EFLM Biological Varation Database : BIVAC Minimum Data Set for Prostate specific antigen (PSA) EFLM Biological Variation

Prostate specific antigen (PSA)

Reference

Komatsu K, Wehner N, Prestigiacomo A et al, 1996, Urology, 47(3), 343-6 , Physiologic (intraindividual) variation of serum protate-specific antigen in 814 men from a screening population

Scoring

Total Score

C_8,10,11,13

Parameter	Score
1. Scale	A
2. Study Population	A
3. Samples	B
4. Measurand	A
5. Pre-Analytical	B
6. Replicate Analysis	B
7. Steady State	B
8. Outlier Analysis	C
9. Normality	B
10. Variance Homogeneity	C
11. ANOVA	C
12. CI	A
13. No of Results	C
14. Concentrations	B
15. Total Score	C_8,10,11,13
Comment

Item Details

Parameter	Score
Matrix	Serum
Measurand	Prostate specific antigen (PSA)
Unit	ng / mL
Overall Analytical Principle Method	Chemiluminescence
Number of Subjects	98
Number of Subjects included in BV estimation	98
Ethinicity	Unknown
Age Mean / Median
Age Min
Age Max
Age SD
Number of Males	98
Number of Females	0
State of Well Being	Healthy (excl pregnant)
Study Duration Length	1
Study Duration Units	Year
Sampling Intervals, e.g. X sample(s) per Interval Unit
Interval Units	Other
Sampling Times	Start Time: End Time:
Number of Samples	2
Average Number of Samples Used for BV Estimation	2.0
Average Number of Replicates	1.0
Estimates of CVi	11.9
Calculated Confidence Intervals of CVi	Lower: 10.37, Upper: 13.91
Estimates of CVg
Calculated Confidence Intervals of CVg	Lower: , Upper:
Analytical CV	2.5
Calculated Confidence Intervals of Analytical CV	Lower: 1.90, Upper: 3.65
Measurand Mean
Measurand Min	7.3
Measurand Max	17.9
Measurand SD

Coding

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