BLOOD REAGENT LABORATORY

• Laboratory has the expertise to carry out tests on finished Blood Grouping Reagents.

Tests done on finished products Reports

• i)  Physical Appearance

ii) Potency
iii) Avidity
iv) Intensity
v)  Specificity
vi) Prozone
vii) Haemolysis
viii) Rouleaux

Tests are carried out as per the requirements given in Reports
 

• i) Indian Pharmacopoeia, 2007.
• ii)Transfusion Medicine Technical Manual,2nd edition, 2003,sponsored by WHO in liaison with DCG(I), CDSCO, DGHS, MOHFW, New Delhi. 
• iii) Centre for Biologics Evaluation and Research (CBER), FDA, USA.
• iv) International Blood Group Reference Laboratory (IBGRL), UK.
• v) United Kingdom Blood Transfusion Services (UKBTS), UK.
• vi) Code of Federal Regulation (CFR), FDA, USA.

• Quantity of samples required for testing

The quantity calculated on the basis of the tests required for the complete batch testing and the quantity to be retained.

• Scrutiny of Protocols.
• Information required to be submitted for evaluation of QC tests on blood  grouping reagents have been prepared as Document .

• Calibration of working and in house standards using International minimum potency reference reagent from National Institute of Biological Standards and Controls (NIBSC),UK,a WHO International Standards, CBER/FDA reference preparations and British Minimum Potency reference preparation.

• I) There is no National Reference Standards available in the country for Blood Grouping Reagents.
• II) International biological standards are the “Primary Standards” against which Secondary Standards (in-house controls) are calibrated.
• III) Using Secondary Standards, working reference reagents are calibrated.
• IV) Details of International reference standards used for calibration of  Secondary Standards (in-house controls) are given in the table below: 

• Calibration for Potency
  as per requirements laid down in IP-2007 using International minimum potency reference reagent from National Institute of Biological Standards and Controls (NIBSC), UK, a WHO International Standards,CBER/FDA reference preparations and British Minimum Potency reference preparation.
• The test is performed on blood grouping reagents purchased from different manufacturers.
• The test method is followed as per recommendations of NIBSC, UK.
• The results obtained for candidate reagents to have potency greater than or equal to potency of reference standard.

 

• Calibration for  parameters
• like specificity, avidity, intensity, rouleaux, prozone, haemolysis are done as per transfusion medicine technical manual.
• Panel Preparation of Reagent Red Blood Cell

The laboratory has  34 Red Blood Cell panel members and a 1441 aliquots of red blood cell are available, which include the routine blood groups (A1, B, A1B, O)  and rare blood groups for e.g  A2, A2B, Ax, Oh (Bombay group) and  Ror, R1r- Rh phenotypes.

• Participation in the Inter Laboratory Collaborative study.

United Kingdom National External Quality Assessment Scheme (UKNEQAS), UK, Feb,  2001 – Web link – www.ukneqash.org.uk

• United Kingdom National External Quality Assessment Scheme (UKNEQAS), UK, March, 2001 – Web link – www.ukneqash.org.uk
• United Kingdom National External Quality Assessment Scheme (UKNEQAS), UK, July, 2001 – Web link – www.ukneqash.org.uk
• United Kingdom National External Quality Assessment Scheme (UKNEQAS), UK, October, 2001 – Web link – www.ukneqash.org.uk
• WHO/NIBSC International collaborative study for preparation of International Standard for Minimum Potency Of Anti-A (03/188) and Anti-B (03/164) Blood Grouping Reagents. Web link – www.nibsc.ac.uk
• WHO/NIBSC International collaborative study for preparation of International Standard for Minimum Potency of Anti-D (99/836) Blood Grouping Reagents.

Web link – www.nibsc.ac.uk

• Scientific Links:

Name of Organization / Institute / Body – National or International

• Drugs Controller General (I)

First Floor, CHEB Campus,
Room No. 111, FDA Bhawan,
New Kotla Road,
New Delhi – 110 001
email: dci@nb.nic.in

• National Institute of Biologicals

Blanche Lane, South Mimms,
Potters Bar, Hertfordshire EN6 3QG,
United Kingdom
email : enquiries@nibsc.hpa.org.uk
Fax: +44(0)1707641050

• Secretary-cum-Scientific Director,

Indian Pharmacopoeia Commission,
Raj Nagar, Sector -23,
Ghaziabad
Email: ipclab@vsnl.net

• Scientific Documents For References
• Francis. K. Widmann, MD. 1996, Technical Manual of the American Association of Blood Banks, 1117 North 19th Street, Suite – 600 Arlington, VA – 22209.
• Transfusion Medicine Technical Manual, Second Edition 2003, sponsored by W.H.O in liasions with DCG(I), CDSCO,  DGHS, MOHFW, New Delhi.
• International Blood Grouping Reagents Laboratory, Standards and Requirements, 1990.
• FDA/CBER Technical Manual, Blood Grouping Reagents, Forms, Guidelines, Standards and Requirements – Draft –1992.
• Indian Pharmacopoeia
• Guidelines for British T.S., U.K.
• Code of Federal Regulation (CFR) 660.25
• Code of Federal Regulation (CFR) 610.12
• SJ Thorpe, B Fox, AB Heath, M Scott, M de Haas, S Kochman and A Padilla. International Standards for minimum potency of anti-A and anti-B blood grouping reagents: evaluation of candidate preparations in an international collaborative study.  Vox Sang 2006; 91:336-344.
• International Standard for Minimum Potency Of Anti-A (03/188) and Anti-B (03/164) Blood Grouping Reagents. Instructions for use,(Version 2.0, Dated 11/11/05).
• Thorpe SJ, et.al. “An International Standard for specifying the minimum potency of anti-D blood-grouping reagents: evaluation of a candidate preparation in an international collaborative study”; Vox Sang., 2006 Feb, 90(2): 131-9.  
• International Standard for Minimum Potency of Anti-D (99/836) Blood Grouping Reagents. Instructions for use, (Version 2.0, Dated 20/05/05)

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