We all good on composite test!!!!!!!!!!!!!!!!!!!!!!
Agreement with a composite reference method The performance of the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test was compared to a composite reference method that includes a RT-PCR method and a chemiluminescence immunosorbent assay (CLIA). A total of 900 serum samples (287 positive and 613 negative) were tested with the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test and compared to a composite reference method. The agreement results are presented in the table below. Comparator (Composite Method) Subtotal Pos Neg Assurance AB™ COVID19 IgM/IgG Rapid Antibody Test Pos IgG+/IgM+ 15 0 15 IgG-/IgM+ 31 0 31 IgG+/IgM- 221 0 221 Neg IgG-/IgM- 20 613 633 Subtotal 287 613 900 Positive Percent Agreement (PPA): 267/287 (93.0%); (95% CI: 89.4 - 95.7%) Negative Percent Agreement (NPA): 613/613 (100.0%); (95% CI: 99.4 -100.0%)
Agreement with a chemiluminescence immunosorbent assay (CLIA) A total of 900 samples were tested comparing the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test to a reference antibody test. The agreement results of the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test to an antibody reference assay are presented below. IgM Agreement Comparator (CLIA) Subtotal Pos Neg Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test Pos 44 2 46 Neg 5 849 854 Subtotal 49 851 900 Positive Percent Agreement (PPA): 44/49 (89.8%); (95% CI: 77.8-96.6%) Negative Percent Agreement (NPA): 849/851 (99.8%); (95% CI: 99.2-100%) IgG Agreement Comparator (CLIA) Subtotal Pos Neg Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test Pos 230 6 236 Neg 21 643 664 Subtotal 251 649 900 Positive Percent Agreement (PPA): 230/251 (91.6%); (95% CI: 87.5-94.8%) Negative Percent Agreement (NPA): 643/649 (99.1%); (95% CI: 98.0-99.7%)
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