Teste laboratorial remoto para detecção de antígeno do novo-coronavírus (SARS-COV-2): análise crítica das instruções de uso, frequência de solicitação e grau de concordância comparado ao RT-PCR

Abstract

Introduction: During the COVID-19 pandemic, many point of care testing (POCT) for detecting SARS-CoV-2 antigens were approved by ANVISA for emergency use. However, the analytical performance and the information presented in the Instructions For Use (IFU) of these tests were divergent. Objectives: To report the quantity and the reactivity rate of POCTs during the pandemic; to evaluate the content and the quality of information of IFU founded in POCT kits; to measure the degree of agreement between the results of POCT and RT-PCR when performed at different time intervals. Method: This is an analytical observational and descriptive study, with analysis of the results from 27,354 RLTs for SARS-CoV-2, conducted by a national support laboratory, between October 2020 and March 2022. The Instructions For Use of 108 POCTs approved by ANVISA and of others 17 approved by FDA were evaluated jointly by two qualified professionals. The results of 5.625 POCT were correlated to RT-PCR, using the Kappa index, considering IC 95% and p<0,05. Results: Throughout the pandemic, there was a significant increase of POCTs, with peaks of 5,500 positive test results between the first and fourth week of 2022. Overall, 18.3% of the results were reactive. Differences were observed in the content and in the quality of IFU among the different kits. The POCTs kits that were approved by ANVISA met 84% of the 19 parameters evaluated, compared to 91% IFU approved by the FDA. The Kappa Index ranged from 0.46 to 0.87. The POCTs presented 85.1% sensitivity and 99% specificity when POCT and RT-PCR were performed on the same day, and 65.9% sensitivity and 97.1% specificity when were performed after 24 hours. Conclusions: the POCTs were frequently requested during the pandemic, with significant reactivity rates. There were differences between the content and the comprehension of the Information For Use in the kits, with greater emphasis on kits approved by FDA. The degree of agreement between POCT and RT-PCR was high, but it reduced as the interval between them increased.