INFECTIOUS DISEASE TESTING. ULTRA Product Line. Safety is not a Matter of Chance. Bio-Rad Laboratories

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1 Bio-Rad Laboratories INFECTIOUS DISEASE TESTING Safety is not a Matter of Chance Bio-Rad Laboratories

2 Bio-Rad Laboratories INFECTIOUS DISEASE TESTING The best answer for HBV, HCV and HIV screening: a global automated solution for safe results. Genscreen ULTRA HIV Ag-Ab Assay Monolisa HCV Ag-Ab ULTRA V2 Assay Monolisa HBs Ag ULTRA Assay ULTRA Line Assays Monolisa HCV Ag-Ab ULTRA V2 Assay Design Suitable for: Monolisa HBs Ag ULTRA Assay Variant detection Genscreen ULTRA HIV Ag-Ab Assay 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.

3 Monolisa HCV Ag-Ab ULTRA V2 Assay EIA for Shorten 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. NAT detection single unit Monolisa HCV Ag-Ab ULTRA V2 Monolisa HCV Ag-Ab ULTRA HCV Ag/Ab microplate assay Internal data and data from commercial panels % Window Period Reduction HCV Ab Closed system A Days Average delay HCV Ab microplate assay D 25.0 HCV Ab microplate assay E HCV Ab microplate assay A 21.6 HCV Ab Closed system B 21.9 HCV Ab microplate assay B 23.5 HCV Ab Closed system C 23.5 HCV Ab microplate assay C 23.5 Genscreen ULTRA HIV Ag-Ab Assay EIA for Det Early 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 HBs Ag ULTRA Assay EIA for Detection Shorten 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. NAT detection single unit Monolisa HBs Ag ULTRA % Window Period Reduction A Monolisa HBs Ag Plus 5.2 D Days B 7.6 Average delay M O 7.4 Internal data and data from commercial panels

4 Detection of HCV Antigen and HCV Antibodies 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. Specificity Very high level of specificity for Blood Banks: 99.94% and for hospitalized patients: 99.80%. S / CO HCV RNA detection + Negative Monolisa HCV Ag-Ab ULTRA V Bleed date (days) Seracare seroconversion panel N 915 Cut off Monolisa HCV Ag-Ab Ultra V2 Monolisa HCV Ag-Ab Ultra HCV Ag-Ab assay HCV Ab Closed system HCV Ab microplate assay A HCV Ab microplate assay B ection of HIV Antigen and HIV-1 / HIV-2 Antibodies Early 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 BioClinical Partners seroconversion panel N 9017 Specificity Very high level of specificity for Blood Banks: 99.95% and for hospitalized patients: 99.75% of HBs Antigen Variant Hepatitis B Virus Strain Detection HBs Ag EIA competitor kit sensitivity on mutated HBs Ag recombinant protein samples from plasmidic construction Monolisa HBs Ag ULTRA Number of Samples 15/15 Detected M D O B A 15/15 14/15 3/15 10/15 12/15 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. 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 IU/ml using the second international WHO standard (00/588) Specificity Very high level of specificity for Blood Banks and diagnostics labs: 99.94%. Safety is not a Matter of Chance

5 Global Automated Solution Elite System PR 4100 IPS PW40 EVOLIS Twin Plus System 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, Elite ) and stand-alone systems (PR4100, PW40 & 41, 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)

6 INFECTIOUS DISEASE TESTING Ordering Information Catalog No. Description Monolisa HCV Ag-Ab ULTRA V2 Assay 96 tests Monolisa HCV Ag-Ab ULTRA V2 Assay 480 tests Monolisa HBs Ag ULTRA Assay 96 tests Monolisa HBs Ag ULTRA Assay 480 tests Genscreen ULTRA HIV Ag-Ab Assay 96 tests Genscreen ULTRA HIV Ag-Ab Assay 480 tests Complete Systems Elite 1 system EVOLIS Premium 1 system EVOLIS Twin Plus 1 system Stand-Alone Systems PR 4100 Reader 1 system PW40 Washer 1 system IPS Incubator 1 system For further information, please contact the Bio-Rad office nearest you or visit our website at Bio-Rad, S.N.C. au capital de Euros, Locataire-Gérant, RCS Nanterre N Intracommunautaire FR Siret Clinical Diagnostics Group Website Australia Austria Belgium Brazil +55 (31) Canada China Czech Republic Denmark Finland France Germany +49 (0) Greece Hong Kong Hungary India Israel Italy Japan Korea Mexico +52 (55) The Netherlands New Zealand Norway Poland Portugal Russia Singapore South Africa Spain Sweden Switzerland +41 (0) /06 Taiwan Thailand United Kingdom +44 (0) Printed in France with soy-based inks on paper from sustainably managed forests Bio-Rad Rev A 11/2013