International collaborative study to evaluate a candidate reference preparation to define an appropriate specified limit of anti-D in intravenous immunoglobulin products

Vox Sanguinis

Volumn 88, Issue 4, 2005, Pages 278-287

  Thorpe, S J ^a   Fox, B ^a   Heath, A ^a   Dolman, C ^a   Virata, M L ^b   Yu, M W ^b   Thorpe, R ^a  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^b CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

Anti D; Haemagglutination; IVIG; Reference method; Specification

Indexed keywords

IMMUNOGLOBULIN G; PAPAIN; RHESUS D ANTIBODY;

ARTICLE; DIAGNOSTIC ACCURACY; EVALUATION; FOOD AND DRUG ADMINISTRATION; GOOD LABORATORY PRACTICE; HEMAGGLUTINATION; METHODOLOGY; PRIORITY JOURNAL; QUALITY CONTROL; SAFETY; SENSITIVITY AND SPECIFICITY; STANDARD; STANDARDIZATION; UNITED STATES;

COOPERATIVE BEHAVIOR; HEMAGGLUTINATION TESTS; HUMANS; IMMUNOGLOBULINS, INTRAVENOUS; INTERNATIONAL COOPERATION; OBSERVER VARIATION; REFERENCE STANDARDS; RHO(D) IMMUNE GLOBULIN;

EID: 18944405816     PISSN: 00429007     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1423-0410.2005.00622.x     Document Type: Article

References (7)

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7. Anon: Human normal immunoglobulin for intravenous administration. 2.6.26. Test for anti-D antibodies in intravenous immunoglobulin. Pharmeuropa 2004; 16:119-121