About Our COVID-19 Rapid Test Cassette
SureScreen’s 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.
Benefits Of Our COVID-19 Rapid Test Cassette
- Significant time and cost saving over lab methods
- Results within 10 minutes icon
- Identifies infection before symptoms appear
- Assists in the control of viral transmission
- Screen anywhere, anytime
- Accuracy of 97.8% (IgM) and 99.6% (IgG)
- Easy to use and read, with no specialist equipment required
Current Diagnosis of Coronavirus Cassette
The current method of diagnosing COVID-19 is to measure body temperature and testing blood and sputum samples, as well as monitoring symptoms. However, symptoms can take 14 days or longer to develop, in which time the patient could have spread the virus to others. Additionally, analysing blood and sputum takes time, as samples have to be sent to laboratories for processing and analysis. Earlier diagnosis would mean infected individuals can be isolated sooner, preventing them spreading the virus to others.
SureScreen Diagnosis have developed a rapid lateral flow test to detect immune markers of coronavirus. This test uses a tiny capillary blood sample and takes as little as 10 minutes to get a result.
How Does The Test Work?
Lateral flow tests are common rapid tests used to diagnose a variety of illnesses. They are popular due to their simplicity and low cost. In general, lateral flow tests use monoclonal antibodies that are specific to the analyte of interest, which may be a protein or other molecule, to give a positive or negative result on a test strip.
Normally, the sample (blood, saliva etc.) is added to one end of the test strip, along with a buffer solution. The sample flows along the test strip via capillary action into a reservoir of antibodies that are specific to the analyte of interest. If the analyte is present in the sample, the antibodies will bind to it and continue to flow along the test strip. It will then reach a test line, which contains a second set of bound antibodies specific to the analyte. The analyte will bind to these (if present) and will be immobilised along the line. The remaining sample will continue to flow until it reaches a second line, known as the control line. The control line contains more bound antibodies, but these are specific to the flowing antibodies themselves, not the analyte. The remaining antibodies are captured on the control line. The flowing antibodies usually contain a coloured dye or gold nanoparticles, so the line can be seen with the naked eye when they bind.
If both test and control lines are seen, the sample is positive for the analyte. If only a control line is seen, the result is negative. If only the test line is seen, the test is void and should be repeated.
Our Coronavirus Test Cassette is 98.9% Accurate
SureScreen’s 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:
- Sensitivity = 97.4%
- Specificity = 99.3%
- Accuracy = 98.9%
- Sensitivity = 86.8%
- Specificity = 98.6%
- Accuracy = 96.1%
About Coronavirus (COVID-19)
COVID-19 is an infectious disease that can affect your airways and lungs, caused by the most recently discovered coronavirus.
This infectious disease was unknown until the recent outbreak which originated in China in late 2019. At time of writing, cases of COVID-19 continue to rise daily across the globe.
The most common symptoms associated with COVID-19 are fever, tiredness and a dry cough, but symptoms can take up to 14 days to appear so it is difficult to know if someone has been infected ahead of these conditions appearing. In the meantime, infected people can spread the virus unknowingly.
Accuracy, sensitivity and specificity?
SureScreen’s 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 = 100%, specificity = 99.5%, accuracy = 99.6%, IgM - sensitivity = 91.8%, specificity = 99.2%, accuracy = 97.8%
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?
This is a relatively new test, but is now being used successfully in many countries around the world.
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.
Established in 1996, SureScreen have been providing proactive, bespoke diagnostic solutions to organisations just like yours for nearly 25 years. Believing early diagnosis is key to preventing disruption to both time and finances, SureScreen deliver tailored services and products across the UK and Europe.
Test Kits That You Can Trust
SureScreen Diagnostics is an award-winning business that provides providing quality rapid diagnostic equipment and services around the globe. Across Europe, every two seconds a SureScreen testing kit is being used.
SureScreen believe that early, accurate diagnosis is better than waiting for problems to arise, and a pro-active approach greatly benefits people's health, identifies issues early in their development, prevents accidents from happening and has a positive effect on performance, productivity and reputation.
Our mission is to provide the best quality diagnostic products that meet and exceed their customer's expectations at a fair price.