COVID-19 Test FAQs
When is the ideal time to use the test kit to identify antibodies?
Using the test at least 14 days post infection will give the best results.
How does the test cassette work?
This test is CE marked for Professional use only. Check My Body Health’s COVID-19 rapid test identifies the body’s response to coronavirus after the onset of infection, and gives a qualitative yes/no result within 10 minutes.
What are IgG and IgM?
Immunoglobulins are antibodies themselves and are part of our immune system. When we get an infection, such as COVID-19, immunoglobulins are produced, which attach to the virus and activate the rest of the immune system to attack and clear the virus. IgM is the first immunoglobulin to be produced and is a general antibody that can bind to many different types of pathogen. The presence of IgM is an indicator of early infection. IgG is a more specialised antibody that specifically binds to the SARS-CoV-2 virus. The presence of IgG is an indicator of later stage infection (usually 14 days or longer after infection).
Is the test specific for COVID-19?
The IgG that the test detects is specific to COVID-19, so a positive result would indicate COVID-19 infection. Although the IgM is a more generalised antibody, its presence, combined with IgG and/or the common symptoms of COVID-19, would also indicate infection with the novel SARS-CoV-2 virus. The test can be used for primary and secondary diagnosis of COVID-19.
What samples can I use?
The test cassette will work with whole blood, plasma or serum. Capillary blood is the easiest to obtain via a finger pinprick, however, venous blood obtained via venepuncture is also suitable. The type of sample will not affect the sensitivity or accuracy of the test.
What is the buffer solution for and can I use any buffer with the test?
The buffer solution has two functions. It acts as the carrier for the sample, allowing it to laterally flow along the test strip, and it maintains a constant sample pH as it flows, preventing degradation of the biomarkers and the antibodies. We recommend that you only use the buffer solution provided with the test kits, as other ones may affect the accuracy of the test.
How does the test compare to testing in a laboratory?
A conducted clinical study in Wuhan, China compared the test cassette to conventional laboratory tests for COVID-19 diagnosis, which also detected the presence of IgG/IgM in 902 blood samples. The following results were obtained:
Sensitivity > 91% Specificity > 99% Accuracy > 97%
This clinical study is evidence of the usability and effectiveness of the test.
Will IgG and IgM remain in the blood after I’ve recovered from COVID-19?
There is some evidence that IgG/IgM remains in the blood after recovery to prevent reinfection. We have tested some patients and noticed that they still test positive for at least 33 days after first displaying symptoms. You won’t be infectious after you recover, even if you test positive, but you should still be cautious as long term immunity has not yet been confirmed and reinfection may still occur.
Can babies and young children be tested?
Yes, there are no issues with testing babies and young children.
Can pregnant or breast feeding women be tested?
Yes, there is no harm to the mother or baby when performing a test.
Is there anyone that shouldn’t be tested?
No, the more people that are tested, the better it will be to understand the spread of the virus, which will result in better measures being taken to prevent its spread. However, as the test requires a blood sample, anyone with a blood-related health condition (such as haemophilia) should discuss this with a healthcare professional before performing a test.
So can the test detect asymptomatic patients?
Yes, the test will be able to detect IgM/IgG in asymptomatic people, as they will have an immune response even though they don’t display symptoms. The timeline of infection will be the same as someone displaying symptoms.
I didn’t read the results after 10 minutes. What should I do?
For the result, the window of accuracy is 10-15 minutes after you add the sample and buffer solution. If you forget to read the results after this time, the test may not be accurate and you should repeat it.
What is the shelf-life of the test cassette?
The shelf-life is 18 months from the date of manufacture. The product expiry is printed onto the packaging for reference. Do not use after the expiry date.
How should I store the tests?
The recommended storage temperature is 2 – 30°C, however, we do not recommend you store them in the fridge, unless there is a risk of them overheating. Do not freeze the test cassettes or buffer solution. Tests should be performed at room temperature (15 – 30°C), so if you have stored tests in the fridge, you should allow them to reach room temperature before performing a test.
Do any medications, drugs or other proteins in the blood affect the test result?
To date we have tested numerous common pharmaceuticals, none of which have interfered with the test. Also, Rheumatoid Factor does not interfere with the test, hence we currently see no cross-reactivity issues. We are looking at more drugs and will update customers accordingly.
Is the test CE marked? Does it have IVD certification?
Yes, the COVID-19 test is CE marked for professional use and is therefore a registered IVD device.
Is the product already on the market, e.g. in Great Britain?
This is a relatively new test but is now being used successfully in many countries around the world.
Has the test been accredited?
The COVID-19 test is CE marked for professional use and is therefore suitable and ready for use by a healthcare professional. In addition to our clinical evaluations already completed on the product, we are currently working with a number of independent laboratories and Departments of Health across Europe to further validate the product and gain best practice approvals.
How accurate is the test?
The COVID-19 IgG/IgM rapid test cassette was compared with confirmed clinical diagnosis and has an accuracy of 98.6%. IgG results have a diagnostic sensitivity of 100% and diagnostic specificity of 99.5%, giving an accuracy of 99.8%. IgM results have a diagnostic sensitivity of 91.8% and diagnostic specificity of 99.2%, with an accuracy of 97.8.%.
Please remember, we recommend any non-negative results are referred to a medical health practitioner through the NHS. Phone 111 from any mobile or landline or visit https://111.nhs.uk/ for further information. Do NOT visit your local surgery to avoid spreading any potential infections.