Evaluation of the COBAS ampliprep/COBAS TaqMan system for quantification of human immunodeficiency virus type 1 (HIV-1) RNA by real-time PCR

Abstract

BACKGROUND: Viral load quantification is standard for monitoring HIV-1 therapy and is crucial in deciding whether to switch or to continue a current antiretroviral regimen. In Japan, serum is widely adapted as a specimen of the HIV-1 viral load quantification assay. METHODS: We evaluated an emerging HIV-1 RNA quantification of the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (COBAS TaqMan). The test was evaluated for matrix equivalence between plasma and serum and for correlation with the AMPLICOR HIV-1 Monitor Test v1.5 (Amplicor) for HIV-1 RNA quantification. RESULTS: The test result from serum specimens showed good correlation with test results from plasma specimens. HIV-1 RNA quantification results using serum specimens correlated well with those obtained by both ultrasensitivity assay and standard Amplicor assay. CONCLUSIONS: The fully automated COBAS AmpliPrep/COBAS TaqMan HIV-1 Test meets requirements for a wide dynamic range and reliable quantification of HIV-1 RNA in serum clinical specimens.