Rapid Serological Tests for SARS-CoV-2: Diagnostic Performance of 4 Commercial Assays

<b><i>Objective:</i></b> To assess the diagnostic performance of lateral flow immunochromatographic assays (LFAs) 4 different manufacturers to identify SARS-CoV-2 antibodies (IgM, IgG, or total), comparing them with nucleic acid amplification test (NAAT) clinical defined (definite probable infection, respectively). <b><i>Methods:</i></b> One hundred nineteen serum samples were randomly selected by convenience and distributed in following groups: (1) group infection (<i>n</i> = 82; RT-qPCR positive [definite, <i>n</i> 70] [<i>n</i> 12]); (2) other diseases 27; viruses identified 8] SARS etiologies 19]); (3) healthy control 10). LFAs compared: MedTest Coronavirus (COVID-19) IgG/IgM (MedLevensohn, Brazil); COVID-19 ECO Test (Ecodiagnóstica, Camtech IgM/IgG Rapid Kit (Camtech Diagnostics Pte Ltd, Singapore); 1-Step for total (Guangzhou Wondfo Biotech Co., China). <b><i>Results:</i></b> The tests studied showed high characteristics diagnoses definite infection. best measures test: sensitivity (86.59%; 95% CI: 77.26–93.11%), specificity (100%; 90.51–100%), DOR (257; 60–1,008), LR+ (33.43; 4.82–231.85), LR? (0.13; 0.08–0.23), accuracy (90.76%; 84.06–95.29%), Matthews correlation coefficient (MCC) 0.82. Although considering only (PCR?) cases, all kits limited values. <b><i>Conclusion:</i></b> Our data demonstrate excellent LFA There was substantial heterogeneity sensitivities IgM IgG among kits. cannot replace molecular diagnostics but should be used as an additional screening tool.