Analytical Sensitivity Of HIV P-24 Antigen In 4th Generation HIV Product Insert

To avoid pointless delay of evaluation, the drug controller general of India has ordered all the manufacturers as well as the importers of the 4th generation HIV in-vitro diagnostics kits to provide the analytical sensitivity for HIV P-24 antigen on kit insert.

DCGI gave this necessary direction after the National Institute of Biologicals or NIB in Noida figured out that various manufacturers of 4th generation HIV in-vitro diagnostics kits are not mentioning the sensitivity required for HIV P-24 antigen on the product. This delays the required evaluation of the diagnostic kits.

Taking this on a serious note, Dr. VG Somani, the DCGI, asked all the licensees to do upgradation of the product insert and include the analytical sensitivity for HIV  24 antigen to make sure the evaluation is done correctly.

HIV is a virus that attacks the immune system of the human body. When left untreated, it leads to AIDS. When someone is exposed to HIV, the human body produces an antigen called P-24. This protein is found in those people having an acute infection. It triggers the immune system to respond to the disease. The fourth-generation test can recognize both HIV-specific antigen P-24 and HIV antibodies with the sample of blood. This helps in identifying the virus much sooner than early tests.

With a fourth-generation test, HIV can be easily detected within a span of four weeks after the person has acquired infection. It helps in the early treatment of the disease. Because of early detection and its treatment, people who have HIV can live a lengthy as well as healthy life.

NIB is considered as the Central Medical Device Testing Laboratory under rule 19 of Medical device rules 2017. It carries out all tests as well as evaluation of all in-vitro diagnostics for human immunodeficiency virus, hepatitis B surface antigen and Hepatitis C virus, blood grouping sera, fully automated analyzer based glucose reagent.

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