We have the UK distributorship for this kit and have sold thousands over the past few months. The Cov-2 Rapid Test (SARS-Cov-2 IgM/IgG test kit) measures IgM and IgG in a two-drop blood sample. The result is available in 20 minutes and has been scientifically validated (also by NHS) and are CE marked. The test kits are being used extensively by the NHS as well as large and corporate companies across the globe, to test their employees for Covid-19.
The kits are simple to use blood sample tests, quick and cost effective. They are manufactured in Germany by an ISO13485 accredited company. The attached IFU outlines the test itself and the kit contents and these are designed for professional use as certified and approved by MHRA.
The negative predictive value is 100%. In the early stages of infection (day 4-10) it has an IgM positive conformity rate of 70%. Between 11 – 24 days the positive conformity rate for IgM is 92.3% and for IgG is 98.6%. IgG persists in the bloodstream for weeks and months after infection and its presence can be used as a biomarker for successful recovery from Covid-19.
Attached documents with the results from PharmACT AG showing how the SARS-Cov-2 antibody test performed against PCR positive and negative cases and what the specific antigen in the test is. There is also a paper from Li et al (attached) that describes the validation of the original version of the test in Chinese patients infected with Covid-19.
Also attached are 3 documents covering the validation results so far based on original results from early testing in China with test results are increasing each week.
The product now has approval to ship into the USA by the FDA and MHRA have approved the product for shipment into the UK. They are also currently being supplied into Germany, Italy, China (the original tests results were done in Wuhan in December), Israel, Brazil and other countries around the world each week.
The kits are designed and certified for professional use only. We can supply up to 1,000,000 test kits per week and we have samples available if required.
CEO, Trinity PPE (UK) Ltd
M: 0044 7376 536261