Evidence map›Paper›PMID 36829164›Full record

ArticleVirology journal2023

Assessment of the clinical and analytical performance of the Aptima SARS-CoV-2 assay using the VALCOR protocol.

Sharonjit K Dhillon, Cindy Simoens, Lize Cuypers, Jannes Bode, Jesper Bonde, Philippe Corbisier, Clementina E Cocuzza, Marc Van Ranst, Marc Arbyn

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In one paragraph

Article in Virology journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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

5 citing papers in PubMed.

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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

9 authors.

Sharonjit K DhillonUnit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, J. Wytsmanstreet 14, B1050, Brussels, Belgium.
Cindy SimoensUnit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, J. Wytsmanstreet 14, B1050, Brussels, Belgium.
Lize CuypersNational Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium.
Jannes BodeNational Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium.
Jesper BondeMolecular Pathology Laboratory, Department of Pathology, Copenhagen University Hospital -Amager and Hvidovre Hospital, Copenhagen, Denmark.
Philippe CorbisierEuropean Commission, Joint Research Centre, Directorate F - Health, Consumers and Reference Materials, Geel, Belgium.
Clementina E CocuzzaLaboratory of Clinical Microbiology and Virology, Department of Medicine and Surgery, University of Milano - Bicocca, Monza, Italy.
Marc Van RanstLaboratory of Clinical and Epidemiological Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.
Marc ArbynUnit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, J. Wytsmanstreet 14, B1050, Brussels, Belgium. marc.arbyn@sciensano.be.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe COVID-19 pandemic highlighted the importance of diagnostic testing against curbing the spread of SARS-CoV-2. The urgent need and scale for diagnostic tools resulted in manufacturers of SARS-CoV-2 assays receiving emergency authorization that lacked robust analytical or clinical evaluation. As it is highly likely that testing for SARS-CoV-2 will continue to play a central role in public health, the performance characteristics of assays should be evaluated to ensure reliable diagnostic outcomes are achieved.

methodsVALCOR or "VALidation of SARS-CORona Virus-2 assays" is a study protocol designed to set up a framework for test validation of SARS-CoV-2 virus assays. Using clinical samples collated from VALCOR, the performance of Aptima SARS-CoV-2 assay was assessed against a standard comparator assay. Diagnostic test parameters such as sensitivity, specificity and overall per cent agreement were calculated for the clinical performance of Aptima SARS-CoV-2 assay.

resultsA total of 180 clinical samples were tested with an addition of 40 diluted clinical specimens to determine the limit of detection. When compared to the standard comparator assay Aptima had a sensitivity of 100.0% [95% CI 95.9-100.0] and specificity of 96.7% [95% CI 90.8-99.3]. The overall percent agreement was 98.3% with an excellent Cohen's coefficient of κ = 0.967 [95% CI 0.929-1.000]. For the limit of detection, Aptima was able to detect all of the diluted clinical samples.

conclusionIn conclusion. validation of Aptima SARS-CoV-2 assay using clinical samples collated through the VALCOR protocol showed excellent test performance. Additionally, Aptima demonstrated high analytical sensitivity by detecting all diluted clinical samples corresponding to a low limit of detection.

Indexed as

COVID-19SARS-CoV-2Clinical Laboratory TechniquesCOVID-19 TestingHumansMolecular Diagnostic TechniquesPandemicsSensitivity and SpecificityAptimaCOVID-19Diagnostic test accuracyQuality controlRT-PCRSARS-CoV-2Test validationTranscription mediated amplificationVALCOR

Identifiers

PMID36829164
PMCPMC9951132

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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.