QIAGEN launches world’s first syndromic test for monkeypox

The test can distinguish between monkeypox and other diseases that cause similar symptoms. 

The test, called QIAstat-Dx Viral Vesicular Panel RUO, comes in cartridge form to run on QIAGEN’s QIAstat-Dx automated syndromic testing devices. It tests for the two known forms of monkeypox virus (the so-called West African and Congo Basin clades), herpes simplex virus 1 (HSV1), HSV2, human herpesvirus 6 (HH6), varicella-zoster virus (VZV) and enterovirus – pathogens that all produce similar-looking vesicular lesions.  

The panel is for research use only (RUO) and there are currently around 3,000 QIAstat-Dx PCR devices installed in specialised laboratories around the world.  

Jean-Pascal Viola, SVP, Head of the Molecular Diagnostics Business Area at QIAGEN, commented: ‘Monkeypox cases are soaring across the globe with many demographic groups infected. Surveillance is an essential tool in the fight against infectious diseases. QIAstat-Dx Viral Vesicular Panel in combination with the QIAstat-Dx platform will allow medical researchers to detect monkeypox with gold-standard PCR testing-technology in about one hour.’  

‘Currently the world’s only syndromic test for the pathogen, the panel will prove to be crucial for detecting and then combatting the spread of monkeypox around the globe,’ he added.  

The panel’s RUO-status means it currently can only be used for the surveillance of monkeypox cases, not screening or diagnosing. However, the company said it is prepared to make applications for clinical use should authorities in the United States and the European Union open new diagnostic pathways. 

As of August 16, there have been more than 31,000 monkeypox cases recorded in 89 countries, according to CDC data. Of these 89 countries, just seven are places where monkeypox is endemic.  

Monkeypox is a viral infection that spreads through close contact and can be identified by flu-like symptoms, distinctive rashes and lesions on the skin. The World Health Organisation (WHO) designated the outbreak as a public health emergency of international concern in late July.