Universität zu Köln

Malecki, Monika ORCID: 0000-0003-2009-8204, Luesebrink, Jessica, Wendel, Andreas F. and Mattner, Frauke (2021). Analysis of external quality assessment samples revealed crucial performance differences between commercial RT-PCR assays for SARS-CoV-2 detection when taking extraction methods and real-time-PCR instruments into account. J. Virol. Methods, 295. AMSTERDAM: ELSEVIER. ISSN 1879-0984

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Abstract

In limelight of the ongoing pandemic SARS-CoV-2 testing is critical for the diagnosis of infected patients, contacttracing and mitigating the transmission. Diagnostic laboratories are expected to provide appropriate testing with maximum accuracy. Real-time reverse transcriptase PCR (RT-PCR) is the diagnostic standard. However, only a handful of studies have reviewed their performance in clinical settings. The aim of this study was to compare the performance of the overall analytical matrix including the extraction kit (BD MAX, Promega, Qiagen), the PCR instrument (Agilent Mx3005 P, BD MAX, Qiagen Rotor-Gene, Roche Cobas z 480) and the RT-PCR assay (Altona Diagnostics, CerTest Biotec, R-Biopharm AG) using predefined samples from proficiency testing organizers. The greatest difference of the cycle threshold values between the matrices was nine cycles. One borderline sample could not be detected by three out of twelve analytical matrices and yielded a false negative result. We therefore conclude that diagnostic laboratories should take the complete analytical matrix in addition to the performance values published by the manufacturer for a respective RT-PCR kit into account. With limited resources laboratories have to validate a wide range of kits to determine appropriate analytical matrices for detecting SARS-CoV2 reliably. The interpretation of clinical results has to be adapted accordingly.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Malecki, Monika UNSPECIFIED orcid.org/0000-0003-2009-8204 UNSPECIFIED Luesebrink, Jessica UNSPECIFIED UNSPECIFIED UNSPECIFIED Wendel, Andreas F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mattner, Frauke UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-562432
DOI:	10.1016/j.jviromet.2021.114202
Journal or Publication Title:	J. Virol. Methods
Volume:	295
Date:	2021
Publisher:	ELSEVIER
Place of Publication:	AMSTERDAM
ISSN:	1879-0984
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language Biochemical Research Methods; Biotechnology & Applied Microbiology; Virology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/56243