Aim: To re-optimize the pneumococcal (Pn) electrochemiluminescence (ECL) assay and to validate and bridge the enhanced assay to the WHO ELISA, to support the Phase III clinical trial program for V114, a 15-valent Pn conjugate vaccine. Materials & methods: The Pn ECL assay was re-optimized, validated and formally bridged to the WHO ELISA. Results: The enhanced Pn ECL assay met all prespecified validation acceptance criteria and demonstrated concordance with the WHO ELISA. The corresponding threshold value remains at 0.35 μg/ml for all 15 serotypes. Conclusion: The enhanced Pn ECL assay has been validated for the measurement of antibodies to 15 Pn capsular polysaccharides and is concordant with the WHO ELISA, supporting its use in clinical trials.
Aim: To re-optimize the pneumococcal (Pn) electrochemiluminescence (ECL) assay and to validate and bridge the enhanced assay to the WHO ELISA, to support the Phase III clinical trial program for V114, a 15-valent Pn conjugate vaccine. Materials & methods: The Pn ECL assay was re-optimized, validated and formally bridged to the WHO ELISA. Results: The enhanced Pn ECL assay met all prespecified validation acceptance criteria and demonstrated concordance with the WHO ELISA. The corresponding threshold value remains at 0.35 μg/ml for all 15 serotypes. Conclusion: The enhanced Pn ECL assay has been validated for the measurement of antibodies to 15 Pn capsular polysaccharides and is concordant with the WHO ELISA, supporting its use in clinical trials.
Authors: Laura L Hammitt; Dean Quinn; Ewa Janczewska; Francisco J Pasquel; Richard Tytus; K Rajender Reddy; Katia Abarca; Ilsiyar M Khaertynova; Ron Dagan; Jennifer McCauley; Kyeongmi Cheon; Alison Pedley; Tina Sterling; Gretchen Tamms; Luwy Musey; Ulrike K Buchwald Journal: Open Forum Infect Dis Date: 2021-12-18 Impact factor: 3.835
Authors: Randall Severance; Howard Schwartz; Ron Dagan; Laurie Connor; Jianing Li; Alison Pedley; Jonathan Hartzel; Tina M Sterling; Katrina M Nolan; Gretchen M Tamms; Luwy K Musey; Ulrike K Buchwald Journal: Hum Vaccin Immunother Date: 2021-11-02 Impact factor: 3.452