TRUE METRIX
®
PRO Professional 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 TRUE METRIX
®
PRO
System users. If your proficiency sample results are
not within acceptable limits of other TRUE METRIX
®
PRO 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
Comprehensive Resource Guide assists you with this
process.
The TRUE METRIX
®
PRO 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 sodium
heparin blood only (green top). This preserves the
sample for approximately 30 minutes. Refer to the
TRUE METRIX
®
PRO Owners Booklet and TRUE
METRIX
®
PRO Test Strip Instructions for Use for
further information.
TRUE METRIX
®
PRO System Comprehensive Resource Guide (GDH-FAD Enzyme)
Resources to learn about and obtain proficiency
samples:
• College of American Pathology (CAP) www.cap.org
• American Association of Bioanalysts www.aab.org
Proficiency Testing
Information
Содержание True Metrix Pro
Страница 3: ...Introduction...
Страница 9: ...System Components...
Страница 16: ...Clinical Information...
Страница 21: ...Meter Setup Quality Control Testing...
Страница 29: ...Blood Glucose Testing...
Страница 32: ...Diabetes Data Management Capabilities...
Страница 37: ...System Maintenance...
Страница 43: ...Training Program...
Страница 53: ...References...
Страница 55: ...Appendix A Clinical Studies Note Available for download at www niprodiagnostics com...
Страница 57: ...Appendix C Safety Data Sheets...
Страница 60: ...Appendix D Forms...
Страница 62: ...Appendix E Proficiency Testing Information...