TRUEresult Blood Glucose Monitoring System
Proficiency Testing Information
The objective of proficiency testing is to qualitatively determine the skill of the
user of a specific product and the accuracy of the results obtained using the
product. Participating laboratories receive specimens from a distributor, test the
specimens and report the results back to the distributor. The results of all
participants are summarized in a report that is sent to the participating
laboratories. The report contains an evaluation of the individual laboratory
performance as well as a comparison to a summary of results from other
participating labs.
It is important to be aware that proficiency samples are not fresh blood and may
behave differently on different glucose test systems. The accuracy of the result
from a proficiency sample is not an indicator of the accuracy of your system
when tested with fresh whole blood obtained from a patient. The proficiency
testing only serves to show how your results compare to other TRUEresult
system users. If your proficiency sample results are not within acceptable limits
of other TRUEresult users’ results, then you should investigate possible sources
of testing error such as expiration date and storage conditions for the test strips.
Always perform quality control testing per your facility’s procedures and
policies to make sure your system is working properly. The Owner’s Booklet or
QA Manual will assist you with this process.
The TRUEresult system is optimized to give accurate results with fresh, capillary
whole blood and venous whole blood samples. Venous whole blood samples
must be tested immediately or preserved in a vacutainer tube containing EDTA
(purple top) or heparin (green top). This will preserve the sample for
approximately 30 minutes. Refer to the TRUEresult Owners Booklet and
TRUEtest Strip Instructions for Use for further information.
Resources to learn about and obtain Proficiency Samples:
College of American Pathology (CAP) www.cap.org
American Association of Bioanalysts www.aab.org
TRUEresult
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Quality Assurance / Quality Control Manual
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