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• Accuracy of full genotyping oncopredict QT assay was evaluated on self-samples. • HPV testing in self-samples was similarly sensitive for CIN2+ versus cervical samples. • OncoPredict QT assay provides genotype specific viral load normalised by cellularity. The VALHUDES initiative was established to assess the clinical accuracy of HPV assays to detect cervical precancers using urine and vaginal self-samples compared to cervical clinician-collected samples. Here, the clinical performance of OncoPredict HPV Quantitative Typing (QT) assay (OncoPredict QT) was evaluated. 490 women referred to colposcopy self-collected a urine and a vaginal specimen using Colli-Pee and FLOQSwab, respectively. Subsequently, a colposcopy was performed, and a cervical sample was collected with Cervex-Brush, followed by biopsy if clinically indicated. Vaginal samples were transported dry and resuspended in 5 mL of eNAT medium, whilst cervical brushings were immediately transferred in 20 mL ThinPrep. The clinical sensitivity of OncoPredict HPV QT testing for CIN2+ in urine and vaginal self-samples was similar to cervical samples (ratios of 0.99 [95 % CI 0.94–1.05] and 1.00 [95 % CI 0.96–1.04]), respectively, when manufacturer's cut-offs were applied. The specificity for

Objective: To analyze and evaluate the value of serum human epididymis protein 4 (HE4) for the diagnosis of endometrial cancer (EC).Methods: Studies involving HE4 and the diagnosis of EC were retrieved from the following medical literature databases: Medline, PubMed, Web of Science, China National Knowledge Infrastructure, China Biology Medicine Disc, Vip Journal Integration Platform, and Wanfang Data Knowledge Service Platform. Quality assessment was performed independently by two reviewers using Review Manager 5.3 (Cochrane Collaboration Group). A quality table of included studies was made using Review Manager 5.3, and the pooled sensitivity (SEN), specificity (SPE), positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic accuracy, and receiver operating characteristic curve (SROC) were analyzed using Review Manager 5.3 and Meta-Disc 1.4 software.Results: Of 887 studies, 17 passed quality assessment and were included in the final study. The pooled SEN was 0.65 (95 % confidence interval [CI]: 0.63-0.67), SPE was 0.913 (95 % CI: 0.92-0.95), PLR was 10.06 (95 % CI: 4.75-21.35), NLR was 0.41 (95 % CI: 0.33-0.50), diagnostic odds ratio (DOR) was 26.7 (95 % CI: 11.7-60.93), and the area under curve (AUC) of the receiver operating characteristic curve (SROC) curve was 0.75 (95 % CI: 0.81-0.87).Conclusions: HE4 is a potential biomarker for the diagnosis of EC with a high specificity and relatively low sensitivity. Considering high heterogeneity and selection bias, the value of HE4 for diagnosing EC should be further evaluated in strictly-designed diagnostic studies as well as in different pathological types and stages of EC. [ABSTRACT FROM AUTHOR]

• No muscle size, shape nor brightness differences were found between US methods. • B-mode and panoramic US demonstrated good-to-excellent concordance. • Panoramic US could be used as an accessible, low-cost and valid imaging tool. Despite panoramic ultrasound imaging (US) is a promising advance for the morphological and histological assessment of large musculature which cannot be entirely assessed using B-mode, there is no evidence assessing if this technology produces muscle deformation during imaging acquisition. We aimed to analyze differences in size, shape and brightness descriptors between B-mode and panoramic US images and to assess the concordance between both methods. Methods We analyzed size (cross-sectional area and perimeter), shape (circularity, aspect ratio and roundness) and brightness (mean echo-intensity) features of cervical multifidus (CM) and short rotators (SR) in 46 healthy volunteers. Images were acquired in B-mode and extended field-of-view mode. For validity analysis, mean differences between methods were calculated. For agreement analysis, intraclass correlation coefficients (ICCs), standard error of measurements (SEM), minimal detectable changes (MDC) and coefficient of variation (CV%) were calculated. All parameters showed no significant differences between both methods for either CM or SR (P > 0.05). Panoramic US showed excellent concordance with B-mode for assessing all CM parameters (all ICCs > 0.9), while for SR the agreement ranged from good-to-excellent (ICC from 0.861 to 0.978). Panoramic US seems to be a valid tool for assessment of muscle size, shape and brightness as no deformation in comparison with B-mode images was seen. Further research is needed to corroborate these findings comparing panoramic US imaging with Gold Standard methods. [ABSTRACT FROM AUTHOR]

