EFLM Biological Varation Database : BIVAC Minimum Data Set for TPA level EFLM Biological Variation

TPA level

Reference

Plebani M, Giacomini A, Beghi L, De Paoli M, Roveroni G, Galleotti F, Corsini A, Fraser CG, 1996, Anticancer Res, 16, 2249-52 , Serum tumor markers in monitoring patients: interpretation of results using analytical and biological variation

Originally from this reference: Anticancer Res, Plebani M, Giacomini A, Beghi L, De Paoli M, Roveroni G, Galleotti F, Corsini A, Fraser CG, 1996

ID: 0132

Scoring

Total Score

C_8,10,12,13

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	A
8. Outlier Analysis	C
9. Normality	B
10. Variance Homogeneity	C
11. ANOVA	B
12. CI	C
13. No of Results	C
14. Concentrations	A
15. Total Score	C_8,10,12,13
Comment	C8,10,12

Item Details

Parameter	Score
Matrix	Serum
Measurand	TPA level
Unit	U / L
Overall Analytical Principle Method	Immunoassay; RIA
Number of Subjects	22
Number of Subjects included in BV estimation	22
Ethinicity	Caucasian
Age Mean / Median
Age Min
Age Max
Age SD
Number of Males	12
Number of Females	10
State of Well Being	Non-healthy (excl pregnant)
Study Duration Length	2
Study Duration Units	Month
Sampling Intervals, e.g. X sample(s) per Interval Unit	3
Interval Units	Month
Sampling Times	Start Time: End Time:
Number of Samples	6
Average Number of Samples Used for BV Estimation	6.0
Average Number of Replicates	1.0
Estimates of CVi	25.7
Calculated Confidence Intervals of CVi	Lower: 22.55, Upper: 29.75
Estimates of CVg	144.7
Calculated Confidence Intervals of CVg	Lower: 111.70, Upper: 205.08
Analytical CV	5.0
Calculated Confidence Intervals of Analytical CV	Lower: 3.62, Upper: 8.06
Measurand Mean	69.0
Measurand Min
Measurand Max
Measurand SD

Coding

Parameter	Score
Healthy Population	false
Adult Population	true
Weekly Samplings	true
Reviewed	true
Published	true
Gender for Meta-Analysis	Males
Snomed CT
NPU
LOINC
Comment

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