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 |