Purpose: Amplitude-integrated electroencephalogram (aEEG) is being used increasingly for monitoring seizures in neonatal units. Its accuracy, compared with "the gold-standard" conventional elecroencephalogram (cEEG) is still not well established. We aimed to conduct a systematic review to evaluate the diagnostic accuracy of aEEG when compared with cEEG, for detection of neonatal seizures.Method: A systematic review was conducted using the Cochrane methodology. EMBASE, CINAHL and PubMed databases were searched in September 2014. Studies comparing simultaneous recordings of cEEG and aEEG for detection of seizures in neonatal population were included. QUADAS 2 tool was used to examine "risk of bias" and "applicability".Results: Ten studies (patient sample 433) were included. Risk of bias was high in five studies, unclear in one and low in four. For the detection of individual seizures, when "aEEG with raw trace" was used, median sensitivity was 76% (range: 71-85), and specificity 85% (range: 39-96). When "aEEG without raw trace" was used, median sensitivity was 39% (range: 25-80) and specificity 95% (range: 50-100). Detailed meta-analysis could not be done because of significant clinical/methodological heterogeneity. Seizure detection was better when interpreted by experienced clinicians. Seizures with low amplitude/brief duration and those occurring away from aEEG leads were less likely to be detected.Conclusion: Studies included in the systematic review showed aEEG to have relatively low and variable sensitivity and specificity. Based on the available evidence, aEEG cannot be recommended as the mainstay for diagnosis and management of neonatal seizures. There is an urgent need of well-designed studies to address this issue definitively. [ABSTRACT FROM AUTHOR]

Background European health systems have developed referral guidelines for the selection of patients for the urgent investigation of suspected colorectal cancer. Aim To evaluate whether quantitative faecal immunochemical testing performs better than commonly used high-risk symptoms based strategies for fast-tracking cancer referrals. Methods We prospectively studied 1054 symptomatic patients referred for a colonoscopy who provided a sample for faecal immunochemical testing. The usefulness of faecal immunochemical testing and two current guidelines for urgent referral were compared for their efficacy in the detection of colorectal cancer and advanced neoplasia. Results The guidelines detected 46.7% and 43.3% of cases of colorectal cancer while faecal haemoglobin concentration ≥15 μg Hb/g detected 96.7% of cases. The diagnostic accuracy of both the guidelines and faecal haemoglobin concentration ≥15 μg Hb/g for the detection of advanced neoplasia was: sensitivity 38.3%, 36.1%, 57.1% and specificity 71.8%, 69.5%, 86.6%, respectively. Male gender (OR 2.35; p < 0.001), age (1.34; p = 0.002), and faecal haemoglobin concentration ≥10 μg Hb/g (7.81; p < 0.001) were independent predictive factors of advanced neoplasia. Conclusions A faecal immunochemical test based-strategy performs better than current high-risk symptoms based strategies for fast-tracking cancer referrals. A score that combines gender, age and a faecal immunochemical test could accurately estimate the risk of advanced neoplasia. [ABSTRACT FROM AUTHOR]

