ACCURACY OF DIAGNOSTIC TESTS REGISTERED AT ANVISA FOR COVID-19

A study by the Ministry of Health compares different methodologies of the 64 diagnostic tests registered in ANVISA for SARS-CoV-2, being: 15 by RT-PCR, 38 immunochromatographic tests, six by ELISA, two chemiluminescence immunoassays (CLIA) and three by immunofluorescence (FIA) for the detection and differentiation of IgA, IgG or IgM antibodies.

The following data about the characteristics of the diagnostic tests were extracted: accuracy, sensitivity and specificity, Positive and Negative Predictive Values [PV+ and PV-], Positive and Negative Likelihood Ratio [LR+ and LR-], method of diagnosis, type of biological sample, time for reading the result, among others.

In general, the sensitivity of the tests was greater than 85% and the specificity greater than 94%. It is important to highlight that a low sensitivity of the diagnostic test can result in a higher probability of detecting false negatives, which could interfere mainly in cases of asymptomatic individuals.

The document was prepared by the Department of Management and Incorporation of Technologies and Innovation in Health – DGITIS/SCTIE.

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