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Prospective evaluation of the efficacy of immunoassays in the diagnosis of rupture of the membranes
Ist Teil von
The journal of maternal-fetal & neonatal medicine, 2020-08, Vol.33 (15), p.2594-2600
Ort / Verlag
England: Taylor & Francis
Erscheinungsjahr
2020
Link zum Volltext
Beschreibungen/Notizen
Objective: To assess efficacy of immunoassays to diagnose spontaneous rupture of membranes (SROM).
Study design: We performed a prospective, observational analysis comparing two immunoassays designed to diagnose SROM (rupture of membranes (ROM) Plus
®
and Amnisure
®
) to standard clinical assessment for SROM and 48 h follow-up. Subjects had a singleton pregnancy ≥15 weeks' and suspected SROM. Sterile speculum exam (SSE) for nitrazine, ferning and pooling was performed. Immunoassays were run by independent providers blinded to results of SSE. The primary outcome was a final diagnosis of SROM at 48 h after initial evaluation.
Results: Three hundred twenty-four subjects were enrolled (121 (37.3%) with SROM and 203 (62.7%) without SROM). Both ROM Plus
®
and Amnisure
®
had sensitivities and specificities >91% for the primary outcome. McNemar's test revealed no significant difference between immunoassay test sensitivities and specificities.
Conclusion: Both the ROM Plus
®
and Amnisure
®
immunoassays may be used to accurately diagnose SROM. Performance of the two immunoassays was statistically equivalent.