| 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 |
Summary 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.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.
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. |
Diagnostic Kit for Luteinizing Hormone (Fluorescence Immunochromatographic Assay)
Diagnostic Kit for Human Chorionic Gonadotropin (fluorescence immunochromatographic assay)
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