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National Institute of Biologicals

(राष्ट्रीय जैविक संस्थान)

Ministry of Health & Family Welfare, Government of India

(स्वास्थ्य एवं परिवार कल्याण मंत्रालय,भारत सरकार)

 


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Immunodiagnostic Kit & Molecular Diagnostic & Blood Reagent 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.

 

The Immunodiagnostic kit Laboratory of the Institute is a WHO Collaborating Centre for Quality Control of HIV, HCV, HBsAg and Syphilis In-Vitro Diagnostic Assays and Support Cell for WHO Pre-Qualification Programme for In-Vitro Diagnostics.

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 17025:2005 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. 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.

 

The Blood Reagent Laboratory is a notified Central Drugs Laboratory(CDL) by Government of India vide Gazette No. 600 E, dated 27th August, 2002 and re-notified vide Gazette No. 908E, dated, 22nd December, 2014 and 2237E, dated 1st June, 2018 for quality control evaluation of Blood Grouping Reagents. The laboratory has the infrastructure and expertise for testing different types of Blood Grouping Reagents and Gel cards for safe blood transfusion. The Laboratory has a Quality Management System in place and is NABL accredited for testing of blood grouping reagents and gel cards in accordance with ISO/IEC 17025:2005 standard for Chemical Biological tests, vide Certificate No. T-2010, T-2011. In-house reference standards are prepared using International reference standards obtained from National Institute of Biological Standards and Control (NIBSC), UK. For batch release, tests are carried out as per the Indian Pharmacopoeia, Transfusion Medicine Technical Manual Second Edition, Center for Biologics Evaluation and Research (CBER) and as per manufacturers specifications. A total of 6 monographs have been published in the Indian Pharmacopoeia.

       

 

 


Notifications !!  

 
Revised specification/

criteria of acceptance for quality test performed on HIV 1 &/or 2-Ab, HIV 1 p24 Ag, HCV-Ab and HBsAg kits
 
WHO Collaborating Centre for Quality Control of HIV, HCV, HBsAg and Syphilis In-Vitro Diagnostic Assays
 
Support Cell for WHO Pre-Qualification Programme for In-Vitro Diagnostics

 

 

 

   

 

 

 

 

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