Frequently Asked Questions

We know you might have questions about the Lepu Medical Rapid SARS-CoV-2 (Colloidal Gold) Antigen Test Kits, so we have prepared answers to some of the most frequently asked questions.

If you can’t find what you are looking for please contact us for more info.

What is a SARS-CoV-2 Rapid Antigen test for?

To check if you are carrying the virus and are infectious to others

Why would I do the SARS-CoV-2 Rapid Antigen test?

To quickly check if you are infectious to others, to prevent risks to the health of others. With results in 15 minutes this test will confirm if you are a risk to others and let you know if you are infected with SARS-CoV-2.
Workplaces and other organisations will benefit from regular testing to ensure they are not at risk of infecting each other.

How does the test work?

The test is a lateral flow immunoassay test and operates in a similar way to a pregnancy test. Embedded
into the test strip are antibodies that bind to a SARS-CoV-2 specific biomarker, Immunoglobulin G (IgG), and
another infection biomarker, Immunoglobulin M (IgM). When a sample is added to one end of the test, it flows along the test strip and interacts with these antibodies. If the patient has contracted SARS-CoV-2, the biomarkers in their blood will bind to the antibodies on the test strip, leaving a visible test line. If the patient doesn’t have SARS-CoV-2, no biomarkers should be present in their blood and
no test line will be visible. There are separate test lines for IgG and IgM and only one needs to be visible for
a positive result.

What type of test is the Rapid Antigen test?

It is a swab test which detects the presence of protein particles from the virus that causes the SARS-CoV-2 virus.
The test must be administered by a trained healthcare professional. A swab is taken from the nose, a fluid is added and this fluid is then tested for the presence of viral protein using a lateral flow device.

How long does it take to get the results?

Results are observed within 15 minutes.  Positive results might be observed much sooner and will be valid

What do I do if I find out I have coronavirus on my swab in the SARS-CoV-2 Rapid Antigen test?

You should isolate yourself and follow the guidance at: 

https://www.nhs.uk/conditions/coronavirus-covid-19/

And If you are feeling unwell you should follow the guidance at: https://111.nhs.uk/covid-19/

What Regulatory Approvals does the test Have?

The Test Kit is CE marked

What is "return to work" testing?

There are some healthcare professionals and businesses who are taking a calculated risk that it is perhaps safe to return to work in some circumstances if people have both a SARS-CoV-2 Rapid Antigen test which detects no virus, and a positive antibody test confirming the presence of antibodies – indicating that an individual is not carrying the virus and has been infected and recovered. 

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.  You should only use the buffer solution provided with the test kits.

So can the test detect asymptomatic patients?

Yes, the test will be able to detect asymptomatic people, as they will have an immune response even though they don’t display symptoms.

I didn’t read the results in the instructed timeframe. What should I do?

For the result, the window of accuracy is 15-20 minutes after you add the sample and buffer solution. If you forget to read the results after this time you should consider the test to be invalid.

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 4 – 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, hence we currently see no cross-reactivity issues. We are looking at more drugs and will update customers accordingly.

Can babies and young children be tested?

Yes, there are no issues with testing babies and young children.  The test is used in nearly all schools in Germany and also other European countries

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.

Is the test CE marked? Does it have IVD certification?

Yes, the test is CE marked for professional use and is therefore a registered IVD device.