COVID-19 IgM/IgG Rapid Test Kit – FDA EUA Authorized
Each Box Contains:
25x Individual sealed pouches (1x Test cassette, 1x Desiccant pouch), 25x disposable pipettes, sample diluent and instructions for use (IFU).
In response to the Coronavirus (COVID-19) pandemic, Aurora is now offering the IgM/IgG antibody rapid test kit to equip healthcare workers for rapid COVID-19 antibody detection. This COVID-19 Rapid Test Kit is suitable for the qualitative detection of SARS-CoV-2 IgM/IgG antibodies in human serum, plasma, or whole blood. Common signs of infection with SARS-CoV-2 include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, 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, sneezing, physical contact, and through air droplets. For molecular diagnostic test kit using Real-Time RT-PCR, please visit this page.
- IgG sensitivity: 96.7%, specificity: 98.0%. IgM sensitivity: 86.7%, specificity: 99.0%.
- Overall positive agreement rate of 96.7%, negative agreement rate of 97.0%.
- Sample Volume: 10µL fingertip blood and whole blood sample, or 5µL serum and plasma
- Detection Method: Colloidal Gold
- Detection Time: 10 – 15 minutes
- Suitable for Point of Care Testing, no need for extra equipment
- FDA EUA approved; CE Certified
How Does COVID-19 IgM IgG Rapid Test Kit Work?
The COVID-19 IgM/IgG antibody rapid test is a fast and effective method for screening IgM and IgG antibodies against SARS-CoV-2. This test can also suggest information on the stage of 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 an 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 detectable about 7 days after the IgM appears.
Validated by Clinical Study
Aurora’s COVID-19 IgM/IgG Rapid Test Kit has been validated by a comprehensive clinical study in which 191 clinical samples were selected.
IgM: 90 cases of positive samples confirmed by PCR test: tested with COVID-19 IgM rapid test, 78 cases were positive, 12 cases were negative. 101 cases of negative samples confirmed by PCR test: tested with COVID-19 IgM rapid test, 100 cases were negative, 1 cases were positive. COVID-19 IgM rapid test and PCR test positive coincidence rate of 86.7%, negative coincidence rate of 99.0%.
IgG: 90 cases of positive samples confirmed by PCR Test: tested with COVID-19 IgG Ab rapid test, 87 cases were positive, 3 cases were negative. 101 cases of negative samples confirmed by PCR Test: tested with COVID-19 IgG Ab rapid test, 99 cases were negative, 2 cases were positive. COVID-19 IgG rapid test and PCR test positive coincidence rate of 96.7%, negative coincidence rate of 98.0%.
Instructions for Use
Interpretation of Test Results
IgG and IgM POSITIVE (left): Both the test lines and the quality control line are colored in the COVID-19 IgM/IgG Antibody Test Cassette.
IgG POSITIVE (middle): 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.
IgM POSITIVE (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.
NEGATIVE: One coloured line appears in the control region. No apparent coloured line appears in the IgG or IgM test region.
INVALID: Control line fails to 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, discontinue using the COVID-19 rapid test kit immediately and contact your local distributor.
Disclaimer: (The picture is for representation only, markings on test cassette may vary.)
Limitation of COVID-19 IgM/IgG Rapid Test
- The product is designed only for use with human serum, plasma, or whole blood samples for the qualitative detection of SARS-CoV-2 IgM and IgG antibody.
- As in case of all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test but should rather be made after all the clinical findings have been evaluated and should be confirmed by other conventional detection methods, such as molecular diagnostics and CT.
- A false negative may occur if the amount of SARS-CoV-2 IgM or IgG antibody is below the detection level of the kit.
- If the product gets wet prior to use, or is stored improperly, it may cause incorrect results.
- The test is for qualitative detection of SARS-CoV-2 IgM or IgG antibody in human serum, plasma, or blood samples, it does not indicate the quantity of the antibodies present.
Frequently Asked Questions
The Real-Time RT-PCR (nucleic acid test) for SARS-CoV-2 is based on the detection of viral RNA, and it is the gold standard for COVID-19 diagnosis. The results for this nucleic acid test might take up to 3.5 hours, and the increased complexity of viral RNA extractions and PCR reaction setups require highly trained laboratory personnel. The COVID-19 IgM/IgG antibody rapid test is a qualitative test for COVID-19 IgM and IgG antibodies to. It is less complex and can provide results in less than 15 minutes. However, it should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status
As per FDA’s guidance on March 16th, 2020, FDA does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:
- COVID-19 rapid test kits have not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Following-up with a molecular diagnostic testing should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- 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.
No, the IgM/IgG rapid test does not require any other equipment. Aurora’s COVID-19 IgM/IgG Rapid Test Kit provides all the tools you need from sample collection to result reading.
Please refer to product manual included with the test.
Yes, each test is packed separately in the box. Each test includes: COVID-19 IgM/IgG Rapid Test cassette, disposable pipet, and sample dilution buffer. Each box contains one copy of the product manual.
COVID-19 IgM/IgG Rapid Test Kits are not intended for at home use. If you feel you need to be tested, please reach out to a local clinic or physician and ask them about offering this test
The COVID-19 Antibody Rapid Test can only be used as a reference, please contact your local physician or hospital.
Health Canada has not approved any COVID-19 antibody rapid test cassette yet, therefore it is not available in Canada. Please fill out a inquiry form on our website and we will keep you updated on the regulatory status in Canada.