Update product insert of 4th generation HIV In-vitro diagnostics kits: CDSCO to all licensees
New Delhi: In order to avoid unnecessary delays in evaluation, the Central Drugs Standard Control Organization (CDSCO) has requested all the licensees to update the product insert of the 4th generation HIV In-vitro diagnostics kits for mentioning analytical sensitivity for HIV P-24 antigen.
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.
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