Early Pregnancy Test HCG Human Chorionic Gonadotropin urine rapid test

Short Description:

Diagnostic Kit for Human Chorionic Gonadotropin

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 in vitro qualitative detection of human chorionic gonadotropin (HCG) in serum sample,which’s suitable for auxiliary diagnosis of early trimester of pregnancy. This kit only provides human chorionic gonadotropin test results, and results obtained shall be used in combination with other clinical information for analysis.

    2. PRODUCT SPECIFICATION

    Model No. HCG
    Methodology Colloidal Gold 
    Sample Type Urine/Serum 
    Time to Result 10-15mins
    Storage 2~30 ℃/36~86℉
    Shelf Life 24 months
    Certificate ISO13485, CE Certificate, UCKA MHRA Certificate
    AV-7
    AV-6

    MAIN KIT COMPONENTS

    * Test device

    * Sample collection tube

    * Disposable pipette

    * Instructions for Use

    PACKING

    * 25 test /kit

    * Aluminum foil bag labeling

    * shrink wrap

     

    3.TEST METHOD

    4.RESULT EVALUATION AND EXPLANATION

    POSITIVE01 Positive:

    There are two stripes in control area (C) and test area (T).

    Positive result indicates that: content of HCG in sample is higher than 25mIU/mL.

     NEGATIVE-01 Negative:
    There is only one red stripe in control area (C). There’s no red stripe in test area (T).
    Negative result indicates that: content of HCG in sample is lower than 25mIU/mL.
    iNVALID Invalid:
    Failure to show control line C. Invalid result indicates that: it can be caused by incorrect operation process or deteriorated and damaged reagent. Retest shall be conducted in case of invalid result, which shall be operated strictly in accordance with the specification. If the problem still exists, please immediately stop using products of the lot number, and contact local supplier.

    5.CLINICAL PERFORMANCE

    Clinical performance of this product’s assessed through collection of 311 cases of clinical samples. Marketed kit of colloidal gold’s used as reference reagent. The BAYSEN  reagent test will be compared with the control reagent:

    Baysen Result of RV/AV
    Test result of Reference reagent Positive coincidence rate:
    99.40% (95%C.I. 96.69%~99.89%)
    Negative coincidence rate:
    100.00% (95%C.I.97.40%~100.00%)
    Total coincidence rate:
    99.68% (95%C.I.98.20%~99.94%)
    Positive  Negative  Total
    Positive 166 0 166
    Negative  1 144 145
    Total 167 144 311

    6. CERTIFICATE

    * ISO System Certificate

    * CE Certificate

    * EU Registration

    * UCKA MHRA Registration


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