tetano
Editor, Senior Moderator
Med Princ Pract
. 2021 Apr 22.
doi: 10.1159/000516776. Online ahead of print.
Rapid Serological Tests for Sars-Cov-2: Diagnostic Performance of Four Commercial Assays
S?rgio Monteiro de Almeida, Regiane Nogueira Spalanzani, Meri Bordignon Nogueira, Beatriz Sanada, Barbara Maria Cavalli, Indianara Rotta, Gislene Reche de Almeida Takahashi, Luciane Aparecida Pereira, Francielli Brusco Moreira, Carolina Lumi Tanaka Dino, Maria Esther Graf, Bernardo Montesanti Machado de Almeida, Natalia Ramos Domino, Gustavo Genelhoud, Lucas Bochnia Bueno, Sonia Mara Raboni
Abstract
To assess the diagnostic performance of lateral flow immunochromatographic assays (LFA) of four different manufacturers to identify SARS-CoV-2 antibodies (IgM, IgG or total), comparing them with the nucleic acid amplification test (NAAT) or clinical defined (definite or probable SARS-CoV-2 infection respectively).
Methods: 119 serum samples were randomly selected by convenience and distributed in the 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), SARS of other etiologies (n=19)]; (3) healthy control group (n=10). LFA essays of four manufacturers were compared: MedTest Coronav?rus (COVID-19) IgG/IgM (MedLevensohn, Brazil); COVID-19 IgG/IgM ECO Test (Ecodiagn?stica, Brazil); Camtech COVID-19 IgM/IgG Rapid Test Kit (Camtech Diagnostics Pte Ltd, Singapore); and one Step COVID-19 Test for total antibodies (Guangzhou Wondfo Biotech Co, China).
Results: The four 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; 60-1008); 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 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 manufacturers. LFA tests cannot replace molecular diagnostics, but should be used as additional screening tool.
. 2021 Apr 22.
doi: 10.1159/000516776. Online ahead of print.
Rapid Serological Tests for Sars-Cov-2: Diagnostic Performance of Four Commercial Assays
S?rgio Monteiro de Almeida, Regiane Nogueira Spalanzani, Meri Bordignon Nogueira, Beatriz Sanada, Barbara Maria Cavalli, Indianara Rotta, Gislene Reche de Almeida Takahashi, Luciane Aparecida Pereira, Francielli Brusco Moreira, Carolina Lumi Tanaka Dino, Maria Esther Graf, Bernardo Montesanti Machado de Almeida, Natalia Ramos Domino, Gustavo Genelhoud, Lucas Bochnia Bueno, Sonia Mara Raboni
- PMID: 33887722
- DOI: 10.1159/000516776
Abstract
To assess the diagnostic performance of lateral flow immunochromatographic assays (LFA) of four different manufacturers to identify SARS-CoV-2 antibodies (IgM, IgG or total), comparing them with the nucleic acid amplification test (NAAT) or clinical defined (definite or probable SARS-CoV-2 infection respectively).
Methods: 119 serum samples were randomly selected by convenience and distributed in the 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), SARS of other etiologies (n=19)]; (3) healthy control group (n=10). LFA essays of four manufacturers were compared: MedTest Coronav?rus (COVID-19) IgG/IgM (MedLevensohn, Brazil); COVID-19 IgG/IgM ECO Test (Ecodiagn?stica, Brazil); Camtech COVID-19 IgM/IgG Rapid Test Kit (Camtech Diagnostics Pte Ltd, Singapore); and one Step COVID-19 Test for total antibodies (Guangzhou Wondfo Biotech Co, China).
Results: The four 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; 60-1008); 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 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 manufacturers. LFA tests cannot replace molecular diagnostics, but should be used as additional screening tool.