Table 5.
Calculation of the trueness according to the European Urinalysis Guidelines2
| Parameter | Test strip | FP at LD | FN in LG | FN at LC |
|---|---|---|---|---|
| Glucose | 50mg /dL | 50‐250mg /dL | >250mg /dL | |
| UC‐11A | 40.0% (6/15) | 0.0% (0/20) | ND | |
| Protein | <30mg /dL | 30‐150mg /dL | >150mg/dL | |
| UC‐9A | 37.5% (6/16) | 44.7% (17/38) | 23.1% (3/13) | |
| UC‐11A | 43.8% (7/16) | 44.7% (17/38) | 38.5% (5/13) | |
| Hemoglobin peroxidase | <25 cells/µL | 25‐125 cells/µL | >125 cells/µL | |
| UC‐9A | 10.7% (30/280) | 28.1% (9/32) | 2.9% (1/35) | |
| UC‐11A | 11.4% (32/280) | 28.1% (9/32) | 2.9% (1/35) | |
| Leukocyte esterase | <25 cells/µL | 25‐125 cells/µL | >125 cells/µL | |
| UC‐9A | 8.3% (22/265) | 31.8% (14/44) | 5.3% (2/38) | |
| UC‐11A | 7.2% (19/265) | 31.8% (14/44) | 2.6% (1/38) | |
| Albumin | <20mg /dL | 20‐100mg /dL | >100mg /dL | |
| UC‐11A | 10.0% (11/110) | 25.5% (12/47) | ND | |
| Creatinine | <150mg /dL | 150‐250mg /dL | >250mg /dL | |
| UC‐11A | 10.8% (10/93) | 8.3% (1/12) | 33.3 (1/3) |
In brackets, the absolute numbers of samples are displayed.
FP, false positive; FN, false negative, LD, detection limit; LG, limit grey zone; LC, confirmation limit; ND, not determined.