The 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 conducting Quality Control Evaluation of Immunodiagnostic Kits for HIV, HCV and HBsAg. The kits indigenously manufactured or imported are referred to NIB by Central Drugs Standard Control Organization and United Nations Office for Project Services (UNOPS), India for evaluation purpose since 1997.Details are here

• The type of kits referred for evaluation are as follows:

• RAPID Tests for

• HIV 1&/ 2 Antibody,
• HCV Antibody and
• HBsAg.
• ELISA Tests for
• HIV 1&/ 2 Antibody,
• HCV Antibody and
• HBsAg.

• Confirmatory Tests (Western Blot and Line Immuno assay for HIV & HCV and Neutralization antibody test for HBsAg).
• Rapid Plasma Reagin (RPR) Test And TPHA (Hemagglutination) Test for  Syphilis.

 

• Quantity of samples required to be submitted for evaluation of each batch is given here
• Biological test that are carried out are given here
• Scrutiny of Protocols: Information required to be submitted by the manufacturer for evaluation of immunodiagnostic kits have been prepared. The format on which the information should be submitted is available here
• HIV, HCV, HBsAg and Syphilis Reference Panels for supply to manufacturers:

NIB has prepared HIV 1&2 antibody, HCV antibody, Hepatitis B surface antigen and Syphilis panels for supply to manufacturers (having valid license) of Rapid / ELISA diagnostic kits. ^{Details are shown here}

 

Transfusion Transmitted Infection (TTI) testing of Blood Products:
     The laboratory also evaluates Blood Products for TTI as per the IP 2007.

National External Quality Assessment Scheme

National Institute of Biologicals (NIB) has been designated as National Reference Laboratory by National AIDS Control Organization (NACO) for HIV testing, for the states of Uttar Pradesh and Uttarakhand are present here

INTERNATIONAL EQAS/PROFICIENCY TESTING: The laboratory has participated thrice i.e., April,July and October 2009 in International EQAs for HIV and HCV serology with the National Reference Laboratory, Australia.

Training organized:
  The laboratory conducts training for medical officers and laboratory technicians for HIV testing  is available here

9. Scientific Links

• MOHFW: www.mohfw.nic.in/
• CDSCO (DCG(I)): www.cdsco.nic.in.
• WHO: www.who.int
• CBER: http://www.fda.gov/cber/
• NIBSC: http://www.nibsc.ac.uk/
• FDA: www.fda.gov
• NSRL: www.nrl.gov.au/

Scientific Documents for references: