C4Diagnostics’ C4Covid-19 Human has received CE marking

C4Diagnostics’ C4Covid-19 Human, for the rapid diagnostic of COVID-19 from a saliva sample, has received CE marking.

The performance of the test, which was carried out in collaboration with Synlab Provence Laboratories, was analysed upon a largescale clinical trial of one-thousand, three hundred and twenty participants. Specificity is 97.5%, and sensitivity is 86%.

The in vitro test has been designed to address the need for saliva-based screening, which can be deployable outside of the clinical laboratory while having high performance. Based on RT-LAMP technology, it requires minimal equipment, and the results are delivered within thirty minutes.

CEO of C4Diagnostics, Younes Lazrak, stated: “The CE marking of our C4COVID-19 Human test is great news as it offers new perspectives to control the disease spread with painless immediate diagnosis. It is also a significant milestone for C4Diagnostics as C4Covid-19 Human is our first in vitro diagnostic product to be CE marked and on the market for a medical use. We have overcome the usual limitations of LAMP technology and of saliva samples to offer a kit with performances close to those of RT-PCR analysis on nasopharyngeal swabs.”

Medical biologist, principal investigator of the clinical trial and general manager of Synlab Provence Laboratories, Dr Farid Mersali, stated: “Synlab Provence is perfectly equipped to handle large batches of samples in its laboratories and since the beginning of the pandemic we have tested over five-hundred thousand samples for COVID-19. The C4Covid-19 Human test completes our testing capabilities as we also need saliva-based rapid tests to extend COVID-19 screening to specific populations. The C4Covid-19 Human test allows us to offer on the field a quality of analysis comparable to that of the laboratory.”