Evidence map›Paper›PMID 33921930›Full record

ArticleDiagnostics (Basel, Switzerland)2021

Diagnostic Performance and Usability of the Genedrive

Francois M J Lamoury, Richard Njouom, Marie Amougou-Atsama, Euloge Yiagnigni Mfopou, Nino Berishvili, Manana Sologashvili, Emmanuel Fajardo, Agnes Malobela, Aurélien Macé, Maxwell Chirehwa and 2 more

Open access · goldAbstract read
In one paragraph

Article in Diagnostics (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. Review
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 4 countries.

Francois M J LamouryFoundation for Innovative New Diagnostics, 1202 Geneva, Switzerland.
Richard NjouomCentre Pasteur du Cameroun, Yaoundé 1274, Cameroon.
Marie Amougou-AtsamaCentre Pasteur du Cameroun, Yaoundé 1274, Cameroon.
Euloge Yiagnigni MfopouPolyclinique Les Promoteurs de la Bonne Santé, Yaoundé 8463, Cameroon.
Nino BerishviliLugar Center for Public Health Research, National Center for Disease Control and Public Health, 0198 Tbilisi, Georgia.
Manana SologashviliHepa Plus, 0190 Tbilisi, Georgia.
Emmanuel FajardoFoundation for Innovative New Diagnostics, 1202 Geneva, Switzerland.ORCID 0000-0002-7561-3368
Agnes MalobelaFoundation for Innovative New Diagnostics, 1202 Geneva, Switzerland.
Aurélien MacéFoundation for Innovative New Diagnostics, 1202 Geneva, Switzerland.ORCID 0000-0002-3282-1650
Maxwell ChirehwaDivision of Clinical Pharmacology, University of Cape Town, Cape Town 7700, South Africa.
Maia AlkhazashviliLugar Center for Public Health Research, National Center for Disease Control and Public Health, 0198 Tbilisi, Georgia.ORCID 0000-0002-1702-2308
Elena Ivanova ReipoldFoundation for Innovative New Diagnostics, 1202 Geneva, Switzerland.
FIND · CHCentre Pasteur du Cameroun · CMNational Center for Disease Control and Public Health · GEUniversity of Cape Town · ZA

Funding

Unitaid HEAD-Start
6 · The paper itself

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.

Indexed as

diagnosticsGenedriveHCV RNAHepatitis Cpoint-of-care

Identifiers

PMID33921930
PMCPMC8143533
OpenAlexW3155716399

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.