No more swabs up the nose if alternative tests approved

Industry

Published: 24 Apr. 2022, 07:01 Updated: 24 Apr. 2022, 13:04

No more swabs up the nose if alternative tests approved

A Covid-19 rapid antigen self test is administered in Seoul on March 1. [YONHAP]

Covid-19 tests are evolving and becoming less invasive and easier to administer.

The Ministry of Food and Drug Safety is reviewing a self-test kit that can detect the Covid-19 virus with saliva from the mouth, the ministry announced April 10. It did not disclose the company or the product.

Saliva testing is similar to the existing antigen rapid self-test kits in it relies on the binding of an antigen, or a protein on the surface of the virus. But it is considered more convenient than the widely distributed antigen kits that require people to insert a swab deep into their nose, which is invariably an uncomfortable process.

Interest in saliva testing has surged, especially after the Education Ministry in March recommended all elementary, middle, and high schools across the country make their students test themselves twice a week. It was reduced to once a week on April 18.

"Children have weak nasal cartilage, and making them repeatedly use nose-swabbing kits is a kind of child abuse, as it can cause not only nose bleeds but also serious injury to nasal cartilage, and even possible situations that would require surgery," wrote Kim Myung-hoon, parent of an elementary school student, on the online board of the Ministry of Food and Drug Safety.

"Almost all developed economies, including the United States, Europe and Japan, have approved saliva testing," he continued. "Please allow it in Korea as soon as possible for our safety."

PCL, a Seoul-based diagnostics company, is one of the front runners in the virus testing business. Its Covid-19 Ag Gold saliva test kit recently received formal use authorization from health regulators in Canada. The company has been exporting the product to many countries, including Thailand, Germany and Austria.

Boditech Med received permission to export its saliva testing self-kit last year, the first Korean company to do so. The kit achieved 80 percent sensitivity and 100 percent specificity at the time. The Chuncheon, Gangwon-based company said it then improved the quality of the kit and is set to apply for approval in Korea in April.

The company said that marketing will probably begin in the first half.

A Dogok Middle School student looks at a Covid-19 rapid antigen self-test kit in Gangnam, southern Seoul, on March 2. [YONHAP]

SD Biosensor has already developed one product and received a CE marking, which is granted by European Union (EU) and indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements.

But whether Korea will approve saliva test kit remains to be seen as the Korean government has stricter standards than many countries.

Under Korea's health law, only kits that achieve over 90 percent sensitivity and 99 percent specificity can be the candidates. The sensitivity refers to the ability to correctly identify those patients with the disease, which means a test with 100 percent sensitivity correctly identifies all patients with the disease. Specificity is the ability of the test to correctly identify those patients without the disease.

In most European countries, the standard is around 80 percent sensitivity and 97 percent specificity.

PCL applied for approval for its saliva self-test kit last year, but was rejected by the food and drug ministry after six months of review. In February, it withdrew its application.

The Korea Basic Science Institute has a technology to detect the Covid virus using a gargle solution made with beans. Developed in collaboration with Bio3S and Jeonbuk National University Hospital, the kit achieves 97.8 percent sensitivity within six days of infection, according to the institute.

Joseph Kwon, who led the project, predicts that clinical trials will be done in September, and data will be submitted to the ministry in October.

A total of 89 test kits have gained approvals in Korea, of which 33 are antigen test kits. Of them, only nine are self-test kits available to the general public for home use.

"Some people, especially children, are very afraid of pushing a swab deep into the nose, and when they move their body while resisting, the results may not be accurate," said Kim Kyung-woo, a family medicine professor at Inje University Seoul Paik Hospital. "It would be great if the country can offer people different options for testing if it has been proved that their accuracy is not significantly lower than the existing nose-swabbing kit."