Bangkok, July 26- The FDA recommends that HIV self-screening tests be used for primary screening only. in order to quickly know the situation of HIV infection Those at risk must undergo a confirmation examination and advice from a medical professional.
Pharmacist Lertchai Lertwut, deputy secretary-general of the Food and Drug Administration, revealed that Thailand aims to end the AIDS problem by 2030 by reducing new HIV infections to no more than 1,000 per year. People with risky behaviors can quickly know the situation of HIV infection by using HIV self-testing screening kits. However, the Food and Drug Administration (FDA) ) would like to clarify for the correct understanding that The HIV self-screening test is only a preliminary screening test. Those at risk must undergo a confirmation examination at a medical facility. to enter the system for rapid prevention and treatment
The HIV self-screening test kit is a medical device that must be approved by the FDA. The general public can purchase and use it on their own. At present, the FDA has authorized 4 registrations of test kits related to HIV self-screening, divided into 2 registers for manufacturers and 2 registers for importers. The FDA will inspect quality, efficiency and safety according to relevant standards, such as quality management systems for medical devices according to ISO 13485 or GMP standards, test results from manufacturers and test results submitted for quality assessment by laboratories. The results of a usability test conducted in Thailand. The labeling and accompanying documentation for medical devices must be made in Thai language. along with documents about information that users should know Both before the examination and after knowing the results of the examination
The deputy secretary-general of the FDA adds to the case that there are allegations that “A test kit for fingertip blood testing gives results within 1 minute, and a test kit for oral fluid test results in 20 minutes.” Importantly, ask consumers to choose the test kit. That has been approved by the FDA only because it has received the standard quality certification as specified by the Ministry of Public Health. .-Thai News Agency
Source: Thai News Agency