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
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%...
November 16, 2023: Diagnostics