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
8
12.
Limitations
The NADAL® PROM Amniotic Fluid Test is for professional
in-vitro
diagnostic use and should be only used for the
qualitative detection of IGFBP-1.
The NADAL® PROM Amniotic Fluid Test only detects the
presence of IGFBP-1 in the specimen and should not be
used as the sole criterium for the diagnosis of PROM.
• In pregnant women, the IGFBP-1 concentration in the blood
is much lower than in the amniotic fluid, meaning that a
definitive diagnosis is normally possible. However, if the
sample material has been contaminated by blood, false
positive results may occur which cannot be attributed to
membrane rupture.
The epithelial cells in the cervix may contain IGFBP-1
concentrations which may cause a false positive test result
even without the presence of premature rupture of
membranes. This also applies to non-pregnant women, as
IGFBP-1 is a major protein in the endometrium around mid-
cycle.
According to existing theories (e.g. 'double sac'), ruptures
can occur which may lead to a temporary loss of amniotic
fluid. Tests carried out at different times can therefore
deliver different results.
If the test result is negative and clinical symptoms persist,
additional testing using other clinical methods is
recommended.
As with all diagnostic tests, a confirmed diagnosis should
only be made by a physician after all clinical and laboratory
findings have been evaluated.
13.
Performance Characteristics
Sensitivity
The analytical sensitivity of the NADAL® PROM Amniotic Fluid
Test is 5 ng/mL IGFBP-1.
Accuracy
The results obtained using the NADAL® PROM Amniotic Fluid
Test were compared to those of another commercially
available PROM rapid test in a multi-center clinical evaluation.
The results of the study demonstrated 97.7% accuracy of the
NADAL® PROM Amniotic Fluid Test when compared to the
PROM rapid test of a different manufacturer.
PROM rapid test of a different
manufacturer
NADAL®
PROM
Amniotic
Fluid Test
Positive
Negative
Total
Positive
83
3
86
Negative
2
133
135
Total
85
136
221
Sensitivity: 97.6%
Specificity: 97.8%
Overall agreement: 97.7%
Interfering substances/microorganisms
The following substances and microorganisms have been
evaluated at the concentrations listed below. None of them
were found to affect the test performance of the NADAL®
PROM Amniotic Fluid Test.
Substance/microorganism
Concentration
Pevaryl®
30 mg/mL
GYNO-TROSYD®
20 mg/mL
Flagyl®
100 mg/mL
Canesten®
40 mg/dL
Glucose
8 mg/mL
Candida albicans
11.2 x 10
8
CFU/mL
Gardnerella vaginalis
8.6 x 10
8
CFU/mL
Neisseria gonorrhoeae
10.6 x 10
8
CFU/mL
Baby powder
10 mg/mL
Vagisan® Myco Kombi (Creme)
1 mg/mL
Baby oil
1 mg/mL
Medical silicone oil
13 g/mL
Note:
blood of pregnant women may cause false positive
results.
Intra-lot and inter-lot variability
Negative and positive controls at concentrations of 5 ng/mL
and 25 ng/mL were tested in 10 replicates with 3 independent
lots on 3 consecutive days. Each control was recognized
correctly.
14.
References
1.
Friedman ML, McElin TW. Diagnosis of ruptured fetal membranes. Am J Obstet
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2.
Steinman G, Kleiner GJ, Greston WM. Spontaneous rupture of membranes. NY St. J
Med 1979:1849-1851
3.
Koninckx PR, Trappeniers H, van Assche FA. Prolactin concentration in vaginalfluid:
a new method for diagnosing ruptured membranes. Br J Obstet Gynaecol
1981;88:607–610
4.
Rochelson BL, Richardson DA, Macri JN. Rapid assay: possible application in the
diagnosis of premature rupture of the membranes. Obstet Gynecol 1983;62:414–
418
5.
Bell SC, Hales MW, Patel SR, Kirwan PH, Drife JO, Milford-Ward A. Amniotic fluid
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6.
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7.
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8.
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Medina TM, Hill DA. Preterm premature rupture of membranes: diagnosis and
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11.
Guibourdenche J, Luton D, André E, Noël M, Porquet D. Détection rapide de
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12.
Sucak A, Moroy P, Cakmak P, Mungan T, Mollamahmutoglu L, Danisman N. Insulin-
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13.
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14.
Akercan F, Cirpan T, Kazandi M, Terek MC, Mgoyi l, Ozkinay E. The value of insulin-
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clinically unconfirmed preterm premature rupture of membranes. Eur J Obstet
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15.
Schuman W. Double sac with secondary rupture of the bag of waters during labor;
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