AccuSpeed Pregnancy Test Card is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. The test uses two lines to indicate results. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The control line is composed of goat polyclonal antibodies and colloidal gold particles. The assay is conducted by adding a urine specimen to the specimen well of the test device and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as as procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both urine and serum or plasma as early as 7 to 10 days after conception. hCG levels continue to rise very rapidly, frequently exceeding 100 mIU/ml by the first missed menstrual period and peaking in the 100,000-200,000 mIU/ml range about 10-12 weeks into pregnancy. The appearance of hCG in both the urine and serum or plasma soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy.
AccuSpeed Pregnancy Test Card is a rapid test that qualitatively detects the presence of hCG in urine specimen at the sensitivity of 25 mIU/ml. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine. At the level of claimed sensitivity, AccuSpeed Pregnancy Test Card shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.
AccuSpeed Pregnancy Test Card is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of prgenancy.
Bring the pouch to room temperature (15-30°C) before opening it. Remove the cassette from the sealed pouch and use it as soon as possible.
Place the cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approximately 120 ul) to the specimen well of the cassette, and then start the timer. Avoid trapping air bubbles in the specimen well.
Wait for the colored line(s) to appear. The result should be read at 3 minutes.
NOTE: A low hCG concentration might result in a weak line appearing in the test line region (T) after an extended period of time; therefore, do not interpret the result after 10 minutes.
For professional in vitro diagnostic use only. Do not use after the expiration date.
The test should remain in the sealed pouch until ready to use.
All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
The used test should be discarded according to local regulations.
Store as packaged at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
AccuSpeed Pregnancy Test Card
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