Expected Waiver Performance - Henry Schein Urispec Plus User Manual

User manual Urispec
8. Expected waiver performance
At 3 sites, 66 untrained users with no laboratory experience tested randomized
samples using the Urispec
lyzer. The CLIA waiver study demonstrated that the performance of the Urispec
Plus Urine Analyzer is acceptable in the hands of non-technical users when only
the Quick Reference Guide is used to learn and perform tests. The performance
of the Urispec ® urine test strips with the Urispec
users, met the primary performance criteria that 90% of the results should be
within ± one level of the expected results.
Concentrations
Analyte tested
Ascorbic Acid 0, 10, 20
Bilirubin 0, 1, 4
Blood 0, 10, 250
Glucose 0, 50, 500
Ketone 0, 25, 300
Leukocyte 0, 25, 500
Nitrite Neg, pos
pH 5, 6, 8
Protein 0, 30, 500
Specific Gravity 1.005, 1.010,
1.015, 1.025
Urobilinogen 0.2, 2, 5
Table 1: Percent Agreement of the Urispec
RY SCHEIN masked Samples) for Lay-users
28
Plus
®
urine test strips and the Urispec
®
Exact Agreement
(%) Lay-user
98.5, 92.4, 100
100, 92.4, 100
100, 96.9, 71.2
98.5, 83.3, 100
96.9, 100, 98.5
98.5, 62.1, 100
98.5, 100
98.5, 93.9, 100
100, 98.5, 100
95.5, 81.8, 46.9, 100 1.005, 1.010,
100, 95.5, 98.5
Plus Results to Target Levels (HEN-
®
Manual Urispec
®
Plus Urine Ana-
®
® Plus, in the hands of the Lay-
Exact and ±
One (1) color block
Concentration Level (%) Lay-user
10 96.9
1 95.5
10 96.9
50 100
25 100
25 96.9
100
6 93.9
30 98.5
95.5, 100, 98.5, 100
1.015, 1.025
2 100
Plus V2.01 HS USA / 04-19
®