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

Simple item page
dc.contributor.authorLamoury, Francois M J
dc.contributor.authorNjouom, Richard
dc.contributor.authorAmougou-Atsama, Marie
dc.contributor.authorYiagnigni Mfopou, Euloge
dc.contributor.authorBerishvili, Nino
dc.contributor.authorSologashvili, Manana
dc.contributor.authorFajardo, Emmanuel
dc.contributor.authorMalobela, Agnes
dc.contributor.authorMacé, Aurélien
dc.contributor.authorChirehwa, Maxwell
dc.contributor.authorAlkhazashvili, Maia
dc.contributor.authorIvanova Reipold, Elena
dc.date.accessioned2021-10-13T09:28:49Z
dc.date.available2021-10-13T09:28:49Z
dc.date.issued2021-04-22
dc.date.updated2021-05-24T15:04:27Z
dc.description.abstractPoint-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.en_US
dc.identifier10.3390/diagnostics11050746
dc.identifier.apacitationLamoury, F. M. J., Njouom, R., Amougou-Atsama, M., Yiagnigni Mfopou, E., Berishvili, N., Sologashvili, M., ... Ivanova Reipold, E. (2021). Diagnostic Performance and Usability of the Genedrive® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgia. <i>Diagnostics</i>, 11(5), 746. http://hdl.handle.net/11427/35225en_ZA
dc.identifier.chicagocitationLamoury, Francois M J, Richard Njouom, Marie Amougou-Atsama, Euloge Yiagnigni Mfopou, Nino Berishvili, Manana Sologashvili, Emmanuel Fajardo, et al "Diagnostic Performance and Usability of the Genedrive® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgia." <i>Diagnostics</i> 11, 5. (2021): 746. http://hdl.handle.net/11427/35225en_ZA
dc.identifier.citationLamoury, F.M.J., Njouom, R., Amougou-Atsama, M., Yiagnigni Mfopou, E., Berishvili, N., Sologashvili, M., Fajardo, E. & Malobela, A. et al. 2021. Diagnostic Performance and Usability of the Genedrive® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgia. <i>Diagnostics.</i> 11(5):746. http://hdl.handle.net/11427/35225en_ZA
dc.identifier.ris TY - Journal Article AU - Lamoury, Francois M J AU - Njouom, Richard AU - Amougou-Atsama, Marie AU - Yiagnigni Mfopou, Euloge AU - Berishvili, Nino AU - Sologashvili, Manana AU - Fajardo, Emmanuel AU - Malobela, Agnes AU - Macé, Aurélien AU - Chirehwa, Maxwell AU - Alkhazashvili, Maia AU - Ivanova Reipold, Elena AB - 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. DA - 2021-04-22 DB - OpenUCT DP - University of Cape Town IS - 5 J1 - Diagnostics LK - https://open.uct.ac.za PY - 2021 T1 - Diagnostic Performance and Usability of the Genedrive® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgia TI - Diagnostic Performance and Usability of the Genedrive® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgia UR - http://hdl.handle.net/11427/35225 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/35225
dc.identifier.vancouvercitationLamoury FMJ, Njouom R, Amougou-Atsama M, Yiagnigni Mfopou E, Berishvili N, Sologashvili M, et al. Diagnostic Performance and Usability of the Genedrive® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgia. Diagnostics. 2021;11(5):746. http://hdl.handle.net/11427/35225.en_ZA
dc.language.isoenen_US
dc.publisher.departmentDivision of Clinical Pharmacologyen_US
dc.publisher.facultyFaculty of Health Sciencesen_US
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.sourceDiagnosticsen_US
dc.source.journalissue5en_US
dc.source.journalvolume11en_US
dc.source.pagination746en_US
dc.source.urihttps://www.mdpi.com/journal/diagnostics
dc.titleDiagnostic Performance and Usability of the Genedrive® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgiaen_US
dc.typeJournal Articleen_US
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
diagnostics-11-00746.pdf
Size:
721.79 KB
Format:
Adobe Portable Document Format
Description:
Download
License bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
license.txt
Size:
0 B
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
Journal Articles