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Virus test kit accuracy questioned, China bans export of unlicensed products

Virus test kit accuracy questioned, China bans export of unlicensed products

After several European countries complained about the accuracy of the coronavirus detection reagents produced in China, Beijing is stepping up its supervision of the export of coronavirus detection kits.




The Ministry of Commerce, the General Administration of Customs and the State Drug Administration issued a "Announcement on the Orderly Development of Medical Materials Export" on Tuesday (March 31). The announcement stipulates that from April 1, Chinese companies that export new coronavirus detection reagents, medical masks, medical protective clothing, ventilator, infrared thermometers must provide written or electronic declarations when they declare to the customs, promising that the export products have been obtained by the country. The medical device product registration certificate complies with the quality standards of the importing country (region).

The regulations of the above three departments stated that the customs shall accept and release the medical device product registration certificate approved by the drug regulatory department.

Beijing has been encouraging Chinese companies to export test kits and other supplies to assist fight the coronavirus pandemic, resulting in a surge in companies providing kits to countries eager to control this rapidly spreading and highly infectious disease.

Some Chinese kit makers have been taking advantage of the less stringent EU regulations to get their products on the market before domestic approval.

Lei Chaozi, director of the Science and Technology Department of the Ministry of Education of the People's Republic of China, said in March this year that 14 types of virus detection kits developed by Chinese universities have entered the EU market and supplied to 11 countries including Britain, Italy and the Netherlands.
However, some virus detection reagents have not been certified by Chinese authorities before entering the European market, raising questions about the accuracy of the tests by European health authorities.

Reuters reported that Spain has withdrawn a batch of rapid test reagents produced by China's Shenzhen Yirui Biotechnology Company because the products were found to have low sensitivity, which means that they cannot adequately detect infection cases.

Yirui said in a statement on the 27th that the inaccurate readings may be due to the fact that the Spanish side did not strictly follow the operating instructions during the sampling and sample extraction process, which led to a decline in the accuracy of sample detection.

Separately, Slovak government officials allegedly questioned the reliability of the rapid tests purchased from China. The Slovak government did not immediately respond to a request for comment from Reuters reporters.

It was also found that the quality of the anti-epidemic materials provided by China was the Netherlands. The Dutch Ministry of Health issued a statement on March 28 stating that it received 1.3 million Chinese-made masks labeled "KN95" on the 21st, but after two tests, the authorities found that the masks failed to adhere to the face and failed to filter viruses. The first batch of 600,000 masks has been distributed to hospitals for medical use. Authorities ordered the full recovery, and inspections will be more stringent.

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