NEXT is pleased to offer COVID-19 testing. The assay being utilized is a modified CDC SARS CoV2 rtPCR assay for detection of COVID19, for which NEXT has applied for Emergency Use Authorization (EUA) from the FDA. The cash price for this assay is $150.
Next Bio-Research has submitted and is under review by the FDA, an Emergency Use Authorization (EUA) request for use of a SARS-CoV-2 molecular diagnostic test to be performed for the in vitro qualitative detection of RNA from the SARS-CoV-2 in respiratory samples from patients as recommended for testing by public health authority guidelines.
The SARS-CoV-2 assay is a real-time RT PCR (rRT-PCR) assays for the in vitro qualitative detection of 2019-Novel Coronavirus (2019-nCoV) in respiratory specimens intended for the presumptive detection of nucleic acid from the SARS-CoV-2 in nasal pharyngeal swabs taken from individuals suspected of COVID-19. Testing is limited to laboratories that are Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a certified high-complexity laboratories.
Results are for the [presumptive] detection and identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of active infection with SARS-CoV-2 but do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.