Evaluation of two human plasma pools as candidate international standard preparations for syphilitic antibodies.
A collaborative study was designed to asses two freeze-dried human plasma preparations containing anti-Treponema pallidum antibodies, 05/132 and 05/122, for their suitability as international reference reagents for syphilis serology. Both preparations are intended as replacements of the first international standard (IS) for syphilitic serum antibodies (HS). Samples were tested by eight laboratories using the T. pallidum passive particle agglutination assay (TPPA), the venereal disease research laboratory test (VDRL) and the rapid plasma reagin test (RPR). In addition a range of immunoassays was also used. The outcome of the collaborative study revealed that candidate standard 05/132 contains T. pallidum-specific 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 1st IS for human syphilitic plasma IgG and IgM with a unitage of 3 IU per ampoule relative to HS and 05/122 as the 1st IS for human syphilitic plasma IgG with a unitage of 300 mIU per ampoule relative to 05/132.
Biostatistics Section, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, EN6 3QG, United Kingdom.
Peter
P
Rigsby
Catherine
C
Ison
Matthew
M
Brierley
Ron
R
Ballard
Hans-Jochen
HJ
Hagedorn
David A
DA
Lewis
Daan W
DW
Notermans
Jørn
J
Riis
Peter
P
Robertson
Ilkka J T
IJ
Seppälä
Sjoerd
S
Rijpkema
D000906:Antibodies / Q000032:analysis*; D001800:Blood Specimen Collection / Q000379:methods; D019411:Clinical Laboratory Techniques / Q000592:standards; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis / Q000097:blood; D010949:Plasma / Q000737:chemistry / Q000276:immunology*; D055550:Protein Stability; D013587:Syphilis / Q000097:blood / Q000175:diagnosis* / Q000276:immunology*; D013588:Syphilis Serodiagnosis / Q000379:methods / Q000592:standards*; D014210:Treponema pallidum / Q000276:immunology
D000906:Antibodies; D007074:Immunoglobulin G