Appendix F: Clia Waiver Performance Characteristics - Bayer HealthCare Clinitek Status Operator's Manual

10 Appendices

Appendix F: CLIA Waiver Performance Characteristics

The Clinitek Status received CLIA waiver status (42 CFR 493) for the
entire urinalysis menu in 2005. Clinitek Microalbumin required a separate
CLIA Waiver submission for use on the Clinitek Status. All additional tests
using new urinalysis chemistries or new immunoassay analytes will
require Clinitek Status system CLIA Waiver approval.
Clinitek Multistix Expected Waiver Performance
At 3 sites, 75 untrained users with no laboratory experience, tested
randomized samples using Bayer Multistix reagent strips and 35
Clinitek Status urinalysis analyzers. The CLIA waiver study demonstrated
that the performance of the Clinitek Status analyzer is acceptable in the
hands of non-technical users when only a Quick Reference Guide is used
to learn and to perform tests.
The performance of the Bayer Multistix reagent strips with the
Clinitek Status analyzer, in the hands of LAY-users, met the primary
performance criteria that 90% of the results should be within +/- one level
of the expected result.
TABLE 1 Percent Agreement of Clinitek Status Results to Target Levels
(Bayer Masked Samples) tor LAY-users
Analyte
Blood (occult)
Creatinine
Glucose
Ketone
Leukocyte
Nitrite
pH
Protein
Specific Gravity
132387 Rev. D, 2006-06
Exact Agreement (%)
LAY-user
96.6
66.8
87.6
92.7
92.8
100
87.8
90.9
58.4
± One (1) Level (%)
LAY-user
98.8
97.8
99.5
99.9
99.9
100
99.5
100
96.7
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