Performance characteristics of the Cavidi ExaVir viral load assay and the ultra-sensitive P24 assay relative to the Roche Monitor HIV-1 RNA assay
| Autor: | Susan A. Fiscus, Daniel Bettendorf, Peter Bohlin, Sonia Napravnik, Ian Frank, Ada Cachafeiro, Ronald J. Bosch, Charles van der Horst, Paul W. Stewart, Joseph J. Eron |
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| Rok vydání: | 2010 |
| Předmět: |
viruses
HIV Core Protein p24 HIV Infections Convenience sample Sensitivity and Specificity HIV 1 RNA assay Article Predictive Value of Tests Virology Positive predicative value Humans Ultra sensitive biology virus diseases Viral Load biology.organism_classification P24 antigen Molecular biology Infectious Diseases Lentivirus HIV-1 RNA Viral Performance curves Reagent Kits Diagnostic Viral load |
| Zdroj: | Journal of Clinical Virology. 49:198-204 |
| ISSN: | 1386-6532 |
| DOI: | 10.1016/j.jcv.2010.07.022 |
| Popis: | Background The Cavidi viral load assay and the ultra-sensitive p24 antigen assay (Up24 Ag) have been suggested as more feasible alternatives to PCR-based HIV viral load assays for use in monitoring patients infected with HIV-1 in resource-limited settings. Objectives To describe the performance of the Cavidi ExaVir Load™ assay (version 2.0) and two versions of the Up24 antigen assay and to characterize their agreement with the Roche Monitor HIV-1 RNA assay (version 1.5). Study design Observational study using a convenience sample of 342 plasma specimens from 108 patients enrolled in two ACTG clinical trials to evaluate the performance characteristics of the Up24 Ag assay using two different lysis buffers and the Cavidi ExaVir Load™ assay. Results In analysis of agreement with the Roche assay, the Cavidi assay demonstrated superiority to the Up24 Ag assays in accuracy and precision, as well as sensitivity, specificity, and positive and negative predictive values for HIV-1 RNA ≥400, ≥1000 and ≥5000 copies/mL. Logistic performance curves indicated that the Cavidi assay was superior to the Up24 assays for viral loads greater than 650 copies/mL. Conclusions The results suggest that the Cavidi ExaVir Load assay could be used for monitoring HIV-1 viral load in resource-limited settings. |
| Databáze: | OpenAIRE |
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