EFLM Biological Varation Database : BIVAC Minimum Data Set for Haemoglobin A1c (HbA1c) EFLM Biological Variation

Haemoglobin A1c (HbA1c)

Reference

Howey JEA, Bennet WM, Browning MCK, Jung RT and Fraser CG, 1989, Diabetic Medicine, 6, 793-6 , Clinical utility of assays of glycosilated haemoglobin and serum fructosamine comapred: use of data on biological variation

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	B
6. Replicate Analysis	A
7. Steady State	B
8. Outlier Analysis	C
9. Normality	B
10. Variance Homogeneity	C
11. ANOVA	A
12. CI	C
13. No of Results	C
14. Concentrations	A
15. Total Score	C_8,10,12,13
Comment	1) Data may not be used for estimation of RCV (9B). 2) Data is not necessarily representative for the total population (10C).

Item Details

Parameter	Score
Matrix	Whole Blood EDTA
Measurand	Haemoglobin A1c (HbA1c)
Unit	ug / ug
Overall Analytical Principle Method	Spectrophotometry; UV/VISIBLE
Number of Subjects	8
Number of Subjects included in BV estimation	8
Ethinicity	Caucasian
Age Mean / Median
Age Min	50.0
Age Max	88.0
Age SD
Number of Males	3
Number of Females	5
State of Well Being	Non-healthy (excl pregnant)
Study Duration Length	3
Study Duration Units	Week
Sampling Intervals, e.g. X sample(s) per Interval Unit	2
Interval Units	Week
Sampling Times	Start Time: End Time:
Number of Samples	6
Average Number of Samples Used for BV Estimation	6.0
Average Number of Replicates	2.0
Estimates of CVi	7.3
Calculated Confidence Intervals of CVi	Lower: 5.86, Upper: 9.49
Estimates of CVg	10.8
Calculated Confidence Intervals of CVg	Lower: 6.90, Upper: 21.30
Analytical CV	3.0
Calculated Confidence Intervals of Analytical CV	Lower: 2.50, Upper: 3.75
Measurand Mean	9.2
Measurand Min
Measurand Max
Measurand SD

Coding

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