Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comparative Study
. 2021 Dec;101(4):115518.
doi: 10.1016/j.diagmicrobio.2021.115518. Epub 2021 Aug 6.

Comparison of diagnostic performance of five molecular assays for detection of SARS-CoV-2

Neena Kanwar  1 , Dithi Banerjee  1 , Anjana Sasidharan  2 , Ayah Abdulhamid  2 , Marissa Larson  3 , Brian Lee  4 , Rangaraj Selvarangan  5 , Rachael M Liesman  6
Affiliations
Comparative Study

Comparison of diagnostic performance of five molecular assays for detection of SARS-CoV-2

Neena Kanwar et al. Diagn Microbiol Infect Dis. 2021 Dec.

Abstract

We compared the performance of the Abbott Real Time SARS-CoV-2 assay (Abbott assay), Aptima™ SARS-CoV-2 assay (Aptima assay), BGI Real-Time SARS-CoV-2 assay (BGI assay), Lyra® SARS-CoV-2 assay (Lyra assay), and DiaSorin Simplexa™ COVID assay for SARS-CoV-2 detection. Residual nasopharyngeal samples (n = 201) submitted for routine SARS-CoV-2 testing by Simplexa assay during June-July 2020 and January 2021 were salvaged. Aliquots were tested on other assays and compared against the CDC 2019-nCoV Real-Time RT-PCR assay. Viral load in positive samples was determined by droplet digital PCR. Among 201 samples, 99 were positive and 102 were negative by the CDC assay. The Aptima and Abbott assays exhibited the highest positive percent agreement (PPA) at 98.9% while the BGI assay demonstrated the lowest PPA of 89.9% with 10 missed detections. Negative percent agreement for all 5 platforms was comparable, ranging from 96.1% to 100%. The performance of all five assays was comparable.

Keywords: COVID-19; Molecular assay comparison; SARS-CoV-2 detection.

PubMed Disclaimer

Conflict of interest statement

Declaration of competing interest The authors report no conflicts of interest relevant to this article.

Figures

Fig. 1. (A)
Fig. 1. (A)
Correlation of the Ct values (median and range) for assay specific genes with viral load. (B) Correlation of Ct values with viral load of all positive samples on each assay platform.
See this image and copyright information in PMC

References

    1. Hanson KE, Arias CA, Englund JA, Lee MJ, Loeb M, Patel R, et al. IDSA; 2020. Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19.https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnost... AMC. Available at: Accessed 07/15/2020. - PMC - PubMed
    1. AMP . Association for Molecular Pathology; 2020. SARS-CoV-2 molecular testing: summary of recent SARS-CoV-2 molecular testing survey.https://www.amp.org/advocacy/sars-cov-2-survey/ Available at: Accessed 07/15/2020.
    1. Araj GF BM, Bizri NA, Ghizzawi L. Testing for COVID-19: when, who, and what test? Lebanese Med J. 2020;68:16–26.
    1. Axell-House DB, Lavingia R, Rafferty M, Clark E, Amirian ES, Chiao EY. The estimation of diagnostic accuracy of tests for COVID-19: a scoping review. J Infect. 2020;81:681–697. - PMC - PubMed
    1. Babiker A, Myers CW, Hill CE, Guarner J. SARS-CoV-2 testing. Am J Clin Pathol. 2020;153:706–708. - PMC - PubMed

Publication types