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KidneyScreen At Home Accuracy and Reliability
KidneyScreen At Home has been studied using normal and diabetic adult subjects. In comparing results to a clinical laboratory method using liquid urine samples, the dried urine samples were found to be 98% accurate
The correlation on 80 samples tested using KidneyScreen At Home vs. testing on liquid samples in the laboratory when kits were used by patients was y = 1.013x-3.65;r=0.980
Other studies compared results from a dry urine sample collected in a doctors office to results from a second dry urine sample obtained within a few days by the same patients at home. Both samples were mailed to our laboratory for testing. Results were comparable.
FlexSite Diagnostics has performed extensive studies on mailing conditions, finding that the dried urine specimens are stable under typical mailing conditions, even at extreme temperatures up to 130 degrees F. The dried urine samples remain stable up to 18 days.
KidneyScreen At Home was cleared by the FDA (Food and Drug Adminstration) for at-home and in-office use in August 2000 (#K001810).
FlexSite's Laboratory is licensed under CLIA as well as in Florida, NewYork, Pennsylvania, Maryland and Rhode Island, which require additional licensing.
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