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Re: [IP] Comparison of Lifescan One Touch Ultra to One Touch Profile
Andrew Aronoff <email @ redacted> wrote:
> ...except, IMHO, to identify those of unacceptable accuracy, per my 1991
But that's exactly what is inappropriate. Meters aren't designed nor are
they approved to be tested against each other. The standard for accuracy
and precision is set by CMS (formerly known as HCFA) on recommendation by
the Standards Branch, Division of Laboratory Systems, Public Health Practice
Program Office of the Centers for Disease Control and Prevention*. That
standard - the same for all "waived" lab tests - is that the readings be
within 5% of a laboratory standard (i.e. a moderate complexity test done in
an approved lab) 50% of the time. That works out to approximately +/- 20%.
With that much acceptable variability, comparisons between meters **cannot**
statistically provide valid bases for comparison.
The only way for an individual to obtain anything near an acceptable test of
their meter(s) (other than using the test control solution) is to do their
own test at the same time as a tube is drawn for a lab test done by the
method I mentioned above . . . and then compare the results. And even then,
if it's outside the 5% range, that's only one test. It must be done many
more times before one will have sufficient data to make a legitimate
Now if, for any reason, you suspect your meter is not as accurate or as
precise as you think it should be, call the manufacturer. They generally
have very liberal replacement policies.
*For those who may not know, I work in the Information Systems Activity,
Office of the Director of the aforementioned Division of Laboratory Systems.
I have done some of the statistical work to assist the Standards Branch.
email @ redacted
The opinions expressed are mine and do not necessarily represent those of my
wife who runs our house and makes more important decisions than I do.
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