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 |