| Parameter | Score |
|---|---|
| 1. Scale | A |
| 2. Study Population | A |
| 3. Samples | A |
| 4. Measurand | A |
| 5. Pre-Analytical | A |
| 6. Replicate Analysis | B |
| 7. Steady State | B |
| 8. Outlier Analysis | C |
| 9. Normality | A |
| 10. Variance Homogeneity | C |
| 11. ANOVA | B |
| 12. CI | A |
| 13. No of Results | B |
| 14. Concentrations | A |
| 15. Total Score | C8,10 |
| Comment |
| Parameter | Score |
|---|---|
| Matrix | Serum |
| Measurand | Cancer antigen 19-9 (CA 19-9) |
| Unit | U / mL |
| Overall Analytical Principle Method | Immunoassay; RIA |
| Number of Subjects | 49 |
| Number of Subjects included in BV estimation | 38 |
| Ethinicity | Unknown |
| Age Mean / Median | 33.0 |
| Age Min | 18.0 |
| Age Max | 60.0 |
| Age SD | |
| Number of Males | 25 |
| Number of Females | 24 |
| State of Well Being |
Healthy (excl pregnant)
|
| Diseases | |
| Study Duration Length | 6 |
| Study Duration Units | Week |
| Sampling Intervals, e.g. X sample(s) per Interval Unit | 14 |
| Interval Units | Day |
| Sampling Times | Start Time:
08:00
End Time: 10:00 |
| Number of Samples | 4 |
| Average Number of Samples Used for BV Estimation | 4.0 |
| Average Number of Replicates | 2.0 |
| Estimates of CVi | 27.2 |
| Calculated Confidence Intervals of CVi | Lower: 24.01, Upper: 31.33 |
| Estimates of CVg | 64.24 |
| Calculated Confidence Intervals of CVg | Lower: 51.88, Upper: 83.53 |
| Analytical CV | 5.39 |
| Calculated Confidence Intervals of Analytical CV | Lower: 4.85, Upper: 6.07 |
| Measurand Mean | 5.098 |
| Measurand Min | 1.9 |
| Measurand Max | 12.253 |
| Measurand SD | 3.147 |