EFLM Biological Varation Database : BIVAC Minimum Data Set for Cancer antigen 19-9 (CA 19-9) EFLM Biological Variation

Cancer antigen 19-9 (CA 19-9)

Reference

Qi Z, Zhang Lin, Chen Y, Ma X et al, 2015, Clin Chim Acta, 450, 233-6 , . Biological variations of seven tumor markers

Scoring

Total Score

C_8,10

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	C_8,10
Comment

Item Details

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)
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

Coding

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