SOPs - Assay Harmonisation

Assay harmonisation is a key process for ensuring that comparable information can be extracted for the varied clinical trials currently underway or planned by different organisations around the world. Although different vaccine constructs will naturally have specific assay issues that are not amenable to generic cross platform harmonisation, a core set of immune assay technologies remains common – Intracellular Cytokine Staining (ICS), ELISPOT, serology and cytokine measurement in supernatants, together with the newer, more functional growth inhibition assay for tuberculosis (TB) and malaria. The standardisation or qualification of an assay has a central requirement for established and agreed SOPs. The subsequent fitness for purpose of the assay has to be established by multi-centre studies and assay performance analysis through robust statistical analysis to establish functional assay characteristics and specifications. We have undertaken the assessment and determination of the use of cross-pathogen assays suitable for use to characterise immunity to malaria, HIV TB, and hepatitis B and C; together with a pathogen specific growth inhibition assay for TB and malaria, and whether these assays are amenable to standardisation or qualification in a cGMP/regulatory environment. Final SOPs are now available for all the assays studied.

1.Direct PBMC Mycobacterial Growth Inhibition Assay (here)

2.Growth Inhibition Assay (GIA) with Lactate Dehydrogenase (LDH) (here)

3.Human intracellular cytokine staining (ICS) assay (here)

4.Competition ELISA for Malaria 10/198 as a standard (here)