Table 2.

Performance of diagnostic tests approved by ANVISA in Brazil for COVID-19. (*data extracted from technical instructions from the diagnostic kits available in the register area ate ANVISA website; NA: not available; CI confidence interval).

Test Name	Accuracy data*	Methodology	Sample	Result time
One Step COVID-2019 Test	Sensibility: 86,43% (CI 95%: 82,41-89,58) Specificity: 99,57% (CI 95%: 97,63 - 99,92%)	Immunochromatographic qualitative assay for detection of both IgG and IgM anti-coronavirus	Whole blood, serum or plasma (10 µL)	15min
CORONAVÍRUS RAPID TEST	Sensibility: 86,4% (CI 95%: 82,41% - 89,58%) Specificity: 99,57% (CI 95%: 97,63% - 99,92%)	Immunochromatographic qualitative assay for detection of both IgG and IgM anti-coronavirus	Whole blood, serum or plasma (10 µL)	15min
CORONAVÍRUS IgG/IgM (COVID-19)	IgG Sensibility: >99,9% Specificity: 98,0% Accuracy: 98,6% IgM Sensibility: 85,0% Specificity: 96,0% Accuracy: 92,9%	Immunochromatographic qualitative assay for detection of both IgG and IgM anti-coronavirus	Whole blood, serum or plasma (10 µL)	10-20 min
MedTeste Coronavírus (COVID-19) IgG/IgM (TESTE RÁPIDO)	IgG Sensibility: 97,4% (CI 95%: 86,2% - 99,9%) Specificity: 99,3% (CI 95%: 96,2% - 99,9%) Accuracy: 98,9% (CI 95%: 96,1% - 99,9%) IgM Sensibility: 86,8% (CI 95%: 71,9% - 95,6%) Specificity: 98,6% (CI 95%: 95,0% - 99,8%) Accuracy: 96,1% (CI 95%: 92,2% - 98,4%)	mmunochromatographic qualitative assay for detection of both IgG and IgM	Whole blood, serum or plasma (10 µL)	NA
Família Teste Rápido em Cassete 2019-nCoV IgG/IgM (sangue total/soro/plasma)	IgG Sensibility: 100% (CI 95%: 86.0% - 100%) Specificity: 98.0% (CI 95%: 89.4% - 99.9%) Accuracy: 98.6% (CI 95%: 92.3% - 99.96%) IgM Sensibility: 85.0% (CI 95%: 62.1% - 96.8%) Specificity: 96.0% (CI 95%: 86.3% - 99.5%) Accuracy: 92.9% (CI 95%: 84.1% - 97.6%)	Immunochromatographic qualitative assay for detection of both IgG and IgM against 2019-nCoV	Whole blood, serum or plasma (10µL)	10 min