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| Product Name | Human chorionic gonadotropin test reagent |
| Catalog No. | GI-0094 |
| Description | Human chorionic gonadotropin (HCG) test reagent is a diagnostic tool for the detection of HCG levels in urine or blood, widely used in early pregnancy testing. Through a specific antigen-antibody reaction, the reagent recognizes and captures the HCG hormone in the sample. The principle is based on immunochromatographic technology, which provides rapid qualitative or quantitative results to assist in determining the status of a pregnancy or screening for certain disease conditions. |
| Sample Type | Urine |
| Testing Time | 3 min |
| Application | This test is designed to qualitatively measure human chorionic gonadotropin levels in specimens in vitro. |
| Operating Temperature | Store at 4-30°C. |
| Transportation Condition | Transportation at room temperature. |
Human Chorionic Gonadotropin (HCG) is a glycoprotein hormone primarily secreted by the trophoblast cells of the placenta during pregnancy, playing a pivotal role in supporting early embryonic development. Its core function is to maintain the secretory activity of the corpus luteum in the ovary during the first few weeks of pregnancy, ensuring a stable hormonal environment for the implantation and growth of the embryo. Clinically, HCG has become an indispensable indicator not only for early pregnancy detection but also for monitoring pregnancy-related health conditions and screening certain diseases.
Physiological Characteristics of HCG: After conception, HCG levels begin to rise as early as 7 days post-fertilization, making it detectable in both blood and urine. The hormone reaches its peak secretion between 8 to 10 weeks of pregnancy, with concentrations ranging from 40,000 to 230,000 IU/L during this period. Following the peak, HCG levels gradually decline and maintain a relatively low, stable range until full-term delivery. This predictable fluctuation pattern forms the basis for using HCG detection in assessing normal pregnancy progression.
Clinical Significance Beyond Pregnancy: While HCG is most commonly associated with pregnancy, abnormal elevations of this hormone can indicate non-pregnancy-related health issues. For example, in females, conditions such as hydatidiform mole (a gestational trophoblastic disease), choriocarcinoma, ovarian dysgerminoma, and immature teratoma may lead to increased HCG levels. In males, elevated HCG can be a marker for testicular cancers like seminoma and testicular teratoma. Additionally, certain non-reproductive system diseases, including liver cancer, lung cancer, pancreatic cancer, and cirrhosis, have also been linked to abnormal HCG secretion. Monitoring changes in HCG levels is therefore crucial for diagnosing these diseases and evaluating the effectiveness of subsequent treatments.
Evolution of HCG Detection Technology: The development of HCG test reagents has evolved alongside advancements in diagnostic technology. Early HCG detection methods were often time-consuming and required complex laboratory equipment, limiting their accessibility. However, with the advent of immunochromatographic technology— the core technology used in our GI-0094 HCG test reagent—detection has become faster, more convenient, and more reliable. This technology leverages specific antigen-antibody reactions to recognize and capture HCG in samples, enabling qualitative or rapid semi-quantitative results. Today, such reagents are widely used in clinical settings (e.g., hospitals, clinics) and even for at-home testing, meeting the diverse needs of healthcare providers and individuals seeking timely pregnancy or health status information.
Market Demand for HCG Test Reagents: The global demand for HCG test reagents continues to grow, driven by several factors. Rising awareness of early pregnancy care has increased the need for fast and accurate at-home pregnancy tests. Meanwhile, in clinical practice, the expanding application of HCG in disease screening (such as for trophoblastic tumors and testicular cancers) has boosted demand for high-performance HCG detection tools in diagnostic laboratories. Additionally, the preference for point-of-care testing (POCT) solutions— which allow for on-site, immediate results—has further highlighted the value of reagents like GI-0094, which combine speed, ease of use, and stability.
Rapid Detection for Timely Results: The GI-0094 HCG test reagent delivers results in just 3 minutes, significantly reducing the waiting time compared to traditional HCG detection methods that may take 15 minutes or longer. This speed is critical for situations where immediate information is needed, such as emergency room evaluations of potential ectopic pregnancy or urgent pregnancy confirmation for women with suspected early pregnancy complications.
