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| Product Name | Human chorionic gonadotropin test, colloidal gold immunochromatographic method |
| Catalog No. | GI-0092 |
| Description | The human chorionic gonadotropin test is a reagent that uses colloidal gold immunochromatography to test for human chorionic gonadotropin (HCG), which provides rapid diagnostic identification of HCG levels in urine or blood samples in vitro. |
| Detection Principle | Colloidal gold immunochromatography |
| Sample Type | Urine |
| Testing Time | 3-10 min |
| Application | The kit can be used to diagnose early pregnancy, predict the prognosis of preeclampsia, early diagnosis of ectopic pregnancy and auxiliary diagnosis of incomplete abortion. |
| Operating Temperature | Store at 4-30°C. |
| Transportation Condition | Transportation at room temperature. |
Human Chorionic Gonadotropin (HCG) is a glycoprotein hormone exclusively secreted by the trophoblast cells of the developing placenta, serving as the most specific and reliable marker for pregnancy detection. Its biological role is critical in the early stages of gestation: after the fertilized egg implants into the uterine wall (typically 7-10 days post-fertilization), HCG begins to be synthesized and released, gradually increasing to maintain the function of the corpus luteum, support the development of the endometrium, and ensure the normal progression of pregnancy.
In clinical practice, monitoring HCG levels not only aids in confirming pregnancy but also provides valuable insights into various pregnancy-related conditions. For instance:
In normal pregnancy, maternal serum β-HCG (the specific subunit of HCG) concentrations start at 5-25 mIU/mL in the early stages, rise exponentially until around 6 weeks of gestation, reach a peak at 8-10 weeks, then gradually decline from 11-13 weeks and stabilize until delivery.
Abnormal HCG fluctuations often indicate potential issues, such as ectopic pregnancy (where HCG rises more slowly than in normal pregnancy), incomplete abortion (where HCG remains elevated due to residual trophoblastic tissue), or gestational trophoblastic diseases like hydatidiform mole (where HCG levels are abnormally high).
Traditional HCG detection methods, such as radioimmunoassay (RIA) and enzyme-linked immunosorbent assay (ELISA), require specialized laboratory equipment, professional operators, and relatively long detection times (often several hours), making them unsuitable for on-site, rapid testing or home use. The emergence of the colloidal gold immunochromatographic method has addressed these limitations. As a rapid in vitro diagnostic (IVD) technology, it leverages the high specificity of antigen-antibody binding and the colorimetric property of colloidal gold to enable qualitative HCG detection in urine or serum samples. This method has become widely adopted in clinical settings (e.g., primary healthcare facilities, emergency departments) and home self-testing scenarios, revolutionizing the efficiency and accessibility of early pregnancy diagnosis and pregnancy-related disease screening.
Our Human Chorionic Gonadotropin Test (Colloidal Gold Immunochromatographic Method, Cat.No: GI-0092) is developed based on this advanced technology, designed to meet the urgent need for fast, accurate, and easy-to-use HCG detection tools in both professional and consumer markets.
Rapid Detection with Short Turnaround Time: The test delivers results within 3-10 minutes, a significant improvement over traditional methods that take hours. This speed is crucial for early pregnancy confirmation (helping women make timely decisions about prenatal care) and emergency scenarios (e.g., screening for ectopic pregnancy in patients with acute abdominal pain, where quick diagnosis guides treatment).
Broad Sample Compatibility for Flexibility: It is optimized for urine samples, which are non-invasive, easy to collect, and require no pre-processing (e.g., centrifugation). This makes the test ideal for home self-testing, as users can collect samples independently without professional assistance. Additionally, it can be adapted for serum samples (with simple pre-treatment) to meet the needs of clinical settings where more precise detection is required.
User-Friendly Operation for Wide Applicability: No specialized technical skills or complex equipment are needed. The test follows a simple "sample addition + result reading" workflow—users only need to add the sample to the designated well and interpret the result by observing the presence or absence of colored bands (Test Line "T" and Control Line "C") within the specified time. This design ensures accessibility for both healthcare workers in resource-limited areas and ordinary consumers for home use.
Stable Performance Under Convenient Storage Conditions: The test can be stored at 4-30°C, eliminating the need for refrigeration during long-term storage. It also supports room-temperature transportation, reducing logistics costs and risks of performance degradation due to temperature fluctuations. This stability ensures consistent performance even in regions with unstable cold chain infrastructure.
Built-In Quality Control for Result Reliability: Each test strip includes a Control Line ("C") that must appear to validate the test’s effectiveness. If the Control Line fails to develop, it indicates potential issues (e.g., expired reagents, incorrect operation), prompting users to retest with a new kit—this built-in check minimizes the risk of misinterpreting invalid results.
High Specificity to Avoid Misdiagnosis: The test uses a double-antibody sandwich principle targeting both the α and β subunits of HCG. Specifically, it employs colloidal gold-labeled mouse anti-human β-HCG monoclonal antibodies (highly specific to the unique β subunit of HCG) and sheep anti-human α-HCG polyclonal antibodies. This design effectively avoids cross-reactivity with structurally similar hormones (e.g., follicle-stimulating hormone FSH, luteinizing hormone LH, thyroid-stimulating hormone TSH), ensuring that positive results are accurately attributed to HCG and reducing false positives caused by hormone interference.
Cost-Effective Solution for Mass Use: Compared to high-end detection methods like chemiluminescence immunoassay (CLIA)—which requires expensive instruments and reagent kits—the colloidal gold-based test has lower production and usage costs. It is suitable for large-scale application in primary healthcare institutions, community clinics, and home self-testing markets, making rapid HCG detection accessible to more users without compromising quality.
Compact and Portable for On-Site Testing: The test is packaged in small, lightweight formats (e.g., individual foil pouches with desiccants), making it easy to carry. This portability is particularly valuable for scenarios such as on-site medical camps, remote area outreach programs, or personal travel—users can perform the test anytime, anywhere without relying on laboratory facilities.
Compliance with Strict Quality Standards: The product adheres to international IVD quality guidelines (e.g., ISO 13485) and relevant regulatory requirements. Each batch undergoes rigorous quality control testing, including sensitivity verification (ensuring detection of HCG concentrations as low as 25 mIU/mL, consistent with WHO international standards), specificity validation (cross-reactivity with interfering substances <0.01%), and stability testing (shelf life meeting industry benchmarks). This compliance guarantees consistent performance and reliability across batches.
Wide Clinical Utility Beyond Pregnancy Detection: While primarily used for early pregnancy diagnosis, the test also supports auxiliary screening for other conditions. For example, it can help monitor the prognosis of preeclampsia (by tracking HCG trends), assist in diagnosing ectopic pregnancy (when combined with ultrasound), and detect incomplete abortion (by identifying persistent HCG elevation). This multi-functional utility expands its application scope in gynecological clinical practice.
For in vitro diagnostic use.
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