Quotient Limited Receives CE Mark for Its SARS-CoV-2 (COVID-19) Antibody Microarray

Quotient Limited (Eysins, Switzerland) 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 Européene) its SARS-CoV-2 (COVID-19) antibody microarray.

Quotient, a commercial-stage diagnostics company, has developed MosaiQ, its proprietary multiplex microarray technology, which offers the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. The company’s 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. The test is now available for sale in Europe and Switzerland.

“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.

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