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BioSafe Laboratories, Inc.
Hemoglobin A1c Test
Dried Blood Spot Hemoglobin
A1c Assay
Performance Characteristics
Within-Run Precision
Within-run precision was determined by assaying dried blood spots containing
various concentrations of Hemoglobin A1c. Each of the dried blood spot
specimens was assayed in replicates of two in twenty different runs. The data
are presented below.
| Mean (% High A1c) |
Standard Deviation | % Coefficient of Variation |
| 5.0 (DBS) 7.6 (DBS) |
0.11 0.11 |
3.3% 2.6% |
Between-Run Precision
Between-run precision was determined by a series of duplicate measurements
of two different samples over a series of twenty different runs (n=20). The data
are presented below.
| Mean (% High A1c) |
Standard Deviation | % Coefficient of Variation |
| 5.0 (DBS) 7.6 (DBS) |
0.21 0.26 |
4.4% 3.5% |
Accuracy
Paired EDTA whole blood and capillary dried blood spot samples containing
varying concentrations of Hemoglobin A1c were analyzed. Percent Hemoglobin A1c concentrations observed for the dried blood spot specimens versus EDTA
whole blood were analyzed by linear regression.
| N=110 | ||
| Correlation Coefficient = 0.98 | ||
| Slope = 0.95 | ||
| Intercept = 0.43 | ||
| Dried Blood %Hgb A1c |
Comparable Whole Blood Methodology |
|
| Mean %HgbA1c | 7.3 | 7.3 |
| %HgbA1c Range | 4.0% - 12.3% | 4.4% - 12.8% |
| Standard Deviation %Hgb A1c |
2.1 | 2.0 |
Expected Values
A population of ninety-one apparently healthy persons was analyzed using
the dried blood % Hgb A1c methodology. The expected values generated
utilizing these values are presented below.
| Lower Limit % Hgb A1c |
Upper Limit % Hgb A1c |
|
| Expected Values | 3.80% | 5.90% |
Specimen
Requirements
The BioSafe Laboratories Dried Blood Spot Hemoglobin
A1c Assay
requires three (3) 50uL drops of capillary whole blood placed onto a
specialized paper card. The blood is dried and placed into a waterproof
outer envelope for shipping via regular mail to BioSafe Laboratories for
testing.
Specimen
Dried blood spot Hemoglobin
A1c specimens are stable for more than 28
days when stored at or below 37 degrees centigrade and for greater than 3
months when stored at -20 degrees C.
Convenient and Simple to Administer
Simple instructions guide the patient through self-collection of a capillary
blood sample onto a collection card using a finger lancet. The BioSafe
Hemoglobin A1c Detection System requires only four simple steps:
Collection kit provided to patient.
Patient applies blood sample onto card
Blood sample sent to BioSafe Laboratories in provided wager.
Hemoglobin A1c results returned within days.
Dried Blood Hemoglobin
A1c: Specimen
Stability Evaluation.
Blood with varying levels of endogenous Hemoglobin A1c was spotted onto specialized paper cards, dried and stored in specimen return bags identical to those provided with the BioSafe Laboratories Hemoglobin A1c Collection Kit
The blood spots were subjected to a variety of harsh storage conditions over a period of 30 days. Periodic analysis was performed on the dried blood specimens, the results of which were compared to the original dried blood hemoglobin A1c value.
Storage Conditions
Blood spots were stored for alternating 12
hour periods at 50
degrees C and -20 degrees C to
determine the effects of multiple freeze
thaw cycles and exposure to high
temperatures.
Blood spots were stored in a humidity chamber at 34 degrees C to determine the effects of moisture on the specimen and packaging,
Results
No statistically significant change was observed over the length of the study regardless of storage conditions. The data is graphically presented.
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