Urine HCG Rapid Test Strip Cassette Midstream Pregnancy Test Human Chorionic Gonadotropin

Pregnancy Test Human Chorionic Gonadotropin HCG Urine Rapid Test Strip Cassette Midstream Pen

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.

FRQ:

For detailed information, please contact Dewei person for Manual Instruction.