Rad

, S.N

.C. a

u ca

pita

l de

50 0

00 0

00 E

uros

, Loc

atai

re-G

éran

t, 4

49 9

9071

2 R

CS

Nan

terr

e •

N°

Intr

acom

mun

auta

ire F

R 6

2 44

9 99

0 71

2 •

Sire

t 44

9 99

0 71

2 00

019

• C

ode

AP

E 2

44 D

Monolisa™ HCV Ag-Ab ULTRA Assay

I N F E C T I O U S D I S E A S E T E S T I N G

Ordering InformationCatalog No. Description

72556 Monolisa™ HCV Ag-Ab ULTRA Assay ......................................................................................................... 96 tests72558 Monolisa™ HCV Ag-Ab ULTRA Assay ....................................................................................................... 480 tests

* Reactive samples after 30 minutes incubation

➊

➋

➌

• Microplate coated with: - Monoclonal Ab for HCV Ag detection - Recombinant protein and peptide for HCV Ab detection

• 100 μl of conjugate 1

• 50 μl of control or sample

• Incubate for 90 minutes at 37°C

• 100 μl of conjugate 2 • Incubate for 30 minutes at 37°C

Test Format Sample/Reagent Addition MonitoringColor of well BEFORE dispensing Color of well AFTER dispensing

WASH

READ at dual wavelength 450/620–700 nm

Anti-HCV capsidmonoclonalantibodies

Biotinylated anti-HCVcapsid monoclonal antibodies

WASH

• 80 μl of TMB substrate

• Incubate for 30 minutes in the dark at room temperature (18-30°C)

Peroxidase labeled streptavidine

* *

Mutated capsid peptide, recombinantprotein NS3 genotype 1 and 3,recombinant protein NS4

Peroxidase labeledantibodies to human IgG

• 100 μl of stopping solution

• Cut off = Mean pos. cont. (O.D. R4) /4