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

Haemoglobin A1c (HbA1c)

Reference

Kolatkar NS, Cembrowski GS, Callahan PL and Etzwiler DD, 1994, Clin Chem, 40, 1608-9 , Intensive diabetes management requires very precise testing of glycohemoglobin

Scoring

Total Score

C_10,12

Parameter	Score
1. Scale	B
2. Study Population	A
3. Samples	A
4. Measurand	A
5. Pre-Analytical	A
6. Replicate Analysis	A
7. Steady State	B
8. Outlier Analysis	A
9. Normality	B
10. Variance Homogeneity	C
11. ANOVA	A
12. CI	C
13. No of Results	A
14. Concentrations	A
15. Total Score	C_10,12
Comment

Item Details

Parameter	Score
Matrix	Unknown
Measurand	Haemoglobin A1c (HbA1c)
Unit	ug / ug
Overall Analytical Principle Method	Spectrophotometry; UV/VISIBLE
Number of Subjects	29
Number of Subjects included in BV estimation	29
Ethinicity	Unknown
Age Mean / Median
Age Min
Age Max
Age SD
Number of Males
Number of Females
State of Well Being	Non-healthy (excl pregnant)
Study Duration Length	72
Study Duration Units	Month
Sampling Intervals, e.g. X sample(s) per Interval Unit
Interval Units	Year
Sampling Times	Start Time: End Time:
Number of Samples	4
Average Number of Samples Used for BV Estimation	4.0
Average Number of Replicates	2.0
Estimates of CVi	2.4
Calculated Confidence Intervals of CVi	Lower: 2.03, Upper: 2.88
Estimates of CVg
Calculated Confidence Intervals of CVg	Lower: 0.00, Upper:
Analytical CV	1.4
Calculated Confidence Intervals of Analytical CV	Lower: 1.24, Upper: 1.61
Measurand Mean
Measurand Min
Measurand Max
Measurand SD

Coding

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