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Clin. Vaccine Immunol. doi:10.1128/CVI.00495-07
Copyright (c) 2008, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Evaluation of two Human plasma pools as candidate International Standard Preparations for syphilitic antibodies

Biostatistics Section, and Division of Bacteriology, National Institute for Biological Standards and Control, South Mimms, Potters Bar, Sexually Transmitted Bacteria Reference Laboratory, Health Protection Agency, Centre for Infections, Colindale, United Kingdom; Laboratory Reference and Research Branch, Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA; Labor Dr. Krone and Partner, Bad Salzuflen, Germany; Sexually Transmitted Infections Reference Centre, National Institute for Communicable Diseases (NHLS), Johannesburg, South Africa; Diagnostic Laboratory for Infectious Diseases & Perinatal Screening Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands; Dept. of Clinical Biochemistry, Statens Serum Institut, Copenhagen, Denmark; SEALS Area Serology Laboratory, Prince of Wales Hospital, Randwick, New South Wales, Australia; and HUSLAB, Unit of Immunology, Clinical Microbiology, Helsinki University Hospital, Helsinki, Finland

^* To whom correspondence should be addressed. Email: srijpkema{at}nibsc.ac.uk.

	Abstract

Two freeze dried human plasma preparations containing anti-Treponema pallidum antibodies, 05/132 and 05/122, were assessed for their suitability as international reference reagents for syphilis serology. A collaborative study was designed to compare these preparations with the first international standard (IS) for syphilitic serum antibodies (HS) by eight laboratories from eight countries. Samples were tested with the T. pallidum passive particle agglutination assay (TPPA) and with two non-treponemal assays: the venereal disease research laboratory test (VDRL) and the rapid plasma reagin test (RPR). In addition a range of other immunoassays was used. The outcome of the collaborative study revealed that candidate standard 05/132 contains T. pallidum-specific immunoglobulin G (IgG) and IgM and is reactive in VDRL or RPR, and that 05/122 contains T. pallidum specific IgG but is not reactive in either the VDRL or RPR test. Both 05/132 and 05/122 are reactive in the TPPA. On the basis of these results the Expert Committee on Biological Standardization of the World Health Organization designated 05/132 as the 1^st IS for human syphilitic plasma IgG and IgM with a unitage of 3 IU per ampoule relative to HS and 05/122 as the 1^st IS for human syphilitic plasma IgG with a unitage of 300 mIU per ampoule relative to 05/132.