Evidence map›Paper›PMID 33270716›Full record

ArticlePloS one2020

Sensitivity and specificity of rapid hepatitis C antibody assays in freshly collected whole blood, plasma and serum samples: A multicentre prospective study.

Beatrice N Vetter, Stefano Ongarello, Alexander Tyshkovskiy, Maia Alkhazashvili, Nazibrola Chitadze, Kimcheng Choun, An Sokkab, Anja De Weggheleire, Fien Vanroye, Elena Ivanova Reipold

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 42% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. 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

10 authors at 5 institutions in 6 countries.

Beatrice N VetterFoundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.ORCID 0000-0002-7898-472X
Stefano OngarelloFoundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.
Alexander TyshkovskiyDivision of Genetics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.
Maia AlkhazashviliNational Center for Disease Control & Public Health/R. Lugar Center for Public Health Research, Tbilisi, Georgia.
Nazibrola ChitadzeNational Center for Disease Control & Public Health/R. Lugar Center for Public Health Research, Tbilisi, Georgia.
Kimcheng ChounSihanouk Hospital Center of Hope, Phnom Penh, Cambodia.
An SokkabSihanouk Hospital Center of Hope, Phnom Penh, Cambodia.
Anja De WeggheleireNeglegted Tropical Diseases Unit, Institute of Tropical Medicine, Antwerp, Belgium.ORCID 0000-0001-9377-4766
Fien VanroyeReference Laboratory HIV/STD, Institute of Tropical Medicine, Antwerp, Belgium.
Elena Ivanova ReipoldFoundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.
FIND · CHInstituut voor Tropische Geneeskunde · BENational Center for Disease Control and Public Health · GESihanouk Hospital Center of HOPE · KHBrigham and Women's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study evaluated performance of two hepatitis C virus (HCV) rapid diagnostic tests (RDTs) performed by intended users in resource-limited settings.

methodsTesting was conducted at three facilities in two countries (Georgia, Cambodia) using matched fingerstick whole blood, plasma and serum samples. Investigational RDTs were compared with a composite reference standard (CRS) comprised of three laboratory tests, and a reference RDT.

resultsIn matched samples from 489 HCV positive and 967 HCV negative participants, specificity with both investigational RDTs was high using either reference method (≥98.4% in all sample types). Sensitivity was lower in whole blood versus plasma and serum for both RDTs compared with the CRS (86.5-91.4% vs 97.5-98.0% and 97.3-97.1%) and reference RDT (93.6-97.8% vs 100% and 99.4%). Sensitivity improved when considering only samples with detectable HCV viral load.

conclusionSensitivity was highest in serum and plasma versus whole blood. The World Health Organization prequalification criterion (≥98%) was narrowly missed by both RDTs in serum, and one in plasma, possibly due to the intended user factor. Performance in whole blood was considered adequate, given potential roles of HCV infection history, improved sensitivity with detectable viral load and performance similarities to the reference RDT.

Indexed as

AdultCambodiaDiagnostic Tests, RoutineFemaleGeorgia (Republic)HepacivirusHepatitis CHepatitis C AntibodiesHumansMaleMiddle AgedPlasmaProspective StudiesReference StandardsSensitivity and SpecificitySerologic TestsHepatitis C Antibodies

Identifiers

PMID33270716
PMCPMC7714359
OpenAlexW3107716170

What OpenQuestion holds

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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.