Human papillomavirus E7 protein detection as a method of triage to colposcopy of HPV positive women, in comparison to genotyping and cytology. Final results of the PIPAVIR study.

The objective of the presented cross-sectional-evaluation-screening study is the clinical evaluation of high-risk(hr)HPVE7-protein detection as a triage method to colposcopy for hrHPV-positive women, using a newly developed sandwich-ELISA-assay. Between 2013-2015, 2424 women, 30-60 years old, were recruited at the Hippokratio Hospital, Thessaloniki/Greece and the Im Mare Klinikum, Kiel/Germany, and provided a cervical sample used for Liquid Based Cytology, HPV DNA genotyping, and E7 detection using five different E7-assays: "recomWell HPV16/18/45KJhigh", "recomWell HPV16/18/45KJlow", "recomWell HPV39/51/56/59", "recomWell HPV16/31/33/35/52/58" and "recomWell HPVHRscreen" (for 16,18,31,33,35,39,45,51,52,56,58,59 E7), corresponding to different combinations of hrHPVE7-proteins. Among 1473 women with eligible samples, those positive for cytology (ASCUS+ 7.2%), and/or hrHPV DNA (19.1%) were referred for colposcopy. Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) was detected in 27 women (1.8%). For HPV16/18-positive women with no triage, sensitivity, positive predictive value (PPV) and the number of colposcopies needed to detect one case of CIN2+ were 100.0%, 11.11% and 9.0 respectively. The respective values for E7-testing as a triage method to colposcopy ranged from 75.0-100.0%, 16.86-26.08% and 3.83-5.93. Sensitivity and PPV for cytology as triage for hrHPV(non16/18)-positive women were 45.45% and 27.77%; for E7 test the respective values ranged from 72.72-100.0% and 16.32-25.0%. Triage of HPV 16/18-positive women to colposcopy with the E7 test presents better performance than no triage, decreasing the number of colposcopies needed to detect one CIN2+. In addition, triage of hrHPV(non16/18)-positive women with E7 test presents better sensitivity and slightly worse PPV than cytology, a fact that advocates for a full molecular screening approach.

Diagnostic accuracy of high-risk HPV DNA genotyping for primary cervical cancer screening and triage of HPV-positive women, compared to cytology: preliminary results of the PIPAVIR study.

PURPOSE: The purpose of the presented PIPAVIR (persistent infections with human papillomaviruses; http://www.pipavir.com ) subanalysis is to assess the performance of high-risk (hr) HPV-DNA genotyping as a method of primary cervical cancer screening and triage of HPV positive women to colposcopy compared to liquid-based cytology (LBC) in an urban female population. METHODS: Women, aged 30-60, provided cervicovaginal samples at the Family-Planning Centre, Hippokratio Hospital of Thessaloniki, Greece, and the Department of Gynecology and Obstetrics in Mare Klinikum, Kiel, Germany. Cytology and HPV genotyping was performed using LBC and HPV Multiplex Genotyping (MPG), respectively. Women positive for cytology [atypical squamous cells of undetermined significance (ASC-US) or worse] or hrHPV were referred for colposcopy. RESULTS: Among 1723/1762 women included in the final analysis, hrHPV and HPV16/18 prevalence was 17.7 and 9.6%, respectively. Cytology was ASCUS or worse in 7.6%. Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) was detected in 28 women (1.6%). Sensitivity of cytology (ASCUS or worse) and HPV DNA testing for the detection of CIN2+ was 50.0 and 100%, and specificity was 94.49 and 85.49%, respectively. The screening approach according to which only women positive for HPV16/18 and for hrHPV(non16/18) with ASCUS or worse were referred to colposcopy presented 78.57% sensitivity and 13.17% positive predictive value (PPV). CONCLUSIONS: HPV testing represents a more sensitive methodology for primary cervical cancer screening compared to cytology. For triage of HPV positive women to colposcopy, partial HPV genotyping offers better sensitivity than cytology, at the cost of higher number of colposcopies.

WELCOME ­ innovative integrated care platform using wearable sensing and smart cloud computing for COPD patients with comorbidities.

We propose WELCOME, an innovative integrated care platform using wearable sensors and smart cloud computing for Chronic Obstructive Pulmonary Disease (COPD) patients with co-morbidities. WELCOME aims to bring about a change in the reactive nature of the management of chronic diseases and its comorbidities, in particular through the development of a patient centred and proactive approach to COPD management. The aim of WELCOME is to support healthcare services to give early detection of complications (potentially reducing hospitalisations) and the prevention and mitigation of comorbidities (Heart Failure, Diabetes, Anxiety and Depression). The system incorporates patient hub, where it interacts with the patient via a light vest including a large number of non-invasive chest sensors for monitoring various relevant parameters. In addition, interactive applications to monitor and manage diabetes, anxiety and lifestyle issues will be provided to the patient. Informal carers will also be supported in dealing with their patients. On the other hand, welcome smart cloud platform is the heart of the proposed system where all the medical records and the monitoring data are managed and processed via the decision support system. Healthcare professionals will be able to securely access the WELCOME applications to monitor and manage the patient's conditions and respond to alerts on personalized level.

Inter-examiner reproducibility of Ocular Response Analyzer using the waveform score quality index in healthy subjects.

PURPOSE: To evaluate the inter-examiner reproducibility of Ocular Response Analyzer (ORA) parameters in healthy subjects using the waveform score (WS) for quality control of acquisition. PATIENTS AND METHODS: Fifteen healthy subjects had their intraocular pressure (IOP) measured with ORA by 2 masked examiners. An acquisition protocol that aimed at obtaining 4 reliable measurements in each eye with WS≥6 and with as few repeated measurements as possible was employed, whereas a maximum of 8 measurements per eye was allowed. Additional good quality criteria included symmetrical force-in and force-out applanation signal peaks on the ORA waveform and few or no distortions of the applanation signal curve. Only the right eyes were included in the analysis. Examiners were trained but not experienced. The inter-examiner reproducibility of ORA parameters was assessed using the intraclass correlation coefficient (ICC). Mean values of the best 4 measurements were considered in analysis. RESULTS: ICC including the best 4 measurements per eye was high for all ORA parameters. Specifically, ICC for Goldmann-correlated IOP was 0.961, for corneal-compensated IOP was 0.962, for corneal resistance factor was 0.987, and for corneal hysteresis was 0.988. Similar reproducibility was found when only the 3 best measurements per eye were included in the analysis. CONCLUSIONS: The protocol for IOP measurement with ORA using the WS ≥6 as quality index achieved high inter-examiner reproducibility for all ORA parameters. High reproducibility was obtained even by inexperienced examiners when considering the mean of the best 3 measurements per eye.