Specifications:
Application | Diagnostic Testing | ||
Storage Temperature | Room Temperature | ||
Product Type | Test Kit | Forms | Kit with Various components |
Product Brand | CTK Biotech | ||
Product Grade | Medical grade | ||
The OnSite hCG Combo Rapid Test (Strip) CE is a lateral flow chromatographic immunoassay designed for the early detection of pregnancy through the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine. This dip strip format allows for quick and convenient pregnancy screening, delivering accurate, visual results in just 5–10 minutes.
The test is validated for professional use and demonstrates high analytical sensitivity and specificity, with a detection threshold of 12.5 mIU/mL in serum/plasma and 25 mIU/mL in urine. It is ideal for use in clinical laboratories, emergency rooms, outreach clinics, and point-of-care settings.
Key Features and Benefits
- Dual Sample Compatibility: Suitable for use with both serum and urine specimens
- High Sensitivity: Detects hCG levels as low as 12.5 mIU/mL in serum/plasma and 25 mIU/mL in urine
- Fast Results: Delivers results in 5–10 minutes
-
Clinically Validated:
- 100% sensitivity and 100% specificity in urine
- 100% sensitivity and 99.5% specificity in serum
- High Specificity: No cross-reactivity with hLH, hFSH, or hTSH (up to 1,000 mIU/mL)
- No Hook Effect: Accurate even at hCG levels up to 500,000 mIU/mL
- No Interference: Tested against 35 common biological and chemical substances
- Simple Workflow: Equipment-free, easy to use by minimally trained personnel
- Long Shelf Life: 24 months under recommended storage conditions
Kit Packaging Options
Box Kit Contents (50 Tests)
-
50 individually sealed foil pouches, each containing:
- 1 dip strip device
- 1 desiccant
- 1 Package insert (Instructions for Use)
Tube Package (optional format)
- 1 Tube with dip strip device
- 1 Desiccant
- 1 Package insert
Product Specifications
Attribute | Details |
---|---|
Target Analyte | Human Chorionic Gonadotropin (hCG) |
Detection Limit | 12.5 mIU/mL (serum), 25 mIU/mL (urine) |
Sample Types | Serum, Urine |
Format | Dip Strip Lateral Flow Assay |
Time to Result | 5–10 minutes |
Accuracy (Urine) | 100% sensitivity / 100% specificity |
Accuracy (Serum) | 100% sensitivity / 99.5% specificity |
Shelf Life | 24 months |
Equipment Required | None |
Use Classification | Professional IVD use only (not for OTC use) |
Regulatory Compliance | CE Marked |
Applications
- Early pregnancy screening in clinical labs
- Rapid pregnancy confirmation in emergency care
- Outreach and rural maternal health services
- Point-of-care diagnostics in OB/GYN settings
- Pregnancy assessment before medical procedures or treatments
The hCG Combo Rapid Test (Strip) CE is a fast, accurate, and user-friendly diagnostic tool for the early detection of pregnancy in professional healthcare settings. With high analytical performance, dual specimen compatibility, and no requirement for specialized equipment, it’s ideal for clinical, mobile, or field-based environments.