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Assessment of the clinical and analytical performance of the Aptima SARS-CoV-2 assay using the VALCOR protocol.
Dhillon, Sharonjit K; Simoens, Cindy; Cuypers, Lize; Bode, Jannes; Bonde, Jesper; Corbisier, Philippe; Cocuzza, Clementina E; Van Ranst, Marc; Arbyn, Marc.
  • Dhillon SK; Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, J. Wytsmanstreet 14, B1050, Brussels, Belgium.
  • Simoens C; Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, J. Wytsmanstreet 14, B1050, Brussels, Belgium.
  • Cuypers L; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium.
  • Bode J; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium.
  • Bonde J; Molecular Pathology Laboratory, Department of Pathology, Copenhagen University Hospital -Amager and Hvidovre Hospital, Copenhagen, Denmark.
  • Corbisier P; European Commission, Joint Research Centre, Directorate F - Health, Consumers and Reference Materials, Geel, Belgium.
  • Cocuzza CE; Laboratory of Clinical Microbiology and Virology, Department of Medicine and Surgery, University of Milano - Bicocca, Monza, Italy.
  • Van Ranst M; Laboratory of Clinical and Epidemiological Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, Leuven, Belgium.
  • Arbyn M; Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, University of Ghent, Ghent, Belgium.
Virol J ; 20(1): 35, 2023 02 24.
Article in English | MEDLINE | ID: covidwho-2257071
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Journal: Virol J Journal subject: Virology Year: 2023 Document Type: Article Affiliation country: S12985-023-01986-4

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Journal: Virol J Journal subject: Virology Year: 2023 Document Type: Article Affiliation country: S12985-023-01986-4