| Parameter | Score |
|---|---|
| 1. Scale | A |
| 2. Study Population | A |
| 3. Samples | B |
| 4. Measurand | A |
| 5. Pre-Analytical | A |
| 6. Replicate Analysis | B |
| 7. Steady State | A |
| 8. Outlier Analysis | C |
| 9. Normality | A |
| 10. Variance Homogeneity | A |
| 11. ANOVA | A |
| 12. CI | C |
| 13. No of Results | C |
| 14. Concentrations | B |
| 15. Total Score | C8,12,13 |
| Comment | C8,12,13 |
| Parameter | Score |
|---|---|
| Matrix | Serum |
| Measurand | Cancer antigen 15-3 (CA 15.3) |
| Unit | U / L |
| Overall Analytical Principle Method | Immunoassay; RIA |
| Number of Subjects | 22 |
| Number of Subjects included in BV estimation | 21 |
| Ethinicity | Caucasian |
| Age Mean / Median | 49.0 |
| Age Min | 34.0 |
| Age Max | 63.0 |
| Age SD | |
| Number of Males | 0 |
| Number of Females | 22 |
| State of Well Being |
Healthy (excl pregnant)
|
| Diseases | |
| Study Duration Length | 3 |
| Study Duration Units | Week |
| Sampling Intervals, e.g. X sample(s) per Interval Unit | 5 |
| Interval Units | Week |
| Sampling Times | Start Time:
07:30
End Time: 09:00 |
| Number of Samples | 14 |
| Average Number of Samples Used for BV Estimation | 14.0 |
| Average Number of Replicates | 1.0 |
| Estimates of CVi | 6.2 |
| Calculated Confidence Intervals of CVi | Lower: 0.00, Upper: 9.48 |
| Estimates of CVg | 62.9 |
| Calculated Confidence Intervals of CVg | Lower: 48.35, Upper: 89.95 |
| Analytical CV | 11.2 |
| Calculated Confidence Intervals of Analytical CV | Lower: 8.92, Upper: 15.06 |
| Measurand Mean | |
| Measurand Min | |
| Measurand Max | |
| Measurand SD |