INTRODUCTION
HCG is a glycoprotein hormone secreted by the developing placenta during pregnancy. The concentration of HCG in serum is approximately equal to the concentration in urine. The concentrations of HCG in urine and serum continue to rise during the first trimester of pregnancy to as high as 100, 000mIU/ml. HCG appears in serum and urine shortly after conception, and continues to increase during the early stages of pregnancy, making it an excellent indicator for the detection of pregnancy
PRINCIPLE
The membrane of the test device was coated with anti HCG antibodies on the test region and goat anti mouse IgG antibodies on the control region. During the test, urine specimen is allowed to react with the HCG monoclonal antibody-colloid gold conjugate, which was pre-dried on the test strip. The mixture then moves upward on the membrane chromatographically by capillary action. For a positive specimen, the conjugate binds to the HCG forming an antibody-antigen complex. This complex is captured by anti HCG antibody immobilized on the test region (T) and produces a pink color band when HCG concentration is equal to or greater than 25mIU/ml. Absence of this colored band in the test region suggests a negative result. To serve as a procedural control, a colored band at the control region(C) will always appear regardless the presence or absence of HCG.
STORAGE
The kits should be stored at temperature 4-30° C in the sealed pouch for the duration of the shelf life.
1. Early detection of pregnancy as early as 7 days after the fertilized egg implantation
2. Simple to use
3. A variety of design specifications suitable for self-testing use and for professional use
4. Results in 3 to 5 minutes
5. Store in room temperature
6. 24 months shelf life
1. Sensitivity:25 mIU/ml, 20 mIU/ml, 10 mIU/ml
2. Specificity:No cross-reactivity with 300 mIU/ml hLH, 300 mIU/ml hFSH, and 1000 mIU/L hTSH
1. Pregnancy Test Strip - very economical and easy to use. This type of Dip and Read test is designed for rapid qualitative diagnosis of hCG pregnancy hormone in urine. It is used all over the world, whether it is in professional setting or for home pregnancy testing. Simply dip the strip into a urine specimen and allow 5 minutes for development of results - control line (negative pregnancy test results) or control and test line (positive pregnancy test results). The pregnancy test strip comes individually packaged in a foil pouch with desiccant for moisture protection. The test pouch also has brief instructions and picture interpretations of the results.
2. Pregnancy Test Cassette - is mainly used by professionals and individuals who prefer to write data on the pregnancy test cassette (on a patient ID window). In this manner a user can eliminate confusion in a busy lab setting. Also individuals who like to monitor and keep track of pregnancy monitoring may choose this device over other formats. The pregnancy cassette has a plastic window that protects the testing region from moisture and other possible contaminants. The pregnancy test cassette comes individually packaged in a foil pouch with desiccant for moisture protection and a sterilized dropper for dispensing of the specimen. Simply put 3-4 drops of urine into a dropping well and allow 5 minutes for development of results - control line (negative results) or control and test line (positive results).
3. Pregnancy Test Midstream - is commonly used for home pregnancy testing, or you can keep it with you on the go. You can apply the pregnancy midstream directly into the urine stream so there is no need for urine collection. The hCG midstream has a removable cap for protective purposes - as well as the plastic window over the testing region. The pregnancy midstream test comes individually packaged in a foil pouch with desiccant for moisture protection. These types of pregnancy testing formats are sold in drugstores and pharmacies usually under different brand names.
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