Thai FDA Approves At-Home HIV Self-Testing, Expanding Private Testing Options

The Thai Food and Drug Administration (FDA), together with the Department of Disease Control and the Thai Red Cross AIDS Research Centre, has opened up public access to kits for self-screening for HIV infection. The goal is to help people learn their HIV status at an early stage, leading to timely and appropriate treatment and prevention, preventing transmission to others, and reducing the incidence of new HIV infections. This is a key measure toward ending the AIDS epidemic.

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Six Benefits of Getting Tested for HIV

• You can start treatment right away, without waiting for symptoms to appear.
• Getting treatment helps you stay healthy and able to work normally.
• You can plan to protect your partner from infection and encourage them to get tested.
• You can plan to prevent passing the infection to your child.
• You can protect yourself from getting HIV.
• You gain accurate knowledge and understanding of HIV/AIDS and how to protect yourself.

Dr. Tares Krassanairawiwong, Secretary-General of the Food and Drug Administration, explained that the Ministry of Public Health, through the Food and Drug Administration (FDA), has issued two Ministry of Public Health notifications: one on Test Kits Related to HIV Infection (No. 2), B.E. 2562 (2019), and one on Test Kits for HIV Self-Screening, B.E. 2562 (2019). Both were published in the Royal Gazette on April 9, 2019.

The key substance of the revised notifications is that they define the relevant key terms and set quality standards and requirements. The kits must be made by manufacturers certified under national or international manufacturing quality systems, such as Good Manufacturing Practice (GMP) and ISO 13485. The notifications also require that labels clearly present important information to consumers, such as indications for use, instructions for use, storage methods, warnings, and precautions.

This information includes knowledge about each kit's window period (the time during which an infection may not yet be detectable), a self-assessment form for HIV risk, and the channels through which the manufacturer or importer supports use of the kit — via a QR code or a website that provides information and guidance, a demonstration of how to test, how to read the results, how to connect to the service system, a phone number for direct further counseling, and how to interpret results, all shown with clear explanatory images. The kit must also carry the statement: “For preliminary self-screening only. If the result is reactive, you must obtain confirmatory HIV diagnosis from a service unit able to provide confirmatory testing.”

In addition, license holders who manufacture or import the kits must provide documents containing the information a person being tested should know (subject information), both before testing and after the result is known. These documents must be included inside the kit packaging so that the counseling process is clear and so people are connected to services for diagnosis, confirmation, treatment, and prevention. This may be presented as clear steps or a defined process. All such information must be reviewed by the FDA in accordance with the criteria set out in the notifications.

In closing, the Secretary-General said that ending the AIDS epidemic by opening up public access to HIV self-screening adds another testing option, rather than requiring people to be tested only at a health facility. This lets people learn their HIV status at an early stage and gives them a chance to prevent transmitting HIV to others.

For those whose behavior puts them at risk of HIV, testing to learn their infection status early makes it possible to begin treatment promptly — a benefit both to themselves and to others.

Information from oryor.com

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Verified references

Links and relevance to the article’s main topic were reviewed on 13 August 2026. Each source supports only the scope stated in the original document and does not replace personalised medical, legal, or service advice.

1. อย. ไทย: คำแนะนำชุดตรวจ HIV ด้วยตนเอง Accessed 13 August 2026
2. กรมควบคุมโรค: ระบบ HIV Self-Test ประเทศไทย Accessed 13 August 2026
3. CDC: Getting Tested for HIV Accessed 13 August 2026