Evidence map›Paper›PMID 32504944›Full record

ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2020

Implementation of rapid SARS-CoV-2 antigenic testing in a laboratory without access to molecular methods: Experiences of a general hospital.

Laurent Blairon, Alain Wilmet, Ingrid Beukinga, Marie Tré-Hardy

2 registry-linked trialsOpen access · greenAbstract readComment
In one paragraph

Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 32 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 7 pooled it
1.5field-weighted citation impact, top 10% 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.

NCT04568356 nacompletednot on this map

A Clinical Performance Evaluation of the SARS-COV-2 Direct Antigen Rapid Test "DART"

TypeinterventionalSponsorE25Bio, Inc.Ran2020 to 2020Enrolled200ConditionsSARS CoV-2ArmsDirect Antigen Tests for COVID-19
NCT04610489 naterminatednot on this map

Diagnostic Performance of an Antigen Test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19)

TypeinterventionalSponsorCarilion ClinicRan2020 to 2021Enrolled117ConditionsCovid-19ArmsQuidel Sofia SARS Antigen FIA
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 7 syntheses or guidelines pooled it, 60 citations in OpenAlex.

  1. Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Guideline
  3. Pooled it
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  5. Pooled it
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  8. Article
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  11. Lateral Flow Immunoassays for SARS-CoV-2.Diagnostics (Basel, Switzerland) · 2022
    Review
  12. Article
  13. Review
  14. SARS-CoV-2 RNA Detection on Environmental Surfaces in a University Setting of Central Italy.International journal of environmental research and public health · 2022
    Article
  15. Article
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  20. Evaluation of a high volume antigen test for detection of SARS-CoV-2.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2021
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Laurent BlaironDepartment of Laboratory Medicine, Iris Hospitals South, Brussels, Belgium.
Alain WilmetDepartment of Laboratory Medicine, Iris Hospitals South, Brussels, Belgium.
Ingrid BeukingaDepartment of Laboratory Medicine, Iris Hospitals South, Brussels, Belgium.
Marie Tré-HardyDepartment of Laboratory Medicine, Iris Hospitals South, Brussels, Belgium; Department of Pharmacy, Namur Research Institute for Life Sciences, University of Namur, Belgium; Faculty of Medicine, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: marie.tre-hardy@ulb.ac.be.
Hôpitaux Iris Sud · BEUniversity of Namur · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe COVID-19 Ag (Antigen) Respi-Strip assay is a new immunochromatographic diagnostic tool recently available for antigenic diagnosis of SARS-CoV-2. The proposed sensitivity is not higher than 60 %, but its high specificity allows both quick decisions for the management of patients and confirmation by molecular diagnosis for only negative tests. However, from the first tests performed, we suspected that the sensitivity observed with routine use was much lower than that announced by the manufacturer. MATERIALS AND

methodsOver a period of one month, we compared the negative results obtained with the COVID-19 Ag Respi-Strip kit with those obtained from qRT-PCR performed in a laboratory qualified for the molecular diagnosis of SARS-CoV-2. All samples tested were naso-pharyngeal smears from UTM-RT medium.

resultsOf 774 patients tested, 714 negative samples were sent for confirmation, and 159 were found to be positive by qRT-PCR. The median positive percentage agreement was 23.9 % (95 % CI: 14.2 %-38.2 %). The Cohen's kappa score was 0.35.

conclusionUsing this immunochromatographic assay as a triage test did not significantly reduce the number of samples outsourced for COVID-19 confirmation by qRT-PCR. In addition, even if the turn-around time is short, the assay is completely manual, which is not suitable for large volumes of routine samples. The sensitivity of this rapid test is poor, and improvements are needed to enhance its performance.

Indexed as

Antigen testingCOVID-19Point-of-careqRT-PCRRapid diagnosisSARS-CoV-2

Identifiers

PMID32504944
PMCPMC7261076
OpenAlexW3029895229

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.