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Diagnostic Accuracy of Insulin-like Growth Factor–Binding Protein-1/alpha-Fetoprotein (AmnioQuick Duo) in Ruptured Fetal Membranes

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Abstract

Failure to identify women with ruptured fetal membranes (RFM) is associated with subsequent infectious morbidity. To evaluate the diagnostic accuracy of AmnioQuick Duo in the detection of RFM, One hundred and twenty-five women (125) in the preterm premature rupture of fetal membranes/premature rupture of fetal membranes (PPRFM/PRFM) group were compared to one hundred and twenty women (120) controls in this study. On admission, after thorough history, the participants were examined by trans-abdominal sonography for evaluation of the amniotic fluid index (AFI), followed by sterile vaginal speculum examination to detect leaking amniotic fluid from the cervix, and for collection of samples for nitrazine, fern, and AmnioQuick Duo tests. The RFM were confirmed at delivery and compared using the recorded data of admission to evaluate the diagnostic accuracy of the AmnioQuick Duo in the detection of RFM (primary outcome). The AmnioQuick Duo test had 97.6% sensitivity, 98.3% specificity, 98.4% positive predictive value (PPV), 97.5% negative predictive value (NPV), and 97.95% overall accuracy in the detection of PPRFM/PRFM. The Nitrazine test had 64.8% sensitivity, 64.2% specificity, 65.3% PPV, 63.6% NPV, and overall accuracy 64.5% in the detection of PPRFM/PRFM. Fern test had 63.2% sensitivity, 59.2% specificity, 61.7% PPV, 60.7% NPV, and 61.2% overall accuracy in the detection of PPRFM/PRFM. The combined IGFBP-1/AFP (AmnioQuick Duo) test is an accurate bedside test with 97.6% sensitivity, 98.3% specificity, 98.4% PPV, 97.5% NPV, and 97.95% overall accuracy in the detection of PPRFM/PRFM. The sensitivity, specificity, PPV, NPV, and the overall accuracy of the AmnioQuick Duo were significantly higher than in the standard diagnostic nitrazine or fern tests in the detection of RFM.

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Acknowledgments

The authors are grateful to Doctor Thierry Paper (CEO and President of Biosynex, SA) for supplying the AmnioQuick Duo kits freely for this study. The authors are also grateful to women who agreed and gave consent to participate in this study.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Ahmadi Hospital, Kuwait Oil Company (KOC), P.O. Box: 9758, 61008, Ahmadi, Kuwait

    Ibrahim A. Abdelazim

  2. Department of Obstetrics and Gynecology, Ain Shams University, Cairo, Egypt

    Ibrahim A. Abdelazim

  3. Department of Obstetrics and Gynecology №1, West Kazakhstan Marat Ospanov Medical University, Aktobe, Kazakhstan

    Svetlana Shikanova, Bakyt Karimova, Mukhit Sarsembayev, Gulmira Mukhambetalyeva & Mariya Bekzhanova

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  1. Ibrahim A. Abdelazim
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  2. Svetlana Shikanova
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  3. Bakyt Karimova
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  4. Mukhit Sarsembayev
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  5. Gulmira Mukhambetalyeva
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  6. Mariya Bekzhanova
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Correspondence to Ibrahim A. Abdelazim.

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The authors declare that they have no conflict of interest.

Ethical Considerations

The study was approved by the ethical committees of the Obstetrics and Gynecology Departments, and registered under the trial number ACTRN12618001891213.

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This is a prospective comparative multicenter study.

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Abdelazim, I.A., Shikanova, S., Karimova, B. et al. Diagnostic Accuracy of Insulin-like Growth Factor–Binding Protein-1/alpha-Fetoprotein (AmnioQuick Duo) in Ruptured Fetal Membranes. SN Compr. Clin. Med. 2, 2834–2839 (2020). https://doi.org/10.1007/s42399-020-00600-w

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