Gynecologie, obstetrique, fertilite & senologie · 2018
[Correlation between automated optical reading and double human reading for two tests of fetal membranes rupture].
Сравнительное исследованиеСтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Four M, Chauffour C, Delabaere A, Pereira B, Sapin V, Gallot D
Аннотация
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.
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.