[Correlation between automated optical reading and double human reading for two tests of fetal membranes rupture]

Abstract

Objectives: To assess concordance between double human and automated optical reading (AOR) concerning two biological tests for rupture of membranes (ROM) METHODS: We conducted a monocentric, prospective, observational study comparing Actim Prom^® (Alere SAS, Jouy-en Josas, France) and Hiprom Duo^® (Fumouze, Levallois-Perret, France). Each test was performed simultaneously in patients with suspected ROM and read independently by 2 biologists and AOR device. ROM was clinically confirmed in case of recurrent leakage or spontaneous labour with no perceived membranes within 48hours.

Results: Concerning Actim Prom^®, concordance was 100 %, 92.5 % and 91.6 % between biologists, biologists-AOR device and biologists or AOR vs. clinical presentation respectively. Concerning Hiprom Duo^®, concordance was 97.2 % between biologists, 97.2 % between biologist 1 and AOR, 95.3 % between biologist 2 and AOR, 63.5 % between clinical presentation and human reading, 62.3 % between clinical presentation and AOR. False positive cases were significantly associated with modified cervix (21 % vs. 46 %, P=0.006).

Conclusion: We demonstrated excellent correlation between biologists and good or excellent correlation between AOR and human reading supporting the use of AOR in clinical practice.

Keywords: Alfa foeto-proteine (AFP); Alfa foetoprotéine (AFP); Automated optical reading; Biological test; Fetal membranes rupture; Insulin-like growth factor binding protein-1 (IGFBP-1); Lecture optique automatisée; Rupture prématurée des membranes; Test biologique.