Panther has new prey

Transcription

1 Raising the Bar for Performance Testing Panther has new prey The Aptima HIV-1 Quant Dx assay leads the hunt for HIV-1 diagnosis and viral load monitoring.

2 Freedom to work the way you choose Run what assays you want, when you need them, and how you want to Reduce turnaround time Increase productivity S Reduce costs WHAT Run the Aptima HIV-1 Quant Dx assay in parallel with Aptima assays for: CT/NG HPV Trichomonas vaginalis HCV* HBV* WHEN True random access. Don t wait for a batch. Access the instrument at any time to load additional samples or reagents. HOW Run as few as 1 or as many as 94 clinical samples, with no additional controls required. Unload and store reagents as needed to reduce waste. No sample transfer or pipetting required. *In development.

3 Viral load testing has evolved: The Panther System Takes Automation to the Next Level Every step of nucleic acid testing, from sample to result, can be completed on the Panther system. A Single, Integrated Instrument Allows you to directly load centrifuged vacutainers Performs extraction, amplification and detection with full automation Does not require manual manipulation, pipetting, or transfer of plates, tubes or carriers before amplification With random access, the ability to continuously load samples and time to first result of about 150 minutes, this assay is a major improvement in the viral load monitoring of HIV-1 infection. Martin Obermeier, Medical Center for Infectious Diseases, Berlin

4 Aptima HIV-1 Quant Dx Assay: Performance by Design Three levels of protection against mutations for reliable diagnosis and monitoring of HIV-1 1 Dual Target Assay Two targets, pol and LTR, within highly conserved genomic regions to ensure accurate detection and quantitation. vif LTR gag vpu tat nef pol rev LTR env 5 vpr Sophisticated Primer Design Increased primer length able to withstand multiple mutations. 3 Redundancy of Oligos Multiple, redundant oligos to provide additional protection.

5 Raising the Bar for Performance Testing Thorough establishment and verification of LLoQ across HIV-1 groups and subtypes with rigorous standards: 3 reagent lots, replicates per lot, 23 runs. Verification of LLoQ* by HIV-1 Subtype or Group 1 Panel Subtype A Subtype CRF01_AE Subtype CRF02_AG Subtype B Subtype C Subtype D Subtype F Subtype G Group N Group O LLoQ (copies/ml) *LLoQ - Lower Limit Of Quantitation Low variation and high precision even at low viremia: Precision of the Aptima HIV-1 Quant Dx Assay 1 Number of Valid Replicates Mean Concentration (log copies/ml) SD Total a Coefficient of Variation (%) b The total number of replicates tested was for each panel; only replicates with a numerical value were analyzed. a Includes inter-instrument, inter-operator, inter-lot and inter-run analysis. b This panel member was diluted 1:3 with specimen diluent and tested to evaluate the precision of the diluted sample.

6 Demand more from your HIV-1 assay Product Design Performance Intended Use Diagnosis of primary HIV-1 infection Confirmation of HIV-1 infection HIV-1 viral load monitoring LoD* 12 copies/ml (3rd WHO International Standard) Technology Real-time transcription-mediated amplification (TMA) LLoQ copies/ml (Reaction volume: 0.5 ml plasma) Target Region pol/ltr Precision <10% CV and <0.2 SD across assay range Groups M, N, O Linear Range to 10 million copies/ml Sample Types Qualitative: Serum or Plasma Quantitative: Plasma Specificity 100% (95% Cl: 99.4%-100%) Sample Input Volume Primary tube (PPT, ACD, EDTA, SST, serum): 1.2 ml Secondary tube: 700 μl 240 μl with validated dilution protocol *LoD - Limit of Detection CV - Coefficient of Variation Ordering Information Item Quality Catalog # Aptima HIV-1 Quant Dx Assay Kit (1 assay box, 1 calibrator kit, 1 control kit) 100 tests PRD-000 Aptima HIV-1 Quant Dx Controls Kit 5 of each control (low, negative, high) PRD-002 Aptima HIV-1 Quant Dx Calibrator Kit 5 calibrators PRD-001 Reference 1. Aptima HIV-1 Quant Dx assay [package insert], San Diego, CA; Hologic, Inc., Visit AptimaVirology.com PB Rev Hologic, Inc. All rights reserved. Hologic, Science of Sure, Aptima, Panther and associated logos are trademarks or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. This information is intended for medical professionals and is not intended as a product solicitation or promotion where such activities are prohibited. Because Hologic materials are distributed through websites, ebroadcasts and tradeshows, it is not always possible to control where such materials appear. For information on specific products available for sale in a particular country, please contact your Hologic representative or write to diagnostic.solutions@hologic.com. The Aptima HIV-1 Quant Dx assay is currently not for sale in the U.S.