Immunodiagnostic Kit & Molecular Diagnostic Laboratory

The National Institute of Biologicals, NOIDA is notified Central Medical Device Testing Laboratory (CMDTL) by Government of India vide Gazette No. S.O. 2237 (E), dated 01st June, 2018 for in-vitro diagnostics for Human Immunodeficiency Virus, Hepatitis B surface Antigen and Hepatitis C virus.

Immunodiagnostic Kit & Molecular Diagnostic Laboratory has been conducting Quality Control testing of indigenously manufactured and imported kits viz. Rapid, ELISA, Confirmatory, CLIA & ELFA Kits for HIV, HCV, HBsAg & syphilis and molecular diagnostic test kits intended to be used for blood donor screening for Human Immunodeficiency virus (HIV), Hepatitis-B virus and Hepatitis-C virus. These kits are forwarded by Central Drugs Standard Control Organization (CDSCO) and its offices, procurement division of NACO and different Government agencies.

Laboratory has a Quality Management System in place and is NABL accredited in accordance with the standard ISO/IEC 17025:2017 for HIV-Ab, HCV-Ab, HBsAg and Syphilis serology. It regularly supplies plasma panels of HIV-Ab, HCV-Ab, HBsAg and Syphilis to indigenous manufacturers for strengthening the quality of indigenously manufactured kits.

The laboratory is regularly participating in PT/EQAS for serology organized by NRL, Australia since 2009 and has been scoring successfully 100% results in each quarter of every year. 10.1 Laboratory has enrolled for EQAS for Nucleic Acid Testing (NAT) from NRL Australia for HBV DNA Viral Load, HCV RNA Qualitative & Viral Load, HIV-1 RNA Viral Load and Multimarker Blood Screening NAT

The Institute is a National Reference Laboratory (NRL) of National AIDS Control Organisation (NACO), India and is monitoring its two states, Uttar Pradesh and Uttarakhand for strengthening HIV testing.