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RAPID TESTS: AMNITOP® |
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Packaging |
CE mark |
Sensitivity |
Specificity |
Total running time |
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| AMNITOP® |
5475 |
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10 tests / kit |
CE mark |
99 % |
99 % |
10 min. |
- FORMAT: S: stick; D: device; M: midstream,
- All the tests are packaged in individual, aluminium, hermetic pouch.
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AMNITOP® |
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AMNITOP® is a qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal secretion of pregnant women.
| - RELIABLE : |
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- Quality system certified ISO 9001 and ISO 13485.
- Highly sensitive monoclonal antibodies.
- Specificity : > 99%.
- Sensitivity : > 99%.
- Positive Predictive Value (PPV) > 99%, Negative Predictive Value (NPV) < 99%.
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| - PRACTICAL : |
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- Made without speculum, just introducing the swab in the vaginal secretions.
- Fast : results between 5 to 10 minutes.
- Long shelf life : 12 months.
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| - EFFECTIVE : |
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- Detection limit : 5 ng of PAMG-1 / ml of vaginal secretion.
- Concentration of PAMG-1 in cervical and vaginal secretions without complications in pregnancy : 0,05 to 0,23 ng/ml.
- Concentration of PAMG-1 in vaginal secretions in case of vaginitis or bleeding : < 3 ng/ml.
- Concentration of PAMG-1 in the amniotic fluid : 2000 - 25000 ng/ml.
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| - PRESENTATIONS : |
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- Each kit contains 10 tests :
>>>>>>>10 reactive strips,
>>>>>>>10 sterile Dacron vaginal swab,
>>>>>>>10 plastic vial with water solvant.
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Premature rupture of the foetal membranes (PROM) occurs in about 10% of pregnancies.
The risks of PROM at term are related to serious neonatal consequences, such as pre-term delivery, foetal distress, prolapsed cord, abruptio placenta and infection. PROM will occur before 37 weeks gestation.
AMNITOP® is a rapid strip test that can detect a rupture of the foetal membranes, providing highly accurate and timely PROM diagnosis. Consequently, measures can be taken in a timely manner to prevent complications.
AMNITOP® detects human PAMG-1 problem present in amniotic fluid of pregnant women. PAMG-1 was selected as a marker of foetal membranes rupture.
The test employs highly sensitive monoclonal antibodies that detect even a minimum amount of the protein, which is present in vaginal cervix secretions after the rupture of the foetal membrane.
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AMNITOP
PROCEDURE
INTERPRETATION
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