ALB Micro-Albumin Rapid Test Device/Strip (Urine)
Product Parameters
| Product Name | ALB Micro-Albumin Rapid Test Device | ALB Micro-Albumin Rapid Test Strip
|
| Used for | For professional in vitro diagnostic use only. | |
| Specimen | Urine | |
| Packing | 25 tests/box , 1 test/polybag | |
| MOQ | 1000 tests | |
| Diverse Coopetation Modes | OEM/ODM | |
PERFORMANCE CHARACTERISTICS
The accuracy of the Microalbumin test was evaluated in comparison to a commercially available immunoassay at a cut-off of 20μg/mL. 100 urine samples, collected from volunteers, have been tested by both procedures with >98% agreement.
Method | Other ALB Rapid Test |
Total Results | ||
| ALB One Step Test Device | Results | Positive | Negative | |
| Positive | 48 | 1 | 49 | |
| Negative | 1 | 50 | 51 | |
Total Results | 49 | 51 | 100 | |
| % Agreement with this Rapid Test Kit | 97.96% | 98.04% | 98.00% | |
B. Reproducibility
The reproducibility of the Microalbumin test was evaluated at 4 different sites using blind
controls. Of 50 samples with albumin concentrations <10μg/mL, all were determined negatives.
Of 50 samples with albumin concentrations >40μg/mL, all were determined positive.
C. Sensitivity
The Microalbumin test has a sensitivity of 20μg/mL urine.
D. Specificity
The specificity for the Microalbumin test was tested by adding various compounds that are likely
to be present in urine. All compounds were prepared in normal human urine with low amounts of
albumin.
