Collier CP, Morales A, Clark A, Lam M, Wynne-Edwards K and Black A, 2010, J Urol, 183, 2294-9 , The significance of biological variation in the diagnosis of testosterone deficiency, and consideration of the relevance of total, free and bioavailable testosterone determinations


Total Score


Parameter Score
1. Scale A
2. Study Population A
3. Samples B
4. Measurand A
5. Pre-Analytical A
6. Replicate Analysis A
7. Steady State A
8. Outlier Analysis C
9. Normality B
10. Variance Homogeneity C
12. CI C
13. No of Results A
14. Concentrations A
15. Total Score C8,10,11,12

Item Details

Parameter Score
Matrix Unknown
Measurand Testosterone
Unit ng / dL
Overall Analytical Principle Method Immunoassay; Competitive
Number of Subjects 87
Number of Subjects included in BV estimation 87
Ethinicity Caucasian
Age Mean / Median
Age Min 50.0
Age Max 80.0
Age SD
Number of Males 87
Number of Females
State of Well Being
Healthy (excl pregnant)
Study Duration Length 1
Study Duration Units Day
Sampling Intervals, e.g. X sample(s) per Interval Unit 2
Interval Units Hour
Sampling Times Start Time: 7
End Time: 22
Number of Samples 2
Average Number of Samples Used for BV Estimation 2.0
Average Number of Replicates 1.0
Estimates of CVi 12.9
Calculated Confidence Intervals of CVi Lower: 10.25, Upper: 15.61
Estimates of CVg 36.5
Calculated Confidence Intervals of CVg Lower: 31.38, Upper: 43.30
Analytical CV 6.0
Calculated Confidence Intervals of Analytical CV Lower: 4.50, Upper: 8.99
Measurand Mean 10.6
Measurand Min 2.9
Measurand Max 21.2
Measurand SD