Delphine Diagnostics Inc., Bordentown, New Jersey, has been informed by the FDA’s Center for Devices and Radiological Health (CDRH) that its Notification of Intent to Distribute the Delphine PrecisQT™ COVID-19 Test Kit has been accepted under Section IV.C.2 of the FDA’s Policy for Coronavirus Disease-2019 Tests. Delphine PrecisQT™ is now listed on the following FDA page: Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 | FDA.

Delphine is proud to have met the criteria for distributing its PrecisQT™ COVID-19 Test Kit while its Emergency Use Authorization (EUA) request is under review by the FDA. Delphine has worked with the FDA in support of Delphine’s current EUA review even as Delphine continues further clinical studies to expand validation of PrecisQT™ to include more laboratory instruments and more patient testing needs.

Included in the Delphine EUA request are studies demonstrating accuracy (inclusivity (including ability to detect new variants) and exclusivity (no false positives due to other infections)), sensitivity (limit of detection), lack of microbial interference (no false negatives due to co-infections), and clinical validation demonstrating agreement with qualitative findings by a comparator EUA-authorized test. A summary of these studies can be found in the Instructions for Use posted here: Delphine-PrecisQT_Instructions-for-Use_DDX101_ver_04.01.2021-.pdf (delphinedx.com).

The Delphine PrecisQT™ COVID-19 Test Kit is a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 virus in nasopharyngeal and oropharyngeal swabs from individuals who are suspected of having COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.