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.