Arkray PU-4010 - Performance Characteristics; Analytical Performance; Clinical Performance

PU-4010 6-2
6-2-1 Analytical Performance
6-2-2 Clinical Performance
In the PocketChem UA PU-4010 system, the measurement results of pH, Creatinine and
Specific Gravity are used to assist the judge of other measurement items. The measurement
result of ALB is used clinically using the calculation result A / C ratio with CRE. Therefore,
Positive Percent Agreement, Negative Percent Agreement, Overall Percent Agreement about
pH, Creatinine, Specific Gravity and Albumin are not described.
[A/C ratio] vs. Quantitative measurement system H7070
[Other than A/C ratio] vs. AUTION MAX AX-4280
Item Specifications (Product specifications)
Accuracy Within 2 ranks of semi-quantitative sign
Reproducibility System: SD of all items shall be equal to or less than 3%
Analyte
Positive Percent
Agreement
Negative Percent
Agreement
Overall Percent
Agreement
Glucose 98 100 100
Protein 95 99 99
Bilirubin 100 100 100
Urobilinogen 100 100 100
Blood 100 99 99
Ketones 100 100 100
Nitrite 95 100 100
Leukocytes 94 99 99
P/C ratio 88 78 82
A/C ratio 84 91 89
6-2 Performance Characteristics