HCV RNA Quantification by a Domestic Commercial Assay: A Case Study among People Who Inject Drugs in Vietnam

Quynh Bach Thi Nhu, Linh Le Thi Thuy, Hong Thi Nguyen, Binh Nguyen Thanh, Delphine Rapoud, Catherine Quillet, Hong Thi Tran, Roselyne Vallo, Thanh Nham Thi Tuyet, Laurent Michel, Laurence Weiss, Philippe Vande Perre, Vinh Vu Hai, Nicolas Nagot, Oanh Khuat Thi Hai, Don Des Jarlais, Huong Thi Duong, Khue Pham Minh, Didier Laureillard, Jean Pierre Molès

Research output: Contribution to journalArticlepeer-review


The desired performance of nucleic acid testing (NAT) may vary if used for disease diagnosis or for the evaluation of the therapeutic efficacy of a treatment, although in most cases, the same assay is used. However, these tests may not be affordable in many situations including in low/middle income countries that in response have developed domestic assays. Given the example of HCV NAT among people who inject drugs in Vietnam, we aimed at evaluating a domestic assay versus an FDA- and CE-approved assay. This cross-evaluation revealed that (i) the domestic assay had a poorer sensitivity with a threshold of detection above 104 IU/mL, and (ii) the FDA-approved assay had a percentage of false negative results close to 1%. Together, in the present study, the domestic assay had a performance compatible with diagnosis purposes (given that this population was 70% HCV seropositive) but not compatible with HCV treatment monitoring (given that treatment failures are rare and the observed viremia frequently below the threshold of detection). This study highlights the need for a proper evaluation of HCV RNA domestic assays in order to efficiently contribute to the WHO HCV elimination target by 2030.

Original languageEnglish (US)
Article number3456
Issue number22
StatePublished - Nov 2023


  • HCV
  • Vietnam
  • assays
  • diagnostic
  • drug users

ASJC Scopus subject areas

  • Clinical Biochemistry


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