Circular No. 15/2013/TT-BYT dated May 24, 2013 of the Ministry of Health on quality assurance and HIV testing technique
Pursuant to the Law on Prevention of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) dated June 29, 2006;
Pursuant to the Decree No. 63/2012/ND-CP dated August 31, 2012 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health;
At the request of the Director of Vietnam Administration of HIV/AIDS Control and the Director of the Legal Department;
The Ministry of Health issues a Circular on quality assurance and HIV testing techniques,
Chapter I
Article 1. Scope of regulation
This Circular provides for:
1. The personnel, infrastructure, equipment, and control of testing quality of screening laboratories, confirmatory laboratories, and National Reference Laboratories (hereinafter referred to as HIV testing laboratories).
2. The procedure for announcing screening laboratories, accrediting confirmatory laboratories, and appointing National Reference Laboratories.
Article 2. Term interpretations
In this Circular, the terms below are construed as follows:
1. Screening laboratories are laboratories that implement one or multiple HIV testing techniques in accordance with Article 3 of this Circular, but are not allowed to confirm the positive result.
2. Confirmatory laboratories are screening laboratories that have been assessed and certified by the Ministry of Health to be eligible to confirm the confirmatory HIV test results.
3. National Reference Laboratories are confirmatory laboratories appointed by the Ministry of Health to perform the tasks in Article 28 of this Circular.
Article 3. Classification of HIV testing techniques
1. Serological HIV testing, including:
a) Testing for HIV by simple techniques without specialized testing equipment (hereinafter referred to as simple tests);
b) Testing for HIV by ELISA assays or chemiluminescence or electrochemiluminescence (hereinafter referred to as immunoblot techniques).
2. Testing for HIV by molecular biology techniques.