Photo: Xinhua

As countries around the world ramp up efforts to vaccinate hundreds of millions of people, Chinese companies that have been making test kits for COVID-19 are shifting focus to a new product expected to be in hot demand worldwide: antibody test kits to evaluate efficacy of vaccines.

Neutralizing antibody detection kits are used to evaluate the immune reaction to the vaccine, but they are not used in the traditional antibody detection process. The former tests are used to detect the neutralizing antibodies produced after a vaccination, while the latter versions are used to detect IgM and IgG antibodies produced spontaneously after an infection, media reports said.

Several domestic producers of antibody testing kits that the Global Times reached said that their recent studies of the new testing measure, and they believe there is potential in the global market.

Chinese leading producer of test kits, Maccura Biotechnology Co, told the Global Times on Monday that the kit is still being used for scientific research and has yet to be launched.

"The product, after it is launched, will target those who have been vaccinated in a bid to understand the level of antibodies generated in their bodies, and whether they need to be vaccinated again," said a source with the company surnamed Li, noting that those who have recovered from an infection can take the test too.

The company has made agreements with 14 domestic medical research institutes on collaboration for clinical trials of the test kit. Corresponding information such as testing accuracy has yet to be released.

The company said that it definitely plans to export the kits once the FDA and CE certificates are acquired.

"We are very optimistic about capacity once we start mass production, because the core materials for the product are not dependent on imports," Li said.

In addition to Maccura Biotechnology Co, other companies such as Guangzhou-based coronavirus test kit maker Wondfo Biotech Co are pinning their hopes on antibody tests, which, according to the company's previous statement, can be done by an individual rather than by professional medical organizations, thus making it possible for such test kits to be delivered to remote areas.

Shanghai Geneodx, a subsidiary of Sinopharm, and Mindray announced that they have jointly developed a new test kit for neutralizing antibodies against the immune effect of the COVID-19 vaccines, providing a reliable test method for evaluating the effectiveness of vaccines, media reported.

More than 245 million doses of vaccines for COVID-19 have been administered across 107 countries and regions, according to data collected by Bloomberg on Tuesday. 

Given the huge population, industry insiders said that the market can also be huge, because the levels of immunity produced in the human body can differ among various people. 

Cai Tianzhi, deputy secretary-general of the China Chamber of Commerce for Import and Export of Medicines and Health Products, told the Global Times on Tuesday that antibodies generated in the human body can be different depending on the person involved, and those who have been vaccinated might want to use the kit to see if the vaccine was effective.

Cai noted that he does not think it is necessary for everyone to use these kits.

"This product was normally used in clinical trials of vaccines, and since vaccines have already been approve

A staff member of Sinovac Biotech, a Chinese biopharmaceutical company, works in the quality inspection lab of COVID-19 inactivated vaccines in Beijing, capital of China, Dec. 23, 2020.(Photo: Xinhua)

 d and put into the market, the vaccine's effectiveness is definitely there," said Cai, noting that future tests will mostly be conducted by individuals or for scientific purpose.

Such tests are also available abroad where vaccinated groups and individuals want to see if the vaccine has done its work by building up the immune system against the virus.

However, there has been considerable debate about the need for its development, mainly focusing on the lack of a clear link between the neutralizing antibody test and the vaccine's efficacy.

In clinical trials, the Pfizer-BioNTech and Moderna vaccines were shown to protect people against the virus 95 percent of the time and 94 percent of the time, respectively. But that does not mean everyone who gets the jab would test positive for antibodies, the Washington Post reported on February 12, citing infectious-disease expert Rob Murphy.

Neutralizing antibody detection after inoculation is not unique to the novel coronavirus vaccines.

The Medical Device Technology Review Center under the National Medical Products Administration published a report concerning novel coronavirus neutralizing antibody detection reagents on February 18, in which it mentioned that the other well-developed vaccines - including those for the flu and rabies - also have established standardized antibody tests that are recognized by the World Health Organization.