Disease Specific In-Vitro Diagnostic
The National Institute of Biologicals, NOIDA has been designated as a 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. Disease Specific In-Vitro Diagnostic Laboratory (DS-IVDL) has been conducting Quality testing of indigenously manufactured and imported kits (Rapid, ELISA, Confirmatory, CLIA & ELFA Kits) for HIV, HCV, HBsAg & syphilis which 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 17025:2005 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.
DS-IVDL is also carrying out Quality testing 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.
The Institute has been designated as 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. It has also been designated as
"Support cell for WHO- Prequalification program for in-vitro Diagnostics
" in November, 2017.