Laboratory Assays in the Clinical Management of Antiretroviral Therapy

  • Author: Mark Holodniy, MD (More Info)
  • Editors in Chief: Daniel R. Kuritzkes, MD; Joseph J. Eron, Jr., MD
  • Last Reviewed: 12/12/17 (What's New)

Supporting Assets

Table 1 | Table 2

Table 1. FDA-Approved HIV-1 Viral Load Assays

Assay

Assay Type

Gene Target

Volume Plasma Required, mL

Dynamic Range, copies/mL

COBAS AmpliPrep/COBAS TaqMan version 2.0 (Roche Diagnostics)

Real-time PCR

gag and long terminal repeat

1.0

20-10,000,000

RealTime (Abbott Diagnostics)

Real-time PCR

Integrase

1.0  (LLD: 40 copies/mL)
0.6 (LLD: 40 copies/mL)
0.5 (LLD: 75 copies/mL)
0.2 (LLD: 150 copies/mL)

40-10,000,000

Versant HIV RNA 3.0 Assay (Siemens Healthcare Diagnostics)

Signal amplification assay

pol

1.0

75-500,000

NucliSENS easyMag/EasyQ HIV-1 v2.0 (bioMérieux)

Real-time nucleic acid sequence–based amplification and molecular beacon-detection technology

gag

1.0

10-10,000,000

LLD, lower limit of detection.

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