Mean % A1c 6.0 6.0
% A1c Range 3.2-19.4 3.2 -20.1
Standard
Deviation A1c 1.2 1.0
Accuracy Paired whole blood (venous/vein) and EDTA capillary samples containing a variety of concentrations of HbA1c were analyzed. Percent (%) HbA1c concentrations observed for capillary samples versus EDTA whole blood (vein) samples were analyzed by linear regression.
% A1c % Bias Total Total Error
Concentration % CV % (HbA1c)
3.2% 0.2 1.4% ± 0.12%
6.0% 0.1 1.3% ± 0.11%
7.6% 0.1 0.8% ± 0.09%
14.6% 0.2 1.6% ± 0.15%
Mean Standard % Coefficient
% A1c Deviation of Variation (CV's)
3.2 (CB) 0.01 1.3%
6.0 (CB) 0.02 1.2%
14.6 (CB) 0.02 1.4%
4.0 (WB) 0.05 1.1%
7.6 (WB) 0.06 1.2%
15.0 (WB) 0.05 1.3%
DTI Laboratories, Inc.
PO Box 1954
Thomasville, GA 31799-1954
Date Submitted: 1/1/2002
WB/CB Comparison
Within-Run Precision Within-run was determined by assaying capillary collected samples containing various concentrations of Hemoglobin A1c. Each sample was assayed in replicates of two in twenty different runs. Both whole blood (WB) and capillary data are presented for comparison below.
Correlation Coefficient 0.992
Slope .980
Intercept 0.988
DTI Laboratories, Inc.
Technical Bulletin
Capillary Hemoglobin A1c
Performance Characteristics
Capillary Venous
Blood Blood
Call Us: +1.888.872.2443
Between-Run Precision Between-run precision was determined by performing a series of duplicate measurements of two different samples over a series of twenty different runs (n=20). Both whole blood (WB) and capillary blood (CB) are presented.Type your paragraph here.
Total Error DeterminationTotal error is a measurement of the overall analytical performance of an assay, and combines both accuracy and precision. Total error is equal to the % Bias of the DTI Laboratories Hemoglobin Capillary A1c assay was calculated using the linear regression formula, derived from the comparison of the capillary % HbA1c assay versus the comparable whole blood methodology. Total CV = 0.09 (CVC 2 + CV WB 2)½.The results of the total error analysis for the DTI capillary % A1c assay at both normal and highly elevated % A1c levels are presented below.
Mean Standard % Coefficient
% A1c Deviation of Variation (CV) 3.2 (CB) 0.02 .051%
6.0 (CB) 0.01 .059%
14.6 (CB) 0.08 .091%
4.0 (WB) 0.02 .065%
7.6 (WB) 0.011 1.00%
15.0 (WB) 0.085 .069%
Expected Values A population of 165 non-diabetic individuals were analyzed using the capillary % A1c methodology. The expected values generated utilizing these values are presented below.
Lower Limit Upper Limit
of % A1c of % A1c
Expected Values 4.2% 5.9%
Linearity of procedure/methodology
(HPLC-IE Linearity range of assay: 3.2% - 19.2%. Specimen Requirements Capillary blood collection requires 10 μl drop of capillary blood. The blood is placed in a 1 ml vial of EDTA/.025KCN,
Specimen Stability Capillary A1c blood samples are stable for 30 days or more. Samples were tested at a following number of days in transit and thresholds of environmental temperatures.
Mean Capillary Bias
Days % A1c (%)
1 9.0 0.0
5-6 9.0 0.0
7-14 9.0 0.0
15-21 9.1 + 0.1
22-30 9.1 +0.1
Temperature Threshold Study
Temperatureindicator failure strips were applied to sample containers containing two levels of A1c capillary samples. The following demonstrates the results of temperature variation.
Temperature Observed
Indicator Strips % A1c Results Variance
130° F 6.0 5.0 -1.00
125° F 6.0 5.9 - 0.10
130° F 14.0 12.0 - 2.00
125° F 14.0 13.8 .200
- 20° F 6.0 5.3 -0.70
-10° F 6.0 5.8 -.200
- 20° F 14.0 13.2 .800
-10° F 14.0 13.8 .200
% A1c values. Known values at 6.0% and 14.0% were applied.