Getein Bita-HCG POCT Test Device
Intended Use
Bita-HCG Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of human chorionic gonadotropin (HCG) in human serum or plasma samples.
About HCG+β
Human chorionic gonadotropin (HCG) is a glycoprotein hormone produced by the placenta, a component of the fertilized egg, after conception. The biologically active hormone (intact HCG) is composed of noncovalently linked α and β subunit. The alpha subunit is similar to hormone (LH), follicle-stimulating hormone (FSH), thyroid-stimulating hormone (TSH). Whereas beta subunit is unique to HCG and confers its biological and immunological specificity. During a normal pregnancy, HCG level can be detected soon after conception. lt will double every 72 hours and reach its peak in the first 8~11 weeks of pregnancy.
Specifications
| Test Item | Sample | Method | Storage Condition |
| HCG+β | S/P | Immunofluorescence
Assay |
4-30℃ |
| Detection Range | Test Time | Cut-off Value | Shelf Life |
| 5.0~100000.0 mlU/ml | 10 min | Refer to User Manual | 24 months |
Clinical Application
1. HCG measurement with blood or urine can be used as an aid in pregnancy test.
2. Elevated values of HCG during pregnancy are indicative of chorionic carcinoma, hydatiform mole, or multiple pregnancy.
3. Bita-HCG measurements can also be used in conjunction with other parameters during the second trimester of pregnancy to assess the risk of trisomy 21 (Down syndrome).

Key Features:
- Rapid and convenient: Provides results in just 5 minutes, making it ideal for quick pregnancy testing at the point of care.
- Simple and user-friendly: Requires minimal training for operation, suitable for use in various settings like clinics, pharmacies, and even at home.
- Portable and compact: Weighs approximately 250 grams and measures around 160mm x 80mm x 24mm, easily fitting into a bag or carrying case for convenient transportation.
- Reliable and accurate: Utilizes immunofluorescence assay technology for accurate hCG-Beta measurement, meeting international quality standards.
- High sensitivity: Detects hCG-Beta levels as low as 25 mIU/mL, making it suitable for early pregnancy detection.
- Wide measuring range: Measures hCG-Beta levels up to 50,000 mIU/mL, covering various pregnancy stages.
- Multiple sample types: Supports whole blood, serum, and plasma samples, offering flexibility for sample collection.
- Cost-effective: Requires minimal maintenance and uses single-use cartridges, reducing operational expenses.
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