Optimization and validation of a microcolony multiplexed opsonophagocytic killing assay for 15 pneumococcal serotypes.

Bioanalysis
Katrina M NolanRocio D Murphy

Abstract

Background: To streamline and improve throughput, the agar-based multiplexed opsonophagocytic killing assay (MOPA) was optimized and validated on a microcolony platform for use in the Phase III clinical trial program for V114, an MSD 15-valent pneumococcal conjugate vaccine candidate. Results & methodology: The precision, dilutional linearity and specificity of the microcolony MOPA (mMOPA) were assessed for each serotype in validation experiments. All prespecified acceptance criteria on assay performance were satisfied. Accuracy was assessed by testing 007sp and the US FDA reference panel and comparing to consensus values. The mMOPA produced comparable results to other opsonophagocytic killing assays/MOPAs. Conclusion: The mMOPA is suitable for measuring functional antibodies in adult and pediatric samples. Benefits include throughput, reduced analyst-to-analyst variability and automation potential.

References

Jan 12, 2005·Clinical and Diagnostic Laboratory Immunology·R A FleckM H Nahm
Jul 26, 2005·Infection and Immunity·Sven HammerschmidtManfred Rohde
Sep 9, 2006·Clinical and Vaccine Immunology : CVI·Robert L Burton, Moon H Nahm
Aug 19, 2010·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Daniel M WeinbergerMarc Lipsitch

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Methods Mentioned

BETA
ELISA

Software Mentioned

SAS
STAT
MOPA

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