VIRALERT SARS-COV-2

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: 

  1. Conjugate pad: recombinant SARS-CoV-2 antigen labeled with colloidal gold which linked FITC, FITC antibody and quality control antibody gold marker. 

  2. 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.

 

CLINICAL STUDY

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)

Quantity

Negative (healthy people) 

200

Positive (Infection time 4-10 days)

80

Positive (Infection time 11-24days)

70

Total

350

 

.3 Procedure

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.

  1. Apply 10µL whole blood / serum / plasma onto the sample well of a test device first, and then apply 2 drops of buffer.

  2. Read the result after 15 minutes.


3.4 Interpretation of Test Results Positive result:  

  1. 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. 

  2. 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. 

  3. 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.

Negative result: 

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.

Invalid result:

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

For more Testing data please contact us.

 

©2020 by Viralert. Naturitious LLC.