An HIV Diagnostic Testing Algorithm Using the cobas HIV-1/HIV-2 Qualitative Assay for HIV Type Differentiation and...

Area of Science:

• Medical Diagnostics
• Virology
• Infectious Diseases

Background:

• Current human immunodeficiency virus (HIV) diagnostic algorithms rely on antigen and antibody detection, often requiring multiple tests.
• Differentiation between HIV-1 and HIV-2 can be challenging with standard assays.

Purpose of the Study:

• To evaluate the performance of a novel cobas HIV-1/HIV-2 qualitative nucleic acid amplification test (NAT) as a differentiation assay in HIV diagnostic algorithms.
• To assess the accuracy of this NAT assay in identifying HIV-1 and HIV-2 infections across various risk groups.

Main Methods:

• Study A: Evaluated the cobas HIV-1/HIV-2 qualitative NAT in individuals with known HIV-1/HIV-2 infections, low-risk, and high-risk populations.
• Study B: Compared the cobas HIV-1/HIV-2 qualitative NAT against alternative HIV-1 or HIV-2 NAT assays.
• Performance metrics included overall percent agreement (OPA) and positive percent agreement (PPA).

Main Results:

• In Study A, OPA for HIV-1 and HIV-2 ranged from 95% to 100%. PPA was 100% for HIV-1 and 99.4% for HIV-2 in known positive groups.
• Negative percent agreement was 100% for both HIV-1 and HIV-2 in the low-risk group.
• Study B demonstrated OPA from 99% to 100% and PPA of 100% for HIV-1 and 99.5% for HIV-2.

Conclusions:

• The cobas HIV-1/HIV-2 qualitative NAT assay accurately discriminates between HIV-1 and HIV-2 based on HIV RNA detection.
• This NAT assay is suitable for inclusion in alternative diagnostic algorithms for human immunodeficiency virus.