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Single-Use Disposible Lancet (100 units)
Single-use Lancet Device is a 2.8mm depth spring-loaded device that punctures the skin to draw up to 40ul of blood using has a 21-gauge metal tip
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.
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.
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.
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.
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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