Abstract
Objective:
The objective of this study was to evaluate the efficacy of IGFBP-1/AFP (insulin-like growth factor-binding protein-1/alpha-fetoprotein) immunoassay (Amnioquick Duo+) in diagnosing rupture of membranes (ROM).
Study Design:
A prospective, observational study was performed in pregnant women with a history of fluid leakage from the vagina. The IGFBP-1/AFP immunoassay and conventional methods were used to diagnose ROM. The obstetricians were blinded to the results of the IGFBP-1/AFP immunoassay. The diagnosis of ROM was finally confirmed by reviewing the medical records after delivery.
Result:
One hundred patients were recruited into this study. The mean gestational age was 37.6 weeks (range 25 to 41 weeks). Twenty-six percent were preterm and 74% were at term. IGFBP-1/AFP immunoassay had a sensitivity of 94.1%, specificity of 87.5%, positive predictive value of 97.5%, negative predictive value of 73.7% and accuracy of 93% in diagnosing ROM.
Conclusion:
IGFBP-1/AFP immunoassay is a rapid immunoassay test for diagnosing ROM with a high sensitivity and specificity. This test can be used as an alternative method for diagnosis of ROM.
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Acknowledgements
We wish to thank Dr Thierry Paper, CEO and President of Biosynex SA, France for his kind support and free supply of the Amnioquick Duo+ tests.
Disclaimer
Biosynex SA, which supplied the Amnioquick Duo+ tests, did not get involved or participate in the study design, collection, analysis and manuscript development.
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Ruanphoo, P., Phupong, V. Evaluation of the performance of the insulin-like growth factor-binding protein-1/alpha-fetoprotein test in diagnosing ruptured fetal membranes in pregnant women. J Perinatol 35, 558–560 (2015). https://doi.org/10.1038/jp.2015.6
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DOI: https://doi.org/10.1038/jp.2015.6
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