HCG Pregnancy Rapid Test
High-sensitivity colloidal gold lateral flow immunoassay for early detection of human chorionic gonadotropin (HCG) in urine. Available in cassette, strip, and midstream formats.
Cassette / Strip / Midstream
3-5 minutes
50,000 tests
24 months
Product Specifications
| Format | Cassette / Strip / Midstream |
| Sample Type | Urine |
| Accuracy | >99% accuracy from expected period date |
| Reading Time | 3-5 minutes |
| Storage | 2-30°C |
| Shelf Life | 24 months |
| Methodology | Lateral Flow Immunoassay (Colloidal Gold) |
Testing Methodology
This product uses lateral flow immunoassay (LFIA) technology with colloidal gold conjugates. The immunochromatographic test strip provides rapid qualitative detection through antigen-antibody reactions. When the sample is applied, it migrates along the membrane by capillary action, interacting with pre-coated reagents to produce visible colored lines indicating the result. No laboratory equipment is required.
Product Details
Product Overview
The Golden Time HCG Pregnancy Rapid Test is a qualitative immunochromatographic assay for the early detection of human chorionic gonadotropin (HCG) in urine specimens. Using colloidal gold lateral flow technology with high-sensitivity antibodies, this test can detect pregnancy as early as 6-8 days after conception, before the first missed period.
Sensitivity Options
- Standard sensitivity: 25 mIU/mL (detects from expected period date)
- High sensitivity: 10 mIU/mL (early detection, 6 days before missed period)
Available Formats
- Cassette — Professional housing for clinic use
- Strip — Cost-effective bulk testing option
- Midstream — Consumer-friendly, no cup required
- Digital — Clear “Pregnant” / “Not Pregnant” display (coming soon)
Intended Use
This pregnancy rapid test is designed for:
- Pharmacy retail consumer sales
- Private clinic point-of-care testing
- Hospital obstetrics and gynecology departments
- Fertility clinic patient screening
- E-commerce health product distribution
- Consumer home testing
Key Features
- Early detection — 10 mIU/mL sensitivity detects pregnancy up to 6 days early
- Fast results — Clear results in 3-5 minutes
- Easy to use — One-step procedure, no special equipment
- Over 99% accurate — When used from the day of expected period
- Compact packaging — Individually foil-pouched for freshness
- Long shelf life — 24 months stability
Test Procedure
For midstream format: Remove cap, hold absorbent tip in urine stream for 5-10 seconds, replace cap, lay flat and read results in 3-5 minutes. Two lines indicate pregnant, one control line indicates not pregnant.
Target Users
Suitable for both professional use in clinical settings and consumer self-testing at home. The midstream format is particularly popular for retail pharmacy and e-commerce distribution.
OEM/ODM Private Label Services
We specialize in private label pregnancy test manufacturing for:
- Pharmacy chains — Custom branded retail packaging
- E-commerce sellers — Bulk private label for online stores
- Distributors — White label for regional markets
- Healthcare brands — Premium packaging options
Customization Options
- Custom box design with your logo and branding
- Multi-language instructions (10+ languages available)
- Sensitivity level selection (10 or 25 mIU/mL)
- Format selection (cassette, strip, midstream)
- Blister pack or individual pouch packaging
- Retail-ready packaging with barcode
Quality Assurance
Each production lot undergoes rigorous quality control testing including sensitivity verification, specificity testing, and stability studies. Certificate of Analysis provided with every shipment.
Regulatory Status
CE marked under IVD Regulation. Manufactured in ISO 13485 certified facility with GMP compliance. Suitable for consumer self-testing markets in Europe, Southeast Asia, Middle East, and Latin America.
Contact our sales team for private label pricing and minimum order quantities.
Certifications & Compliance
Target Markets
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