Introduction
Some things we need to cover first.
Why Measure Something:
- Diagnosis
- Assess Damage
- Monitoring
- Fertility Tracking
- Screening
- Treatment/Therapy
including TDM, Hormone replacement or supression
Organ damage, renal failure etc.
- Research
- Insurance medical
- Pre-employment medical
- Criminal Prosecution
Method/Assay Requirements:
- Performance (LLD, functional sensitivity, accuracy, precision,
clinical utility, Turn Around Times)
- Reference ranges
- Manual assays/Automation
- Sample requirements
- Test numbers
- Reports/interface with LIS.
- Near patient testing/Point of Care Testing
- Biological variation
Assay management:
- Cost and Profit (Charging vs Cost)
- Quality control (internal and external)
- Calibration ( ease, frequency/stability)
- Documentation
- Staff Training
- Maintenance/Reliability
- Stocks/Stores
