After Wuhan trials, China to mass produce rapid test kits

BEIJING:China is getting ready for the rapid screening of people for coronavirus if there’s a spike in cases as millions of people resume work across the country.

Until now, China’s National Medical Products Administration has approved 10 new coronavirus nucleic acid detection reagents and six antibody detection reagents.

As the number of new cases drops in China, the test kits, if mass-produced, could well be exported.

Doctors at the coronavirus epidemic epicentre of Wuhan are said to be using a 15-minute test kit to detect antibodies to the pathogen — then go for a nucleic acid test for the final confirmation, which takes a few hours.

The test kits helped them to check patients at a time when Wuhan’s medical facilities were flooded with suspected patients.

The rapid test kit was developed in the city of Wuxi, in China’s Jiangsu by scientists from National Institute for Viral Disease Control and Prevention and a company based in Wuxi city, a state media report said.

“The kit can detect the virus within eight to 15 minutes,” the city’s bureau of science and technology told state media. The kit was deployed in Wuhan because it had “high sensitivity and is easy to use and transport”.

The company had then said it could produce kits for 4,000 people a day, and the city government was helping the company expand production.

The first batch of the kits was used in Wuhan in early February.

Several institutes and companies in China are continuing research on developing rapid testing kits, possibly with the idea of exporting the kits as the outbreak surges globally.

On March 7, another rapid testing kit to detect the Covid-19 antibody with results available in 29 minutes was approved by China’s National Medical Prod

ucts Administration.

This kit was developed by a research team led by experts from Xiamen University. “The kit can be used for clinical cases, suspected cases and the screening of high-risk groups, improving the testing efficiency of front-line medical institutions,” the official news agency, Xinhua reported.

According to state media, the kit was going through clinical trials in hospitals in Wuhan.

“The combination of nucleic acid tests and antibody detection has improved the detection rate. According to the developer, three antibody reagents for Covid-19 have been approved by the European Union and exported to countries including Italy, Austria and the Netherlands,” the report said.

On Wednesday, a group of Chinese medical scientists said they have developed yet another rapid antibody test that can diagnose the coronavirus within 15 minutes by testing a drop of blood from the fingertips.

Led by Chinese top medical expert Zhong Nanshan, who is heading the Chinese government’s anti-epidemic task force,

the team said that the antibody test aims to offer an accurate and rapid method to quickly identify infected patients and asymptomatic carriers of the virus.

According to the tabloid, Global Times, clinical studies of the new test kit have been carried out in eight clinical sites across the country, which validated the clinical detection sensitivity, specificity and clinical efficacy of the new test kit.

“Compared with the nucleic acid RTPCR test (to detect and measure RNA), which takes 3-4 hours to produce results, the new kit can detect the antibodies against the virus in human blood within 15 minutes with an overall testing the sensitivity of 88.66% and specificity of 90.63%,” the Global Times report said.

The report said the team found that the clinical diagnosis results obtained from finger blood, serum and plasma of venous blood indicated great detection consistency, which means there will be a more convenient test method in the future by only testing the finger blood of a suspected patient.