| Parameter | Score |
|---|---|
| 1. Scale | A |
| 2. Study Population | A |
| 3. Samples | A |
| 4. Measurand | A |
| 5. Pre-Analytical | A |
| 6. Replicate Analysis | A |
| 7. Steady State | B |
| 8. Outlier Analysis | C |
| 9. Normality | A |
| 10. Variance Homogeneity | C |
| 11. ANOVA | A |
| 12. CI | A |
| 13. No of Results | B |
| 14. Concentrations | B |
| 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; Not specified |
| Number of Subjects | 20 |
| Number of Subjects included in BV estimation | 20 |
| Ethinicity | Asian |
| Age Mean / Median | 26.0 |
| Age Min | 21.0 |
| Age Max | 38.0 |
| Age SD | |
| Number of Males | 11 |
| Number of Females | 9 |
| State of Well Being |
Healthy (excl pregnant)
|
| Diseases | |
| Study Duration Length | 5 |
| Study Duration Units | Day |
| Sampling Intervals, e.g. X sample(s) per Interval Unit | |
| Interval Units | Hour |
| Sampling Times | Start Time:
08:00
End Time: 16:00 |
| Number of Samples | 7 |
| Average Number of Samples Used for BV Estimation | 7.0 |
| Average Number of Replicates | 2.0 |
| Estimates of CVi | 6.76 |
| Calculated Confidence Intervals of CVi | Lower: 5.90, Upper: 7.84 |
| Estimates of CVg | 48.56 |
| Calculated Confidence Intervals of CVg | Lower: 37.11, Upper: 70.18 |
| Analytical CV | 3.23 |
| Calculated Confidence Intervals of Analytical CV | Lower: 2.89, Upper: 3.66 |
| Measurand Mean | 11.435 |
| Measurand Min | 2.86 |
| Measurand Max | 20.01 |
| Measurand SD |