Prima Home Test Early Pregnancy Test

Prima Home Test Early Pregnancy Test
Rapid Self-Test for the early detection of hCG in human urine sample (10 mUI/mL)
PREGNANCY & hCG:
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.
The 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.
WHO IS THIS TEST FOR?
EARLY PREGNANCY TEST is useful for any woman who wants to confirm the onset of pregnancy before the expected day of menstruation.
Human 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.
TECH SPECS:
EARLY PREGNANCY TEST is a rapid immunochromatographic device that detects hCG hormone at very low concentrations (10 mUI/mL cut-off).
Specificity     100%
Sensitivity     100%
Accuracy     100%
CONTENT:
1-2 spoon devices
instructions for use
USE PROCEDURE:
1.Remove the protective cap and place the absorbing tip right under the flow of urine for at least 10 seconds;
2.Alternatively, collect the urine in a clean and dry container and dip the absorbing tip into the urine for 10 seconds;
3.Place the protective cap back onto the spoon device and wait 5 minutes before reading the result.
RESULTS INTERPRETATION:
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.
BIBLIOGRAPHY:
1. Batzer FR. “Hormonal evaluation of early pregnancy”, Fertil. Steril. 1980; 34(1): 1-13 2.
2. Snjder J.A., Haymonth F., Parvin C.A. et al. “Diagnostic considerations in the measurement of Human Chorionic Gonadotrophin in aging women” Clin Chem 2005; 51: 1830 – 1835
3. Gnoth C., Johnson S.: “Strips of hope: accuracy of home pregnancy tests and new development”
F.A.Q.:
What happens if the results reading time is not met?
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.
How to prove that the test worked correctly?
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.
How to interpret the test if the control and test lines have different intensities?
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).