Accuracy, sensitivity and specificity?
Our new coronavirus lateral flow test uses antibodies that are specific for immune glycoproteins that are produced by infected individuals in response to the new coronavirus. These glycoproteins are called Immunoglobulin M and G (IgM and IgG). Immunoglobulins are normally produced by the immune system in response to bacterial or viral infections and act to ‘flag’ the pathogen, so that other immune cells can detect and kill it. The IgG/IgM that the test detects are specific to the SARS-CoV-2 virus, so a positive result would indicate the patient has contracted COVID-19. Since there are two analytes of interest (IgM and IgG), there are two test lines on the strip. Only one test line needs to be seen for a positive diagnosis (as well as the control line). Two test lines would also indicate a positive result. The new test has the following specifications: IgG – sensitivity = 97.4%, specificity = 99.3%, accuracy = 98.9%, IgM – sensitivity = 86.8%, specificity = 98.6%, accuracy = 96.1%
Is the coronavirus test CE marked? Does the test 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?
No, this is a new product to the UK market, and is available for most territories.
Is this a new product exclusively for Coronovirus?
Yes, this test is COVID-19 specific, detecting SARS-CoV-2 as an aid in the diagnosis of primary and secondary infections.
What is the evidence for reliability of this test?
Our COVID-19 test has undergone comparative studies for CE certification using PCR analysis, using 181 samples for both IgG and IgM antibodies. This test is actually an evolution of our well-established Influenza rapid test that has been on the market for many years and demonstrated excellent accuracy and diagnostic value.
Has the test been accredited by the NHS or Public Health England (PHE)?
The COVID-19 test is CE marked for professional use, and is therefore suitable for use by any health professional. This test is very new to the market and is an excellent and accurate way to test quickly for the COVID-19 pathogen.
Do you have a confirmation lab test for Coronavirus to confirm positive samples?
This is something we are looking at, but we would recommend any non-negative results are referred to a medical health practitioner through the NHS who have access to confirmatory testing through a laboratory. 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.
COVID-19 Rapid Test
identifies the body’s response to coronavirus 3-7 days after infection, and gives a qualitative yes/no result within 10 minutes.
Implementing rapid screening for COVID-19 has huge time and cost savings when compared to laboratory screening, and will help to control the spread of the virus by identifying infection before symptoms appear.
The Test Cassette is easy to use, needing only a finger-prick sample to function, much like a home blood glucose test.