How does the Pregnafix® Pregnancy Test Strip work?
The Pregnafix® Pregnancy Test Strip is a quick
and simple chromatographic antibody detection test in strip format for the qualitative
detection of human choriongonadotropine (hCG) in the urine, to determine the
existence of a potential pregnancy. The test applies a combination of antibodies
including a monoclonal hCG antibody to detect increased hCG levels. The test
is carried out by dipping the test zone into the urine. The result is shown in
the result window (E) and in the control window (K) in the form of colored lines.
How do I use the Pregnafix® Pregnancy Test Strip?
Urinate into a clean, dry cup. Take the Pregnafix® Pregnancy Test Strip out of its foil package and familiarize yourself with the product.
Dip the test zone vertically into the urine for about 10 seconds maximum, up to the line before the printed arrows. Then place the test, printed side facing upward, onto a level, non-absorbent surface.
When detection begins you might notice a slightly red veil in the result area (E). After waiting 3 minutes you can read the result. In the event a red line has not appeared, wait one more minute at most.
Attention:
After 10 minutes from the completion of the test the result is no longer reliable. However, even if the result is negative, a red line might show up in the result area (E) after the 10 minutes have passed.
Through the above mentioned red veil a white line might also show up initially in the result area.
This only occurs as a result of the color contrast and does not have any influence on the test results. Only a colored line will show a possible pregnancy.
How do I read the result?
Pregnant
Two lines, each in the result window and the control window, respectively, mean that the result is positive and the likelihood of a pregnancy is very high. It does not matter whether or not one line is darker or lighter than the other.
Not pregnant
If only one line appears in the control window only, this means that the result is negative and the probability of you being pregnant is very low.
Invalid Results
The result is invalid if no red line appears in the control window, even if a red line does appear in the result window. In this case you should repeat the test with a fresh pack of Pregnafix® Pregnancy Test Strip.
What can influence the result?
Under the conditions listed below it is possible that the Pregnafix® Pregnancy Test Strip may show incorrect results. In any case, speak with your doctor before you make any medical decisions at all.
1. Medications containing hCG (such as Pregnyl, Profasi, Pergonal and APL) may possibly produce incorrect results. Alcohol, birthcontrol pills, pain medication, antibiotics or hormone treatment preparations which do not contain hCG should not have any influence on the results.
2. Please be aware that increased hCG levels may also be the result of other medical origins, such as ovarian cysts or an ectopic pregnancy (pregnancy outside of the uterus), which might in turn produce an incorrect positive result.
How does the Pregnafix® Pregnancy Test Strip work?
The Pregnafix® Pregnancy Test Strip searches for a hormone in the urine which is produced by the body during pregnancy (hCG : human chorionicdonadotropin). The amounts of this hormone increase with the progression of the pregnancy.
At what time, after I suspect I may be pregnant, can I carry out the Pregnafix® Early Detection Pregnancy Test?
You may perform the Pregnafix® Pregnancy Test Strip beginning on the first day of the absence of your period.
Do I have to test with the first morning urine?
Although you may perform the test at any time of day, the morning urine is the most concentrated, and contains the highest levels of pregnancy hormone, in the event of a pregnancy.
How accurate is the Pregnafix® Pregnancy Test Strip?
A clinical study was carried out, in which the results from the Pregnafix® Pregnancy Test Strip were compared with another, commercially available membrane hCG Test. The clinical trial by users (compared with the membrane test) included 150 urine samples. Both test procedures recognized
78 positive and 72 negative results. The results of this study showed a total accuracy higher than
> 99.0 % for the Pregnafix® Pregnancy Test Strip and the other membrane hCG Test.
How sensitive is the Pregnafix® Pregnancy Test Strip?
The Pregnafix® Pregnancy Test Strip detects hCG even at a concentration level of 25 mIU/ml urine. The test is standardized according to the third international WHO standard. The addition of LH ((300 mIU/ml), FSH (1.000 mIU/ml) and TSH (1.000 µIU/ml) to each a negative (0 mIU/ml hCG) and a positive (25 mIU/ml hCG) urine sample, respectively, did not show any interaction.
What should I do if the result shows that I am pregnant?
A positive result means that your urine contains hCG and you are probably pregnant. Consult your doctor as soon as possible in order to verify the pregnancy and to discuss all future steps.
How do I know if the test was performed correctly?
When a red line appears in the control window this means that you have performed the test correctly and a sufficient amount of urine has been absorbed.
What should I do if the result shows that I am not pregnant?
A negative result means that your urine does not (yet) contain enough hCG and you are most likely not pregnant. If your period does not begin within a week’s time, please repeat the test using a fresh Pregnafix® Pregnancy Test Strip. In the event that the second test also shows a negative result and you still do not have your period, you should consult your doctor.
