CTK Biotech OnSite® hCG Combo Rapid Test Card CE (Serum/Urine)

Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Serum, Plasma, or Urine

The OnSite® hCG Combo Rapid Test is a rapid, easy-to-use lateral flow chromatographic immunoassay for the early detection of pregnancy by identifying human chorionic gonadotropin (hCG) in serum, plasma, or urine. Designed for professional use only, it offers clear, qualitative results within 5–10 minutes and does not require laboratory instrumentation or extensive training.

Product Features

• Dual specimen compatibility: works with human serum/plasma or urine
• Rapid results in just 5–10 minutes
• No laboratory equipment required
• Designed for professional, clinical use (not OTC)
• Individually packaged in sealed foil pouches with dropper and desiccant
• Shelf life: 24 months from manufacture

Clinical Performance

Analytical Sensitivity

• Detects ≥12.5 mIU/mL in serum/plasma
• Detects ≥25 mIU/mL in urine

Analytical Specificity

• No cross-reactivity with:
  • 1,000 mIU/mL human luteinizing hormone (hLH)
  • 1,000 mIU/mL human follicle-stimulating hormone (hFSH)
  • 1,000 mIU/mL human thyroid-stimulating hormone (hTSH)

Dose Hook Effect

• No effect observed up to 500,000 mIU/mL hCG

Interference Testing

• No interference with 35+ common biological and chemical analytes including drugs of abuse, OTC medications, and pH variations (4–9)

Ordering Information

Each test kit includes:

• 1 × test cassette (individually sealed)
• 1 × plastic dropper
• 1 × desiccant
• 1 × instruction for use (IFU)

Intended Use

• Early pregnancy detection in healthcare and diagnostic settings
• For use in clinical laboratories, doctor’s offices, and women’s health clinics
• Not intended for home use or over-the-counter (OTC) sale
• Provides preliminary results; further clinical testing is required for confirmation

OnSite® hCG Combo Rapid Test provides reliable and rapid detection of hCG for early pregnancy assessment, supporting clinical decisions with confidence and ease.