Diagnostic kit for Urine Microalbumin Colloidal Gold

Short Description:

Diagnostic Kit for Urine Microalbumin

Methodology: Colloidal Gold


  • Testing time: 15 minutes
  • Storage temperature: 2°C-30°C
  • Valid Time: 24 months
  • Accurancy: More than 99%
  • Specification: 25 test/box
  • Product Detail

    Product Tags

    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
    25-(OH)VD-3
    25-(OH)VD-2
    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.
    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.

    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.

    微信图片_20231211142004

    5. CERTIFICATE

    * ISO System Certificate

    * CE Certificate

    * EU Registration

    * UCKA MHRA Registration


  • Previous:
  • Next:

  • Related Products