A staff checks the nucleic acid test kit at the plant of Luoyang Ascend Biotechnology Co., Ltd in Luoyang, central China's Henan Province, March 4, 2020. Photo: Xinhua

Chinese test kit makers have ramped up workers recruiting and plant production amid booming overseas orders, especially from the US where the Omicron variant is spreading across the states. 

Despite intensive workers hiring efforts to fill orders from the US and Europe, industry sources said that costly US FDA marking applications make it difficult for Chinese suppliers to deliver the much-needed kits to US consumers soon.

Related shares surged on Monday, with several domestic test kit suppliers -- including Assure Tech (Hangzhou) and Hangzhou Alltest Biotech -- rising by the daily limit of 10 percent.

A large test kit maker based in East China's Zhejiang Province said orders are booming especially from the US, which is testing for Delta and Omicron, and the company is recruiting more temporary workers.

Sansure Biotech, a testing kit manufacturer in Changsha, Central China's Hunan Province, is making kits for the world market, including France and Italy as well as the US.

A source with Sansure Biotech told the Global Times on Monday that the company is using automation to expand output. The current maximum production capacity can reach more than 5 million reagents per day.

The world is in a close battle against the variants, while failures in prevention and control in some countries such as the US have intensified demand for test kits.

The infection surge has caused explosive demand for antigen tests, and kits in many retail outlets in the US are sold out, according to media reports.

"Our exports to the US are rising, although the trend isn't that conspicuous," the person with Sansure Biotech said.

China's production capacity for test reagents has fully recovered from the pandemic, and a large proportion of the test kits in the US are made in China, insiders said. However, barriers such as the FDA application process have caused unexpected challenges.

"Most of the test kits made in China have CE markings for Europe but there are very few holding the FDA marking for the US, because of the complicated and expensive application procedures," Chen Hongyan, secretary-general of the Medical Appliances Branch of the China Medical Pharmaceutical Material Association, told the Global Times on Monday, calling for easier access to the market in the US.

US President Joe Biden announced last month that the federal government would purchase 500 million rapid at-home tests that any American could request to be sent to their home, with the first batch expected to go out in January, according to media reports.

But industry insiders said that more market access is needed before this can be achieved.