Description
ICON 25 hCG Test Kit
The ICON 25 hCG Test Kit is a rapid, qualitative test designed to detect human chorionic gonadotropin (hCG) in urine for the early indication of pregnancy. hCG is a hormone produced shortly after implantation and rises quickly during early pregnancy. This test kit is intended for in vitro diagnostic use and provides clear results in minutes, supporting timely decision-making in clinics, physician offices, and other point-of-care or laboratory settings.
Using immunochromatographic technology, the ICON 25 hCG Test Kit employs antibodies specific to hCG to determine whether the hormone is present at or above the stated sensitivity. The “25” designation refers to a sensitivity level of 25 mIU/mL, enabling detection near the early stages when hCG first becomes measurable in urine. The format is engineered for straightforward handling and consistent performance when used according to the instructions for use.
Key Features
- Rapid qualitative detection of hCG in urine
- 25 mIU/mL sensitivity for early pregnancy indication
- Easy-to-read visual result interpretation
- Designed for professional workflows in clinical and laboratory environments
- Internal procedural control to help verify proper test function
Intended Use
The ICON 25 hCG Test Kit is intended for the qualitative detection of hCG in urine specimens as an aid in the early detection of pregnancy. Results should be interpreted in conjunction with clinical findings and patient history. As with any diagnostic test, a single result should not be used as the sole basis for clinical decisions.
How It Works
When a urine specimen is applied, it migrates through the test device. If hCG is present at or above the detection threshold, it binds to labeled antibodies and forms an immune complex that produces a visible test line. A separate control line indicates the test has run properly, helping to confirm adequate specimen flow and reagent integrity.
Result Interpretation
- Positive: Control line and test line are visible
- Negative: Control line is visible; no test line appears
- Invalid: Control line does not appear; repeat with a new test
Performance and Limitations
This is a qualitative screening test and does not measure hCG concentration. Very early pregnancy, diluted urine specimens, or testing too soon may yield false-negative results. Certain medical conditions and medications containing hCG may affect results. If results are unexpected or inconsistent with clinical presentation, repeat testing with a fresh specimen and/or confirm with an alternative method, such as a serum hCG test.
What’s Included
- hCG test devices
- Package insert with step-by-step instructions and interpretation guidance
Storage and Handling
Store as directed in the product labeling. Do not use beyond the expiration date. Use appropriate infection control practices when handling specimens and dispose of used materials in accordance with local regulations for biohazard waste.
