The One Step HCG Pregnancy Test is a professional-grade, rapid qualitative immunoassay designed for the precise detection of Human Chorionic Gonadotropin (HCG) in urine samples. By utilizing a sophisticated combination of monoclonal dye conjugates and polyclonal solid-phase antibodies, this diagnostic tool ensures an extremely high degree of sensitivity and selectivity, making it an essential asset for both clinical diagnostics and home self-testing.
Engineered for efficiency and reliability, the test delivers accurate results in as little as 3 to 5 minutes. With a detection threshold as low as 25mIU/ml (and options for 10mIU/ml), it provides early and dependable pregnancy confirmation. This medical device is manufactured under strict quality controls, holding CE, ISO, NMPA, and FSC certifications to guarantee international safety and performance standards.
Detailed Parameters
| Methodology | Colloidal gold immune chromatographic assay | Specimen Type | Urine |
|---|---|---|---|
| Sensitivity | 25mIU/ml or 10mIU/ml | Accuracy | ≥ 99.99% |
| Reaction Time | 1 - 5 minutes | Reading Time | 3 - 5 minutes |
| Cassette Material | High-quality ABS Plastic | Available Specs | 2.5mm / 3.0mm / 4.0mm / 5.0mm |
| Shelf Life | 36 months | Storage Temp | 4 ~ 30°C (Room Temperature) |
Key Advantages
Ultra-High Accuracy
Achieves a precision rate of ≥ 99.99%, ensuring reliable results for medical units and end-users.
Rapid Turnaround
Provides definitive qualitative results within 3-5 minutes, reducing patient anxiety and wait times.
Superior Sensitivity
Detects HCG levels as low as 25mIU/ml, allowing for early pregnancy detection with confidence.
Zero Cross-Reactivity
No interference from hLH, hFSH, or hTSH, eliminating false positive results from similar hormones.
Clear Visual Read
The high-contrast colloidal gold line provides an unambiguous visual result for easy interpretation.
Certified Quality
Fully compliant with CE, ISO, NMPA, and FSC standards for global pharmaceutical distribution.
Product Gallery
Management Platforms
OEM Customization
Full support for Buyer's logo and customized branding to align with your corporate identity.
Flexible Packaging
Multiple packing options from 1 to 100 tests per box to suit retail or clinical needs.
Quality Assurance
Rigorous batch testing ensuring stability and accuracy across all 36 months of shelf life.
Regulatory Support
Comprehensive documentation provided for CE, ISO, and NMPA regulatory compliance.
Supply Chain Stability
Scalable production capacity for rapid test cassettes to meet urgent global market demands.
Kit Integration
Complete kits provided including dropper, urine cup, and detailed package inserts.
Investment Return Comparison
| Performance Metric | Standard Rapid Tests | Our HCG Cassette | Business Value |
|---|---|---|---|
| Accuracy Rate | 95% - 98% | ≥ 99.99% | Reduced False Results |
| Detection Limit | 50 mIU/ml | 10 - 25 mIU/ml | Earlier Diagnosis |
| Read Time | 10 - 15 mins | 3 - 5 mins | Higher Patient Throughput |
| Cross Reactivity | Moderate Risk | Zero Reactivity | Medical Grade Reliability |
| Certifications | Partial/Local | CE, ISO, NMPA, FSC | Global Market Access |
Frequently Asked Questions
Our HCG test is available in sensitivity levels of 25mIU/ml and 10mIU/ml, allowing for the detection of early pregnancy stages with high precision.
No. The test is specifically designed with no cross-reactivity against 500mIU/ml of hLH, 1000mIU/ml of hFSH, and 1mIU/ml of hTSH.
They should be stored at room temperature (4~30°C) and kept away from direct sunlight to maintain stability until the expiry date.
Yes, we provide professional OEM services allowing you to apply your own logo and customized packaging for commercial distribution.
Our HCG cassettes are fully certified by CE, ISO, NMPA, and FSC, ensuring they meet strict international medical device standards.
The reaction starts in 1 minute, and the final results should be read between 3 to 5 minutes for maximum accuracy.