Table 3: FDA-Approved Quantitative HIV-1 RNA Assays for Viral Load Monitoring
Test Name Method Lower and Upper LOQ
Abbott RealTime HIV-1 (Abbott Laboratories)Real-time PCR
  • 40 copies/mL [a]
  • 10,000,000 copies/mL
Cobas AmpliPrep/Cobas TaqMan HIV-1 Test, version 2.0 (Roche Diagnostics)Real-time PCR
  • 20 copies/mL
  • 10,000,000 copies/mL
Cobas HIV-1 quantitative NAT for use on Cobas 6800/8800 systems (Roche Diagnostics)Real-time PCR
  • 20 copies/mL
  • 10,000,000 copies/mL
Cobas TaqMan HIV-1 Test, v2.0 for use with the high pure system (Roche Diagnostics)Real-time PCR
  • 34 copies/mL
  • 10,000,000 copies/mL

Abbreviations: FDA, U.S. Food and Drug Administration; LOQ, limit of quantification; NAT, nucleic acid test; PCR, polymerase chain reaction.

Note:

a

This lower LOQ applies when 1.0 mL of plasma is used. When 0.5 and 0.2 mL of plasma are used, the lower LOQ is 75 copies/mL and 150 copies/mL, respectively.

From: Virologic and Immunologic Monitoring in HIV Care

Cover of Virologic and Immunologic Monitoring in HIV Care
Virologic and Immunologic Monitoring in HIV Care [Internet].
Merrick ST, Fine SM, Vail R, et al.
Baltimore (MD): Johns Hopkins University; 2022 Jun.
Copyright © Johns Hopkins University Clinical Guidelines Program 2000-2024. The Clinical Guidelines Program, a collaborative effort of the NYSDOH AI and the Johns Hopkins University School of Medicine, Division of Infectious Diseases, encourages the use, reproduction, and distribution of original documents and related graphics from this program website accompanied by a full citation of source that includes: Author(s). Committee. Title. Date of publication. Full URL. Date accessed. Links to pages on this Clinical Guidelines Program website are also encouraged and may be created without seeking permission. Requests to adapt material, i.e., to change or alter in any way material from this website for inclusion in another publication, should be sent to aiguidelines@jhmi.edu. Please include detailed information about the intended use and desired adaptations.

This book is licensed under the terms of the Attribution-NonCommercial-NoDerivs 3.0 Unported (CC BY-NC-ND 3.0).

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.