ICON 20 hCG Rapid Test Kit, Diagnostic, Monoclonal/Monoclonal Antibody Technology

ICON 20 hCG Rapid Test Kit (Monoclonal/Monoclonal Antibody Technology)

The ICON 20 hCG Rapid Test Kit is a qualitative in vitro diagnostic test designed to detect human chorionic gonadotropin (hCG) in urine specimens. As a rapid, point-of-care style pregnancy test, it delivers clear visual results using monoclonal/monoclonal antibody technology to support high specificity for hCG. The kit is intended for professional or laboratory use in clinical settings where fast screening is needed. Results should be interpreted in conjunction with clinical findings and, when indicated, confirmed with additional testing.

Intended Use

This test kit provides a qualitative indication of pregnancy by detecting hCG, a hormone that may be present in urine shortly after conception. The ICON 20 hCG Rapid Test Kit is designed for use with urine samples collected in a clean, dry container and tested according to the instructions for use. It is not intended to determine gestational age, monitor pregnancy progression, or diagnose medical conditions unrelated to hCG detection.

Test Principle

The ICON 20 hCG Rapid Test Kit uses immunochromatographic lateral flow methodology. Monoclonal antibodies specific to hCG are incorporated to capture and detect the hormone as the specimen migrates along the test membrane. When hCG is present at or above the test’s detection capability, a visible test line forms along with a control line. The control line indicates that the test has run properly and that the reagents are functioning.

Key Features

• Rapid qualitative results for hCG screening in urine specimens.
• Monoclonal/monoclonal antibody technology to enhance specificity for the hCG molecule.
• Built-in procedural control via a visible control line to verify test validity.
• Simple workflow suitable for routine testing environments.
• Pack size of 20 tests to support regular clinic or laboratory use.

Kit Contents

• Individually packaged hCG rapid test devices (20)
• Instructions for use (IFU)

Result Interpretation

A positive result is indicated by the appearance of both the control line and the test line. A negative result is indicated by the appearance of the control line only. An invalid result occurs when the control line does not appear, and the test should be repeated with a new device. Faint test lines may occur and should be interpreted according to the IFU and institutional policy.

Limitations and Precautions

This test provides a qualitative result and does not measure hCG concentration. False results may occur due to very early pregnancy, improper specimen collection, user error, diluted specimens, or interfering substances. Certain medical conditions, recent pregnancy events, or hCG-containing therapies may affect results. For best practice, follow the IFU precisely, use appropriate quality control procedures, and consult a healthcare professional for clinical correlation.

Product Summary