ULTRA Product Line Safety is not a Matter of Chance

Infectious Disease Testing

Monolisa™ HCV Ag-Ab ULTRA V2 Assay

ULTRA Product LineThe best answer for HBV, HCV and HIV screening: a global automated solution for safe results.

Genscreen™ ULTRA HIV Ag-Ab Assay

Monolisa™ HBs Ag ULTRA Assay

ULTRA Line AssaysDesign Suitable for:■ Variant detection

■ Significant reduction of window periods

■ Sensitivity close to those observed with Nucleic Acid Testing (NAT)

■ Very high level of specificity

And with the highest level of safety and ease of use.

ULTRA Product Line:■ Monolisa™ HCV Ag-Ab ULTRA V2 Assay

■ Monolisa™ HBs Ag ULTRA Assay

■ Genscreen™ ULTRA HIV Ag-Ab Assay

Monolisa™ HBs Ag ULTRA Assay ■ EIA for Detection of HBs AntigenShorten the HBs Ag Negative Window Period after Hepatitis B Infection

Average delay (days) for detection of Hepatitis B infection with Monolisa™ HBs Ag ULTRA assay and HBs Ag EIA competitors kits versus Nucleic Acid Testing (NAT).

Ranking generated from Bio-Rad analysis on 27 commercial seroconversion panels (104 samples) from Boston Biomedical Inc. Day zero represents the first positive day with Nucleic Acid Testing.

2 310 4 Days

Monolisa™ HBs Ag Plus 5.2

Microplate Competitor M 5.0

Microplate Competitor B 7.6

5.9Microplate Competitor D2.1Monolisa™ HBs

Ag ULTRA

53% WindowPeriod Reduction

NA

T de

tect

ion

sing

le u

nit

Average delay

Microplate Competitor O 7.4

6 7 8

4.5Competitor A

5

Internal data and data from commercial panels

Genscreen™ ULTRA HIV Ag-Ab Assay ■ EIA for Detection of HIV Antigen and HIV-1 / HIV-2 AntibodiesEarly HIV Global (Antigen-Antibody) Detection

The earliest detection among the HIV Ag-Ab combined tests to reduce the serological window period.

Ranking generated from Bio-Rad analysis on 85 commercial seroconversion panels (300 samples) from BBI, NABI and BCP. Day zero represents the first positive day with Nucleic Acid Testing.

Average delay (days) for detection regarding the best potential test

Internal data and data from commercial panels

Monolisa™ HCV Ag-Ab ULTRA V2 Assay ■ EIA for Detection of HCV Antigen and HCV AntibodiesShorten the Anti-HCV Ab Negative Window Period

70% reduction of the serologic HCV Ab negative window period.The Monolisa™ HCV Ag-Ab ULTRA V2 assay detects exposure to HCV on average 22 days before other anti-HCV Ab tested and before HCV combo assays. The delay between Monolisa™ HCV Ag-Ab ULTRA V2 and NAT is less than 4 days.

Ranking generated from Bio-Rad analysis on 23 commercial seroconversion panels from Seracare and Zeptometrix. Day zero represents the first positive day with Nucleic Acid Testing.

8 1240 16 20 Days

HCV Ab microplate assay C

21.9

HCV Ab microplate assay A 21.6

23.5

HCV Ab microplate assay E 24.1

HCV Ab microplate assay D 25.0

HCV Ab Closed system B

23.5HCV Ab Closed system C

3.8Monolisa™ HCV

Ag-Ab ULTRA V2

4.4Monolisa™ HCVAg-Ab ULTRA

70% WindowPeriod Reduction

NA

T de

tect

ion

sing

le u

nit

Average delay

4.8HCV Ag/Ab

microplate assayHCV Ab microplate assay B 23.5

24

19.6HCV Ab Closed system A

Internal data and data from commercial panels

Monolisa™ HBs Ag ULTRA Assay ■ EIA for Detection of HBs Antigen

SpecificityVery high level of specificity for Blood Banks and diagnostics labs: 99.94%.

Outstanding Sensitivity

The analytical sensitivity has been estimated during clinical evaluations and was less than 0.06 ng/ml on the French SFTS 2001 HBs Ag panel and 0.025 IU/ml using the second international WHO standard (00/588).

Variant Hepatitis B Virus Strain Detection

HBs Ag EIA competitor kit sensitivity on mutated HBs Ag recombinant protein samples from plasmidic construction.

A panel of 15 diluted recombinant HBs Ag proteins has been designed to represent a total of 30 single or multiple mutations located at 22 different amino acid positions in the “a” determinant of HBs Ag. All of these mutations based on the clinically relevant mutation reported by the literature are detected with Monolisa™ HBS Ag ULTRA.

Number of SamplesDetected

3/15 12/15

CompetitorA

MicroplateCompetitor

B

MicroplateCompetitor

O

MicroplateCompetitor

D

MicroplateCompetitor

M

15/15 14/15 10/15

Monolisa™

HBs Ag ULTRA

15/15

Genscreen™ ULTRA HIV Ag-Ab Assay ■ EIA for Detection of HIV Antigen and HIV-1 / HIV-2 AntibodiesEarly HIV Antibody Detection

The Genscreen™ ULTRA HIV Ag-Ab assay shows the highest sensitivity for antibody detection of all HIV screening kits, taking into account the variability of seroconversion profiles (seroconversion with undetectable or low HIV antigen levels).

