Reliability of CE-marked NATs for HIV-1 subtype C detection and quantitation

Area of Science:

• Virology
• Clinical Diagnostics
• Public Health

Background:

• HIV-1 subtype C is the predominant strain globally, particularly in sub-Saharan Africa.
• Nucleic acid amplification technology (NAT) assays are crucial for early HIV-1 detection and viral load monitoring.
• Standardization of HIV-1 NAT assays is essential for accurate diagnosis and treatment efficacy.

Purpose of the Study:

• To evaluate the performance of seven CE-marked HIV-1 RNA NAT assays for HIV-1 subtype C detection.
• To assess the quantitation concordance of these assays when analyzing HIV-1 subtype C specimens.
• To determine the reliability of current HIV-1 NAT assays for diagnosing recent HIV-1 subtype C infections.

Main Methods:

• Comparative analysis of seven CE-marked HIV-1 RNA NAT assays.
• Testing of 398 plasma samples from South African blood donors with confirmed HIV-1 subtype C infection.
• Evaluation of detection efficiency and quantitation concordance across different assay designs (mono- vs. dual-target).

Main Results:

• All seven HIV-1 RNA NAT assays successfully detected 100% of HIV-1 subtype C specimens.
• No significant difference in detection was observed between mono- and dual-target assay designs for subtype C.
• High concordance in HIV-1 subtype C quantitation was achieved across the tested NAT assays.
• Unlike some subtype B variants, no HIV-1 subtype C variants were missed by the evaluated assays.

Conclusions:

• CE-marked HIV-1 RNA NAT assays demonstrate high sensitivity and specificity for HIV-1 subtype C detection.
• The standardization of HIV-1 NAT assays has led to reliable quantitation for subtype C.
• These findings support the continued use and potential expansion of NAT-based screening for HIV-1 subtype C.