International external quality assessment for SARS-CoV-2 molecular detection and survey on clinical laboratory preparedness during the COVID-19 pandemic

13 July 2020

On July 9th 2020, the RECOVER project team published an article in Eurosurveilance  presenting results of a first  external quality assessment (EQA) on molecular detection of SARS-CoV-2, as well as data from a RECOVER survey assessing the molecular testing capacity and throughput of clinical laboratories in 36 countries.

Extensive laboratory testing is a prerequisite in containing and mitigating the impact of the ongoing coronavirus disease (COVID-19) pandemic while neither vaccine nor treatment are available. Access to reliable diagnostic assays and adequate testing capacity for the causing SARS-CoV-2 is essential for preparedness and response strategies worldwide. Molecular methods such as RT-PCR are fundamental to early SARS-CoV-2 detection in suspected cases. Many in-house and commercial assays have been developed rapidly. However, the quality and diagnostic performance of these tests have not been adequately validated; the World Health Organization (WHO) has therefore encouraged laboratories to participate in EQA schemes for this novel virus. In this paper we present the results of a first EQA on molecular detection of SARS-CoV-2 introduced by Quality Control for Molecular Diagnostics (QCMD, Glasgow, Scotland), an independent International EQA organisation. We also present data from a survey by the EU project RECOVER assessing the molecular testing capacity and throughput of clinical laboratories in 36 countries.

Molecular testing capacity and throughput on clinical diagnostic level have been rapidly implemented and should be supported by proficiency testing panels. EQA schemes, such as the one presented here, are a good opportunity for laboratories to assess the performance of their assays against international peer groups in line with agreed clinical practice, based on well-characterised samples, to identify any weaknesses with their procedures or methods. Laboratories should be aware of the limitations of their assays and perform their own validation and verification in line with ISO 15189 or equivalent requirements. Also, EQA data can provide valuable information for post-market surveillance of commercial assays, which is of particular importance in outbreak situations where data about the relative performance of methods are still limited and further clinical evaluations are ongoing. This way, the quality of COVID-19 diagnostic testing can be continuously ensured. Regional-specific EQA studies can also be done, but require a different approach in order to ensure comparability. For 2020, two further EQA programmes are planned by QCMD: a follow-up SARS-CoV-2 EQA study and a respiratory EQA scheme comprising SARS-CoV-2 and other respiratory pathogens.


Read the full article here.

Authors: Veerle Matheeussen, Victor M Corman, Oliver Donoso Mantke, Elaine McCulloch, Christine Lammens, Herman Goossens, Daniela Niemeyer, Paul S Wallace, Paul Klapper, Hubert GM Niesters, Christian Drosten, Margareta Ieven, on behalf of the RECOVER project and collaborating networks

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