OnSite™ hCG Combo Rapid Test (strip) CE

Catalog No :

CAS Number :

Brand :

Availability :

In Stock

Terms and Conditions
30-day money-back guarantee
Shipping: 2-3 Business Days

    This combination does not exist.

    Place Inquiry

    This combination does not exist.

    Specifications:
    Application Diagnostic Testing
    Storage Temperature Room Temperature
    Product Type Test Kit Forms Kit with Various components
    Product Brand CTK Biotech
    Product Grade Medical grade

    The OnSite hCG Combo Rapid Test (Strip) CE is a lateral flow chromatographic immunoassay designed for the early detection of pregnancy through the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine. This dip strip format allows for quick and convenient pregnancy screening, delivering accurate, visual results in just 5–10 minutes.

    The test is validated for professional use and demonstrates high analytical sensitivity and specificity, with a detection threshold of 12.5 mIU/mL in serum/plasma and 25 mIU/mL in urine. It is ideal for use in clinical laboratories, emergency rooms, outreach clinics, and point-of-care settings.

    Key Features and Benefits

    • Dual Sample Compatibility: Suitable for use with both serum and urine specimens
    • High Sensitivity: Detects hCG levels as low as 12.5 mIU/mL in serum/plasma and 25 mIU/mL in urine
    • Fast Results: Delivers results in 5–10 minutes
    • Clinically Validated:
      • 100% sensitivity and 100% specificity in urine
      • 100% sensitivity and 99.5% specificity in serum
    • High Specificity: No cross-reactivity with hLH, hFSH, or hTSH (up to 1,000 mIU/mL)
    • No Hook Effect: Accurate even at hCG levels up to 500,000 mIU/mL
    • No Interference: Tested against 35 common biological and chemical substances
    • Simple Workflow: Equipment-free, easy to use by minimally trained personnel
    • Long Shelf Life: 24 months under recommended storage conditions

    Kit Packaging Options

    Box Kit Contents (50 Tests)

    • 50 individually sealed foil pouches, each containing:
      • 1 dip strip device
      • 1 desiccant
    • 1 Package insert (Instructions for Use)

    Tube Package (optional format)

    • 1 Tube with dip strip device
    • 1 Desiccant
    • 1 Package insert

    Product Specifications

    AttributeDetails
    Target AnalyteHuman Chorionic Gonadotropin (hCG)
    Detection Limit12.5 mIU/mL (serum), 25 mIU/mL (urine)
    Sample TypesSerum, Urine
    FormatDip Strip Lateral Flow Assay
    Time to Result5–10 minutes
    Accuracy (Urine)100% sensitivity / 100% specificity
    Accuracy (Serum)100% sensitivity / 99.5% specificity
    Shelf Life24 months
    Equipment RequiredNone
    Use ClassificationProfessional IVD use only (not for OTC use)
    Regulatory ComplianceCE Marked

    Applications

    • Early pregnancy screening in clinical labs
    • Rapid pregnancy confirmation in emergency care
    • Outreach and rural maternal health services
    • Point-of-care diagnostics in OB/GYN settings
    • Pregnancy assessment before medical procedures or treatments


    The hCG Combo Rapid Test (Strip) CE is a fast, accurate, and user-friendly diagnostic tool for the early detection of pregnancy in professional healthcare settings. With high analytical performance, dual specimen compatibility, and no requirement for specialized equipment, it’s ideal for clinical, mobile, or field-based environments.

    Product Specification not found.


    Add a Review

    Rate this Product  
    Name *
    Email *

    Your Review *
    30844





    0

    0  Reviews
    (0) 
    (0) 
    (0) 
    (0) 
    (0) 

    Customer Review