The Ministry of Health and Family Welfare in Notification No. G.S.R. 601(E), dated 27th August, 2002 has notified in vitro diagnostic devices for HIV, HBsAg and HCV as “Drug” under Section 3 Clause (b), sub – clause (iv) of the Drugs and Cosmetics Act 1940.
Considering the seriousness involved in the diagnosis of HBsAg, HCV & HIV, a quality control evaluation of Immunodiagnostic kits used for diagnosis of thesediseases was conducted by Immunodiagnostic Kit Laboratory at National Institute of Biologicals (“NIB”), Noida.
The Technical Committee, NIB re-evaluated the approved acceptance criteria of the kits, as laid down in the Office Order: 26-1/Misc./2003-DC dt. 12.06.2003 issued by the Directorate General of Health Services and recommended the following revised criteria of acceptance of sensitivity and specificity for these kits:
|Analyte||ELISA / CLIA / ELFA / ECLIA / CMIA / MEIA etc.||Rapid Kit|
|Anti-HIV-1/2 and / or HIV-1 p24Ag||100%||≥98%||100%||≥98%|
Relying on the above recommendations for the, the revised criteria is approved for quality control testing and lot release of immunodiagnostic kits.
Source: Drugs Control General (India)