Update product insert of 4th generation HIV In-vitro diagnostics kits: CDSCO to all licensees

This came after the National Institute of Biological (NIB) discovered that several manufacturers of 4th generation HIV In-vitro Diagnostics kits neglected to note sensitivity for HIV P-24 antigen on the product insert.

The human immunodeficiency virus (HIV) is a virus that attacks the immune system of the body. If HIV is not treated, it can lead to AIDS (acquired immunodeficiency syndrome).

In order to diagnose HIV, fourth-generation tests are used which can detect both HIV antibodies and p24 antigens.

After getting infected by the HIV virus, one's immune system produces HIV antibodies. This is the body's protective mechanism against the virus. In response to p24 antigens, the immune system generates these antibodies.P24 antigens are a component of the virus, and studies have shown that they occur within two weeks of HIV infection. A fourth-generation test can accurately diagnose HIV as early as one month after infection.

Most healthcare centres provide these examinations, as this test only requires a small blood sample. Fourth-generation research aids in the early detection and treatment of HIV, which can greatly increase a person's quality of life.

The current notice mentioned that the National Institute of Biologicals (NIB), Noida is designated as Central Medical Device Testing Laboratory under the provision of rule 19 of Medial Device Rules, 2017 vide S.O. 2237 (E) dated 01/06/2018 for carrying out test and evaluation of In-Vitro Diagnostics for human Immunodeficiency virus, Hepatitis B Surface Antigen and Hepatitis C Virus, Blood Grouping sera, Glucose Test Strip, Fully Automated Analyser Based Glucose Reagent.

Accordingly, samples of In-vitro Diagnostics of 4th generation HIV kits were being received by NIB, Noida for QC evaluation. NIB, Noida had informed CDSCO in a letter dated February 18, 2021, that many manufacturers of such 4th generation HIV In-vitro Diagnostics kits do not mention sensitivity for HIV P-24 antigen on the product insert.

In view of the above, the apex drug regulatory body has requested all manufacturers and importers of 4th generation HIV kits to update the product insert of these 4th generation HIV In-vitro diagnostics kits for inclusion of analytical sensitivity for HIV P-24 antigen, in order to avoid unnecessary delay of evaluation.