Chinese testing kits for monkeypox get CE mark approval, overseas orders surge
Published: May 26, 2022 08:51 PM
Photo shows a polymerase chain reaction (PCR) laboratory in China Photo: VCG

Photo shows a polymerase chain reaction (PCR) laboratory in China Photo: VCG

A few Chinese testing kit manufacturers announced that they have received CE mark approval in the EU for their monkeypox testing kits and their overseas orders have surged, as monkeypox virus threats are mounting in many countries.

The Chinese companies include Jiangsu Bioperfectus Technologies, Sansure Biotech Inc and Wondfo Biotech. With CE mark approval, their kits may be sold in the EU and other regions that recognize the CE mark.

Experts said that the rapid response by Chinese testing kit makers enriches their product categories and helps meet demand in a timely manner amid a global public health emergency.

There have been urgent inquiries from many countries, and nearly 100,000 reagents will be sent to more than 50 countries and regions, according to a statement that Jiangsu Bioperfectus Technologies sent to the Global Times on Thursday.

The company has started registration applications in some countries and regions where monkeypox is present.

Another kit manufacturer - Sansure Biotech in Changsha, Central China's Hunan Province - told the Global Times on Thursday that it had received dozens of inquiries every day from abroad, even before it got  the CE certificate on Wednesday.

Order intentions have been registered from Spain, the United Arab Emirates and South Africa, according to Sansure Biotech.

The company said that the reagent for monkeypox virus acts faster than that for COVID-19, which can detect the virus within eight minutes via point-of-care testing (POCT), and 96 samples can be tested in half an hour via polymerase chain reaction (PCR). 

Its reagent production capacity can be rapidly expanded in accordance with demand, Sansure Biotech added.

So far, 19 countries where monkeypox is not endemic have reported flare-ups, with more than 100 confirmed and suspected cases mostly in Europe, data from the World Health Organization showed.

Monkeypox Photo: VCG

Monkeypox Photo: VCG

No confirmed cases of monkeypox have been reported in China. Experts from the country's disease control and prevention authorities suggested that the popularization of knowledge about the viral disease should be carried out immediately.

The smallpox vaccine is 85 percent effective against the monkeypox virus, so it can play a preventive role.