C4Diagnostics, a French biotech, has received CE marking for their C4Covid-19 Human for the rapid diagnosis of Covid-19 from a saliva sample. The performance of the test was calculated upon a clinical trial of 1320 participants, carried out in collaboration with Synlab Provence Laboratories. Sensitivity is 86% and specificity is 97.5%.
C4Covid-19 Human is an in vitro diagnostic test (IVD) designed to address the growing need for saliva-based screening, combining high performance while being deployable outside the clinical laboratory. Based on RT-LAMP technology, which is close to RT-PCR, it requires minimal equipment, namely a portable reader-analyzer, and the result is delivered in less than 30 minutes. The distinct advantages of the RT-LAMP technology are its speed, ease of use and robustness.
“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 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,” swabs,” said Younes Lazrak, CEO of C4Diagnostics.