hCG Pregnancy Rapid Test Strip MonlabTest® (Siero/Plasma/Urina)
The hCG Pregnancy Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine, serum or plasma to aid in the early detection of pregnancy.
What is HCG?
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.1,2,3,4 hCG levels continue to rise very rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period,2,3,4 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. The hCG Pregnancy Rapid Test Cassette is a rapid test that qualitatively detects the presence of hCG in urine or serum or plasma specimen at the sensitivity of 10mIU/mL. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine or serum or plasma. At the level of claimed sensitivity, the hCG Pregnancy Rapid Test Cassette shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.
What is the hCG Pregnancy Rapid Test
The hCG Pregnancy Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum or plasma 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 immersing the test cassette in a urine or serum or plasma specimen 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 a 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.
- Test Cassettes.
- Package insert.
MATERIALS REQUIRED BUT NOT PROVIDED
- Specimen collection containers.
DIRECTIONS FOR USE hCG Pregnancy Rapid Test
1. Bring the pouch to room temperature (15-30ºC) before opening it. Remove the cassette from the sealed pouch and use it within one hour.
2. Place the cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine or serum or plasma (approximately 120ul) to the specimen well of the cassette, and then start the timer. Avoid trapping air bubbles in the specimen well. See
3. Wait for the colored line(s) to appear. Read the result at 3 minutes when testing a urine specimen, or at 5 minutes when testing a serum or plasma specimen.
NOTE: A low hCG concentration might result in a weak line appearing in the test line region (T) after an extended period; therefore, do not interpret the result after 10 minutes.
POSITIVE*: Two distinct colored lines appear. One line should be in the control line region (C) and another line should be in the test line region (T). *NOTE: The color intensity of the test zone line (T) may vary depending on the concentration of hCG present in the sample. Therefore, any color, however weak it may be, on the line of the test area (T) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).
INVALID: The result is invalid if no colored line appears in the control line region (C). Insufficient sample volume or incorrect technique are the most frequent reasons for failure of the control line. Review the procedure and repeat the test with a new cassette. If the problem persists, stop using that kit immediately and contact the supplier