Multicenter comparison of levels of antibody to the Neisseria meningitidis group A capsular polysaccharide measured by using an enzyme-linked immunosorbent assay.
There is no standard immunoassay for evaluating immune responses to meningococcal vaccines. We developed an enzyme-linked immunosorbent assay to measure total levels of antibody to Neisseria meningitidis group A capsular polysaccharide. Five laboratories measured the antibody levels in six paired pre- and postvaccination serum samples by using the enzyme-linked immunosorbent assay. Methylated human serum albumin was used to bind native group A polysaccharide to microtiter plate surfaces. The between-laboratory coefficients of variation for pre- and postvaccination sera had ranges of 31 to 91 and 17 to 31, respectively. The mean laboratory coefficients of variation for pre- and postvaccination sera, respectively, were 17 and 11 (Molecular Biology Laboratory, Centers for Disease Control), 12 and 15 (Immunodiagnostic Methods Laboratory, Centers for Disease Control), 22 and 19 (Dana-Farber Cancer Institute), 38 and 38 (Bacterial Polysaccharide Laboratory, U.S. Food and Drug Administration), and 11 and 10 (Praxis Biologics, Inc.). Standardization of this enzyme-linked immunosorbent assay should allow interlaboratory comparison of meningococcal vaccine immunogenicity, thus providing a laboratory-based assessment tool for evaluating meningococcal vaccines.
Carlone
G M
GM
Menigitis and Special Pathogens Branch, Centers for Disease Control, Atlanta, Georgia 30333.
Frasch
C E
CE
Siber
G R
GR
Quataert
S
S
Gheesling
L L
LL
Turner
S H
SH
Plikaytis
B D
BD
Helsel
L O
LO
DeWitt
W E
WE
Bibb
W F
WF
D000328:Adult; D000907:Antibodies, Bacterial / Q000096:biosynthesis / Q000737:chemistry*; D000942:Antigens, Bacterial / Q000276:immunology*; D001666:Binding Sites, Antibody; D001667:Binding, Competitive; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D006801:Humans; D015337:Multicenter Studies as Topic; D009345:Neisseria meningitidis / Q000276:immunology*; D011135:Polysaccharides, Bacterial / Q000276:immunology*
D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D011135:Polysaccharides, Bacterial; C043226:meningococcal group A polysaccharide