The first saliva rapid screening reagent ready to be in Taiwan

 Report by : Gan Yung Chyan, KUCINTA SETIA

No need to poke the nostrils, Taiwan Food and Drug Administration approved the first "saliva rapid screening" estimated to import 30 million doses

Image : Researcher's Picture

In the afternoon of 29 April 2022, the Food and Drug Administration of the Republic of China approved the first household saliva rapid screening reagent in Taiwan. The country of origin is South Korea. The positive rate of PCR positive is 95.83% after efficacy verification. Sold in Taiwan.

The domestic covid epidemic is severe, and the demand for rapid screening reagents has greatly increased. Considering that some groups such as children are not suitable for nasal examinations, some operators apply for a project to import household saliva rapid screening reagents.

Chen Shizhong, commander of the Central Epidemic Epidemic Command Centre, said at a press conference on the epidemic in the afternoon that rapid saliva screening is a new form of testing. After a recent assessment, the Food and Drug Administration should approve imports.

The Food and Drug Administration announced the latest project entry list in the evening, announcing that it will approve the project entry of the "Fujimay Household Novel Coronavirus Saliva Antigen Rapid Test Kit", which is the first household saliva rapid screening reagent in the Republic of China.

In a telephone interview with reporters in the evening, Jane Ren Jizheng of the Medical Equipment and Cosmetics Group of the Food and Drug Administration, Lin Xinhui, said that the country of origin of this household saliva quick screener is South Korea, and it is currently sold in Australia. In particular, the efficacy verification was carried out in the Republic of China, and the positive consistency rate between the test results and PCR was 95.83%, and the negative consistency rate was 99.6%.

Lin Xinhui said that the industry applied to the Food and Drug Administration about a week ago. After the efficacy verification, document review and other procedures, the project was approved for import in the afternoon. The total application for import is 30 million doses. After the product is imported in the future, it must be affixed to domestic medical material factories. Only if the Chinese label, the epidemic prevention brand name, and the Chinese manual are attached, can it be officially sold. The import schedule and future sales price will be announced by the manufacturer.

Lin Xinhui said that there are currently other application projects for household rapid saliva screening reagents, and there are also domestic rapid saliva screening reagent evaluations transformed into household rapid screening. As for whether household saliva quick screening is expected to be included in the real-name system for quick screening, Lin Xinhui pointed out that the relevant details must be evaluated and planned by the command centre.