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

Author(s)

Rodrigues, Carolaine de Oliveira ; Olivares, Igor Renato Bertoni ; Reischak, Dilmara ; Catozzi, Mariana Benatti ; Cardoso, Fernanda Gomes ; Pinhel, Maria de Fatima Martins

• Document type: Journal article
• Source: DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE; v. 107, n. 2, p. 6-pg., 2023-10-01.

Abstract

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 dif-ferentiate performance between laboratories, according to Table 2. Based on the participants' total qualita-tive 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.& COPY; 2023 Elsevier Inc. All rights reserved. (AU)

• FAPESP's process: 20/01238-4 - Development of proficiency tests for agricultural laboratories aiming reproducibility of results and maintenance of ISO/IEC 17025
• Grantee: Igor Renato Bertoni Olivares
• Support Opportunities: Regular Research Grants