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10.1093/ajcp/aqaa221

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33135049!7665287!33135049
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suck abstract from ncbi


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pmid33135049      Am+J+Clin+Pathol 2021 ; 155 (2): 286-295
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  • Evaluation of the Truvian Easy Check COVID-19 IgM/IgG Lateral Flow Device for Rapid Anti-SARS-CoV-2 Antibody Detection #MMPMID33135049
  • Chan CW; Shahul S; Coleman C; Tesic V; Parker K; Yeo KJ
  • Am J Clin Pathol 2021[Feb]; 155 (2): 286-295 PMID33135049show ga
  • OBJECTIVES: To evaluate the analytical and clinical performance of the Truvian Easy Check coronavirus disease 2019 (COVID-19) IgM/IgG anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody test.Serologic assays have become increasingly available for surveillance through the Food and Drug Administration emergency use authorization in the ongoing COVID-19 global pandemic. However, widespread application of serologic assays has been curbed by reports of faulty or inaccurate tests. Therefore, rapid COVID-19 antibody tests need to be thoroughly validated prior to their implementation. METHODS: The Easy Check device was analytically evaluated and its performance was compared with the Roche Elecsys anti-SARS-CoV-2 antibody assay. The test was further characterized for cross-reactivity using sera obtained from patients infected by other viruses. Clinical performance was analyzed with polymerase chain reaction-confirmed samples and a 2015 prepandemic reference sample set. RESULTS: The Easy Check device showed excellent analytical performance and compares well with the Roche Elecsys antibody assay, with an overall concordance of 98.6%. Clinical performance showed a sensitivity of 96.6%, a specificity of 98.2%, and an overall accuracy of 98.1%. CONCLUSIONS: The Easy Check device is a simple, reliable, and rapid test for detection of SARS-CoV-2 seropositivity, and its performance compares favorably against the automated Roche Elecsys antibody assay.
  • |Antibodies, Viral/*blood[MESH]
  • |COVID-19 Serological Testing/*instrumentation[MESH]
  • |COVID-19/*diagnosis[MESH]
  • |Cross Reactions[MESH]
  • |Humans[MESH]
  • |Immunoglobulin G/blood[MESH]
  • |Immunoglobulin M/blood[MESH]
  • |SARS-CoV-2/*immunology[MESH]


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