FDA has granted emergency use authorization for the Sentosa SA ZIKV reverse transcription polymerase chain reaction (RT-PCR) test from Vela Diagnostics, Singapore.
The company’s test enables qualitative detection of RNA from Zika virus in human specimens. FDA’s authorization permits Vela to make the test available for use in laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high-complexity tests, or by similarly qualified non-US laboratories.
The test is authorized for use with ethylenediaminetetraacetic acid plasma, serum, and urine collected alongside a patient-matched serum or plasma specimen, from individuals meeting Zika virus clinical and epidemiological criteria established by the US Centers for Disease Control and Prevention.
To prepare a patient sample for the Zika test, nucleic acid extraction is carried out using Vela’s Sentosa SX virus total nucleic acid kit v2.0, performed on the company’s automated Sentosa SX101 RT-PCR pipetting workstation. Authorized laboratories can process 22 samples per run for rapid detection of Zika virus, with a turnaround time of approximately 3 hours.
The test has not been FDA cleared or approved, and has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens. The test is only authorized for the duration of the FDA declaration that circumstances exist justifying emergency use of in vitro diagnostic tests for detection of Zika virus and diagnosis of Zika virus infection.
For more information, visit Vela Diagnostics.