The hCG Rapid Test Strip (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine specimens. This kit is intended for use as an aid in the early detection of pregnancy.
The hCG Rapid Test Strip (Urine) detects human chorionic gonadotropin through visual interpretation of color development on the strip. Anti-hCG antibodies are immobilized on the test region of the membrane and anti-mouse antibodies on the control region. During testing, the specimen reacts with anti-hCG antibodies conjugated to colored particles and precoated onto the sample pad of the strip. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient hCG in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred
Individually packed test strips
Test Procedure and Result Interpretation
Bring tests, specimens, and/or controls to room temperature before use.
1. Remove the test from its sealed pouch and use it as soon as possible. For best results, the assay should be performed within one hour.
2. Hold the strip by the end, where the product name is printed. To avoid contamination, do not touch the strip membrane.
3. Holding the strip vertically, dip the test strip in the urine specimen for at least 10-15 seconds. Do not immerse past the maximum line (MAX) on the test strip.
4. As the test begins to work, color will migrate across the membrane.
5. After the test has finished running, remove the strip from the specimen and place it on a non-absorbent flat surface. Start the timer and wait for the colored band(s) to appear. The result should be read at 3 minutes. Do not interpret the result after 10 minutes.NOTE: Low hCG concentrations may produce very weak test bands (T) after a prolonged period of time. Therefore, do not interpret the result after 10 minutes.
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE:Only one colored band appears, in the control region (C). No colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.