1. Generic Name: Novel Coronavirus COVID-19 IgG Antigen Test Kit
2. Brand Name: NIL
3. Notified Category: Other than above substances intended for qualitative determination of COVID-19 infection
4. Class of Medical Device: Class D
5. Shelf life :15 months
6. Sterile/Non-Sterile: Non-Sterilized
7. Contains Drugs: No
8. Medical Device Grouping Category: IVD-Kit
9. Grouping Description: Intended for qualitative determination of COVID-19 infection
10. Intended Use: The Novel Coronavirus COVID-19 IgG Kit is intended for the qualitative detection of human anti-COVID- 19 IgG antibody in human serum/plasma. Any reactive specimen with the Novel Coronavirus COVID-19 IgG Kit must be confirmed with alternative testing method(s).
11. Product Description: Assay controls and 1:10 diluted human serum samples are added to the microtiter wells of a microplate that was coated with COVID-19 recombinant full length recombinant protein. After the first incubation period, the unbound protein matrix is removed with a subsequent washing step. A horseradish peroxidase (HRP) labeled polyclonal goat anti-human IgG tracer antibody is added to each well. After an incubation period, an immunocomplex of "COVID-19 recombinant antigen-human anti-COVID-19 IgG antibody - HRP labeled anti human IgG tracer antibody" is formed if there is specific Coronavirus IgG antibody present in the tested specimen. The unbound tracer antibody is removed by the subsequent washing step. HRP-Labeled tracer antibody bound to the well is then incubated with a substrate solution in a timed reaction and then measured in a spectrophotometric microplate reader. The enzymatic activity of the tracer antibody bound to the anti-COVID-19 IgG on the wall of the microtiter well is proportional to the amount of the anti-COVID-19 IgG antibody level in the tested specimen.
SALIENT FEATURES:
â?¢ Recombinant COVID-19 Spike subunit Protein coated on Microwell Plate
â?¢ HRP Conjugated Polyvalent Anti-Human IgG
â?¢ Assay Time: 80 mins (30mins+30 Mins+20mins)
â?¢ Strip Format Microwell Plate
â?¢ Ready to use Substrate and Controls
â?¢ Only 20 pL of human serum is required for measurement in duplicate.
â?¢ Works on any open ELISA system
â?¢ Assay procedure is easy to automate
OUR TEST:
â?¢ Principle: Indirect ELISA
â?¢ The normal healthy patients with samples collected prior to the COVID-19 outbreak [December 3, 2019] (n = 150) and RT-PCR confirmed positive patients in after the second week of the onset of the disease (n = 32). The Positive sample evaluation was done at external Approved Lab. The results are as follows:
â?¢ Diagnostic sensitivity is 100% (>98%)
â?¢ Diagnostic specificity is 98.67% (>97%)
â?¢ PPV: 94.12�°/0
â?¢ NPV: 100%
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