Delphine PrecisQT™ COVID-19 Test Kit
Delphine PrecisQT™ COVID-19 test kit is a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended to detect the SARS-CoV-2 infection in nasopharyngeal and oropharyngeal swabs sampled 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.
A notification of the Intent to distribute the Delphine PrecisQT™ COVID-19 Test Kit has been accepted by the FDA’s Center for Devices and Radiological Health (CDRH) under Section IV.C.2 of the FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) | FDA. Review of the validation of the Delphine PrecisQT™ COVID-19 Test Kit has not been completed by FDA. The Delphine listing under the policy can be found at : Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 | FDA
Delphine PrecisQT™ COVID-19 Test Kit Overview
Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostics information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
The Delphine test kit is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Delphine test kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.
The Delphine test kit is not intended for use in a general, asymptomatic screening population as part of an infection control plan, that may include additional preventative measures, such as a predefined serial testing plan or directed testing of high-risk individuals. The Delphine test kit is not intended for use with pooled samples or samples obtained using home collection kits. The Delphine test kit is not intended for use at the Point of Care.
Review of the validation of Delphine PrecisQT™ COVID-19 Test Kit has not been completed by FDA. Review under the EUA program is pending. Distributed in accordance with the guidance under the FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, Section IV.C.2.