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. Author manuscript; available in PMC: 2010 Jan 6.
Published in final edited form as: Proteomics Clin Appl. 2009 Jan 1;3(9):1023–1028. doi: 10.1002/prca.200800244

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