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Re: [IP] Accuracy of DEX

There may be standards but many of us have tried different glucose machines
and find there are too many differences to make us comfortable about using
I think the proof is in the use..:)

At 09:13 AM 03/30/2000 -0500, you wrote:
><< Professional mode = ON >>
>All home glucose meters fall into the regulatory category of waived
laboratory tests under the Clinical Laboratory Improvement Amendments of
1988 (CLIA88).  In order for a test procedure to qualify for this category,
it must meet certain minimum criteria.  First, the instructions for use of
the device must be understood and followed unassisted by someone with a
seventh grade education; and second, the device must be return results
within five percent (5%) of a standard value (i.e. a comperable non-waived
laboratory test) half of the time.  Unofficially, the required accuracy is
considered to be overall within 20% of that standard.  Of course, the
appropriate conversion must be applied for comparing meters that return a
blood glucose measurement against the serum glucose measured by non-waived
laboratory tests.
>All, repeat all, meters must meet these requirements.  If a meter is not
advertized at being more accurate than other meters (there is one -- the
Precision claims accuracy within 3% instead of 5%), then you can reasonably
expect to have this accuracy with your meter.  
><< Professional mode = OFF >>
>Manufacturers are very careful that there be no body of evidence built
that their meter does not meet the above criteria.  If that could be
demonstrated, then the FDA would pull their approval for marketing as a
waived laboratory test under CLIA88.  As a result, they generally have
*very* liberal replacement policies.  If you suspect your meter is not as
accurate as the above criteria require, a telephone call (with *some*
evidence, of course) will, more often than not, get you a replacement meter.
>Also, the choice of meters generally can be made based on matters other
than accuracy and precision.  If you like the features of one, or the ease
of use of another, or (as in my case) your insurance will support only one
meter, then that is the basis you should use for your decision.  
>While it is possible that an occasional meter may give problematic
readings, it is also highly probable that varied readings are be an
accurate reflection of your blood glucose.  I encourage you not to discount
widely swinging readings as just a problem with your meter.
>Jim Handsfield
>Division of Laboratory Systems, Public Health Practice Program Office
>Centers for Disease Control and Prevention
>Home: email @ redacted
>Work: email @ redacted
>The opinions expressed are mine and do not necessarily reflect those of
the Centers for Disease Control and Prevention, the U. S. Public Health
Service, or any other agency of the United States Government.
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