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Field evaluation of GeneXpert

Momoko Iwamoto1,2, Aurelie Calzia2, Amelie Dublineau1

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Journal of Viral Hepatitis
|September 11, 2018
PubMed
Summary

The GeneXpert® assay accurately detects hepatitis C virus (HCV) RNA, including genotype 6 (GT6) strains, in resource-limited settings. This WHO-prequalified platform offers high sensitivity and specificity for point-of-care HCV testing.

Keywords:
CambodiaHCV genotype 6Hepatitis CPoint-of-care testingRNA viral load

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Area of Science:

  • Virology
  • Infectious Diseases
  • Diagnostics

Background:

  • The GeneXpert® platform is the sole WHO-prequalified nucleic acid amplification test for hepatitis C virus (HCV) suitable for resource-limited point-of-care settings.
  • Limited data exists on the performance of GeneXpert® for detecting HCV genotype 6 (GT6), a prevalent subtype in certain regions.

Purpose of the Study:

  • To evaluate the field performance of the GeneXpert® HCV assay for viral load testing in a Cambodian patient population predominantly infected with GT6 HCV.
  • To compare GeneXpert® results against a standard laboratory method for accuracy and turnaround time.

Main Methods:

  • Plasma samples from 769 patients were tested for HCV viral load using GeneXpert® and compared with the COBAS® AmpliPrep/Cobas® TaqMan® HCV assay (Roche).
  • The study population in Cambodia primarily consisted of patients infected with GT6 HCV.

Main Results:

  • GeneXpert® demonstrated high sensitivity (100%) and specificity (98.5%) compared to the Roche assay.
  • Quantitative agreement was good, with a mean viral load difference of -0.07 log10 IU/mL for GT6 strains.
  • The GeneXpert® assay showed a significantly shorter median turnaround time (0 days) compared to the Roche assay (4 days), with a 1% error rate.

Conclusions:

  • The GeneXpert® HCV assay is a reliable tool for viral load testing in real-world, resource-limited settings, even for patients with GT6 HCV infections.
  • Its high accuracy, rapid turnaround time, and suitability for point-of-care use make it valuable for managing HCV in underserved areas.