1.Product Name:One Step Gold Rapid Preganacy Screen Tests
3.Packing:50 strips/box
4.Shelf Life:36 months
5.Registration documents are available.
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*The following content is generated by AI and is for reference only.
The product in question is a rapid immunochromatographic assay designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine samples. Its primary purpose is to assist women in determining pregnancy status early, often before a missed menstrual period occurs. By detecting specific hCG levels typically rising above 25 mIU/mL, this test provides a reliable indication of conception within minutes, making it an essential tool for home use and clinical screening settings where immediate results are required.
The device operates on a lateral flow principle, utilizing monoclonal antibodies conjugated with colloidal gold particles. When a urine sample migrates along the nitrocellulose membrane, any present hCG binds to these antibodies, forming a complex that is subsequently captured at the test line, producing a visible colored band. A separate control line ensures the test has functioned correctly by capturing excess conjugate, confirming the validity of the result regardless of hCG presence. Users should strictly follow the provided instructions regarding sample collection, ensuring the dipstick is immersed for the correct duration and placed horizontally to allow proper fluid migration.
Critical precautions must be observed to ensure accuracy. Results should ideally be read within the specified time window, usually between three to five minutes; reading after ten minutes may yield false positives due to evaporation lines. The test is not suitable for diagnosing ectopic pregnancies or monitoring pregnancy progression, as hCG levels can vary significantly in such cases. Furthermore, certain medications containing hCG, such as those used in fertility treatments, can cause false-positive outcomes. Storage conditions are vital; the device must be kept in a cool, dry place away from direct sunlight and extreme temperatures to maintain reagent stability. Expired kits should never be used, as degraded antibodies compromise sensitivity and specificity. While highly effective for initial screening, any positive result should be confirmed by a healthcare professional through serum testing or ultrasound examination for definitive medical diagnosis and appropriate prenatal care planning.