Product Manual

41
Results of CLIA Waiver Study
A total of nine untrained non-laboratory users from three clinical sites in the US participated in the
study by testing a total of 560 urine samples using the Clarity Urocheck 120C Urine Analyzer over
2 month period. The Clarity Urocheck 120C Urine Analyzer is intended for use in conjunction with
the Clarity Urinalysis Reagent Strips for detection of the following analytes in urine: Glucose,
Blood, Protein, Leukocytes, Nitrite, Bilirubin, Ketone, pH, Specific Gravity, and Urobilinogen. At
each study site, approximately 120 clinical urine specimens were tested by three untrained,
non-laboratory participants: phlebotomist, medical assistants, and ultrasound technician. The
results (WM) were compared with the same specimens tested by professionally trained operators
using Bayer’s Clinitek 500 Urine Chemistry Analyzer (CM).
The CLIA waiver study demonstrated that the following performance data of the Clarity Urocheck
120C Urine Analyzer in the hands of non-technical users when using only the Quick Start Guide.
Bilirubin
Bayer Clinitek 500 Urine Chemistry Analyzer
0 1 2 4
Tota l
Clarity
Urocheck
120C Urine
Analyzer
0
410 8 1 0 419
1
8 15 0 0 23
2
4 12 21 5 42
4
0 1 1 74 76
Total
422 36 23 79 560
The exact agreement between the CM and the WM is 92.9% (520/560) with 95% CI: (90.4%;
94.8%). Agreement within +/- 1 block is 96.1% (538/560) with 95% CI: (94.1%; 97.5%).
Blood
Ba
y
er Clinitek 500 Urine Chemistr
y
Anal
y
zer
0 102580200Total
Clarity
Urocheck
120C Urine
Analyzer
0
191 16 1 0 0 208
10
11 37 4 0 0 52
25
0 14 39 8 0 61
80
0 0 7 35 0 42
200
0 0 0 13 184 197
Total
202 67 51 56 184 560
The exact agreement between the CM and the WM were 86.8% (486/560) with 95% CI: (83.7%;
89.5%). Agreement within +/- 1 block was 95% (532/560) with 95% CI: (92.9%; 96.7%).
Glucose
Ba
y
er Clinitek 500 Urine Chemistr
y
Anal
y
zer
0 100 250 500 1000 Total
Clarity
Urocheck
120C Urine
Analyzer
0
389 4 0 0 0 393
100
4 32 5 0 0 41
250
3 14 45 2 0 64
500
0 0 8 9 1 18
1000
002348 44
Total
396 50 60 45 9 560