Open AccessRapid Serological Tests for SARS-CoV-2: Diagnostic Performance of 4 Commercial Assays
Author(s) -
de Almeida Sérgio M.,
Spalanzani Regiane N.,
Nogueira Meri B.,
Sanada Beatriz,
Cavalli Barbara M.,
Rotta Indianara,
Takahashi Gislene R.A.,
Pereira Luciane A.,
Moreira Francielli B.,
Dino Carolina L.T.,
Graf Maria E.,
de Almeida Bernardo M.M.,
Domino Natalia R.,
Genelhoud Gustavo,
Bochnia-Bueno Lucas,
Raboni Sonia M.
Publication year - 2021
Publication title -
medical principles and practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.426
H-Index - 45
eISSN - 1423-0151
pISSN - 1011-7571
DOI - 10.1159/000516776
Subject(s) - original paper
Objective: To assess the diagnostic performance of lateral flow immunochromatographic assays (LFAs) of 4 different manufacturers to identify SARS-CoV-2 antibodies (IgM, IgG, or total), comparing them with the nucleic acid amplification test (NAAT) or the clinical defined test (definite or probable SARS-CoV-2 infection, respectively). Methods: One hundred nineteen serum samples were randomly selected by convenience and distributed in the following groups: (1) group with SARS-CoV-2 infection ( n = 82; RT-qPCR positive [definite, n = 70] and probable [ n = 12]); (2) other diseases ( n = 27; other viruses identified [ n = 8] and SARS of other etiologies [ n = 19]); and (3) healthy control group ( n = 10). LFAs of 4 manufacturers were compared: MedTest Coronavirus (COVID-19) IgG/IgM (MedLevensohn, Brazil); COVID-19 IgG/IgM ECO Test (Ecodiagnóstica, Brazil); Camtech COVID-19 IgM/IgG Rapid Test Kit (Camtech Diagnostics Pte Ltd, Singapore); and 1-Step COVID-19 Test for total antibodies (Guangzhou Wondfo Biotech Co., China). Results: The 4 tests studied showed high diagnostic performance characteristics for the diagnoses of definite or probable SARS-CoV-2 infection. The best measures were for the Wondfo 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%), and Matthews correlation coefficient (MCC) 0.82. Although considering only the probable SARS-CoV-2 infection (PCR−) cases, all the kits studied showed limited values. Conclusion: Our data demonstrate the excellent performance of LFA for the diagnoses of definite or probable SARS-CoV-2 infection. There was substantial heterogeneity in sensitivities of IgM and IgG antibodies among the different kits. LFA tests cannot replace molecular diagnostics but should be used as an additional screening tool.