Versatile Sample Compatibility with Urine: Designed specifically for urine samples, the reagent eliminates the need for invasive blood collection procedures. Urine sampling is non-painful, easy to perform, and can be done in a private setting (e.g., at home), making the reagent accessible to a wide range of users—from individuals conducting at-home pregnancy tests to healthcare providers in resource-limited clinics where blood sampling equipment may be scarce.
Wide Operating Temperature Range for Enhanced Stability: The reagent can be stored at 4-30°C and transported at room temperature, offering exceptional flexibility in storage and logistics. Unlike some HCG test reagents that require refrigeration (2-8°C) during transportation and long-term storage— which increases shipping costs and risks of temperature-related damage—our product’s stability at ambient temperatures ensures consistent performance even in regions with limited cold chain infrastructure.
Reliable Immunochromatographic Technology: Built on proven immunochromatographic principles, the reagent enables highly specific antigen-antibody binding, minimizing cross-reactivity with other glycoprotein hormones (such as luteinizing hormone, LH, or follicle-stimulating hormone, FSH). This specificity ensures accurate detection of HCG, reducing the likelihood of false-positive or false-negative results that could lead to misdiagnosis or incorrect clinical decisions.
Suitable for Qualitative Early Pregnancy Screening: The reagent is optimized for qualitative measurement of HCG levels, making it ideal for early pregnancy detection. It can identify HCG elevations as early as 7-10 days post-fertilization—when HCG concentrations are still relatively low—allowing users to confirm pregnancy at the earliest possible stage. This early detection supports timely prenatal care initiation and helps identify potential pregnancy-related issues (e.g., threatened miscarriage) in their initial phases.
User-Friendly Operation, No Specialized Training Required: The GI-0094 reagent features a simple, step-by-step operation process that does not require advanced laboratory skills or specialized equipment. Users only need to collect a urine sample, apply it to the designated sample well of the test device, and read the results within 3 minutes based on the appearance of control and test bands. This ease of use makes the reagent suitable for non-professional users (for at-home testing) and healthcare staff in busy clinical environments who need to conduct rapid screenings without extensive training.
Cost-Effective Solution for Both Clinical and Home Use: Compared to high-end quantitative HCG detection kits (e.g., ELISA or chemiluminescent kits) that require expensive instruments and consumables, our immunochromatographic HCG test reagent offers a more cost-effective alternative for qualitative testing needs. It reduces overall testing costs for clinics and hospitals, especially those with high patient volumes for pregnancy screening. For individual users, it provides an affordable option for at-home pregnancy confirmation, eliminating the need for costly laboratory tests.
Exceptional Stability Reduces Wastage: With a storage temperature range of 4-30°C and room-temperature transportation capability, the reagent maintains its performance stability even under less-than-ideal storage conditions. This reduces the risk of reagent degradation due to temperature fluctuations during shipping or storage— a common issue with refrigeration-dependent reagents. As a result, healthcare facilities and distributors experience less product wastage, lowering inventory costs and ensuring a reliable supply of usable reagents.
High Sensitivity for Early Detection: The reagent exhibits high sensitivity to HCG, capable of detecting low concentrations of the hormone that are indicative of early pregnancy. This sensitivity aligns with the clinical need to confirm pregnancy as soon as possible, enabling users to take proactive steps in managing their health (e.g., adjusting medications, avoiding harmful substances) in the early stages of pregnancy. It also helps in the early identification of abnormal pregnancy conditions, such as ectopic pregnancy, where early detection is critical for preventing life-threatening complications.
Compliant with Clinical Diagnostic Standards: The GI-0094 HCG test reagent adheres to strict clinical diagnostic quality standards, ensuring consistent and reliable performance across different batches. Each batch of reagents undergoes rigorous quality control testing, including assessments of sensitivity, specificity, and reproducibility, to meet the requirements of clinical diagnostic applications. This compliance gives healthcare providers confidence in the accuracy of test results, supporting informed clinical decision-making for patient care.
For in vitro diagnostic use.
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