Background: In 1976, the first home pregnancy test was introduced, and since then, it has become the most commonly used diagnostic assay for home use. These tests use antibodies to detect human chorionic gonadotropin (hCG), which is an ideal marker of pregnancy. This is because hCG levels rise consistently and rapidly in early pregnancy and can be detected in urine [5].
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. [1-4] hCG levels continue to rise very rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period [2-4] and peaking in the 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy. The appearance of hCG 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.
hCG Pregnancy Rapid Test Dipstick 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, hCG Pregnancy Rapid Test Dipstick shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.
Objective: The main significance of this paper is to verify the accuracy, specificity, and sensitivity of the hCG Pregnancy Rapid Test Dipstick manufactured by ACRO Biotech, Inc. through comparative experiments, in order to explore the significance of highprecision hCG rapid detection products in early pregnancy testing.
Method: The hCG Pregnancy Rapid Test Dipstick is a fast and efficient way to detect human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. The test uses a combination of monoclonal hCG antibodies and goat polyclonal antibodies to selectively detect elevated levels of hCG in the urine specimen. The test is conducted by immersing the test dipstick in the urine specimen and observing the formation of colored lines. The presence of two colored lines, one in the test line region and one in the control line region, indicates a positive result, while the absence of the test line suggests a negative result. A colored line in the control line region always appears to confirm that the proper volume of specimen has been added and membrane wicking has occurred. This test is a rapid chromatographic immunoassay, which provides accurate results quickly and easily.
Result: The hCG Pregnancy Rapid Test Dipstick is a highly accurate and sensitive product for detecting pregnancy. Its sensitivity is greater than 99.9% and its specificity is greater than 99.9%, with an accuracy of over 99.9%.
Conclusion: The hCG Pregnancy Rapid Test Dipstick manufactured by ACRO Biotech, Inc. is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.
According to the results of a multi-centre clinical comparative experiment, this product is user-friendly, provides rapid results, and readings can be obtained within 3 minutes of testing the sample. When compared to 608 samples, the product demonstrated a high accuracy rate of 99.9% and excellent specificity of 99.9%.
Furthermore, this test dipstick is a reliable option for women who want to obtain accurate results and determine early in their pregnancy whether they are pregnant or not. With its high accuracy and convenience, this test kit can provide women with peace of mind and help them take the necessary steps to ensure a healthy pregnancy.
Published Date: 2023-05-29; Received Date: 2023-04-29
