Assessment of biomarker stability and assay performance parameters for medical diagnosis: a case study of diagnosis of major depressive disorder

Aim: Assessing the stability profiles and assay performance of 24 biomarker assays in 32 biomarker/body fluid combinations identified as relevant for prediction of major depressive disorder.

Materials & methods: Combinations were tested for stability and assay performance with ELISA at different storage and freeze–thaw conditions in pooled samples of 40 patients.

Results: Stability and assay performance issues were found in almost all cases except three biomarkers in urine and three in serum.

Conclusion: This study shows that, to produce reliable measurement data, assessments of stability and assay performance are essential. In development, other quality assurance parameters might be implemented to increase the level of measurement reliability by increasing assay performance control.