VivaDiagTM 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. This test is to be used by medical professionals.
The test kit consists of test devices and buffer. It is for in vitro diagnostic use only, and can be used in point-of-care testing settings and central laboratories.
The test kit is based on immunoassay technology. 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.
When sample is added to the sample well of the test device, it will move forward along the test device. If the sample contains IgM antibodies, antibodies will bind to the virus antigen labeled with colloidal gold, then forms a sandwich complex with the coated anti-human IgM mono- clonal antibody at IgM line, IgM line will appear purplish red, prompting the COVID-19 IgM antibody is positive.
If the sample contains IgG antibodies, antibodies will bind to the virus antigen labeled with colloidal gold, then forms a sandwich complex
with the coated anti-human IgG monoclonal antibody at IgG line, IgG line will appear purplish red, prompting the COVID-19 IgG antibody is positive.
If either line IgG or IgM does not show color, the negative result will
be displayed. The test device also contains a quality control line C, whether there is a test line or not, quality control line C should display purplish red. Test result will be invalid if quality control line C does not show color, this sample needs to be retested.
Discounts available subject to quantity. Available in two weeks.
- Fast - results ready in 15 minutes
- Easy to use
- Room temperature storage
- Small sample volume - 10µl of whole blood, plasma or serum
|Product Name||VivaDiag™ SARS-CoV-2 IgM/IgG Rapid Test|
|Test Principle||Colloidal gold|
|Sample Type||Whole blood (fingertip/venous ), serum or plasma|
|Sample Volume||10 μL|
|Test Time||15 min|
|Shelf Life (Unopened)||12 months|