Development and validation of a respiratory syncytial virus multiplex immunoassay

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2024年2月8日

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Patrick Marsall,
Madeleine Fandrich,
Johanna Griesbaum,
Manuela Harries,
Berit Lange,
Stephanie Ascough,
Pete Dayananda,
Christopher Chiu,
Jonathan Remppis,
Tina Ganzenmueller,
Hanna Renk,
Monika Strengert,
Nicole Schneiderhan-Marra,
Alex Dulovic

摘要

Purpose

Respiratory syncytial virus (RSV) is one of the leading causes of severe respiratory disease in infants and adults. While vaccines and monoclonal therapeutic antibodies either are or will shortly become available, correlates of protection remain unclear. For this purpose, we developed an RSV multiplex immunoassay that analyses antibody titers toward the post-F, Nucleoprotein, and a diverse mix of G proteins.

Methods

A bead-based multiplex RSV immunoassay was developed, technically validated to standard FDA bioanalytical guidelines, and clinically validated using samples from human challenge studies. RSV antibody titers were then investigated in children aged under 2 and a population-based cohort.

Results

Technical and clinical validation showed outstanding performance, while methodological developments enabled identification of the subtype of previous infections through use of the diverse G proteins for approximately 50% of samples. As a proof of concept to show the suitability of the assay in serosurveillance studies, we then evaluated titer decay and age-dependent antibody responses within population cohorts.

Conclusion

Overall, the developed assay shows robust performance, is scalable, provides additional information on infection subtype, and is therefore ideally suited to be used in future population cohort studies.