Disease Specific In-Vitro Diagnostic
Immunodiagnostic Laboratory is notified as Central Drugs Laboratory (CDL)
by Government of India vide Gazette No.
G.F.R. 601 (E)
, dated 27th August 2002 for in-vitro
diagnostic devices for HIV, HCV and HBsAg. Since 1997, Immunodiagnostic
Laboratory has been conducting Quality evaluation of indigenously manufactured
and imported kits (Rapid, ELISA, Confirmatory, Ag/Ab & Combo Kits) for
HIV, HCV, HBsAg & syphilis which were forwarded by Central Drugs Standard
Control Organization (CDSCO) and procurement division of NACO. The
Immunodiagnostic Laboratory has a Quality Management System in place and is
NABL Accredited for testing of Rapid, ELISA and Confirmatory Immunodiagnostic
Kits HIV, HBV & HCV in accordance with the standard ISO/IEC17025; 2005 in
the field of biological testing of diagnostic Kits vide Certificate No. T-2011
dated 06/06/2011. This ensures quality evaluation of diagnostic kits for
safeguarding public health in the country.
Disease Specific In-Vitro Diagnostic Laboratory is also carrying out
evaluation of molecular diagnostic test kits indented to be used for blood
donor screening for Human Immunodeficiency virus (HIV), Hepatitis-B virus and
Hepatitis-C virus. For evaluation of such kits the laboratory has developed
plasma panels. Each plasma panel represents a dynamic range of viral load i.e.
viral load in each panel varies from few copies to billion copies.