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

Autor: Nhu QBT; Public Health Faculty, Hai Phong University of Medicine and Pharmacy, Hai Phong 180000, Vietnam., Thuy LLT; Public Health Faculty, Hai Phong University of Medicine and Pharmacy, Hai Phong 180000, Vietnam., Nguyen HT; Public Health Faculty, Hai Phong University of Medicine and Pharmacy, Hai Phong 180000, Vietnam., Thanh BN; Public Health Faculty, Hai Phong University of Medicine and Pharmacy, Hai Phong 180000, Vietnam., Rapoud D; Pathogenesis and Control of Chronic and Emerging Infections, University of Montpellier, Inserm, 34394 Montpellier, France., Quillet C; Pathogenesis and Control of Chronic and Emerging Infections, University of Montpellier, Inserm, 34394 Montpellier, France., Tran HT; Public Health Faculty, Hai Phong University of Medicine and Pharmacy, Hai Phong 180000, Vietnam., Vallo R; Pathogenesis and Control of Chronic and Emerging Infections, University of Montpellier, Inserm, 34394 Montpellier, France., Tuyet TNT; Supporting Community Development Initiatives, Hanoi 111000, Vietnam., Michel L; Inserm UMRS 1018, Pierre Nicole Center, French Red Cross, 75005 Paris, France., Weiss L; Université Paris Descartes, Sorbonne Paris Cité, Inserm U976, 75006 Paris, France., Perre PV; Pathogenesis and Control of Chronic and Emerging Infections, University of Montpellier, Inserm, 34394 Montpellier, France., Hai VV; Infectious and Tropical Diseases Department, Viet Tiep Hospital, Hai Phong 180000, Vietnam., Nagot N; Pathogenesis and Control of Chronic and Emerging Infections, University of Montpellier, Inserm, 34394 Montpellier, France., Hai OKT; Supporting Community Development Initiatives, Hanoi 111000, Vietnam., Des Jarlais D; School of Global Public Health, New York University, New York, NY 10012, USA., Duong HT; Public Health Faculty, Hai Phong University of Medicine and Pharmacy, Hai Phong 180000, Vietnam., Minh KP; Public Health Faculty, Hai Phong University of Medicine and Pharmacy, Hai Phong 180000, Vietnam., Laureillard D; Pathogenesis and Control of Chronic and Emerging Infections, University of Montpellier, Inserm, 34394 Montpellier, France.; Infectious Diseases Department, Caremeau University Hospital, 30900 Nîmes, France., Molès JP; Pathogenesis and Control of Chronic and Emerging Infections, University of Montpellier, Inserm, 34394 Montpellier, France.
Jazyk: angličtina
Zdroj: Diagnostics (Basel, Switzerland) [Diagnostics (Basel)] 2023 Nov 16; Vol. 13 (22). Date of Electronic Publication: 2023 Nov 16.
DOI: 10.3390/diagnostics13223456
Abstrakt: 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 10 4 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.
Databáze: MEDLINE
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