NEW YORK – The US Food and Drug Administration said on Tuesday it has granted Emergency Use Authorization for DiaCarta's monkeypox PCR test.
Pleasanton, California-based DiaCarta's laboratory-use QuantiVirus MPXV Test Kit is intended to qualitatively detect monkeypox virus DNA in human lesion swab samples from people with suspected monkeypox infections, as determined by a healthcare provider. The firm said Thursday that its real-time multiplex PCR test is designed for use on qPCR instruments including Thermo Fisher Scientific's QuantStudio5, its 7500 Fast Dx, Bio-Rad Laboratories' CFX384, and Roche LightCycler 480 II Systems, the firm said.
DiaCarta said the QuantiVirus MPXV test targets two regions of the MPXV genome, as recommended by the US Centers for Disease Control and Prevention, to ensure the test remains effective if the virus mutates in one of the target regions. The FDA said in its letter that while positive test results indicate the virus DNA is present, correlation with a patient's clinical history and other diagnostic information is needed to determine their infection status.