Diagnostic Indexes of a Rapid IgG/IgM Combined Antibody Test for SARS-CoV-2

Ying Liu; Yueping Liu; Bo Diao; Feifei Ren; Yue Wang; Jinya Ding; Qianchuan Huang

The ease-of-use IgG/IgM combined test kit under study was developed based on gold immunochromatography assay (GICA), which can generate results in less than 15 minutes from human serum without laboratory equipment or skilled personnel or sample transportation. Its diagnostic indexes or so-called test characristics, including sensitivity, specificity, PPV, NPV and accuracy were evaluated to determine its diagnostic usefulness [11] . Our results revealed that the above-mentioned five indexes were 85.6%, 91%,95.1%, 82.7%, and 88.3%, respectively which was in agreement with a recently published research [5] . In that study, sensitivity and specificity were 88.66% and 90.63%. Sensitivity is the ability to diagnose those with the disease correctly identified as positive by the test. From the definition of sensitivity, we can suggest that manufacturer should try to improve IgG/IgM test kit's detection sensitivity. Because the lower the sensitivity, the more false-negative cases.