BACKGROUND: The COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5 (Amplicor) has been replaced with the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 2.0), a real-time polymerase chain reaction human immunodeficiency virus type 1 (HIV-1) assay with higher sensitivity and broader dynamic range. HIV-1 RNA values at the 50 copies/mL cutoff drive major patient management decisions and clinical study outcomes. METHODS: A total of 2217 samples were collected from 1922 HIV-1-infected subjects taking antiretroviral therapy for at least 48 weeks and had at least 2 consecutive samples with HIV-1 RNA <50 copies/mL by Amplicor from 7 recent clinical trials. HIV-1 RNA results were obtained from the Amplicor and TaqMan 2.0 assays in parallel by a reference laboratory. RESULTS: The overall concordance between assay results was 96% at the cutoff of 50 copies/mL. However, statistically significant discordance at the 50 copies/mL cutoff was found between the assays for 3.9% of samples (n = 87). By TaqMan 2.0, virologic failure defined as HIV-1 RNA ≥ 50 copies/mL was reported for 2.8% more samples than Amplicor. Of these 87 samples, 68 samples fell within the predicted range of assay variability. Retesting of HIV-1 RNA by TaqMan 2.0 confirmed the discordance in only 28 of the 87 samples. CONCLUSIONS: The TaqMan 2.0 assay reports fewer subjects below the clinical endpoint of HIV-1 RNA <50 copies/mL in HIV clinical trials than the Amplicor assay. This difference must be considered when assessing disease progression, designing clinical trials, and comparisons with historical trials that used the Amplicor assay.
BACKGROUND: The COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5 (Amplicor) has been replaced with the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 2.0), a real-time polymerase chain reaction human immunodeficiency virus type 1 (HIV-1) assay with higher sensitivity and broader dynamic range. HIV-1 RNA values at the 50 copies/mL cutoff drive major patient management decisions and clinical study outcomes. METHODS: A total of 2217 samples were collected from 1922 HIV-1-infected subjects taking antiretroviral therapy for at least 48 weeks and had at least 2 consecutive samples with HIV-1 RNA <50 copies/mL by Amplicor from 7 recent clinical trials. HIV-1 RNA results were obtained from the Amplicor and TaqMan 2.0 assays in parallel by a reference laboratory. RESULTS: The overall concordance between assay results was 96% at the cutoff of 50 copies/mL. However, statistically significant discordance at the 50 copies/mL cutoff was found between the assays for 3.9% of samples (n = 87). By TaqMan 2.0, virologic failure defined as HIV-1 RNA ≥ 50 copies/mL was reported for 2.8% more samples than Amplicor. Of these 87 samples, 68 samples fell within the predicted range of assay variability. Retesting of HIV-1 RNA by TaqMan 2.0 confirmed the discordance in only 28 of the 87 samples. CONCLUSIONS: The TaqMan 2.0 assay reports fewer subjects below the clinical endpoint of HIV-1 RNA <50 copies/mL in HIV clinical trials than the Amplicor assay. This difference must be considered when assessing disease progression, designing clinical trials, and comparisons with historical trials that used the Amplicor assay.
Authors: F Damond; V Avettand-Fenoel; G Collin; B Roquebert; J C Plantier; A Ganon; D Sizmann; R Babiel; J Glaubitz; M L Chaix; F Brun-Vezinet; D Descamps; C Rouzioux Journal: J Clin Microbiol Date: 2010-02-03 Impact factor: 5.948
Authors: Paul E Sax; Edwin DeJesus; Anthony Mills; Andrew Zolopa; Calvin Cohen; David Wohl; Joel E Gallant; Hui C Liu; Lijie Zhong; Kitty Yale; Kirsten White; Brian P Kearney; Javier Szwarcberg; Erin Quirk; Andrew K Cheng Journal: Lancet Date: 2012-06-30 Impact factor: 79.321
Authors: Dorothea Sizmann; Joachim Glaubitz; Christian O Simon; Sebastian Goedel; Philippe Buergisser; Daniel Drogan; Martin Hesse; Michael Kröh; Pascale Simmler; Manuela Dewald; Marion Gilsdorf; Marion Fuerst; Ralph Ineichen; Anette Kirn; Paul Pasche; Zhijun Wang; Sabrina Weisshaar; Karen Young; Gerd Haberhausen; Reiner Babiel Journal: J Clin Virol Date: 2010-07-15 Impact factor: 3.168
Authors: Edwin DeJesus; Jürgen K Rockstroh; Keith Henry; Jean-Michel Molina; Joseph Gathe; Srinivasan Ramanathan; Xuelian Wei; Kitty Yale; Javier Szwarcberg; Kirsten White; Andrew K Cheng; Brian P Kearney Journal: Lancet Date: 2012-06-30 Impact factor: 79.321
Authors: Lu Zheng; Ronald J Bosch; Ellen S Chan; Sarah Read; Mary Kearney; David M Margolis; John W Mellors; Joseph J Eron; Rajesh T Gandhi Journal: Antivir Ther Date: 2012-08-22
Authors: Christie Joya; Seung Hyun Won; Christina Schofield; Tahaniyat Lalani; Ryan C Maves; Karl Kronmann; Robert Deiss; Jason Okulicz; Brian K Agan; Anuradha Ganesan Journal: Clin Infect Dis Date: 2019-11-27 Impact factor: 9.079