Product Manual

39
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
Pro Advantage
®
Urine Analyzer over 2
month period. The Pro Advantage
®
Urine Analyzer is intended for use in conjunction with the Pro
Advantage
®
Urine 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 Pro Advantage
®
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
Total
0
410 8 1 0 419
1
8 15 0 0 23
2
4 12 21 5 42
Pro
Advantage
®
Urine
Analyzer
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 10 25 80 200 Total
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
Pro
Advantage
®
Urine
Analyzer
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
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
Pro
Advantage
®
Urine
Analyzer
1000
002348 44
Total
396 50 60 45 9 560