HIV Laboratory Testing: Regulatory Issues

The 7 th International & 12 th National Congress on Quality Improvement in Clinical Laboratory

17 till 20 April 2014، Tehran - Iran

Presentation Type: Speech

Although in most of the countries HIV laboratory testing is based on a certain defined policy and standard, not all of them have legal and regulatory requirements. Fortunately, blood donor screening for HIV, Hepatitis and other blood born agents, since years, have been considered as the critical focus point of pertaining international and national laws, regulations and standards. Legal and regulatory requirement for HIV diagnostic testing could include Pretest, Testing and Post-testing requirements. Due to widespread application of HIV rapid test devices in health care settings, HIV testing is not any more exclusive to the medical laboratory. Therefore, test performing personnel may also be considered in the regulations. Use of diagnostic devices for HIV self testing is a new area that undoubtedly will be added, very soon, to the above mentioned issues.