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

Prostate specific antigen (PSA)

Reference

Nixon RG, Wener MH et al, 1997, J Urol, 157, 2183-90 , Biological variation of prostate specific antigen levels In serum: an evaluation of day-to-day physiological fluctuations in a well-defined cohort of 24 patients

Scoring

Total Score

C_7,8,10,11,13

Parameter	Score
1. Scale	A
2. Study Population	A
3. Samples	B
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	A
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; Not specified
Number of Subjects	3
Number of Subjects included in BV estimation	3
Ethinicity	Unknown
Age Mean / Median	71.0
Age Min
Age Max
Age SD
Number of Males	3
Number of Females	0
State of Well Being	Non-healthy (excl pregnant)
Study Duration Length	2
Study Duration Units	Week
Sampling Intervals, e.g. X sample(s) per Interval Unit	1
Interval Units	Day
Sampling Times	Start Time: End Time:
Number of Samples	10
Average Number of Samples Used for BV Estimation	9.8
Average Number of Replicates	2.0
Estimates of CVi	11.5
Calculated Confidence Intervals of CVi	Lower: 8.75, Upper: 16.10
Estimates of CVg
Calculated Confidence Intervals of CVg	Lower: , Upper:
Analytical CV	5.0
Calculated Confidence Intervals of Analytical CV	Lower: 3.95, Upper: 6.81
Measurand Mean	14.2
Measurand Min	10.0
Measurand Max
Measurand SD

Coding

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