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RE: [IP] One Touch Ultra and varying consecutive readings - comme nts?

Curtis Lomax [mailto:email @ redacted] wrote:

> How does the precision of the Ultra compare with that of other meters?

<< Professional mode = ON >>

I guess it's time to review again just what the standards are for all waived
laboratory tests.

First of all, waived means that the device or process is not subject to the
requirement to meet proficiency testing standards under the Clinical
Laboratories Improvement Amendments of 1988 (CLIA88) which mandated the
establishment of quality standards for laboratories, and further mandated
the development of mechanisms for assuring those standards.  They went into
full effect in 1994.  In order for a laboratory test to be waived, it must
meet two principal criteria (other than the general efficacy - that is it
tests what it is designed to test): 1) the instructions must be written and
followable by someone with a seventh grade education without further
training; and 2) the results of the test must be within 5% of a standard
laboratory test 50% of the time.

This standard applies to *ALL* waived tests, including glucose meters, the
Minimed's CGMS, rapid HbA1c test (those that are done in a doctor's office
that returns results in a few minutes), rapid fructosamine tests, rapid
cholesterol tests, and probably 50% of the systems currently on the market
designed for use in a physician's office.

This standard of accuracy and precision is approximated as +/- 20%, and is
the same for all meters.  About a year and a half ago, one manufacturer
advertised that its meter met a tighter standard for accuracy and precision
(sorry, I don't recall which).  For whatever reason, that ad was pulled
after a couple of months, and there have been no further claims of that sort
by any manufacturer.

So when selecting a meter, choose one that has the features you like, since
they all meet the same accuracy and precision standards.  

James Handsfield
Division of Laboratory Systems
Public Health Practice Program Office
Centers for Disease Control & Prevention
email @ redacted / (770)488-8106
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