The National Blood Service (England) Approach to Evaluation of Kits for Detecting Infectious Agents

Transfusion Medicine Reviews

Volumn 21, Issue 2, 2007, Pages 147-158

  Barbara, John ^a,b   Ramskill, Steve ^a,b   Perry, Keith ^a,b   Parry, John ^a,b   Nightingale, Mark ^a,b  

^a NBS Southampton   (United Kingdom)

^b HPA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; AUTOMATION; BLOOD ANALYSIS; BLOOD AND HEMOPOIETIC SYSTEM; BLOOD BANK; BLOOD DONOR; BLOOD SAMPLING; BLOOD TRANSFUSION; DIAGNOSTIC ACCURACY; ECONOMIC ASPECT; ETHICS; EUROPEAN UNION; EVALUATION; HUMAN; LABORATORY TEST; LICENSING; MICROBIOLOGICAL EXAMINATION; PROCESS CONTROL; SEROCONVERSION; UNITED KINGDOM;

BLOOD DONORS; BLOOD TRANSFUSION; COMMUNICABLE DISEASES; DONOR SELECTION; ENGLAND; EVALUATION STUDIES; HUMANS; INFECTION; INFECTION CONTROL; LICENSURE, PHARMACY; REAGENT KITS, DIAGNOSTIC;

EID: 33947626190     PISSN: 08877963     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.tmrv.2006.11.007     Document Type: Article

References (10)

1. Rules and Guidance for Pharmaceutical Manufacturers and Distributors, Medicines Control Agency. The Stationary Office (2002) ISBN 0 11 322 559 8
2. Guidelines for the Blood Transfusion Services in the United Kingdom. The Stationary Office. ed 23 (2005) ISBN 0 11703371 5
3. Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices. Off J Eur Communities L331 (1998) 1-37
4. Medical Devices Agency Device Bulletin. Management of in vitro diagnostic medical devices, MDA DB2002(02) (2002)
5. Commission decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices. Off J Eur Communities Vol. L131 (2002) 17-30
6. The HIV Testing Kits and Services Regulations Statutory Instrument (1992) No. 460 ISBN: 011023460X
7. Delieu E., Perry K.R., and Parry JV. Access HCV Ab PLUS automated assay. Medical Devices Agency Evaluation Report 02027 (2002) (HMSO-ISBN 1 84182 517 4)
8. Cooray S., Perry K.R., Dean L., et al. An evaluation of AxSYM HIV Ag/Ab Combo assay. Medicines and Healthcare products Regulatory Agency, Evaluation Report 03132 (2003) (HMSO-ISBN 1 84182 797 5)
9. O'Connor T., Delieu E., Cole M., et al. Enzygnost HBsAg 5.0. Medical Devices Agency Evaluation Report 02096 (2003) (HMSO-ISBN 1 84182 597 1)
10. White R., Perry K.R., Parry J.V., et al. Four anti-HBc kits. Medicines & Healthcare products Regulatory Agency: Evaluation Report 03136 (2003) (HMSO-ISBN 1 84182 799 1)