FDA Emergency Use Authorized COVID-19 “Coronavirus” IgG/IgM Rapid Test Kit
What is Coronavirus?
Coronaviruses are a large family of viruses that are common in many different species of animals, including camels, cattle, cats, and bats.
The two highly pathogenic viruses, SARS-CoV and MERS-CoV, cause a severe respiratory syndrome in humans, and the other four human coronaviruses (HCoV-NL63, HCoV-229E, HCoV-OC43, and HKU1) induce only mild upper respiratory diseases in immunocompetent hosts, although some of them can cause severe infections in infants, young children, and elderly individuals.
What Does the COVID-19 IgG/IgM Rapid Test Device Detect?
The COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-s IgM and anti-SARS-CoV-2 IgG in human whole blood, serum or plasma as an aid in the diagnosis of primary and second SARS-COV-2 infections.
This test is for professional use only. Verification of Medical use will be needed upon purchase.
Covid-19 IgG/IgM Rapid Test Instructions for Use
- Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
- Place the test device on a clean and level surface.
- (For Whole Blood Specimen): Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the specimen well(S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.(For Serum or Plasma Specimens): With a 5 μL mini plastic dropper provided, draw serum/plasma specimen to exceed the specimen line as showed in the following image and then transfer drawn serum/plasma specimen into the sample well (S). Then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
- Wait for the colored line(s) to appear. After 2 minutes, if the red color has not moved across the test window or if blood is still present in the specimen well (S), add 1 additional drop of the sample buffer to the buffer well (B).
- The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.
For IgM detection:
|COVID-19 IgG/IgM Rapid Test||IgM+||74||2||76|
For IgG detection:
|COVID-19 IgG/IgM Rapid Test||IgG+||82||3||85|