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INTENDED USE
The LH Rapid Test Device (Urine) is a rapid visual immunoassay for
the qualitative, presumptive detection of luteinizing hormone in
human urine specimens. This kit is intended for use as an aid in
the detection of ovulation.
INTRODUCTION
While a woman’s body always produces a small amount of human
luteinizing hormone (LH), there is a sudden increase of this
hormone during the middle of the menstrual cycle. This increase of
the LH level, called the LH surge, promotes the release of a mature
egg from the ovaries (ovulation). For most women, ovulation will
occur within 24-36 hours after the peak of the LH surge.
Immediately after ovulation, the egg is capable of being fertilized
for a short time (approx. 12 hours). With the LH Rapid Test Strip
(Urine), the LH surge will be detected in urine within 6 days. The
fertile days of the menstrual period start after this LH surge.
TEST PRINCIPLE
The LH Rapid Test Device (Urine) detects human luteinizing hormone through visual interpretation of color development on the strip. Anti-LH antibodies are immobilized on the test region of the membrane, and anti-mouse antibodies immobilized on the control region. During testing, the specimen reacts with anti-LH antibody 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 LH 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.
STORAGE AND STABILITY
• Store at 2 ~ 30 º C in the sealed pouch for 18 months.
PRECAUTIONS
• For in vitro diagnostic use only.
• Do not use after expiration date.
• The test Cassette should remain in the sealed pouch until use.
• The used test Cassette should be discarded according to local
regulations.
OPERATION
INTERPRETATION
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 apparent 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.
For detailed information, please contact Dewei person for Manual Instruction.