A new ultrasensitive assay for quantitation of HIV-1 RNA in plasma

Nucleic acid-based diagnostic assays for the quantitation of plasma HIV-1 R NA levels are used to monitor disease progression and the response of patie nts to antiretroviral drug therapy. The LCx (R) HIV RNA Quantitative Assay (Abbott Laboratories, North Chicago, IL) is an assay for the quantitation o f HIV type I RNA in plasma that Lists competitive reverse transcription PCR (RT-PCR) followed by Microparticle Enzyme Immunoassay;. and includes an in ternal control for inhibition and RNA recovery, that is taken through the e ntire sample preparation procedure. The performance of the assay was assess ed for 1 and 0.2 mi sample volumes. For a 1 ml sample volume. the lower lim it of detection was found to be 50 copies,,ml with a linear range from 50 t o I million copies/ml. For a 0.2 ml sample volume. the lower limit of detec tion was found to be 178 copies/ml with a linear range from 178 to 5 millio n copies/ml. The assay is able to detect and quantitate HIV subtypes AG and group O. LCx (R) HIV RNA assay quantitation results are highly correlated to the standard and ultrasensitive: Amplicor (R) HIV-I Monitor assay (Roche Molecular Systems) quantitation results. Assay performance is consistent w ith the use of this test for routine quantitation of HIV-1 RNA in plasma. ( C) 2001 Elsevier Science B.V. All rights reserved.