THE ANTIBODY TEST
Quick Profile TM 2019-nCoV IgG/lgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of lgG and IgM antibodies to the 2019 novel coronavirus(2019-nCoV, SARS-CoV-2) in human serum, plasma or whole blood.
Quick Profile TM 2019-nCoV IgG/lgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.
The product contains 20 tests, one IFU (instruction for use) and one lot number card.
For each test, it contains one testing strip, one dropper and one package of desiccant.
The testing strip is composed of one gold standard mat (colloidal gold labeled SARS-CoV-2 recombinant protein), sample mat, cellulose nitrate membrane (Mouse-anti human IgM antibody immobilized in M area, Mouse-anti human IgG antibody immobilized in G area; Goat anti-mouse antibody immobilized in C area), absorbing paper, plastic carrier board.
1. Remove the test strip from the packaging reagent bag and use it within 1 hour, especially in an environment with room temperature higher than 30 ° C or in high humidity.
2. Place the kit on a clean platform.
⚫ Serum or plasma sample: Add 10 uL of serum or plasma sample to well A, and then add two drops (about 80 uL) of sample dilution to well B, and start timing.
⚫ Whole blood sample: Add 20 uL of whole blood sample to sample well A, and then add two drops (about 80 uL) of sample dilution to sample well B, and start timing. 3. Wait for the fuchsia band to appear. The test results should be read within 10-20 minutes. Do not read the results after 20 minutes.
【The Explanation of the Testing Results】
⚫ Positive (+): There appear purple stripes in both quality control area and either area M or G.
⚫ Negative (-): There is only one purple stripe in the quality control area (C), and without purple stripe in either test area M and test area G.
⚫ Invalid: There is no purple stripe in the quality control area (C), indicating incorrect operating procedures or the testing strip has already deteriorated. Under this conditions, it must read the instruction for use again carefully, and then use the new test strips to test again. If the problem still exists, stop using this lot number immediately and contact the local suppliers.
Feel Free to Contact Us for More Information
TUV Test Report
Medical CE certification
IFU User Manual
Clinical Report for SARS-CoV-2 or COVID-19 TEST