Bayer HealthCare Clinitek Status Operator's Manual page 122

10
Appendices
Appendix F: CLIA Waiver Performance Characteristics
The following analyte test results were derived from a Physician Office
Laboratory (POL) study conducted at 3 POL sites and 1 clinical laboratory
site. The performance of the Clinitek Status analyzer and Multistix reagent
for these analytes met the primary performance criteria that 90% of the
results should be within +/- one level of the expected result.
TABLE 2 Percent Agreement of Clinitek Status Results to Target Levels
(Bayer Masked Samples) in POL/clinical laboratory settings
Analyte
Bilirubin
Urobilinogen
Clinitek Microalbumin Expected Waiver Performance
To evaluate the expected performance of the Bayer Clinitek Microalbumin
urinalysis product used on the Clinitek Status Analyzer in a CLIA-waived
setting, a lay user field study was performed at three non-laboratory study
sites. The 72 participants represented diverse demographics, had no
previous laboratory experience, and received no training for the study.
Participants were provided with six (6) masked samples consisting of two
replicate samples at each of three albumin concentrations: negative
(0 mg/L), weak positive (35.6 mg/L), and strong positive (179 mg/L). The
lay user results were compared to results using a comparator quantitative
method. A summary of the performance is shown below.
Lay User Results: 431
Lay Users: 72
The overall accuracy rates for microalbumin were:
Negative
Weak Positive
Strong Positive
*One result was omitted due to an error by the study monitor.
Statistical analysis (Fisher's Exact Test) demonstrated that the observed
differences between the three study sites were not significant.
10-22
Exact Agreement (%)
POL-user
96.7
92.6
100% (144/144) with 95% CI: (97.5% - 100.0%)
99.3% (142/143)* with 95% CI: (96.2% - 100.0%)
100% (144/144) with 95% CI: (97.5% - 100.0%)
± One (1) Level (%)
POL-user
100
99.5
132387 Rev. D, 2006-06