HOW YOU CAN BEST PROTECT YOURSELF
FREQUENTLY ASKED QUESTIONS
If your test is positive, please remain calm and call 111 (or the emergency number in your country) and follow your local government and health authority advice.
The Covid-19 Rapid Test is being used by governments and health authorities around the world, including China. The combination use of IgM and IgG test can detect virus infection and the immune status of the body effectively.
COVID-19 Rapid test is a single use finger prick test kit which detects IgG and IgM antibodies to COVID-19 in human whole blood with only 10 minutes assay time. This type of test is self-administered at home and is less invasive than a venous sample.
The individual test kits contain instructions, a finger prick, pipette, cassette, buffer and plastic disposal bag. The finger prick is used to prick the finger which allows the individual to collect a small blood sample using the pipette. A drop of blood is then dropped into the cassette followed by 2 drops of the buffer liquid. The cassette then displays either a positive or negative result.
Yes, CE-IVD Certified and therefore registered IVD device.
The COVID-19 IgG/IgM Rapid Test Cassette is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to COVID-19 in whole blood, serum or plasma specimen. The test identifies whether the person is either positive or negative for the antibodies. That means if a person is a carrier but not symptomatic, they will still test positive.
The COVID-19 IgG/IgM Rapid Test Cassette should be used only for the detection of IgG and IgM antibody to COVID-19. Neither the quantitative value nor the rate of increase in the concentration of IgG or IgM antibodies to COVID-19 can be determined by this qualitative test. In short it can only tell if the subject has the antibodies associated with the virus and cannot be used to diagnose or determine the severity of the condition or monitor their progress.
The COVID-19 IgG/IgM Rapid Test Cassette will only indicate the presence of IgG and IgM antibodies to COVID-19 in the specimen and should not be used as the sole criteria for the diagnosis of COVID-19 infections.
As with all diagnostic tests, all results must be considered alongside other clinical information available to a health professional.
If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of COVID-19 infection. Always follow the advice published by your government and health authority.
The haematocrit level of the whole blood can affect the test results. Haematocrit level needs to be between 25% and 65% for accurate results.
No. We would recommend any positive results are referred to a medical health practitioner through the NHS who have access to confirmatory testing through a laboratory. Phone 111 or visit https://111.nhs.uk/ for further information. Do NOT visit your local surgery to avoid spreading any potential infections.
Not at present as it is a brand new test. The FDA in the US are starting to approve Covid-19 Tests for home use. The COVID-19 test kit has a CE-IVD Marking which is required for all in vitro diagnostic (IVD) devices sold in Europe. CE Marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC) and that the device may be legally commercialised in the EU.
The 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 a well-established influenza rapid test that has been on the market for many years and demonstrated excellent accuracy and diagnostic value.
Yes, this test is COVID-19 specific. This test is very new to the market and is a way to test quickly for the COVID-19 pathogen.