OBJECTIVES: To prospectively validate the diagnostic performance of a non-invasive point-of-care tool (Rapid IAI System), including vaginal alpha-fetoprotein and interleukin-6, to predict the occurrence of intra-amniotic inflammation in a Spanish cohort of patients admitted with a diagnosis of preterm labor and intact membranes. METHODS: From 2017 to 2022, we prospectively evaluated a cohort of pregnant women diagnosed with preterm labor and intact membranes admitted below 34+0 weeks who underwent amniocentesis to rule-in/out intra-amniotic infection and/or inflammation. Vaginal sampling was performed at the time of amniocentesis or within 24-48 h. Amniotic fluid IL-6, vaginal alpha-fetoprotein and vaginal IL-6 concentrations were measured using a point-of-care tool provided by Hologic Inc., "Rapid IAI System". We defined intra-amniotic inflammation when amniotic fluid IL-6 values were greater than 11.3 ng/mL. During recruitment, clinicians were blinded to the results of the point-of-care tool. The original prediction model proposed by Hologic Inc. to predict intra-amniotic inflammation was validated in this cohort of patients. RESULTS: We included 151 patients diagnosed with preterm labor and intact membranes. Among these, 29 (19.2 %) had intra-amniotic inflammation. The algorithm including vaginal IL-6 and alpha-fetoprotein showed an area under curve to predict intra-amniotic inflammation of 80.3 % (±5.3 %) with a sensitivity of 72.4 %, specificity of 84.6 %, positive predictive valuve (PPV) of 52.5 %, negative predictive value (NPV) of 92.9 %, and a positive likelihood ratio (LR+) of 4.6 and negative likelihood ratio (LR-) of 0.33. CONCLUSIONS: External validation of a non-invasive rapid point-of-care tool, including vaginal alpha-fetoprotein and IL-6, showed very good diagnostic performance for predicting the absence of intra-amniotic inflammation in women with preterm labor and intact membranes.

BCNatal Barcelona Center for Maternal Fetal and Neonatal Medicine Institut Clínic de Ginecología Obstetrícia 1 Neonatología Fetal i D Fetal Medicine Research Center Barcelona Spain

Biomedical Research Center University Hospital Hradec Kralove Hradec Kralove Czech Republic

Center for Biomedical Research on Rare Diseases 28029 Madrid Spain

Center for Biomedical Research on Rare Diseases Madrid Spain

Department of Genetics and Bioinformatics Area of Health Data and Digitalisation Norwegian Institute of Public Health Oslo Norway

Department of Obstetrics and Gynecology Hospital Most Most Czech Republic

Department of Obstetrics and Gynecology Sahlgrenska Academy University of Gothenburg Gothenburg Sweden

Institut d'Investigacions Biomèdiques August Pi 1 Sunyer Departament de Cirurgia i Especialitats Medicoquirúrgiques Universitat de Barcelona Barcelona Spain

Institut d'Investigacions Biomèdiques August Pi 1 Sunyer University of Barcelona Barcelona Spain

Microbiology department Center of Biomedical diagnostic Hospital Clinic ISGlobal Barcelona Spain

Microbiology department Hospital Sant Joan de Déu Barcelona Spain

MovumTech Barcelona Spain

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