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INTENDED USE
The Human Chorionic Gonadotropin hCG Rapid Test Kit (Urine) is a
rapid visual immunoassay for the qualitative, presumptive detection
of human chorionic gonadotropin in human urine specimens. This kit
is intended for using as an aid in the early detection of
pregnancy.
INTRODUCTION
Human chorionic gonadotropin (hCG), a glycoprotein hormone secreted
by viable placental tissue during pregnancy, is excreted in urine
approximately 20 days after the last menstrual period. hCG levels
rise rapidly, reaching peak levels after 60-80 days. The appearance
of hCG in urine soon after conception and its rapid rise in
concentration makes it an ideal marker for the early detection and
confirmation of pregnancy. However, elevated hCG levels are
frequently associated with trophoblastic and non-trophoblastic
neoplasms and hence these conditions should be considered before a
diagnosis of pregnancy can be made.
TEST PRINCIPLE
The hCG Rapid Test (Urine) detects human chorionic
gonadotropin through visual interpretation of color development in
the internal strip. Anti-hCG 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-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.
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.
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.