SARS-CoV-2 IgM/IgG Test Kit (Colloidal Gold)
SARS-CoV-2 IgM/IgG Test Kit is intended for the qualitative detection of SARS-CoV-2 IgM and IgG antibodies in human serum, plasma and whole blood specimens, as an auxiliary diagnosis of COVID-19.
The kit based on the principle of colloidal gold immunochromatography to detect the SARS-CoV-2 IgM/IgG antibodies in human serum, plasma and whole blood specimens. When the specimen is added to the specimen well, the specimen is absorbed into the device by capillary action, If the specimen contains SARS-CoV-2 IgM antibody, the antibody will bind to the colloidal gold-labeled SARS-CoV-2 antigen. The antibody/antigen complex will be captured by the anti-human IgM antibody immobilized on the nitrocellulose membrane, forming a red M line and indicating an IgM positive result. Similarly as the IgM antibody, If the specimen contains IgG antibody, G line will appear red color and indicate an IgG positive result. If neither antibody is present, a negative result is displayed.
1. The kit is designed to test the specimens of whole blood, plasma, serum, not suit for other type of specimens.
2. The kit is a qualitative assay. It is not designed to determine the quantitative concentration of SARS-CoV-2 antibody.
3. The test result is only for clinical reference, a confirmed diagnosis should only be made after all clinical and laboratory findings have been evaluated.
4. Negative results may be caused by low concentrations of SARS-CoV-2 IgG/IgM antibody in the specimen, and should not be the sole basis of a patient management decision.
1. 59 confirmed case specimens were tested by SARS-CoV-2 IgM/IgG Test Kit(Colloidal Gold),55 were positive and the sensitivity was 93.22%(95% CI:82.73%~97.81% ). 147 negative specimens were detected by SARS-CoV-2 IgM/IgG Test Kit(Colloidal Gold), 145 were negative and the specificity was 98.64%(95% CI: 94.67%~99.76%).
2. Specimens which tested positive with parainfluenza virus antibody,influenza A antibody,influenza B antibody,hepatitis B surface antigen,hepatitis C virus antibody,treponema pallidum antibody,HIV antibody,EB virus antibody from patients were investigated with by SARS-CoV-2 IgM/IgG Test Kit(Colloidal Gold), the results showed no cross reactivity.
3. The specimens with hemoglobin, triglyceride and bilirubin will interfere the test results, and the maximum allowable concentrations are 5mg/ml, 10mg/ml and 0.2mg/ml respectively.
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