Diagnostic Kit for free β‑subunit of human chorionic gonadotropin

short description:

Diagnostic Kit for free β‑subunit of human chorionic gonadotropin

fluorescence immunochromatographic assay


  • Testing time: 10-15 minutes
  • Valid Time: 24 month
  • Accurancy: More than 99%
  • Specification: 1/25 test/box
  • Storage temperature : 2℃-30℃
  • Methodology: fluorescence immunochromatographic assay
  • Product Detail

    Product Tags

    Diagnostic Kit for Human Chorionic Gonadoteopin (Colloidal Gold)

    Production information

    Model Number HCG Packing 25 Tests/ kit, 30kits/CTN
    Name Diagnostic Kit for free β‑subunit of human chorionic gonadotropin Instrument  classification Class I
    Features High sensitivity, Easy opeation Certificate CE/ ISO13485
    Accuracy > 99% Shelf life Two Years
    Methodology fluorescence immunochromatographic assay OEM/ODM service Avaliable


    Test procedure

     1 Open the aluminum foil bag package of reagent and take out the test device. Horizontally insert the test device into the slot of immune analyzer.
     2 On home page of operation interface of immune analyzer, click “Standard” to enter test interface.
     3 Click “QC Scan” to scan the QR code on inner side of the kit; input kit related parameters into instrument and select sample type.
    4 Check the consistency of “Product Name”, “Batch Number” etc. on test interface with information on the kit marker
    5 After information consistency is confirmed, take out sample diluents, add 20µL of serum sample, and mix well
    6 Add 80µL of above mixed solution into the sample hole of test device.
    7 After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the interface.


    Intend Use

    This kit is applicable to in vitro quantitative detection of free β-subunit of human chorionic gonadotropin (F-βHCG) in human serum sample, which’s suitable for auxiliary evaluation of the risk for women to carry a child with trisomy 21 (Down syndrome) in the first 3 months of pregnancy. This kit only provides free β-subunit of human chorionic gonadotropin test results, and results obtained shall be used in combination with other clinical information for analysis. It must only be used by healthcare professionals.



    F-βHCG is a glycoprotein consists of α and β subunits, which accounts for around 1%-8% of total amount of HCG in mother’s blood. The protein's secreted by trophoblast in placenta, and it's very exnsitive to chromosomal abnormalities. F-βHCG is the most commonly used serological indicator for clinical diagnosis of Down syndrome. In the first 3 months of pregnancy (8 to 14 weeks), women with increased risk of carrying a child with Down syndrome can be also identified through combined use of F-βHCG, pregnancy associated plasma protein-A (PAPP-A) and nuchal translucency (NT) ultrasound.



    •  High sensitive

    •  result reading in 15 minutes

    •  Easy operation

    • Factory direct price



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