Table 2.
Confounding factors to be addressed for the clinical application of urinary proteomics.
Major factors | Specific aspects | Comments |
---|---|---|
Cost of the assay | Equipment | Newer generations of mass spectrometers likely to be more affordable |
Reagents | Mostly relevant to separation (HPLC, CE) | |
Skill level of technician(s) | Automation will reduce expense | |
Turn-around time | Goal varies by acuity of clinical situation | Generally, not less than 24 h |
Processing and handling of sample | Preferably, minimal on-site processing | |
Reference laboratory versus on-site laboratory | High-volume reference laboratory may be less expensive | |
Throughput of analysis | Cost reduced with higher throughput | |
Statistical aspects and interpretation | Identification of the appropriate biomarker(s) | Biomarker development and validation for translation into clinical use |
- Sensitivity and specificity of the assay | ||
- Level of confidence in the result | - Analysis that accounts for repeat testing of multiple variables | |
- Cohort size, sufficient to avoid flawed results due to β- type errors | ||
- Validation in separate cohort | ||
Interpretation by clinicians not well versed in the technical aspects of assay | The results should be expressed in well defined standardized notations |