Uncut sheet for Urine Microalbumin ALB Rapid test
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. It must only be used by healthcare professionals.
The Urine Microalbumin (ALB) Rapid Test Device (the "Uncut sheet " format for manufacturing use) is intended for the semi-quantitative detection of human urinary albumin (microalbumin) in human urine specimens.
This test is intended for in vitro diagnostic professional use and serves as an aid in the early screening and detection of incipient nephropathy, particularly in patients with diabetes mellitus or hypertension, who are at increased risk of developing kidney disease
This kit only provides urine microalbumin test results, and results obtained shall be used in combination with other clinical information for analysis.
This product is intended for use by trained healthcare professionals or laboratory personnel.This product is for manufacturing use only and is intended for further processing into final device format.
2. PRODUCT SPECIFICATION
| Model No. | ALB Uncut sheet |
| Methodology | Colloidal Gold |
| Sample Type | Urine |
| Time to Result | 15~20mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 | Remove test device from aluminum foil pouch, lie it on a horizontal workbench, and do a good job in marking. |
| 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. |
| 3 | Interpret result within 10-15 minutes, and detection result is invalid after 15 minutes (see detailed results in result interpretation). |
4.RESULT EVALUATION AND EXPLANATION
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
6.EXHIBITION
