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10.1159/000516776

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33887722!8339017!33887722
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suck abstract from ncbi


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pmid33887722      Med+Princ+Pract 2021 ; 30 (4): 385-394
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  • Rapid Serological Tests for SARS-CoV-2: Diagnostic Performance of 4 Commercial Assays #MMPMID33887722
  • de Almeida SM; Spalanzani RN; Nogueira MB; Sanada B; Cavalli BM; Rotta I; Takahashi GRA; Pereira LA; Moreira FB; Dino CLT; Graf ME; de Almeida BMM; Domino NR; Genelhoud G; Bochnia-Bueno L; Raboni SM
  • Med Princ Pract 2021[]; 30 (4): 385-394 PMID33887722show ga
  • 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 (Ecodiagnostica, 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.
  • |Antibodies, Viral/*blood[MESH]
  • |Brazil/epidemiology[MESH]
  • |COVID-19 Testing/*methods[MESH]
  • |Case-Control Studies[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Immunoassay/methods[MESH]
  • |Immunoglobulin G/blood[MESH]
  • |Immunoglobulin M/blood[MESH]
  • |Male[MESH]
  • |Nucleic Acid Amplification Techniques[MESH]
  • |Pandemics[MESH]
  • |SARS-CoV-2[MESH]
  • |Sensitivity and Specificity[MESH]


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