Performance of plasma separation cards for HIV drug-resistance genotyping in a resource-limited setting: comparison

Thang Hong Pham1, Hanh Thi Hong Ngo1, Tram Thi Phuong Pham1

  • 1National Institute of Hygiene and Epidemiology (NIHE), Hanoi 100000, Vietnam.

Insights

The Cobas Plasma Separation Card (PSC) shows high accuracy for HIV drug resistance genotyping compared to plasma. This method can expand access to HIV genotyping in resource-limited settings.

Area of Science:

  • Virology
  • Public Health
  • Clinical Diagnostics

Background:

  • HIV drug resistance (HIVDR) poses a significant threat to the efficacy of antiretroviral therapy (ART) in low- and middle-income countries.
  • The Cobas Plasma Separation Card (PSC) offers a promising solution for decentralized HIVDR genotyping, potentially improving access in remote areas.

Purpose of the Study:

  • To evaluate the performance of the Cobas Plasma Separation Card (PSC) for HIV drug resistance genotyping against traditional plasma methods.

Main Methods:

  • Paired plasma and PSC specimens were collected from 250 individuals with HIV on ART and viral load ≥1000 copies/mL.
  • HIVDR genotyping was performed using the CDC Atlanta in-house protocol, with resistance interpretation via the Stanford HIVdb algorithm.
  • Paired sequences were analyzed for subtype, nucleotide similarity, mutation profiles, and drug resistance classification.

Main Results:

  • Of 20 valid paired specimens, HIV-1 Pol gene amplification was successful in 95% of PSC samples.
  • Nucleotide similarity between PSC and plasma sequences was high at 98.5%.
  • 94.6% of major drug-resistance mutations identified in plasma were concordantly found in PSC specimens, with minimal impact on clinical interpretation.

Conclusions:

  • The Cobas Plasma Separation Card (PSC) demonstrates strong concordance with plasma for HIV drug resistance genotyping.
  • PSC is a viable alternative specimen type for HIVDR genotyping in clinical practice and surveillance, particularly in resource-limited settings.
Abstract

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