PCR Test Detects Non-Variola Orthopoxviruses, Including Monkeypox Virus, in 3.5 Hours

Monkeypox is a DNA virus endemic to Central and West African countries. An Orthopoxvirus, monkeypox is part of the genus of viruses that cause diseases like smallpox. It is associated with skin lesions and lymph node swelling among other symptoms. Now, a new polymerase chain reaction (PCR) test can detect non-variola Orthopoxviruses, including monkeypox virus, in approximately three-and-a-half hours.

The Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit from Thermo Fisher Scientific Inc. (Waltham, MA; USA) is a PCR test intended for the qualitative detection of DNA from monkeypox virus (clade I/II) and screening for non-variola Orthopoxviruses in human lesion swab specimens from individuals suspected of monkeypox (mpox) infection by their healthcare provider. The TaqPath Monkeypox/Orthopox Virus DNA Kit is also designed for identification of other non-variola Orthopoxvirus DNA. While positive results are indicative of the presence of DNA from monkeypox virus or other non-variola Orthopoxvirus, clinicians must correlate PCR results with patient history and other diagnostic information to determine infection status.

Image: The Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit has received FDA EUA (Photo courtesy of Thermo Fisher)

The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit. In early 2020, Thermo Fisher was among the first companies to distribute an emergency use authorized assay to identify active SARS-CoV-2 infections with the TaqPath COVID-19 Combo Kit. The TaqPath Monkeypox/Orthopox Virus DNA Kit builds off that technology and reflects Thermo Fisher’s continued commitment to develop diagnostic tools designed to address pressing public health emergencies as soon as possible.

“Ensuring that all U.S. laboratories have access to monkeypox PCR testing is a critical part of the response to this public health emergency,” said Manoj Gandhi, senior medical director for Genetic Testing Solutions, Thermo Fisher Scientific. “This helps expedite availability of results so that patients can receive the appropriate treatment quickly. Authorized testing also enables public health agencies to stay one step ahead of the virus by monitoring viral spread and addressing affected populations accordingly.”

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