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

Overview

Journal Clin Vaccine Immunol

Publisher American Society for Microbiology

Specialties Allergy & Immunology
Pathology

Date 2006 Aug 9

PMID 16893991

Citations 9

Authors

Rocio D Marchese

Neil T Jain

Joseph Antonello

Laura Mallette

Kristin L Butterfield-Gerson

Jennifer Raab

Pamela Burke

Cheryl Schulman

Hilary Adgate

Daniel J Sikkema

Narendra Chirmule

Affiliations

Soon will be listed here.

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.

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