ASSIGNMENT OF NEISSERIA-MENINGITIDIS SEROGROUP-A AND SEROGROUP-C CLASS-SPECIFIC ANTICAPSULAR ANTIBODY CONCENTRATIONS TO THE NEW STANDARD REFERENCE SERUM CDC1992
Pk. Holder et al., ASSIGNMENT OF NEISSERIA-MENINGITIDIS SEROGROUP-A AND SEROGROUP-C CLASS-SPECIFIC ANTICAPSULAR ANTIBODY CONCENTRATIONS TO THE NEW STANDARD REFERENCE SERUM CDC1992, Clinical and diagnostic laboratory immunology, 2(2), 1995, pp. 132-137
A new standard meningococcal reference serum designated CDC1992 was pr
epared to replace meningococcal reference sera ECG and PB-2, which are
not available in sufficient quantities for continued use as primary r
eference sera. CDC1992 was prepared from 14 healthy adult volunteers w
ho underwent plasmapheresis 4 to 12 weeks postvaccination with a singl
e dose of a Neisseria meningitidis quadrivalent polysaccharide vaccine
, Total and/or class-specific meningococcal serogroup A and C anticaps
ular antibody concentrations (in micrograms per milliliter) were assig
ned to CDC1992 by using homologous and heterologous enzyme-linked immu
nosorbent assay (ELISA) formats. The reference serum ECG was used as a
reference standard to assign total anticapsular antibody concentratio
ns to CDC1992 by a homologous ELISA format. A heterologous ELISA forma
t, with the Haemophilus influenzae type b standard reference serum FDA
1983, was used to assign total and class-specific antibody concentrat
ions to CDC1992. Alkaline phosphatase-labeled mouse anti-human monoclo
nal antibody conjugates were used as secondary antibodies in both ELIS
A formats. The total, immunoglobulin G (IgG), IgA, and IgM antibody co
ncentrations, assigned to CDC1992 for serogroup A were 135.8, 91.8, 20
.1, and 23.9 mu g/ml, respectively, and those for serogroup C were 32.
0, 24.1, 5.9, and 2.0 mu g/ml, respectively. Meningococcal serogroup A
and C antibody concentrations were in good agreement when homologous
and heterologous ELISA format results were compared. Total and class-s
pecific serogroup A and C antibody concentrations were determined in s
ix adult quality control serum samples from the Centers for Disease Co
ntrol and Prevention by using the homologous ELISA and our assigned an
tibody concentrations for CDC1992. Antibody concentrations in referenc
e sera ECG and PB-2 were measured in order to provide a historical lin
k to previous studies. The general acceptance of CDC1992 as the standa
rd reference serum and the assigned antibody concentrations will allow
investigators to compare antibody levels in serum to those in a singl
e reference preparation.