The BioCode SARS-CoV-2 Assay from Applied BioCode, Santa Fe Springs, Calif, has been granted an FDA emergency use authorization. The Clinical Laboratory Improvement Amendments (CLIA) high-complexity multiplex nucleic acid assay is for the qualitative detection of SARS-CoV-2 nucleic acids in respiratory samples including nasopharyngeal swabs, nasal swabs, oropharyngeal swabs, and bronchoalveolar lavage from individuals who are suspected of covid-19 by their healthcare provider.
The BioCode SARS-CoV-2 runs on the BioCode MDx-3000, an automated molecular diagnostic system, and it can deliver up to 564 sample results in a day (188 sample results in an 8-hour shift) to help address covid-19 testing needs. The BioCode SARS-CoV-2 Assay is designed to detect two different regions of the SARS-CoV-2 virus N gene which are also utilized by the CDC EUA assay. The assay can be run as an independent assay or in parallel with the FDA-cleared BioCode Respiratory Pathogen Panel for a more complete respiratory infection profile of patients.
“We are extremely pleased to provide our BioCode SARS-CoV-2 Assay with the high throughput automated MDx-3000 system to help with the fight against the covid-19 pandemic,” says Winston Ho, PhD, president of Applied BioCode. “Our automated assays can provide CLIA high complexity laboratories with the capability to perform high throughput, efficient testing to meet testing needs. Furthermore, our multiplex BioCode Respiratory Pathogen Panel offers comprehensive tests combined with flexible ordering and reporting capabilities. We are very proud of our company’s ability to respond to this crisis and are committed to provide sensitive and reliable diagnostic information to laboratorians to better manage their patients.”
For more information, visit Applied BioCode.