Both companies have just signed a Product Registration Services Agreement, with the aim of achieving the CE mark for the in vitro diagnostic medical device ELA CHEMSTRIP COVID-19.
The elaboration of the Technical File to be presented in the certification and registration process of the CE mark will be supervised by GTF M.Camps, a partner of CMC based in Barcelona, specialized in legal procedures in the biosanitary sector.
CHEMTEST (www.chemtest.net), a company based in Argentina, offers innovative solutions for the detection of infectious diseases in a simple and precise way, thus contributing to improve the health and quality of life of our society. CHEMTEST has developed high precision tests for the diagnosis of viral, bacterial and parasitic infections, of great impact on public health. Its technological platforms allow it to develop user-friendly, fast and highly reliable tests.
Thanks to the incorporation of the exclusive ELA (Easy Loop Amplification) and GenCap (inmunochromatographic detection of nucleic acids) technologies, combined in a single diagnostic test, the ELA CHEMSTRIP COVID-19 kit (www.chemtest.net/chemstrip-covid-19.php) has an excellent performance for the detection of the SARS-Cov2 in a fast, early and simpler way than the traditional RT-PCR in real time.
The kit can be implemented in health centers with low diagnostic infrastructure, does not require sophisticated equipment and its reading is easy to interpret.