How it Works

How does the coronavirus rapid test work?

It is widely accepted that Immunoglobulin M (IgM) provides the first line of defense during viral infections, followed by the generation of adaptive, high affinity Immunoglobulin G (IgG) responses for long-term immunity and immunological memory. Therefore, testing of COVID-19 IgM and IgG antibodies is a tool that can be used in detecting the COVID-19 infection.

    • Detection of IgM antibodies tends to indicate a recent exposure to COVID-19.
    • Detection of IgG antibodies indicates a later stage of infection.

Instructions for Use:

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.

2. Lay device on flat surface and add specimen (see specific instructions for each specimen type below):

  a. For Serum or Plasma SpecimenWith 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 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 buffer vial tip does not touch the sample. Avoid air bubbles.

  b. For Whole Blood SpecimenHold 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 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. 

The COVID-19 IGG/IGM RAPID TEST DEVICE is a lateral flow immunoassay. The SARS-CoV-2 antigen is designed to detect from anti-SARS-CoV-2 IgM and IgG in blood from patients with signs and symptoms of infection who are suspected of COVID-19. IgM shows up in the body from 4 to 7 days.

Please note, after taking or administering the rapid antibody test, which is a screening tool, a PCR test should be taken/administered for further confirmation if the test is positive; Lateral flow device uses standard colloidal gold nanoparticle technology as is standard in the art. The gold nanoparticles are decorated with SARS-CoV-2 antigens which will be selectively bound by anti-SARS-CoV-2 IgG or IgM in the patient’s sample (whole blood/serum/oral fluids).

Gold nanoparticles bearing patient IgG and IgM flow over 2 test lines spotted with anti-human IgG and anti-human IgM antibodies. Gold nanoparticles that are retarded on the test lines create a visual signal. A control line at the top of the device is spotted with anti-mouse antibodies which will detect the gold nanoparticles and provide evidence that the lateral flow test delivered patient samples to both test lines. A schematic of how the test operates is given below.

Please note, when using antibody test kits, health care professionals also have an option to administer a follow up PCR test for further confirmation.
 
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