The US Food and Drug Administration has granted emergency use authorisation (EUA) for DiaCarta’s QuantiVirus MPXV test.

The new qPCR multiplex assay has been designed for the qualitative detection of monkeypox virus (MPXV) DNA in lesion swabs collected from people who are suspected of infection.

As recommended by the US Center for Disease Control and Prevention (CDC), the QuantiVirus MPXV test targets two different regions of the MPXV genome, which are said to be less prone to mutation compared to other genome parts.

The assay detects two virus-specific genes, J2L and B6R, using the human RNase P as a control.

DiaCarta stated that the dual-target approach enables the detection of the virus even if a mutation occurs in one of the target regions.

The QuantiVirus MPXV test is intended for use by authorised laboratories on qPCR instruments, including the Bio-Rad CFX384, Thermo Fisher (ABI) 7500 Fast Dx, Thermo Fisher (ABI) QuantStudio5 and Roche LightCycler 480 II Systems.

DiaCarta CEO Adam (Aiguo) Zhang said: “I am very proud of our speed, dedication and ability to develop the QuantiVirusTM MPXV test, which now places us at the forefront of combating potential problems from Monkeypox.

“When cases of the Monkeypox virus infection were initially reported, DiaCarta quickly allocated resources to develop a test kit that could meet the testing needs and provide an easy, safe and reliable testing solution.

“Through our proprietary technology, we developed the QuantiVirus MPXV test as a high-throughput solution on an open qPCR system to better serve patients and healthcare providers.”

In 2021, the company’s QuantiVirus SARS-CoV-2 Variant Detection Test received CE-IVD mark for marketing in the European Union (EU) and other regions.