In response to the coronavirus (COVID-19) pandemic, Aurora is now offering the Rapid IgM/IgG Antibody Test Kit to equip healthcare workers for rapid detection of antibodies to COVID-19. This COVID-19 rapid test kit is suitable for the qualitative detection of IgM/IgG antibodies against SARS-CoV-2 in human serum, plasma or whole blood. Common signs of SARS-CoV-2 infection include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, the infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death. SARS-CoV-2 can be excreted through respiratory secretions or transmitted through oral fluids, sneezes, physical contact, and air droplets.
How does the COVID-19 IgM IgG rapid test kit work?
The COVID-19 IgM/IgG Antibody Rapid Test is a rapid and effective method to detect IgM and IgG antibodies against SARS-CoV-2. This test can also suggest information about the stage of the infection. Both immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies are produced during the primary immune response. As the body’s largest antibody, IgM is the first antibody to appear in response to initial exposure to antigens.
IgM provides the first line of defence during viral infections, followed by the generation of adaptive high-affinity immunoglobulin G (IgG) responses for long-term immunity and immunological memory. IgG is usually detected about 7 days after the first sign of clinical symptoms.
Interpretation of test results
- IgG and IgM POSITIVE (left): Both the test lines and the QC line are stained on the COVID-19 IgM/IgG Antibody Test Cassette.
- IgG POSITIVE (centre): Two lines appear on the COVID-19 IgM/IgG Antibody Test Cassette. One coloured line appears in the control line region and another coloured line appears in the IgG test line region. The result is positive for SARS-CoV-2 specific IgG antibodies.
- POSITIVE IgM (right): Two lines appear on the COVID-19 IgM/IgG Antibody Test Cassette. One coloured line appears in the control line region and another coloured line appears in the IgM test line region. The result is positive for SARS-CoV-2 specific IgM antibodies.
- INVALID: Control line does not appear. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new Test Cassette. If the problem persists, stop using the COVID-19 Rapid Test Kit immediately and contact your local dealer.
Limitation of the rapid IgM/IgG antibody test for COVID-19
- The test is intended only for use with human serum, plasma, or whole blood specimens for the qualitative detection of IgM and IgG antibodies to SARS-CoV-2.
- As with all diagnostic tests, a definitive clinical diagnosis should not be based on a single test result but should be made after all clinical findings have been evaluated and confirmed by other conventional screening methods. such as molecular diagnostics. and CT.
- A false negative may occur if the amount of SARS-CoV-2 IgM or IgG antibodies is below the detection level of the kit.
- If the test gets wet before use or is stored incorrectly, it may cause incorrect results.
- The test is for the qualitative detection of IgM or IgG antibodies against SARS-CoV-2 in human serum, plasma or blood samples, it does not indicate the number of antibodies present.
- Positive results may be due to past or present infection with coronavirus strains other than SARS-CoV-2, such as coronavirus HKU1, NL63, OC43, or 229E.
- This test is intended for healthcare professional use and not for home use.
- This test is not for the screening of donated blood.
1. This test has been authorized by the FDA under a EUA for use by authorized laboratories.
2. This test has not been licensed or approved by the FDA.
3. This test is only authorized for the duration of the declaration that there are circumstances that justify the authorization of the emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 USC § 360bbb-3(b)(1) unless the authorization is terminated or revoked earlier.