General information about this test:
NADAL® PROM Amniotic Fluid Test is a rapid immunoassay for qualitative detection of Insulin Growth Factor Binding Protein 1 (IGFBP-1) in vaginal swab. IGFBP-1 is a protein marker found in the amniotic fluid. NADAL® PROM Amniotic Fluid Test is designed for to aid diagnosis of the rupture of fetal membranes in pregnant women and is intended for professional use only.

Reagents and material supplied:

• 20 test strips, individually packed with desiccant

• Provided additional material according to 93/42/EEC: 20 sterile Copan flocked swabs (FLOQSwabs™)

• 20 collection tubes with extraction buffer

• 1 tube holder

• 1 package insert

Test time: 10 min

Performance characteristics:
The analytical detection limit of the NADAL® PROM Amniotic Fluid Test is 5 ng/mL IGFBP-1.

The sensitivity and specificity of the NADAL® PROM Amniotic Fluid Test were determined by comparing the results for 221 samples to those of another commercially available assay.

Sensitivity: 97.6%
Specificity: 97.8%
Overall agreement: 97.7%

The following substances and microorganisms do not interfere with the performance of the NADAL® PROM Amniotic Fluid Test: Pevaryl® (30 mg/ml), GYNO-TROSYD® (20 mg/ml), Flagyl® (100 mg/ml), Canesten® 40 mg/100 mL),Glucose (8 mg/ml), Candida albicans (11.2 x 108 CFU/ml), Gardnerella vaginalis (8.6 x108 CFU/ml), Neisseria gonorrhoeae (10.6x 108 CFU/ml).

Test principles:
The NADAL® PROM Amniotic Fluid Test constitutes a test strip for qualitative detection of Insulin Growth Factor Binding Protein-1 (IGFBP-1) in vaginal secretion. Anti-IGFBP-1 antibodies are immobilized in the test line region of the membrane. During testing, IGFBP-1, if present in the sample binds to anti-IGFBP-1 antibodies conjugated to colored particles precoated on the membrane. Further, the specimen mixture migrates along the membrane by capillary forces and reacts with the reagents in it. If IGFBP-1 is present in the specimen in detectable quantity, a colored line will appear in the test line region of the test strip, thus indicating positive result from the test.A colored line should always appear in the control line region. It serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Clinical significance:
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. PROM is not readily detected during a conventional clinical examination, thus biological assays for the alkalization of vaginal pH (very nonspecific) and the presence of marker molecules present in the amniotic fluid (diamine oxidase, alpha feto protein, fibronectin or IGFBP-1) are needed.If PROM is not diagnosed timely it may prevent from taking life-saving measure – unless detected up to 32 hours after the initialization of the process, PROM may result in neonatal sepsis. On the other hand, a false diagnosis of PROM can lead to inappropriate interventions (e.g. hospitalization, induction of labour). The lack of “gold standard” for diagnosing of PROM makes it a challenge for the obstetrics. Most of the commonly available tests are either inaccurate or to some degree invasive. With its rapidity, performance characteristics and ease of use the NADAL® PROM Amniotic Fluid Test solves these problems.