The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used 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 COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals and birds that cause respiratory, enteric, hepatic and neurological diseases. Four viruses – 229E, OC43, NL63 and HKU1 are prevalent and typically cause common cold symptoms in immuno-compromised individuals. Three other strains SARS-CoV, MERS-CoV and SARS-CoV-2 (COVID-19) are can be transmitted from between non-human vertebrates to humans.
- This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has not been FDA cleared or approved.
- This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- This product is intended for professional use and not for home use.
Instructions for Use (Video Instruction Available HERE):
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 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 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 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 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.
WARNING: This Coronavirus COVID-19 rapid test not been reviewed by FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status. This test is FDA approved for professional use during the SARS-CoV-2 pandemic according to FDA Emergency Use Authorization. The test is recommended for medical professionals use in medical offices and/or laboratories under the CLIA license.
For Professional IVD Use Only for Researches, Training, and Forensic Needs.