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

Prostate specific antigen (PSA)

Reference

Mannini D, Maver P, Aiello E, et al, 1988, Urol Res, 16(1), 9-12 , Spontaneous circadian fluctuations of prostate specific antigen and prostatic acid phosphatase serum activities in patients with prostatic cancer

Scoring

Total Score

C_7,8,10,11,13

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	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	B
15. Total Score	C_7,8,10,11,13
Comment

Item Details

Parameter	Score
Matrix	Serum
Measurand	Prostate specific antigen (PSA)
Unit	ng / mL
Overall Analytical Principle Method	Immunoassay; RIA
Number of Subjects	32
Number of Subjects included in BV estimation	32
Ethinicity	Unknown
Age Mean / Median	72.0
Age Min	55.0
Age Max	81.0
Age SD
Number of Males	32
Number of Females	0
State of Well Being	Non-healthy (excl pregnant)
Study Duration Length	24
Study Duration Units	Hour
Sampling Intervals, e.g. X sample(s) per Interval Unit	8
Interval Units	Hour
Sampling Times	Start Time: 08:00 End Time: 00:00
Number of Samples	14
Average Number of Samples Used for BV Estimation	4.0
Average Number of Replicates	1.0
Estimates of CVi	21.5
Calculated Confidence Intervals of CVi	Lower: 13.02, Upper: 26.38
Estimates of CVg
Calculated Confidence Intervals of CVg	Lower: , Upper:
Analytical CV	13.0
Calculated Confidence Intervals of Analytical CV	Lower: 9.32, Upper: 21.46
Measurand Mean
Measurand Min
Measurand Max
Measurand SD

Coding

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