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. 2020 Aug 17;10(3):156-164.
doi: 10.1556/1886.2020.00017.

Evaluation of the automated cartridge-based ARIES SARS-CoV-2 Assay (RUO) against automated Cepheid Xpert Xpress SARS-CoV-2 PCR as gold standard

Konstantin Tanida  1   2 , Lars Koste  1 , Christian Koenig  1 , Werner Wenzel  1 , Andreas Fritsch  2 , Hagen Frickmann  1   3
Affiliations

Evaluation of the automated cartridge-based ARIES SARS-CoV-2 Assay (RUO) against automated Cepheid Xpert Xpress SARS-CoV-2 PCR as gold standard

Konstantin Tanida et al. Eur J Microbiol Immunol (Bp). .

Abstract

Introduction: To evaluate the automated cartridge-based PCR approach ARIES SARS-CoV-2 Assay targeting the ORF-sequence and the N-gene of SARS-CoV-2.

Methods: In line with the suggestions by Rabenau and colleagues, the automated ARIES SARS-CoV-2 Assay was challenged with strongly positive samples, weakly positive samples and negative samples. Further, intra-assay and inter-assay precision as well as the limit-of-detection (lod) were defined with quantified target RNA and DNA. The Cepheid Xpert Xpress SARS-Cov-2 Assay was used as gold standard.

Results: Concordance between the ARIES assay and the Cepheid assay was 100% for strongly positive samples and for negative samples, respectively. For weakly positive samples as confirmed applying the Cepheid assay, a relevant minority of 4 out of 15 samples (26.7%) went undetected by the ARIES assay. Intra- and inter-assay precision were satisfactory, while the lod was in the 103 DNA copies/reaction-range, in the 103 virus copies/reaction-range, or in the 103-104 free RNA copies/reaction-range in our hands.

Conclusions: The automated ARIES assay shows comparable test characteristics as the Cepheid assay focusing on strongly positive and negative samples but a slightly reduced sensitivity with weakly positive samples. Decisions on diagnostic use should include considerations on the lod.

Keywords: COVID-19; SARS-CoV-2; automated PCR; molecular rapid testing; point-of-care-testing; testing comparison.

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Conflict of interest statement

Conflict of interest: Nothing to declare.

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