The One Step HCG Pregnancy Test is a professional-grade, rapid qualitative assay designed for the precise detection of Human Chorionic Gonadotropin (HCG) in urine samples. Utilizing a sophisticated combination of monoclonal dye conjugates and polyclonal-solid phase antibodies, this diagnostic tool ensures an extremely high degree of sensitivity and specificity, making it an essential asset for both clinical environments and home self-testing.
Engineered for efficiency and accuracy, this colloidal gold immune chromatographic assay can detect HCG levels as low as 25mIU/ml (or 10mIU/ml depending on specification) in under 5 minutes. With a verified accuracy rate of ≥99.99%, it provides reliable results without cross-reactivity with other hormones such as hLH, hFSH, and hTSH, ensuring a trustworthy diagnostic experience for medical units and end-users worldwide.
Detailed Parameters
| Methodology | Colloidal gold immune chromatographic assay | Sensitivity | 25mIU/ml or 10mIU/ml |
|---|---|---|---|
| Accuracy | ≥99.99% | Reaction Time | 1-5 minutes |
| Reading Time | 3-5 minutes | Specimen Type | Urine |
| Strip Material | Paper + PVC | Available Widths | 2.5mm to 6.0mm |
| Shelf Life | 36 months | Certifications | CE, ISO, NMPA, FSC |
Key Advantages
Ultra-High Accuracy
Verified accuracy of ≥99.99% ensures reliable results for critical pregnancy screening.
Rapid Results
Get a definitive qualitative result in just 3 to 5 minutes, reducing patient waiting time.
High Sensitivity
Detects HCG levels as low as 10mIU/ml, allowing for early detection of pregnancy.
Zero Cross-Reactivity
No interference from hLH, hFSH, or hTSH, eliminating false positive risks.
Easy Interpretation
Clear visual readouts via the strip format, suitable for both experts and home users.
Global Certification
Fully compliant with CE, ISO, NMPA, and FSC standards for international distribution.
Product Gallery
Management Platforms
OEM Branding
Complete support for Buyer's logo integration and custom brand packaging.
Flexible Specs
Available in multiple strip widths from 2.5mm to 6.0mm to suit your needs.
Versatile Packing
Options ranging from 1 to 100 tests per box for retail or wholesale.
Quality Assurance
Strict adherence to ISO and CE standards for every production batch.
Supply Chain
Stable inventory of reagents and consumables for rapid global shipping.
Storage Support
Long-term stability at 4-30°C with protective foil pouch packaging.
Investment Return Comparison
| Metric | Standard Test Strips | Golden Time HCG Strips |
|---|---|---|
| Detection Limit | 25mIU/ml | Up to 10mIU/ml |
| Result Speed | 10-15 Minutes | 3-5 Minutes |
| Accuracy Rate | ≥95% | ≥99.99% |
| Cross-Reactivity | Low | Zero (hLH/hFSH/hTSH) |
| Certification | Basic ISO | CE, ISO, NMPA, FSC |
Frequently Asked Questions
Our test strips are available in sensitivities of 25mIU/ml and 10mIU/ml, allowing for highly accurate and early pregnancy detection.
The reaction occurs within 1-5 minutes, and the final result should be read between 3-5 minutes for maximum accuracy.
No. It shows no across-reactivity with 500mIU/ml of hLH, 1000mIU/ml of hFSH, and 1mIU/ml of hTSH, ensuring high specificity.
Our products are certified by CE, ISO, NMPA, and FSC, meeting stringent international quality and safety standards for medical diagnostic devices.
Store the strips at room temperature (4~30°C) and avoid direct sunlight. They remain stable until the expiration date imprinted on the pouch.
Yes, the range of application includes all levels of medical units as well as home self-testing due to the simple operation and clear results.