Quotient Limited, a commercial-stage diagnostics company, headquartered in Eysins, Switzerland, announced that it has completed the process for declaring conformity to the essential requirements of the In Vitro Diagnostics Directive (IVDD 98/79/EC) and has CE marked (Conformité Européenne) its SARS-CoV-2 (COVID-19) antibody microarray. The test is now available for sale in Europe and Switzerland.
The MosaiQ COVID-19 Antibody Microarray is designed as a serological disease screen specific to COVID-19. The assay detects the IgG and IgM antibodies directed at SARS-CoV-2. In addition to the concordance studies, the Company observed seroconversions (the generation of antibodies specific to SARS-CoV-2) in two patients where diagnosis was supported by a polymerase chain reaction (PCR) assay on the patients at the time of symptoms.
In one patient, the antibody negative status changed to positive one day after the PCR positive result, and in another patient, the antibody negative status changed to positive four days post PCR result. This demonstrates that the MosaiQ antibody test can detect antibodies very early in seroconversion process.
“We are very pleased to report the completion of the CE marking process for the SARS-CoV-2 (COVID-19) assay in record time with a 100% sensitivity and 99.8% specificity claim. The test has the best in class performance and overall agreement published to date. The ability to quickly test whether people have developed antibodies due to infection is critical in supporting the response to the global COVID-19 pandemic,” said Franz Walt, Chief Executive Officer of Quotient.
During our final preparations for achieving the CE Mark, our R&D team was able to further optimize one image analysis parameter, which further improved the assay specificity without changing the sensitivity,” said Ed Farrell, Chief Operating officer.
This the Company’s fourth market clearance and the CE certification of the third Microarray within a year. The MosaiQ™ instrument is CE marked and the Company’s microarray manufacturing facility is ISO 13485 certified.
Limited Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial-stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced. MosaiQ, Quotient’s proprietary multiplex microarray technology, offers the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ is designed to be a game changing solution, which Quotient believes will increase efficiencies, improve clinical practice, deliver significant workflow improvements, and operational cost savings to laboratories around the world. Quotient’s operations are based in Eysins, Switzerland, Edinburgh, Scotland and Newtown, Pennsylvania. The Quotient logo and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.