The Panodyne COVID-19 Antibody IgM/IgG Rapid Test Kit, which has gained EU and UK CE certification and regulatory MHRA approval, is intended for Health Professional Use to help identify whether, for example, patients and those in social care settings have had COVID-19 (Coronavirus) – even if no obvious symptoms are present.
We recommend you read the Official Government Guidance regarding SARS-COV-2 Lateral Flow Tests here.
…It’s quick and accurate. The point of care test uses a fingertip blood sample to detect the presence of antibodies produced by the body’s immune system, and a positive or negative result is shown within just 10 to 15 minutes of testing, with accuracy of up to 94.6%.
Each individual test kit includes 1x alcohol wipe, 1x sterile lancet, 1x pipette, 1x cassette, diluent solution, plus full usage instructions, which are all located inside a sealed test kit wallet.
Whilst the test kit works very quickly, requires no specialist equipment, is easy to use, and test results are easy to read, the manufacturers recommend that the kit should be administered by medically trained personnel. Also please note that if you are experiencing any COVID-19 symptoms, you must follow Government guidelines in terms of isolating and testing.
The results will inform you of the following, although please be aware that if the C line does not appear, the test is invalid. There is 1 negative and 3 positive results:
Negative Result: If only the quality control line (C) appears and the detection lines G and M are not visible, then no novel coronavirus antibody has been detected and the result is negative.
Positive Result: M only - if both the quality control line (C) and the detection line M appears, then the novel coronavirus IgM antibody has been detected and the result is positive for the IgM antibody. IgM - Your body has recently produced new antibodies to fight the virus, meaning you have had COVID-19
Positive Result: G only - if both the quality control line (C) and the detection line G appears, then the novel coronavirus IgG antibody has been detected and the result is positive for the IgG antibody. IgG - You have had COVID-19 and your body has produced antibodies to fight the virus.
Positive Result: G and M - if the quality control line (C) and both detection lines G and M appear, then the novel coronavirus IgG and IgM antibodies have been detected and the result is positive for both the IgG and IgM antibodies. IgG and IgM - You are in the latter stages of COVID-19 and are currently fighting off the virus.
Please note that this test is not intended for home use.
Please always follow the latest government guidelines and medical advice. Please read and follow the instructions carefully.
HS CODE: 3822001000
A note about vaccines - this test kit is only to test if you have previously tested positive for COVID-19 and have since developed Antibodies to fight the virus. When you have a vaccine your RNA/DNA is altered to help you fight COVID-19 and you won't actually produce antibodies unless you then contract the virus. A vaccine performance kit is in development and will be available in the future.
A recent article was published on the National Health Executive website about Panodyne tests which can be read here.
Panodyne have produced a very useful Declaration Form for each of their test kits as attached which can be used each time someone is tested and kept as an internal record. Unlike PCR test kits, Lateral flow test kits do not need to be sent off to a lab to be processed and will provide results within 10-15 minutes. If the individual tested is positive, it is recommended that they immediately self-isolate and arrange to take a PCR test.
Panodyne sets the industry standards for unrivalled customer care and excellent client services from order to delivery, providing prompt replies and swift resolution to any queries. All Panodyne products are fully accredited and CE certified and registered with the MHRA where applicable.
With over 20 years of expertise, Panodyne is a well-established and trusted UK manufacturer with full ISO 9001:2015 and ISO:13845 quality management system accreditations. Its production facilities are regulated and audited under the strictest standards to guarantee high quality consistency and product availability, while products are also independently tested by global testing agencies such as SGS and Intertek. All products and medical devices are researched, designed and formulated in the UK and tested to the highest European standards to meet all legal requirements.