The One Step HCG Pregnancy Test Midstream 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 midstream device ensures an extremely high degree of sensitivity and specificity, making it ideal for both clinical medical units and home self-testing.
Engineered for efficiency and reliability, the test delivers accurate results in as little as 3 to 5 minutes, with the capability to detect HCG levels as low as 25mIU/ml (or 10mIU/ml depending on specification). The midstream format provides a convenient, mess-free experience, while the rigorous adherence to CE, ISO, and NMPA certifications guarantees that every test meets the highest international medical standards for diagnostic accuracy.
Detailed Parameters
| Test 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 |
| Material/Format | ABS / Midstream | Cassette Width | 3.0mm to 6.0mm available |
| Shelf Life | 36 months | Storage Temp | 4~ 30°C (Room Temperature) |
Key Advantages
Medical Grade Accuracy
Achieves an accuracy rate of >=99.99% with zero cross-reactivity to hLH, hFSH, and hTSH.
Ultra-Fast Results
Quick reaction time provides a definitive qualitative result within 3 to 5 minutes.
High Sensitivity
Capable of detecting HCG levels as low as 10-25mIU/ml for early pregnancy detection.
Midstream Convenience
ABS material midstream design allows for direct urine sampling without the need for a cup.
Clear Interpretation
High-contrast colloidal gold lines ensure easy reading and eliminate ambiguity.
Certified Compliance
Fully certified by CE, ISO, NMPA, and FSC for global distribution and safety.
Product Gallery
Management Platforms
OEM/ODM Customization
Complete support for buyer's logo branding and customized packaging designs.
Flexible Specifications
Available in multiple widths (3.0mm to 6.0mm) to suit different market preferences.
Bulk Packing Options
Scalable packing from 1 test to 100 tests per box for retail or clinical use.
Quality Control System
Strict ISO-standard quality oversight from reagent preparation to final packaging.
Global Logistics
Optimized supply chain for rapid delivery of diagnostic materials worldwide.
Stability Assurance
Extended 36-month shelf life with moisture-proof foil pouch protection.
Investment Return Comparison
| Feature Metric | Standard Rapid Test | Golden Time Midstream |
|---|---|---|
| Sensitivity Level | 25mIU/ml | Up to 10mIU/ml |
| Detection Speed | 10-15 Minutes | 3-5 Minutes |
| Accuracy Rate | ~98% | >=99.99% |
| User Experience | Cup Required | Direct Midstream |
| Certification | Basic ISO | CE, ISO, NMPA, FSC |
Frequently Asked Questions
The test can detect HCG levels as low as 25mIU/ml, with specific high-sensitivity versions available at 10mIU/ml, allowing for very early detection of pregnancy.
No. The test is designed with high specificity and shows no cross-reactivity with 500mIU/ml of hLH, 1000mIU/ml of hFSH, or 1mIU/ml of hTSH.
Tests should be stored at room temperature between 4°C and 30°C. It is important to avoid direct sunlight to ensure stability until the expiration date.
Yes, the range of application covers all levels of medical units as well as home self-testing, backed by CE and NMPA certifications.
The midstream format is encased in an ABS plastic housing, allowing the user to hold the device directly in the urine stream, eliminating the need for a collection container.
Yes, we offer comprehensive OEM services, including the application of buyer's logos on the device and customized packaging configurations.