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

Prostate specific antigen (PSA) - free

Reference

Ornstein DK, Smith DS et al, 1997, J Urol, 157, 2179-82 , Biological variation of total, free and percent free serumm protate specific antigen levels in screening volunteers

Scoring

Total Score

C_7,8,10,11,13

Parameter	Score
1. Scale	A
2. Study Population	A
3. Samples	B
4. Measurand	B
5. Pre-Analytical	A
6. Replicate Analysis	B
7. Steady State	C
8. Outlier Analysis	C
9. Normality	B
10. Variance Homogeneity	C
11. ANOVA	C
12. CI	A
13. No of Results	C
14. Concentrations	A
15. Total Score	C_7,8,10,11,13
Comment

Item Details

Parameter	Score
Matrix	Serum
Measurand	Prostate specific antigen (PSA) - free
Unit	ng / mL
Overall Analytical Principle Method	Immunoassay; Other
Number of Subjects	84
Number of Subjects included in BV estimation	84
Ethinicity	Unknown
Age Mean / Median	66.0
Age Min	53.0
Age Max	84.0
Age SD
Number of Males	84
Number of Females	0
State of Well Being	Healthy (excl pregnant)
Study Duration Length	1
Study Duration Units	Month
Sampling Intervals, e.g. X sample(s) per Interval Unit	2
Interval Units	Week
Sampling Times	Start Time: End Time:
Number of Samples
Average Number of Samples Used for BV Estimation	3.0
Average Number of Replicates	1.0
Estimates of CVi	16.5
Calculated Confidence Intervals of CVi	Lower: 14.71, Upper: 18.63
Estimates of CVg
Calculated Confidence Intervals of CVg	Lower: , Upper:
Analytical CV	4.7
Calculated Confidence Intervals of Analytical CV	Lower: 3.69, Upper: 6.49
Measurand Mean	0.6
Measurand Min	0.1
Measurand Max	1.1
Measurand SD

Coding

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