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19th December 2022  Product update: rapidmicrobiology staff writer

FDA EUA for TaqPath Monkeypox/Orthopox Virus DNA Kit


Thermo Fisher Scientific have granted Emergency Use Authorization (EUA) for its Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit, a PCR test designed to detect non-variola Orthopoxviruses, including monkeypox virus, in approximately three-and-a-half hours.

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.

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.

For more information on Thermo Fisher’s infectious disease testing platform, please visit www.thermofisher.com

For In Vitro Diagnostic Use. For Emergency Use Authorization Only; Rx Only


    

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Date Published: 19th December 2022

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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.


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