Early HIV Antigen Detection

The excellent antibody detection sensitivity is strengthened by the best HIV Ag detection:Genscreen™ ULTRA HIV Ag-Ab assay is a true Ag-Ab kit for the combined screening of HIV Ag and HIV Ab.

Analytical sensitivity: 0.85 IU/ml (1st International WHO HIV p24 Antigen Standard (90/636) 13.6 pg/ml (“Ag HIV SFTS 1998” panel) from external evaluations.

SpecificityVery high level of specificity for Blood Banks: 99.95% and for hospitalized patients: 99.75%.

BioClinical Partners seroconversion panel N° 9017

Monolisa™ HCV Ag-Ab ULTRA V2 Assay ■ EIA for Detection of HCV Antigen and HCV AntibodiesSpecificity

Very high level of specificity for Blood Banks: 99.94% and for hospitalized patients: 99.80%.

Antigen and Antibody Sensitivity

The highest antigen and global antigen-antibody detection sensitivity of all EIA tests. Particularly when NAT fails to detect infected blood donors.

S /

CO

Bleed date (days)

Cut off

Monolisa HCV Ag-Ab Ultra V2

Monolisa HCV Ag-Ab Ultra

HCV Ag-Ab Microplate assay

HCV Ab Closed system

HCV Ab microplate assay A

HCV Ab microplate assay B

Monolisa™ HCV Ag-Ab ULTRA V2

Negative

HCV RNA detection+ +

00 5 12 14

1

2

3

4

5

6

7

Seracare seroconversion panel N° 915

Website www.bio-rad.com/diagnostics Australia 61-2-9914-2800 Austria 43-1-877-8901 Belgium +32 (3)710-53-00 Brazil +55 (31)3689-6600 Canada 1-514-334-4372 China 86-21-61698500 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 +36-1-459-6100 India 1800-180-1224 Israel 972-3-9636050 Italy +39-02-216091 Japan 81-3-6361-7070 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 +7-495-721-1404 Singapore 65-6415-3170 South Africa 27-11-442-85-08 Spain 34-91-590-5200 Sweden 46-8-555-127-00 Switzerland +41 (0)26-674-55-05/06 Taiwan 886-2-2578-7189 Thailand 662-651-8311 United Kingdom +44 (0)20-8328-2000

Bio-RadLaboratories

Clinical Diagnostics Group

© Bio-Rad 2016/08Bulletin 16048 Rev C Printed in France with soy-based inks on paper from sustainably managed forests10-31-1299

Global Automated Solution

EVOLIS™ Twin Plus System

PR 4100IPS

PW40

EVOLIS™ System

Highest Level of Safety■ Color-coded reagents

■ Sample and reagent addition monitoring for all pipetting steps (sample, reagents and substrate) with Optical Density norms in the package insert

■ Color-coded labels

■ Color-coded control caps

■ Barcode identification for reagents

■ Clear identification of the product on microplate frame and strip

Easy to Use and Easily Automatable■ No sample pre-dilution

■ Low sample and control volume requirements

■ Generic reagents (wash solution, substrate, and stop solution)

■ Validated protocol on Bio-Rad systems, fully automated systems (EVOLIS™ Family) and stand-alone systems (PR4100, PW40 etc.)

■ Easily automatable: vials directly installed onboard with EVOLIS™ Systems

■ All reagents included in the kit (microplate, controls, conjugates, wash solution, substrate and stop solution)

Website www.bio-rad.com/diagnostics Australia 61-2-9914-2800 Austria 43-1-877-8901 Belgium +32 (3)710-53-00 Brazil +55 (31)3689-6600 Canada 1-514-334-4372 China 86-21-61698500 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 +36-1-459-6100 India 1800-180-1224 Israel 972-3-9636050 Italy +39-02-216091 Japan 81-3-6361-7070 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 +7-495-721-1404 Singapore 65-6415-3170 South Africa 27-11-442-85-08 Spain 34-91-590-5200 Sweden 46-8-555-127-00 Switzerland +41 (0)26-674-55-05/06 Taiwan 886-2-2578-7189 Thailand 662-651-8311 United Kingdom +44 (0)20-8328-2000

Bio-RadLaboratories

Clinical Diagnostics Group

© Bio-Rad 2016/08Bulletin 16048 Rev C Printed in France with soy-based inks on paper from sustainably managed forests10-31-1299

72561 Monolisa™ HCV Ag-Ab ULTRA V2 Assay, 96 tests72562 Monolisa™ HCV Ag-Ab ULTRA V2 Assay, 480 tests72346 Monolisa™ HBs Ag ULTRA Assay, 96 tests72348 Monolisa™ HBs Ag ULTRA Assay, 480 tests72408 Monolisa™ HBs Ag ULTRA Confirmatory Assay, 25 tests72386 Genscreen™ ULTRA HIV Ag-Ab Assay, 96 tests72388 Genscreen™ ULTRA HIV Ag-Ab Assay, 480 tests

Complete Systems89700 EVOLIS™ Premium, 1 system93500 EVOLIS™ Twin Plus, 1 system

Stand-Alone Systems94196 PR 4100 Reader, 1 system85499K PW40 Washer, 1 system87530K IPS Incubator, 1 system

Ordering InformationCatalog # Description

Visit www.bio-rad.com/diagnostics for more information.