The One Step HCG Pregnancy Test is a professional-grade, rapid qualitative diagnostic assay designed for the precise detection of Human Chorionic Gonadotropin (HCG) in urine. Utilizing a sophisticated combination of monoclonal dye conjugates and polyclonal-solid phase antibodies, this medical-grade cassette ensures an extremely high degree of sensitivity and specificity for early pregnancy detection.
Engineered for both clinical environments and home self-testing, the device can detect HCG levels as low as 25mIU/ml in under 5 minutes. With a proven accuracy rate of ≥99.99%, it provides reliable, laboratory-quality results through a simple colloidal gold immune chromatographic assay, making it an essential tool for medical units and individual healthcare management.
Detailed Parameters
| Product Name | One Step HCG Urine Pregnancy Test | Brand Name | GOLDEN TIME (OEM Available) |
|---|---|---|---|
| Methodology | Colloidal gold immune chromatographic assay | Sensitivity | 25mIU/ml or 10mIU/ml |
| Accuracy/Specificity | ≥99.99% Accuracy / No cross-reactivity | Reaction Time | 1 - 5 Minutes |
| Cassette Material | High-grade ABS Plastic | Shelf Life | 36 Months |
| Certifications | CE, ISO, NMPA, FSC | Storage Temp | 4~30°C (Room Temperature) |
Key Advantages
Ultra-High Accuracy
Achieves ≥99.99% accuracy using gold-standard monoclonal and polyclonal antibody combinations.
Rapid Results
Fast turnaround with visible results in 3-5 minutes, ideal for urgent clinical or home needs.
Extreme Sensitivity
Detects HCG levels as low as 25mIU/ml, enabling reliable early-stage pregnancy detection.
Zero Cross-Reactivity
No interference from hLH, hFSH, or hTSH, ensuring highly specific diagnostic outcomes.
User-Friendly Design
Simple one-step cassette format with clear reading windows for intuitive result interpretation.
Global Compliance
Fully certified by CE, ISO, NMPA, and FSC for international medical distribution.
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Management Platforms
Flexible Packaging
Customizable box quantities ranging from 1 to 100 tests per box to meet diverse market demands.
OEM/ODM Service
Full support for buyer's logo integration and customized branding for medical distributors.
Quality Control
Strict adherence to ISO and CE standards ensuring every batch meets medical-grade precision.
Supply Chain Stability
High-capacity manufacturing for consistent delivery of consumables and diagnostic kits.
Comprehensive Kits
Each unit includes a dropper, desiccant, and urine cup for a complete testing experience.
Long-Term Stability
Optimized shelf life of 36 months with stable performance under recommended storage conditions.
Investment Return Comparison
| Feature Metric | Standard Generic Tests | Golden Time HCG Test |
|---|---|---|
| Detection Sensitivity | 50mIU/ml | 10-25mIU/ml (Ultra-Sensitive) |
| Accuracy Rate | 95% - 98% | ≥99.99% (Clinical Grade) |
| Result Time | 10 - 15 Minutes | 3 - 5 Minutes (Rapid) |
| Shelf Life | 12 - 24 Months | 36 Months (Extended) |
| Certification | Local Only | CE, ISO, NMPA, FSC (Global) |
Frequently Asked Questions
Our HCG Pregnancy Test cassettes feature an accuracy rate of ≥99.99%, utilizing high-affinity antibodies to ensure clinical-grade precision for both professional and home use.
Due to its high sensitivity (down to 25mIU/ml), this test can detect HCG levels shortly after implantation, typically before or on the first day of a missed period.
No. This device is specifically engineered to have no cross-reactivity with hLH (up to 500mIU/ml), hFSH (up to 1000mIU/ml), or hTSH (up to 1mIU/ml).
Depending on the region, CE, ISO, and NMPA certifications are critical. Our products carry all these certifications, ensuring compliance with international medical safety standards.
The test cassettes should be stored at room temperature (4~30°C) and kept away from direct sunlight to maintain their 36-month shelf life.
Yes, we offer full OEM support, allowing buyers to apply their own brand logo and customized packaging specifications for our rapid test cassettes.