3/10/20 individually packed test strips for detection of IGFBP-1 (Insulin-like Growth Factor Binding Protein 1), a major protein marker of the amniotic fluid, in a vaginal swab
Package contents:
3/10/20 test strips
3/10/20 sterile swabs
3/10/20 collection tubes with extraction buffer
1 tube holder
1 package insert
Exclusively for professional users
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The NADAL® PROM Amniotic Fluid Test is an immunochromatographic rapid test for the qualitative detection of IGFBP-1 (Insulin-like Growth Factor Binding Protein 1), a major protein marker of the amniotic fluid, in a vaginal swab. The test is intended as an aid in the diagnosis of the rupture of fetal membranes in pregnant women and designed for professional use only.
Premature rupture of membranes (PROM) is relatively frequent and occurs in 5 to 10% of all pregnancies. It may lead to premature delivery and fetal infection. Conventional clinical examinations cannot always detect a leakage of amniotic fluid. In some cases, biological tests are required to confirm the suspicion of PROM. Biological tests are based on the detection of alkalinization of vaginal secretion (an easy-to-carry-out, sensitive, inexpensive procedure, but with poor specificity) or on the detection of molecules present in high concentrations in amniotic fluid (diamine oxidase, alpha feto protein, fibronectin or IGFBP-1). Detection of PROM with a simple rapid test usable at the point of care enables an immediate decision-making. Failure to diagnose patients with PROM may result in the failure to implement salutary obstetric measures (e.g. neonatal sepsis occurs if PROM is detected more than 32 hours after initial occurance). On the other hand, a false diagnosis of PROM can lead to inappropriate interventions (e.g. hospitalization, induction of labour). Therefore, a correct and timely diagnosis of this disorder by the clinician is crucial. However, accurate diagnosis of PROM remains a challenge for obstetrics. Unfortunately, there is no ‘gold standard’ for diagnosis of PROM in the clinical practice. Most of the commonly available tests are either inaccurate or to some degree invasive. The NADAL® PROM Amniotic Fluid Test solves all of these problems. It is a rapid test intended to detect the rupture of fetal membranes, providing highly accurate and timely diagnosis of PROM. Consequently, swift measures can be taken to prevent complications (prophylactic use of antibiotics, tocolytic drugs or corticosteroids, labour induction etc.).
