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Rapid immunochromatographic and manual self-test for the qualitative detection of the human Chorionic Gonadotropin (hCG) hormone in urine as an aid to the early identification of the pregnancy status in women
hCG (Human Chorionic Gonadotropin) is a glycoprotein with hormonal activity associated with pregnancy, whose main function is to provide for the maintenance of gestation, favoring an adequate environment for the development of the embryo.
read moreThe hCG hormone is essential for the development and good continuation of pregnancy. The rapid appearance and the rapid increase in the concentration of this hormone in urine make it an excellent indicator for confirming the onset of a pregnancy.
EARLY DETECTION PREGNANCY TEST is useful for any woman who wants to confirm the onset of pregnancy, up to six days before the expected day of menstruation.
read moreHuman Chorionic Gonadotropin starts to be produced by the body during the very early stages of pregnancy, when the fertilized egg is transported from the fallopian tubes to the uterus where it subsequently nestles. It is possible to perform the test three days before the presumed arrival of menstruation, using the first urine in the morning.
EARLY DETECTION PREGNANCY TEST is a rapid immunochromatographic device that detects hCG hormone at very low concentrations (10 mUI/mL cut-off).
| Specificity | >99% |
| Sensitivity | >99% |
| Accuracy | >99% |
| Negative | hCG levels in urine are below the 10 mUI/mL cut-off. |
| Positive | the concentration of hCG hormone in urine is equal to or greater than the cut-off, indicating pregnancy. Contact your doctor or a specialist. |
1. Larsen, John, Philip Buchanan, Sarah Johnson, Sonya Godbert, and Michael Zinaman. “Human Chorionic Gonadotropin as a Measure of Pregnancy Duration.” International Journal of Gynaecology and Obstetrics: The Official Organ of the International Federation of Gynaecology and Obstetrics 123, no. 3 (December 2013): 189–95. https://doi.org/10.1016/j.ijgo.2013.05.028.
2. Cole, Laurence A., Stephen DuToit, and Trefor N. Higgins. “Total HCG Tests.” Clinica Chimica Acta; International Journal of Clinical Chemistry 412, no. 23–24 (November 20, 2011): 2216–22. https://doi.org/10.1016/j.cca.2011.08.006.
3. Pike, Joanna, Sonya Godbert, and Sarah Johnson. “Comparison of Volunteers’ Experience of Using, and Accuracy of Reading, Different Types of Home Pregnancy Test Formats.” Expert Opinion on Medical Diagnostics 7, no. 5 (September 2013): 435–41. https://doi.org/10.1517/17530059.2013.830103.
4. Gnoth, C., e S. Johnson. 2014. “Strips of Hope: Accuracy of Home Pregnancy Tests and New Developments”. Geburtshilfe und Frauenheilkunde 74 (7): 661–69. https://doi.org/10.1055/s-0034-1368589.
5. Moghazy, Dalia, Omar Al-Hendy, and Ayman Al-Hendy. “Krukenberg tumor presenting as back pain and a positive urine pregnancy test: a case report and literature review.” Journal of Ovarian Research 7.1 (2014): 36.
6. El Hage, Lea, and Betul Hatipoglu. “Elevated hCG can be a benign finding in perimenopausal and postmenopausal women.” Cleveland Clinic Journal of Medicine 88.11 (2021): 635-639.
The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" section of the instructions for use.
A colored line will appear at the control region (C) on the test device, showing that the test performed correctly. The absence of the colored line suggests to repeat the test with a new device and a new sample.
The color and intensity of the lines do not affect the interpretation of the result. The test has to be considered positive regardless of the color intensity of the test line (T).
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USE PROCEDURE 