Clinical Study Report of Viralert COVID-19 Antibody IgM & IgG Rapid Test
Viralert COVID-19 IgM/IgG Rapid Test is an in vitro diagnostic test for the qualitative determination of COVID-19’s IgM and IgG antibodies in human whole blood (from vein or fingertip), serum or plasma.
The test devices contain:
Conjugate pad: recombinant SARS-CoV-2 antigen labeled with colloidal gold which linked FITC, FITC antibody and quality control antibody gold marker.
NC membrane: coated with two detection lines (IgG line and IgM line) and one quality control line (C line). The IgM line coated with mouse anti-human IgM monoclonal antibody detects the COVID-19 IgM antibody. The IgG line coated with mouse anti-human IgG monoclonal antibody detects the COVID-19 IgG antibody. The C line coated with quality control antibody.
Viralert COVID-19 Antibody IgM & IgG Rapid Test
Total 350 subjects were invited to participate in this comparison study. All the samples have been tested by COVID-19 RT-PCR and CT, and the concentration distribution of result is as follows.
Concentration distribution of COVID-19 clinical specimen tested by RT-PCR&CT
COVID-19 clinical sample (by RT-PCT&CT)
Negative (healthy people)
Positive (Infection time 4-10 days)
Positive (Infection time 11-24days)
1) Take out the test kit and leave it at room temperature for 30 minutes at least. 2) Put a test device on a dust-free clean surface.
Apply 10µL whole blood / serum / plasma onto the sample well of a test device first, and then apply 2 drops of buffer.
Read the result after 15 minutes.
3.4 Interpretation of Test Results Positive result:
The COVID-19 IgM antibody is detected if the quality control line C and the detection line IgM are both colored, and the detection IgG line is not colored, that means the COVID-19 IgM antibody is positive.
The COVID-19 IgG antibody is detected if the quality control line C and the detection IgG line are both colored, and the detection IgM line is not colored, that means the COVID-19 IgG antibody is positive.
The COVID-19 IgG and IgM antibodies are detected if the quality control line C, the detection line IgM and IgG are both colored, that means both the COVID-19 IgG and IgM antibodies are positive.
If there is only quality control line C is colored, IgG and IgM detection lines are not colored, the COVID-19 IgM/IgG antibody is not detected, that means the result is negative.
If the quality control line C is not colored, no matter whether the detection line IgG/IgM is colored or not, the result is invalid and needs to be tested again.
RESULTS AND CONCLUSION
Relative Specificity: 100%
Relative Sensitivity (infection time 4-10 days, IgM & IgG): 81.25%
Relative Sensitivity (infection time 11-24 days, IgM & IgG): 97.1% Accuracy (infection time 4-10 days, IgM & IgG): 94.6%
Accuracy (infection time 11-24 days, IgM & IgG): 99.3% Total accuracy: 95.1%
From the results of 350 negative and positive samples, we can confirm that Viralert COVID-19 IgM& IgG rapid test has good clinical performance compare with RT-PCR&CT
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