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. 2021 May:291:114102.
doi: 10.1016/j.jviromet.2021.114102. Epub 2021 Feb 16.

Comparative analysis of point-of-care, high-throughput and laboratory-developed SARS-CoV-2 nucleic acid amplification tests (NATs)

Niko Kohmer  1 , Holger F Rabenau  1 , Sebastian Hoehl  1 , Marhild Kortenbusch  1 , Sandra Ciesek  2 , Annemarie Berger  3
Affiliations

Comparative analysis of point-of-care, high-throughput and laboratory-developed SARS-CoV-2 nucleic acid amplification tests (NATs)

Niko Kohmer et al. J Virol Methods. 2021 May.

Abstract

Multiple nucleic acid amplification tests (NATs) are available for the detection of SARS-CoV-2 in clinical specimens, including Laboratory Developed Tests (LDT), commercial high-throughput assays and point-of-care tests. Some assays were just recently released and there is limited data on their clinical performance. We compared the Xpert® Xpress SARS-CoV-2 (Cepheid) and Vivalytic VRI Panel (Schnelltest COVID-19) (Bosch) point-of-care tests with four high-throughput assays and one LDT, the cobas® SARS-CoV-2 test (Roche), the Allplex™ 2019-nCoV Assay (Seegene), the SARS-CoV-2 AMP (Abbott) Kit, the RealStar® SARS-CoV-2 RT-PCR Kit 1.0 (altona) as well as an assay using a SARS-CoV-2 RdRP gene specific primer and probe set. Samples from patients with confirmed SARS-CoV-2 infection, samples from the first and second SARS-CoV-2-PCR External Quality Assessment (EQA) (INSTAND e.V.) and a 10-fold serial dilution of a SARS-CoV-2 cell culture (SARS-CoV-2 Frankfurt 1) supernatant were examined. We determined that the NAT assays examined had a high specificity. Assays using the N gene as target demonstrated the highest sensitivity in the serial dilution panel, while all examined NAT assays showed a comparable sensitivity when testing clinical and EQA samples.

Keywords: NAT; PCR; POCT; SARS-CoV-2.

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Conflict of interest statement

None of the authors have competing interests related to this work.

Figures

Fig. 1
Fig. 1
Schematic overview of each assay specific SARS-CoV-2 RT-PCR gene target examined and the maximum dilution factor where a signal was detected. The figure assumes that dilutions smaller than investigated (<10−3 and <10-4 for the Cepheid, respectively) would also have generated a reactive signal. Roche corresponds to the cobas® SARS-CoV-2, Seegene to the Allplex™ 2019-nCoV Assay, Abbott to the SARS-CoV-2 AMP Kit, Altona to the RealStar® SARS-CoV-2 RT-PCR Kit 1.0, Cepheid to the Xpert® Xpress SARS-CoV-2 and Bosch to the Vivalytic VRI Panel (Schnelltest COVID-19).
See this image and copyright information in PMC

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