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Genotypic Inference of HIV-1 Tropism Using Population-based Sequencing of V3
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Development and genomic characterization of a diverse HIV-1 variant reference panel for nucleic acid-based testing.

Jiangqin Zhao1, Tianxiong Li1, Hanxia Huang1

  • 1Laboratory of Molecular Virology, DETTD, OBRR, CBER, FDA, 10903 New Hampshire Ave, Silver Spring, MD, United States.

Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology
|April 16, 2026
PubMed
Summary

A diverse HIV-1 reference panel was created to address challenges in HIV nucleic acid testing (NAT) due to global genetic diversity. This panel aids in evaluating the analytical performance of HIV NAT assays.

Keywords:
NATPCRdiagnosticsgenetic diversityhuman immunodeficiency virusp24recombinantsubtypeviral load

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Area of Science:

  • Virology
  • Molecular Biology
  • Public Health

Background:

  • Global Human Immunodeficiency Virus (HIV) genetic diversity complicates accurate detection and diagnosis via nucleic acid testing (NAT).
  • Well-characterized reference panels are crucial for assessing the analytical performance of HIV diagnostic tests.

Purpose of the Study:

  • To develop a comprehensive reference panel for HIV NAT that accurately represents the genetic diversity of circulating HIV strains.
  • To create a standardized tool for validating HIV detection methods.

Main Methods:

  • HIV-1 strains were cultured from clinical specimens in Cameroon.
  • Near full-length genomes were sequenced using metagenomic next-generation sequencing and Sanger sequencing.
  • A diverse subset of 18 HIV-1 strains was selected to form the reference panel, with viral loads quantified at low, medium, and high levels.

Main Results:

  • Near full-length HIV-1 genomes (average 9589 bp) were obtained for 37 out of 59 strains.
  • The panel includes 18 diverse HIV-1 strains: 4 subtypes, 4 circulating recombinant forms, and 8 unique recombinant forms.
  • Panel members were prepared at three viral load concentrations (low, medium, high), resulting in 51 total panel members.

Conclusions:

  • The developed HIV reference panel effectively represents diverse circulating strains.
  • This panel is a valuable resource for evaluating the performance of HIV NAT assays.
  • The panel is available to developers and manufacturers of HIV diagnostic tests upon request.