COVID-19 IgM/IgG Rapid Test Kit
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 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.
- Sensitivity: 94.1%, Specificity: 95.1%.
- Sample Volume: 50µL whole or peripheral blood or 20µL Serum and Plasma
- Detection Method: Colloidal Gold
- Detection Time: 10 – 15 minutes
- Suitable for Point of Care Testing. No need for extra equipment.
How Does COVID-19 IgM IgG Rapid Test Kit Work?
Screening for COVID-19 IgM and IgG antibodies is a rapid and effective method for the diagnosis of COVID-19 infection. The IgM and IgG antibody test can also provide information on the stage of infection.
Both Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies are produced during the primary immune response and measles-specific IgM can be detected in the serum as early as the first day of rash onset. 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 is validated by comprehensive clinical study. The study was using clinical COVID-19 patient samples in contrast to Real-Time RT-PCR test. The total results of IgM/IgG serum and whole blood tests of the contrast system and the trail system, positive coincidence rate was 94.67% (≥90%), negative coincidence rate was 98.15% (≥90%), total coincidence rate was 97.25% (≥90%), Kappa value was approximately equal to 0.92 (>0.7), which met the clinical evaluation standards, indicated no significant difference between the two systems.
Instructions for Use
Interpretation of Test Results
IgG POSITIVE: Two lines appear. One coloured line should be in the control line region (C), and a coloured line appears in the IgG test line region. The result is positive for SARS-CoV-2 specific-IgG antibodies.
IgM POSITIVE: Two lines appear. One coloured line should be in the control line region (C), and a coloured line appears in the IgM test line region. The result is positive for SARS-CoV-2 specific-IgM antibodies.
IgG and IgM POSITIVE: Both the test line (T) and the quality control line (C) are colored in an IgG cassette and an IgM cassette.
NEGATIVE: One coloured line appears in the control region (C). No apparent coloured line appears in the IgG or IgM test region (T).
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.
Limitation of COVID-19 IgM/IgG Rapid Test
- The product is designed only for use with human serum, plasma, 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 sample and does not indicate the quantity of the antibodies
Frequently Asked Questions
The Real-Time RT-PCR (nucleic acid test) for SARS-CoV-2 is based on the detection of viral RNA, it is the gold standard for COVID-19 diagnosis. The result for nucleic acid test might take up to 3.5 hours and the high complexity of viral RNA extraction and PCR reaction setup requires highly trained laboratory personnel. The IgM/IgG antibody test is less complex and can provide test result in less than 15 minutes.
- COVID-19 rapid test kits have not been reviewed by FDA
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic 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.
Yes, each test is packed separately in the box. Each test includes: COVID-19 IgM/IgG Rapid Test cassette, blood collection needle, sample dilution tube, dropper, and alcohol pad. Each box only contains one copy of 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.