möLab mö-screen hCG pregnancy test, 1 ST

Get clarity in just a few minutes! The möLab mö-screen hCG pregnancy test is an easy-to-use, highly sensitive early test that provides fast and reliable results.

The mö-screen möLab hCG pregnancy test is a rapid immunochromatographic test for the qualitative determination of human chorionic gonadotropin (hCG) from a concentration of 25 mIU/ml in urine. It is intended for professional use for the early diagnosis of pregnancy from the first missed period.

Human chorionic gonadotropin hCG hormone is produced in the placenta during pregnancy and is responsible for maintaining the pregnancy. The detection of significant amounts of hCG in a woman's blood or urine is a very important indicator of an existing pregnancy.

Advantages

• Qualitative result in 3 or 5 minutes
• Medically and diagnostically suitable cut-off (25 mIU/ml)
• High sensitivity and specificity (100 %)
• Storage of the möLab pregnancy test at 2 to 30 °C
• Long shelf life of up to 24 months
• Complete accessories

Technical features

• Relative sensitivity: >99.9 % (97.5 % - 100 %)*
• Relative specificity: >99.9 % (99.0 % - 100 %)* * 95 % confidence interval
• Accuracy: >99.9 % (99.3 % - 100 %)*

Sensitivity

The mö-screen hCG pregnancy test detects hCG from a concentration of 25 mIU/ml in urine (WHO International Standard).

Specificity

The following related hormones were added to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) samples and tested. No cross-reactions were detected. LH 300 mIU/ml FSH 1,000 mIU/ml TSH 1,000 mIU/ml

Accuracy

Clinical evaluations of the mö-screen hCG Pregnancy Test in comparison with another hCG assay were performed. The results show an accuracy of the mö-screen hCG Pregnancy Test to the comparison test of >99 %.

General information about the möLab hCG pregnancy test

Human chorionic gonadotropin (hCG) is a glycoprotein hormone that is produced by the developing placenta immediately after fertilisation. hCG can be detected in the urine of normal pregnancies as early as 7 - 10 days after fertilisation. The hCG levels rise very quickly and continuously. Values of 100 mIU/ml are often exceeded after the first missed menstrual period. They reach a maximum of 100,000 - 200,000 mIU/ml after 10 - 12 weeks of pregnancy. The appearance of hCG during early pregnancy development makes it an excellent marker for pregnancy detection.

Dosage form

test strip

How to use

Sample collection: Collect the urine in a clean and dry urine cup. The first morning urine is best suited for testing as it contains the highest concentration of hCG. However, urine collected at other times can also be used. Urine with a high level of bacterial contamination should not be used, as otherwise the results may be distorted. Urine with visible precipitates should be centrifuged, filtered or left to settle until a clear sample is available for testing.

Test procedure:

1. Bring cooled samples to room temperature (15 - 30 °C).
2. Bring test strips in unopened foil/tin to room temperature (15 - 30 °C).
3. a) Open the foil by tearing it at the notch. Caution: Take care not to bend the foil pouch or the test strip. b) Open the can and remove the test strip. Caution: Make sure to close the can completely so that the test strips cannot absorb any moisture. After opening the can for the first time, all remaining test strips can be used for 90 days. A false negative result can occur due to an excessively diluted urine sample with a very low specific gravity (does not contain the required hCG concentration) or at an early stage of pregnancy. If pregnancy is suspected, the test should be repeated 48 hours later with fresh morning urine.
4. Very low concentrations (< 50 mIU/ml) may appear in the urine shortly after implantation. As many pregnancies terminate in the first 3 months for natural reasons5, a weak positive result should be confirmed with another test after 48 hours.
5. Trophoblastic diseases, breast cancer, lung cancer, prostate cancer and testicular tumours should be excluded before hCG detection with the mö-screen hCG test, as these cause increased hCG concentrations.
6. The hCG concentration can be very low in ectopic pregnancies. If such a case is suspected, a quantitative method should be used.
7. Urine samples with strong bacterial contamination or samples that have been repeatedly thawed must not be used. They can falsify the results.
8. This test is only used to suspect pregnancy. A confirmed pregnancy diagnosis by the doctor should only be made after all clinical laboratory findings have been analysed.