Infectious Disease Testing ULTRA Product Line Safety is not a Matter of Chance
ULTRA Product Line The best answer for HBV, HCV and HIV screening: a global automated solution for safe results. Monolisa HCV Ag-Ab ULTRA V2 Assay Genscreen ULTRA HIV Ag-Ab Assay Monolisa HBs Ag ULTRA Assay ULTRA Line Assays Design Suitable for: Variant detection Significant reduction of window periods Sensitivity close to those observed with Nucleic Acid Testing (NAT) ULTRA Product Line: Monolisa HCV Ag-Ab ULTRA V2 Assay Monolisa HBs Ag ULTRA Assay Genscreen ULTRA HIV Ag-Ab Assay Very high level of specificity And with the highest level of safety and ease of use.
Monolisa HCV Ag-Ab ULTRA V2 Assay EIA for Detection of HCV 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 3.8 4.4 Internal data and data from commercial panels 4.8 70% Window Period Reduction HCV Ab Closed system A 0 4 8 12 16 20 24 Days Average delay HCV Ab microplate assay D 25.0 HCV Ab microplate assay E 24.1 19.6 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 Detection of HIV Ant 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 of HBs Antigen 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 2.1 53% Window Period Reduction A Monolisa HBs Ag Plus 5.2 D 0 1 2 3 4 5 6 7 8 Days B 7.6 Average delay M 5.0 4.5 5.9 O 7.4 Internal data and data from commercial panels
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 + 7 6 5 Monolisa HCV Ag-Ab ULTRA V2 4 3 2 1 0 0 5 12 14 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 igen 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%. 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 0.025 IU/ml using the second international WHO standard (00/588). Specificity Very high level of specificity for Blood Banks and diagnostics labs: 99.94%.
Global Automated Solution EVOLIS System PR 4100 IPS PW40 EVOLIS Twin Plus System Easy to Use and Easily Automatable No sample pre-dilution 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 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)
Ordering Information Catalog # Description 72561 Monolisa HCV Ag-Ab ULTRA V2 Assay, 96 tests 72562 Monolisa HCV Ag-Ab ULTRA V2 Assay, 480 tests 72346 Monolisa HBs Ag ULTRA Assay, 96 tests 72348 Monolisa HBs Ag ULTRA Assay, 480 tests 72408 Monolisa HBs Ag ULTRA Confirmatory Assay, 25 tests 72386 Genscreen ULTRA HIV Ag-Ab Assay, 96 tests 72388 Genscreen ULTRA HIV Ag-Ab Assay, 480 tests Complete Systems 89700 EVOLIS Premium, 1 system 93500 EVOLIS Twin Plus, 1 system Stand-Alone Systems 94196 PR 4100 Reader, 1 system 85499K PW40 Washer, 1 system 87530K IPS Incubator, 1 system Visit www.bio-rad.com/diagnostics for more information. Bio-Rad Laboratories Clinical Diagnostics Group 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 Bulletin 16048 Rev C 10-31-1299 Printed in France with soy-based inks on paper from sustainably managed forests Bio-Rad 2016/08