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Open AccessArticle

Diagnostic Performance and Usability of the Genedrive® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgia

1
Foundation for Innovative New Diagnostics, 1202 Geneva, Switzerland
2
Centre Pasteur du Cameroun, Yaoundé 1274, Cameroon
3
Polyclinique Les Promoteurs de la Bonne Santé, Yaoundé 8463, Cameroon
4
Lugar Center for Public Health Research, National Center for Disease Control and Public Health, 0198 Tbilisi, Georgia
5
Hepa Plus, 0190 Tbilisi, Georgia
6
Division of Clinical Pharmacology, University of Cape Town, Cape Town 7700, South Africa
*
Author to whom correspondence should be addressed.
Academic Editor: Carmen de Mendoza
Diagnostics 2021, 11(5), 746; https://doi.org/10.3390/diagnostics11050746
Received: 12 March 2021 / Revised: 5 April 2021 / Accepted: 9 April 2021 / Published: 22 April 2021
(This article belongs to the Special Issue New Diagnostics and Testing Strategies for Hepatitis C Virus (HCV))
Point-of-care diagnostics have the potential to increase diagnosis and linkage to care and help reach the WHO targets to eliminate hepatitis C virus (HCV) by 2030. Here, we evaluated the diagnostic accuracy of Genedrive HCV ID assay for the qualitative detection of HCV RNA in decentralized settings in two low- and middle-income countries using fresh plasma specimens from 426 participants. The Abbott RealTime HCV assay was used as the gold standard. Genedrive HCV ID assay was conducted by different users. Users also completed questionnaires to assess the usability of Genedrive. At detection thresholds of 12 IU/mL or 30 IU/mL, 1000 IU/mL, and 2362 IU/mL, the sensitivity was 96.2% (95% CI: 92.7–98.4), 100% (98.2–100), and 100% (98.2–100), respectively; the specificity was 99.5% (95% CI: 97.4–100), 99.5% (97.5–100), and 98.7% (96.1–100), respectively. All genotypes detected using the gold-standard assay were also detected with Genedrive. Users found Genedrive easy to use. Genedrive is a simple and accurate test to confirm chronic HCV infection in decentralized, real-life, resource-limited settings. This novel diagnostic tool could contribute to closing the current gap in HCV diagnosis. View Full-Text
Keywords: Hepatitis C; HCV RNA; diagnostics; point-of-care; Genedrive Hepatitis C; HCV RNA; diagnostics; point-of-care; Genedrive
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MDPI and ACS Style

Lamoury, F.M.J.; Njouom, R.; Amougou-Atsama, M.; Yiagnigni Mfopou, E.; Berishvili, N.; Sologashvili, M.; Fajardo, E.; Malobela, A.; Macé, A.; Chirehwa, M.; Alkhazashvili, M.; Ivanova Reipold, E. Diagnostic Performance and Usability of the Genedrive® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgia. Diagnostics 2021, 11, 746. https://doi.org/10.3390/diagnostics11050746

AMA Style

Lamoury FMJ, Njouom R, Amougou-Atsama M, Yiagnigni Mfopou E, Berishvili N, Sologashvili M, Fajardo E, Malobela A, Macé A, Chirehwa M, Alkhazashvili M, Ivanova Reipold E. Diagnostic Performance and Usability of the Genedrive® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgia. Diagnostics. 2021; 11(5):746. https://doi.org/10.3390/diagnostics11050746

Chicago/Turabian Style

Lamoury, Francois M.J.; Njouom, Richard; Amougou-Atsama, Marie; Yiagnigni Mfopou, Euloge; Berishvili, Nino; Sologashvili, Manana; Fajardo, Emmanuel; Malobela, Agnes; Macé, Aurélien; Chirehwa, Maxwell; Alkhazashvili, Maia; Ivanova Reipold, Elena. 2021. "Diagnostic Performance and Usability of the Genedrive® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgia" Diagnostics 11, no. 5: 746. https://doi.org/10.3390/diagnostics11050746

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