Effect of blood on ROM diagnosis accuracy of PAMG-1 and IGFBP-1 detecting rapid tests

Babett Ramsauer; Wiebke Duwe; Bettina Schlehe; Regina Pitts; Dirk Wagner; Katja Wutkewicz; Dmitry Chuvashkin; Harald Abele; Robert Lachmann

doi:10.1515/jpm-2014-0227

Article

Effect of blood on ROM diagnosis accuracy of PAMG-1 and IGFBP-1 detecting rapid tests

Babett Ramsauer , Wiebke Duwe , Bettina Schlehe , Regina Pitts , Dirk Wagner , Katja Wutkewicz , Dmitry Chuvashkin , Harald Abele and Robert Lachmann

Published/Copyright: November 8, 2014

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From the journal Journal of Perinatal Medicine Volume 43 Issue 4

Abstract

Vaginal bleeding may be present in up to 30% of patients presenting with signs and symptoms of a rupture of the fetal membranes (ROM). The presence of blood may lead to false positive results with biochemical markers. The data presented in this study came from a multi-centric prospective observational clinical study that, for the first time, systematically evaluated the performance of placental alpha microglobulin-1 (PAMG-1) and insulin-like growth factor binding protein-1 (IGFBP-1) detecting tests in 151 women with vaginal bleedings as well as signs and symptoms indicative of ROM. Our data showed better performance for the PAMG-1 compared with the IGFBP-1 detecting tests in all quality parameters evaluated. In detail, sensitivity (SN) was 97.8% (91.0%), specificity (SP) was 91.5% (75.0%), positive predictive value (PPV) was 94.6% (83.5%) and negative predictive value (NPV) was 96.4% (85.7%) for PAMG-1 tests (and IGFBP-1 tests, respectively). A major difference between both tests was related to the number of non-evaluable test results (e.g., hidden bands due to blood smear on the test strips). While 2% of all results were not evaluable for PAMG-1 tests, this artifact appeared in 11% of the results obtained with IGFBP-1 tests. This difference and also those in Specificity and PPV were statistically significant, demonstrating superiority of PAMG-1 over IGFBP-1 detecting tests. In conclusion, the PAMG-1 detecting test was significantly less susceptible to interference by blood than the IGFBP-1 detecting test.

Keywords: Actim PROM; AmniSure; IGFBP-1 (insulin-like growth factor binding protein-1); PAMG-1 (placental alpha-microglobulin-1); premature rupture of fetal membranes (PROM); uncertain rupture; vaginal bleeding

Corresponding author: Babett Ramsauer, Vivantes Klinikum Neukölln – Perinatal Medicine Rudowerstr. 48 Berlin 12351, Germany, Tel.: +004930130148486, Fax: 004930130148599, E-mail: ramsauer.publication@gmail.com

Acknowledgments

We are very grateful to our colleagues for including patients into our study: André Farrokh (Bielefeld), Sabine Peters (Dortmund), A. Zirkel (Dresden), Gerhard Ortmeyer (Hamburg Eppendorf), Martina Weber (Leipzig), Gunnar Schwennicke (Mönchengladbach), Rita Müßing (Meppen), Thomas Möller (Oldenburg), Theresa Bierwald (Paderborn), Christiane Fröhlich (Rheine), Michael Wilhelm (Wolfsburg), and Ralf Bends (Köln-Weyertal).

Conflict of interest statement

The authors of this study have no conflicts of interest to report. The PAMG-1 immunoassay test kits were provided free of charge by AmniSure GmbH, which did not contribute funds toward this study. The IGFBP-1 immunoassay test kits were purchased for routine clinical use from Alere GmbH, (Cologne, Germany). None of the authors own any stock in either of these companies.

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The authors stated that there are no conflicts of interest regarding the publication of this article.

Received: 2014-7-9

Accepted: 2014-9-15

Published Online: 2014-11-8

Published in Print: 2015-7-1

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Articles in the same Issue

https://doi.org/10.1515/jpm-2014-0227

Keywords for this article

Actim PROM; AmniSure; IGFBP-1 (insulin-like growth factor binding protein-1); PAMG-1 (placental alpha-microglobulin-1); premature rupture of fetal membranes (PROM); uncertain rupture; vaginal bleeding