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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Abstract 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.
AbstractList 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.
Author Alkhazashvili, Maia
Njouom, Richard
Yiagnigni Mfopou, Euloge
Berishvili, Nino
Amougou-Atsama, Marie
Macé, Aurélien
Chirehwa, Maxwell
Fajardo, Emmanuel
Ivanova Reipold, Elena
Lamoury, Francois M J
Malobela, Agnes
Sologashvili, Manana
AuthorAffiliation 3 Polyclinique Les Promoteurs de la Bonne Santé, Yaoundé 8463, Cameroon; eyiagni70@gmail.com
2 Centre Pasteur du Cameroun, Yaoundé 1274, Cameroon; njouom@pasteur-yaounde.org (R.N.); marieamougou164@yahoo.com (M.A.-A.)
6 Division of Clinical Pharmacology, University of Cape Town, Cape Town 7700, South Africa; mtchirehwa@gmail.com
5 Hepa Plus, 0190 Tbilisi, Georgia; mananasolog@yahoo.com
4 Lugar Center for Public Health Research, National Center for Disease Control and Public Health, 0198 Tbilisi, Georgia; n.berishvili@ncdc.ge (N.B.); M.Alkhazashvili@ncdc.ge (M.A.)
1 Foundation for Innovative New Diagnostics, 1202 Geneva, Switzerland; lamoury_fr@hotmail.com (F.M.J.L.); fajardoe@who.int (E.F.); Agnes.Malobela@finddx.org (A.M.); Aurelien.Mace@finddx.org (A.M.)
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/33921930$$D View this record in MEDLINE/PubMed
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CitedBy_id crossref_primary_10_3390_diagnostics12051255
crossref_primary_10_1093_infdis_jiad463
crossref_primary_10_1128_jcm_00771_23
crossref_primary_10_3390_bios12050298
crossref_primary_10_3390_life13122271
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Snippet 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...
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StartPage 746
SubjectTerms Chronic illnesses
diagnostics
Disease control
Genedrive
Genotype & phenotype
HCV RNA
Hepatitis C
Infections
Laboratories
Plasma
point-of-care
Population
Sample size
Usability
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Title Diagnostic Performance and Usability of the Genedrive ® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgia
URI https://www.ncbi.nlm.nih.gov/pubmed/33921930
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Volume 11
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