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

Abstract

BACKGROUND: The 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.

METHODS: VALCOR 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.

RESULTS: A 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.

CONCLUSION: In 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.

Original languageEnglish
Article number35
JournalVirology journal
Volume20
Issue number1
Pages (from-to)35
ISSN1743-422X
DOIs
Publication statusPublished - 24 Feb 2023

Keywords

  • Humans
  • SARS-CoV-2
  • COVID-19
  • Clinical Laboratory Techniques/methods
  • COVID-19 Testing
  • Molecular Diagnostic Techniques/methods
  • Pandemics
  • Sensitivity and Specificity

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