Diagnostic kit for Urine Microalbumin Colloidal Gold
1. INTEDED USE
This kit is applicable to semi-quantitative detection of microalbumin in human urine sample (ALB), which’s used for auxiliary diagnosis of early-stage kidney injury. This kit only provides urine microalbumin test results, and results obtained shall be used in combination with other clinical information for analysis.
2. PRODUCT SPECIFICATION
| Model No. | ALB |
| Methodology | Colloidal Gold |
| Sample Type | Urine |
| Time to Result | 10-15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485,CE,MHRA |
| MAIN KIT COMPONENTS: *Test device *solution *Instructions for Use |
Packing: *25 test /kit *Aluminum foil bag labeling *shrink wrap |
3.TEST METHOD
| 1 |
Remove test device from aluminum foil pouch, lie it on a horizontal workbench, and do a good job in marking.
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| 2 |
Use disposable pipette to pipette urine sample in disposable clean container, discard first two drops of urine, add 3 drops (approx. 100μL) of bubble-free urine sample dropwise to well of test device vertically and slowly, and start counting time.
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| 3 |
Interpret result within 10-15 minutes, and detection result is invalid after 15 minutes.
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4.CLINICAL PERFORMANCE
Clinical performance of this product’s assessed through collection of 174 cases of clinical samples. Corresponding marketed kit of turbidimetric inhibition immunoassays used as reference reagent, detection results have been compared and their comparability has been studied through linear regression, and correlation coefficients of the two assays are Y=0.949X + 0.314 and R=0.9855, respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
