ENGLISH
NADAL® PROM Amniotic Fluid Test
(Ref. 431006N-01/431006N-03/431006N-10/431006N-20)
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • [email protected] • www.nal-vonminden.com
6
1.
Intended Use
The NADAL® PROM Amniotic Fluid Test is an immunochro-
matographic 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.
2.
Introduction and 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. 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.).
3.
Test Principle
The NADAL® PROM Amniotic Fluid Test enables the detection
of Insulin-like Growth Factor Binding Protein 1 (IGFBP-1) in
vaginal secretion through visual interpretation of colour
development on the test strip. Anti-IGFBP-1 antibodies are
immobilised in the test line region of the membrane. During
the test, the specimen reacts with further anti-IGFBP-1
antibodies conjugated to coloured particles and precoated
onto the conjugate pad of the test cassette. The mixture then
migrates along the membrane by capillary action and interacts
with the reagents on the membrane. If there is sufficient
IGFBP-1 in the specimen, a coloured line will form in the test
line region of the membrane. The presence of this coloured
line indicates a positive result, while its absence indicates a
negative result. The appearance of a coloured line in the
control line region serves as a procedural control, indicating
that the proper volume of specimen has been added and
membrane wicking has occurred.
4.
Reagents and Materials Supplied
Depending on the packaging unit, the NADAL® PROM Amniotic
Fluid test kit contains:
1/3/10/20 test strips, individually packed with desiccant
Provided additional material according to 93/42/EEC:
1/3/10/20 sterile Copan flocked swabs (FLOQSwabs™)
CE 0123,
Copan Italia S.p.A.,
Via Perotti 10, 25125 Brescia, Italy
1/3/10/20 collection tubes with extraction buffer
1 tube holder (except Ref. 431006N-01)
1 package insert
5.
Additional Materials Required
Timer
6.
Storage & Stability
The NADAL® PROM Amniotic Fluid Test should be stored at
2-30°C until the expiry date printed on the sealed foil pouch.
The test strip must remain in the sealed foil pouch until use.
Do not freeze tests. Care should be taken to protect
components of the test kit from contamination. Do not use
the test if there is evidence of microbial contamination or
precipitation. Biological contamination of dispensing
equipment, containers or reagents can lead to false results.
7.
Warnings and Precautions
For professional
in-vitro
diagnostic use only.
Carefully read through the test procedure prior to testing.
Do not use the test beyond the expiration date indicated on
the package.
Do not use the test if the foil pouch is damaged.
Do not reuse tests.
The test strip should remain in the sealed foil pouch until
use.
Do not dip the test strip beyond the maximum immersion
mark.
Do not add samples to the reaction area (result area).
In order to avoid contamination, do not touch the reaction
area (result area) or the immersion area.
Immersion area
Handling area
Control line (C)
Reaction area
Test line (T)
Maximum immersion mark
