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

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...

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Published inDiagnostics (Basel) Vol. 11; no. 5; p. 746
Main Authors 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
Format Journal Article
LanguageEnglish
Published Switzerland MDPI AG 22.04.2021
MDPI
Subjects
Chronic illnesses
diagnostics
Disease control
Genedrive
Genotype & phenotype
HCV RNA
Hepatitis C
Infections
Laboratories
Plasma
point-of-care
Population
Sample size
Usability
Cameroon
HCV RNA
diagnostics
Genedrive
Hepatitis C
point-of-care
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Summary: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.
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ISSN:2075-4418
2075-4418
DOI:10.3390/diagnostics11050746