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.
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 10 minutes. However, it should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status
1. COVID-19 Rapid Test is for in vitro diagnostic use only. The test should be performed using serum, plasma or whole blood samples only. Neither the quantitative value nor the rate of increase in COVID-19 antibody concentration can be determined by this qualitative test.
2. In the early onset of fever, anti-COVID-19 IgM concentrations may be below detectable levels.
3. The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.
4. Results from immunosuppressed patients should be interpreted with caution.
5. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
6. If the test result is negative and clinical symptoms persist additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of COVID-19 infection.
You could have SARS-CoV-2 and not know it. Not everyone who gets it has symptoms. Experts hope antibody tests can give health officials a better idea of how common the virus is.
Once scientists know who has had the virus, they can find out how sick it makes most people. And they can study what happens if people who've had it come into contact with it again. Along with other scientific information, this can help researchers understand who might be immune to the virus.
The hope is that people with antibodies to COVID-19 can safely get back to work, and normal life, quicker.
These tests may also help with an experimental treatment for COVID-19 called convalescent plasma. Plasma is the liquid part of your blood.
Researchers are studying how antibodies in plasma donated by people who’ve recovered from COVID-19 might help those who are ill with the virus. One theory is that this plasma may help sick people get better faster. But more research is needed.
There is no known limit-of-detection of this assay. The kit is qualitative and is based on antibody interactions, and every person has different antibody affinities.
This is not an over-the-counter product for home use. The test must be administered by a medical professional. However, it is a POC (point of care) test that does not require sending samples to a lab. Therefore, the results can be obtained on-site at a pharmacy, generarl practitioner's office or clinic.
The test cartridges and diluent provided in the finger prick and serum/whole blood kits are identical. The only difference is that the finger prick kit comes with materials necessary for capillary blood collection (lancet, plastic capilliary, alcohol swab).
We have tests to meet all volumes of demand. Please contact our Head of Clinical Diagnostics, Helen McCormack for further information.
Our kits are CE authorised. We are also planning to submit this test for Emergency Use Authorisation following guidance from the FDA. 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.
No, the IgM/IgG rapid test does not require any other equipment. Our COVID-19 IgM/IgG Rapid Test Kit provides all the tools you need from sample collection to result reading.
The COVID-19 Antibody Rapid Test can only be used as a reference, the medical professional administering the test can advise on next steps.
The box includes 10 individually sealed cartridges, along with:
10 Test lateral flow Ab cartridges
10 Alcohol swabs
10 Sterile lancets
10 disposable capillary
1 Buffer solution bottle, sufficient for 10 tests
1 Instruction manual (IFU)