title: Enzyme-linked immunosorbent assay for measuring antibodies to pneumococcal polysaccharides for the PNEUMOVAX 23 vaccine: assay operating characteristics and correlation to the WHO international assay.
abstract: The Merck pneumococcal (Pn) enzyme-linked immunosorbent assays (ELISAs) for measuring antibodies to 12 serotypes (serotypes 1, 3, 4, 6B, 7F, 8, 9V, 12F, 14, 18C, 19F, and 23F) were validated in 1999. Merck Laboratories developed the Pn assays using 10 microg/ml C polysaccharide, 100 microg/ml Pn polysaccharide (PnPs) 25, and 100 microg/ml PnPs 72 for preadsorption of samples, standards, and controls in order to improve the specificity to the Pn serotypes in the vaccine. The Pn assays utilize postimmunization sera obtained from subjects immunized with PNEUMOVAX 23 as standards for measuring immunoglobulin G concentrations in sera obtained from vaccine clinical trials with adults and infants. This material was calibrated to the Pn reference standard serum, 89SF, subjected to the Merck Pn ELISA adsorbants. Comparisons were made between the Merck Pn assay and the international Pn assay, showing moderate agreement between the two assay formats. This work describes the test procedures and operating characteristics of the Merck Pn assays and the results of experiments performed to compare the Merck Pn ELISAs to the international Pn ELISAs.
authors.affiliation: Vaccine and Biologics Research, Merck Research Laboratories, WYN-1, 466 Devon Park Dr., Wayne, PA 19087-8630, USA. rocio_marchese@merck.com
authors.forename: Rocio D
authors.initials: RD
authors.lastname: Marchese
authors.forename: Neil T
authors.initials: NT
authors.lastname: Jain
authors.forename: Joseph
authors.initials: J
authors.lastname: Antonello
authors.forename: Laura
authors.initials: L
authors.lastname: Mallette
authors.forename: Kristin L
authors.initials: KL
authors.lastname: Butterfield-Gerson
authors.forename: Jennifer
authors.initials: J
authors.lastname: Raab
authors.forename: Pamela
authors.initials: P
authors.lastname: Burke
authors.forename: Cheryl
authors.initials: C
authors.lastname: Schulman
authors.forename: Hilary
authors.initials: H
authors.lastname: Adgate
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Sikkema
authors.forename: Narendra
authors.initials: N
authors.lastname: Chirmule
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood*; D002138:Calibration; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D006801:Humans; D007223:Infant; D022242:Pneumococcal Vaccines / Q000276:immunology / Q000592:standards*; D011135:Polysaccharides, Bacterial / Q000276:immunology*; D012015:Reference Standards; D012680:Sensitivity and Specificity; D012703:Serotyping; D013296:Streptococcus pneumoniae / Q000276:immunology*; D014612:Vaccines / Q000276:immunology / Q000592:standards*; D014944:World Health Organization
chemical_list: D000907:Antibodies, Bacterial; D022242:Pneumococcal Vaccines; D011135:Polysaccharides, Bacterial; D014612:Vaccines