| Parameter | Score |
|---|---|
| 1. Scale | A |
| 2. Study Population | A |
| 3. Samples | B |
| 4. Measurand | A |
| 5. Pre-Analytical | A |
| 6. Replicate Analysis | C |
| 7. Steady State | C |
| 8. Outlier Analysis | C |
| 9. Normality | B |
| 10. Variance Homogeneity | C |
| 11. ANOVA | C |
| 12. CI | C |
| 13. No of Results | C |
| 14. Concentrations | A |
| 15. Total Score | C6,7,8,10,11,12,13 |
| Comment |
| Parameter | Score |
|---|---|
| Matrix | Serum |
| Measurand | Prostate specific antigen (PSA) |
| Unit | ng / mL |
| Overall Analytical Principle Method | Immunoassay; Time-resolved immunofluorometric assay (TR-IMFA) |
| Number of Subjects | 149 |
| Number of Subjects included in BV estimation | 149 |
| Ethinicity | Unknown |
| Age Mean / Median | 65.0 |
| Age Min | 60.0 |
| Age Max | 70.0 |
| Age SD | |
| Number of Males | 149 |
| Number of Females | 0 |
| State of Well Being |
Non-healthy (excl pregnant)
|
| Diseases | |
| Study Duration Length | 1 |
| Study Duration Units | Day |
| Sampling Intervals, e.g. X sample(s) per Interval Unit | 7 |
| Interval Units | Hour |
| Sampling Times | Start Time:
End Time: |
| Number of Samples | 2 |
| Average Number of Samples Used for BV Estimation | |
| Average Number of Replicates | 1.0 |
| Estimates of CVi | 4.0 |
| Calculated Confidence Intervals of CVi | Lower: 0.00, Upper: 5.44 |
| Estimates of CVg | |
| Calculated Confidence Intervals of CVg | Lower: , Upper: |
| Analytical CV | 5.0 |
| Calculated Confidence Intervals of Analytical CV | Lower: 3.98, Upper: 6.72 |
| Measurand Mean | 6.7 |
| Measurand Min | 4.55 |
| Measurand Max | 9.75 |
| Measurand SD |