Test Kit FAQ
How accurate is COVID-19 IgG/IgM Rapid Test Device?
The COVID-19 IgG/IgM has been evaluated with the 113 blood samples obtained from patients exhibiting pneumonia or respiratory symptoms.
The sensitivity of the IgM test is 87.9% and specificity 100% when compared to RT-PCR.
The sensitivity of the IgG test is 97.2% during the convalescence period, and specificity is 100%.
Can I freeze the device for long-term storage?
The device should never be frozen. If refrigerated, allow the buffer, specimen and device to reach room temperature before use.
What is the significance of the various test results?
IgM negative, IgG negative: Patient not exposed or too early. A medical professional should observe symptoms and epidemiology of patients. Retesting should be considered if symptoms appear or persist.
IgM positive, IgG positive/negative: Acute or recent infection.
IgM negative, IgG positive: Previous, distant infection.
What specimens to be used?
Whole blood, serum or plasma can be used.
1 drop of whole blood
For 5ul Serum or plasma from blood: Use only clear , non-hemolyzed specimens.
Use fresh samples whenever possible.
Testing should be performed after specimen collection. Do not leave the specimens for prolonged periods. Serum and plasma specimen may be stored at 2-8 C for up to 3 days.
How To Use?
Remove the cassette from the pouch. Ideal results will be obtained if assay is performed within 1 hour after opening.
Place the test device on a clean and level surface. Avoid strong air blowing onto the test device.
Follow the steps as per the graphic below.
Note : The result should be read in 10 minutes. Positive results may be visible within 2 minutes. Results must be interpreted in less than 15 minutes.