Last Updated on April 1, 2021 by The Health Master
In a bid to avoid unnecessary delay of evaluation, the Drugs Controller General of India (DCGI) has directed all the manufacturers and importers of 4th generation HIV in-vitro diagnostics kits to mention analytical sensitivity for HIV P-24 antigen on kit insert.
The DCGI’s direction came after the National Institute of Biologicals (NIB), Noida found that several manufacturers of 4th generation HIV In-vitro diagnostics kits have not mentioned sensitivity for HIV P-24 antigen on the product insert, leading to delay in evaluation of the diagnostic kits.
NIB, which receives samples of In-vitro diagnostics of 4th generation HIV kits for quality control evaluation, wrote to DCGI in this regard on February 18, 2021.
Taking serious note of this, DCGI Dr VG Somani asked all the licensees to update the product insert of these 4th generation HIV In-vitro diagnostics kits for inclusion of analytical sensitivity for HIV P-24 antigen to ensure evaluation in a timely manner.
HIV (human immunodeficiency virus) is a virus that attacks the body’s immune system. If HIV is not treated, it can lead to AIDS (acquired immunodeficiency syndrome).
In the first few weeks after exposure to HIV, one’s body produces an antigen known as P-24. This protein is only present in people who have acute HIV infection. It triggers one’s immune system to respond. The fourth generation tests can identify both HIV-specific antigen P-24 and HIV antibodies with a blood sample. This allows them to identify the virus sooner than the earlier tests.
A fourth-generation test can detect HIV within four weeks after a person acquires it, thus allowing for early treatment. With the early detection and treatment, people with HIV can live long and healthy lives.
NIB is designated as Central Medical Device Testing Laboratory under the provision of Rule 19 of Medical Device Rules, 2017 vide notification 2237(E) dated June 1, 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.
To read or download the above notification No. 2237(E) dated June 1, 2018, click here
For more details on licensing process of Medical devices, click here
For notifications of Medical Devices, click here