FDA grants emergency use authorization to the Zero Contact COVID-19 test kit as a saliva-based diagnostic for at home use to detect COVID-19.- Vitagene

Vitagene has announced the availability of 50,000 FDA authorized at home Zero-Contact or Saliva-based COVID-19 test kits for use during the current public emergency to detect COVID-19. Vitagene is using the 1Health.io platform to facilitate compliance with FDA requirements for assessment of symptoms, telehealth and electronic tracking of the test kit. With the Zero Contact COVID-19 test, patients will get a kit at home eliminating the need to drive or be at risk going to a clinical setting. The device with US FDA EUA approval is the Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay.

Approval is based on a qualitative test for the detection of nucleic acid from SARS-CoV-2 in in oropharyngeal swab, nasopharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, and bronchoalveolar lavage fluid from individuals suspected of COVID-19 by their healthcare provider. Salvia specimens may also be collected for use with the system using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device to self-collect salvia specimens at home or in a healthcare setting by individuals when determined to be appropriate by a healthcare provider.