The HCG Pregnancy Test Cassette is a rapid chromatographic immunoassay designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine, serum, or plasma, which aids in the early detection of pregnancy. This device is a crucial tool for women who wish to confirm their pregnancy at home or in a clinical setting with ease and speed.
Background:
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. The presence and rapid increase of hCG in urine or blood make it an excellent marker for early pregnancy detection .
Principle of the Test:
The HCG Pregnancy Test Cassette operates on the principle of immunoassay, utilizing a combination of antibodies, including monoclonal and polyclonal antibodies, to selectively detect elevated levels of hCG. The test results are indicated by the formation of colored lines after the specimen reacts with the colored conjugate .
Usage:
The test is simple to use; it requires bringing the test, along with the specimen, to room temperature before use. Then, 3 drops of urine or serum are added to the specimen well, and the result is read after a specified time, typically 5 minutes for urine and 3-5 minutes for serum or plasma specimens .
Significance:
The test is significant for its ability to provide quick results, ease of use, and low cost. It is a point of care triage screening tool that can be used in various settings, from homes to clinics, offering a preliminary indication of pregnancy.
Accuracy and Sensitivity:
The HCG Pregnancy Test Cassette is highly sensitive, detecting hCG at a concentration of 20 mIU/mL or 25 mIU/mL. It has been standardized to the W.H.O. International Standard and shows no cross-reactivity with structurally related glycoprotein hormones at high physiological levels, ensuring accuracy and reliability in results .
Storage and Stability:
The test should be stored as packaged at room temperature or refrigerated (2-30°C) and remains stable through the expiration date printed on the sealed pouch or label. It is crucial to note that the test must not be frozen and should be used before the expiration date .
Precautions:
The test is for professional in vitro diagnostic use only and should not be used beyond the expiration date. It is also important to handle all specimens as potentially hazardous and to discard used tests according to local regulations.
In conclusion, the HCG Pregnancy Test Cassette is a valuable diagnostic tool for the early and reliable detection of pregnancy, offering convenience and accuracy in a user-friendly format.