Development and application of proficiency testing (PT) to evaluate the diagnostic capacity of SARS-CoV-2 by RT-qPCR - A practical and metrological approach

•Tools to ensure quality and reliability in the diagnosis of SARs-CoV-2.•The importance of participation in proficiency tests (PT) in the quality of results.•The influence of PT quality on diagnosis quality.•Development of an adequate and standardized PT protocol for diagnosis of SARs-CoV-2.•Applica...

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Bibliographic Details
Published in:	Diagnostic microbiology and infectious disease Vol. 107; no. 2; p. 116021
Main Authors:	Rodrigues, Carolaine de Oliveira, Olivares, Igor Renato Bertoni, Reischak, Dilmara, Catozzi, Mariana Benatti, Cardoso, Fernanda Gomes, Pinhel, Maria de Fátima Martins
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01-10-2023
Subjects:	Metrology Proficiency testing RT-PCR, Quality management SARs-CoV-2 Metrology SARs-CoV-2 Proficiency testing RT-PCR, Quality management
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Summary:	•Tools to ensure quality and reliability in the diagnosis of SARs-CoV-2.•The importance of participation in proficiency tests (PT) in the quality of results.•The influence of PT quality on diagnosis quality.•Development of an adequate and standardized PT protocol for diagnosis of SARs-CoV-2.•Application of appropriate statistical tools to a PT for diagnosis of SARs-CoV-2. It is necessary to use quality tools to evaluate the diagnostic capacity of laboratories, such as implementing a proficiency testing (PT) program. The goal of this work is to develop and apply a PT protocol to assess the diagnostic capacity of SARS-CoV-2 through the RT-PCR method, based on appropriate metrological tools. A 5-item test panel containing items with different dilutions of SARS-CoV-2, including negative controls, was developed to perform this PT with the application of different performance assessment tools to score and differentiate performance between laboratories, according to Table 2. Based on the participants’ total qualitative result, 95% of the negative samples and 73% of the positive samples were correctly identified by the laboratories. The results obtained were compared e validate the systematics of the PT developed, so that it can be implemented and used to monitor and improve the diagnostic capacity of SARS-CoV-2, also helping to improve the quality of these results.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-3 content type line 23 ObjectType-Review-1
ISSN:	0732-8893 1879-0070
DOI:	10.1016/j.diagmicrobio.2023.116021