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

Content Provider	Springer Nature : BioMed Central
Author	Dhillon, Sharonjit K. Simoens, Cindy Cuypers, Lize Bode, Jannes Bonde, Jesper Corbisier, Philippe Cocuzza, Clementina E. Van Ranst, Marc Arbyn, Marc
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.
Related Links	https://virologyj.biomedcentral.com/counter/pdf/10.1186/s12985-023-01986-4.pdf
Ending Page	7
Page Count	7
Starting Page	1
File Format	HTM / HTML
DOI	10.1186/s12985-023-01986-4
Journal	Virology Journal
Issue Number	1
Volume Number	20
Language	English
Publisher	BioMed Central
Publisher Date	2023-02-24
Access Restriction	Open
Subject Keyword	Virology SARS-CoV-2 Diagnostic test accuracy RT-PCR Transcription mediated amplification COVID-19 Test validation Quality control Aptima VALCOR
Content Type	Text
Resource Type	Article
Subject	Virology Infectious Diseases
Journal Impact Factor	4/2023
5-Year Journal Impact Factor	3.8/2023

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