The LabStrip U mALB/CREA urine test strips are in vitro medical diagnostic devices intended for professional use.
The urine test strips were designed for the semi-quantitative determination of albumin and creatinine in fresh human urine and the screening of samples for microalbuminuria. LabStrip U mALB/CREA is intended to be used as a screening test for the detection of pathologies associated with kidney diseases.
Each test strip contains 2 test zones, which incorporate sensitive chemicals. If these zones come into contact with urine, a chemical reaction takes place, which results in the discoloration of the test zone.
Table No. 1: Measurement ranges of the albumin and creatinine test zones
|
Parameters |
Categories |
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|
Albumin (mg/L) |
10 |
30 |
80 |
150 |
500 |
|
Creatinine (mg/dL) |
10 |
50 |
100 |
200 |
300 |
|
Compensation zone |
Only used if the evaluation is performed by a medical device. |
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Table No. 2: Interpreting the albumin/creatinine ratio
|
|
Creatinine |
|||||
|
A (10 mg/dL) (0.9 mmol/L) |
B (50 mg/dL) (4.4 mmol/L) |
C (100 mg/dL) (8.8 mmol/L) |
D (200 mg/dL) (17.7 mmol/L) |
E (300 mg/dL) (26.5 mmol/L) |
||
|
Albumin |
1 (10 mg/L) |
X |
Normal |
Normal |
Normal |
Normal |
|
2 (30 mg/L) |
Highly Abnormal |
Abnormal |
Normal |
Normal |
Normal |
|
|
3 (80 mg/L) |
Highly Abnormal |
Abnormal |
Abnormal |
Abnormal |
Normal |
|
|
4 (150 mg/L) |
Highly Abnormal |
Highly Abnormal |
Abnormal |
Abnormal |
Abnormal |
|
|
5 (500 mg/L) |
Highly Abnormal |
Highly Abnormal |
Highly Abnormal |
Abnormal |
Abnormal |
|
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