Henry Schein Urispec Plus - Expected Waiver Performance

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