The COVID-19 lgG/IgM Rapid Test developed by Hangzhou Clongene Biotech Co., Ltd is for the qualitative detection of antibodies (lgG and lgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. By studying the statistical coincident rate, they could validate if it could be used for the detection of antibodies (IgG and lgM) to Novel coronavirus in human Whole Blood/Serum/Plasma.
Regarding the IgM test, testing was performed on approximately 167 clinical specimens from Professional Point of Care sites. Regarding the IgM test, the result was compared to RT-PCR. Regarding the IgG test, we have counted the positive rate of the 77 patients during the convalescence period
Regarding the COVID-19 IgM – Agreement with RT-PCR:
- Clinical Sensitivity 87 .01%
- Clinical Specificity 98.89%
- Accuracy Rate 93.41%
Regarding the COVID-19 IgG
- Clinical Sensitivity 99.42%