Sejoy UA-105, Owner'S Booklet

Page: 43 / 48

Performance Characteristics
The performance of the system has been evaluated both in laboratory and
in clinical tests.
Range: The display range of the meter is 180umol/L to 1190 umol/L
(3mg/dL to 20 mg/dL). "HI" and "Lo" messages indicate results
outside of this range.

•
Accuracy: The accuracy of the system was assessed by comparing
uric acid results obtained using , a
laboratoryinstrument.
Table1. System accuracy results for uric acid concentration <297umol/L
Mindray Chemistry Analyzer
Table2. System accuracy results for uric acid concentration
≥
297umol/L
Within ±60 umol/L
126
/
126
(
100
%)
fall within 60umol/L (1 mg/dL) of the laboratory result.
If the uric acid is below 297umol/L(5mg/dL), the results generally should
If the uric acid is equal to or over 297umol/L
（
5mg/dL), the results
generally should fall within ±20 % of the laboratory result.
Bias
Percentage
(Within ±1mg/dl)
41
Within ±5 % Within ±10 %
92.2%(437/474)
Within ±15 % Within ±20 %
99.4%(471/474) 100%(474/474)
57.0%(270/474)