Healgen Rapid Test Cassette For COVID-19 25 pieces
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Healgen Rapid Test Cassette For COVID-19 utilizes lateral flow technology for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies.
In general, antibodies can be detected 1-3 weeks after infection.
This test is intended to screen patients for SARS-CoV-2 antibodies. Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds that cause respiratory, enteric, hepatic, and neurologic diseases.
Four viruses – 229E, OC43, NL63, and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals.
Three other strains SARS-CoV, MERS-CoV, and SARS-CoV-2 (COVID-19) can be transmitted from non-human vertebrates to humans.
Warning:-
- This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under a EUA for use by authorized laboratories.
- Authorized only for detecting the presence of IgG and IgM antibodies to SARS-CoV-2, not for any other viruses or pathogens.
- Intended for professional use and not for home use.
- Not for the screening of donated blood.
Instructions for Healgen Rapid Test Cassette For COVID-19
1. Remove the Healgen Rapid Test cassette from the sealed foil pouch and use it as soon as possible.
2. Lay the device on a flat surface and add specimen (see specific instructions for each specimen type below):
a. For Serum or Plasma Specimen: With the plastic dropper provided, draw serum/plasma specimen to exceed the specimen line, as shown in the diagram below. Hold the dropper vertically and transfer the drawn serum/plasma specimen into the sample well (S). Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that the buffer vial tip does not touch the sample. Avoid air bubbles.
b. For Whole Blood Specimen: Hold the plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the sample well (S) of the test device.
Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that the buffer vial tip does not touch the sample. Avoid air bubbles.
3. Wait for the control line (C) to change from blue to a red color. If, after 2 minutes, the sample has not moved across the test window or if blood is still present in the sample well (S), add 1 additional drop of sample buffer to the buffer well (B).
4. The results should be read in 10 minutes. Do not interpret the result after 15 minutes.
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