• Cause of death ICD-10 coding can accurately identify deceased adults with epilepsy. • G40 or G40–41 (epilepsy–status epilepticus) achieve PPV > 90 % but sensitivity ≤71 %. • G40–41 and/or R56.8 (seizures) with AEDs achieve PPVs >90 % and sensitivities >80 %. • PPVs are >85 % and sensitivities >90 % for F25 epilepsy Read codes with AEDs. • PPVs are high (93–95 %) but sensitivity ≤71 % when linking in a third dataset. We investigate the case-ascertainment accuracy for potentially active epilepsy of four administrative healthcare datasets used to identify deceased adults in Scotland. In this diagnostic accuracy study, unique patient identifiers were used to link administrative healthcare data for adults (aged 16 years and over) who died in Scotland between 01/01/09–01/01/16. Cases were ascertained from linking mortality records, hospital admissions, antiepileptic drug (AED) prescriptions, and primary care attendances. We assessed ICD-10 codes G40 (epilepsy), G41 (status epilepticus), and R56.8 (seizures) listed as causes of death and as hospital admission reasons, various AEDs, and F25 primary care epilepsy Read codes. These epilepsy indicators were searched through 01/01/09–01/01/16, suggesting active epilepsy during a maximal period of seven years before death. They were compared to epilepsy diagnoses made from medical records reviewed by a senior epileptologist, with a second senior epileptologist independently reviewing the medical records in a 10 % sample to check for specialist interrater agreement in epilepsy diagnoses. We validated how accurately epilepsy was identified by each dataset alone and when combined, calculating positive predictive value (PPV) and sensitivity (with 95 % confidence intervals (CIs)). 159,032 deceased potential epilepsy cases were captured across the four datasets. Medical records reviewed in a random sample of 936 confirmed that epilepsy was present in 614 and absent in 322. Specialist interrater diagnostic agreement was substantial (100 medical records reviewed in duplicate, kappa = 0.72, CI 0.58–0.86). G40–41 cause of death codes had a PPV of 86 % (CI 84–89 %) and sensitivity of 73 % (CI 69–76 %). Adding R56.8 lowered PPV to 69 % (CI 65–72 %) and raised sensitivity to 87 % (CI 84–90 %). The optimal algorithm combining two datasets consisted of F25 Read codes paired with AEDs (PPV 86 % (CI 80–92 %), sensitivity 93 % (CI 88–97 %)). Also effective was pairing G40–41 and/or R56.8 cause of death codes with AEDs (PPV 91 % (CI 89–94 %), sensitivity 81 % (CI 77–84 %)). Whilst algorithms combining three datasets raised PPV to as high as 93–95 %, the associated sensitivities were low (71 % at most). Routinely-collected Scottish data can accurately identify epilepsy in deceased adults. It may be necessary to combine the diagnostic coding used with AEDs to ensure optimal case-ascertainment. The results help inform the design of future Scottish epilepsy mortality studies recruiting from administrative data sources. [ABSTRACT FROM AUTHOR]

• M. refringens, B. ostreae and B. exitiosa are regulated parasites of flat oysters. • First validated PCR detecting all regulated pathogens of flat oysters in one step. • Multiplex PCR performances similar or higher than currently recommended PCR assays. • Represents a substantial improvement in time, resources and accuracy. • Useful to monitors parasites prevalence or for demonstration of freedom. Aquaculture including shellfish production is an important food resource worldwide which is particularly vulnerable to infectious diseases. Marteilia refringens, Bonamia ostreae and Bonamia exitiosa are regulated protozoan parasites infecting flat oysters Ostrea edulis that are endemic in Europe. Although some PCR assays have been already developed for their detection, a formal validation to assess the performances of those tools is often lacking. In order to facilitate the diagnosis of flat oyster regulated diseases, we have developed and evaluated a new multiplex Taqman® PCR allowing the detection of both M. refringens and Bonamia sp. parasites in one step. First part of this work consisted in assessing analytical sensitivity and specificity of the new PCR assay. Then, diagnostic performances were assessed by testing a panel of field samples with the new real-time PCR and currently recommended conventional PCR methods for the detection of M. refringens and Bonamia sp. Samples were collected from the main flat oyster production sites in France (N = 386 for M. refringens and N = 349 for B. ostreae). In the absence of gold standard, diagnostic sensitivity and specificity of the new PCR were estimated through Bayesian latent class analysis (DSe 87,2% and DSp 98,4% for the detection M. refringens , DSe 77,5% and DSp 98,4% for the detection of Bonamia sp.). Those results suggest equivalent performances for the detection of Bonamia sp. and an improved sensitivity for the detection of M. refringens compared to commonly used conventional protocols. Finally, the new PCR was evaluated in the context of an inter-laboratory comparison study including 17 European laboratories. Results revealed a very good reproducibility with a global accordance (intra-laboratory precision) >96% and a global concordance (inter-laboratory precision) >93% for both targets, demonstrating that this new tool is easily transferable to different laboratory settings. This is the first assay designed to detect both Marteilia refringens and Bonamia sp. in a single step and it should allow reducing the number of analysis to monitor both diseases, and where relevant to demonstrate freedom from infection. [ABSTRACT FROM AUTHOR]

Abstract: Background and Objective: Internal validation of a diagnostic test estimates the degree of random error, using the original data of a diagnostic accuracy study. External validation requires a new study in an independent but similar population. Here we describe whether diagnostic research is validated, which technique is used, and to what extent the validation study results differ from the original. Study Design and Setting: All original diagnostic accuracy studies published in 1993 in a predefined set of journals were selected. Validation of these studies was assessed in the original article and in articles published within a period of 10 years, through a literature search and contacting the authors. Results: None of the original studies reported any form of validation. Validation studies published later could be identified for 7 of the 11 original studies. Test characteristics were difficult to compare. Despite what was generally believed, not every validation study showed results inferior to the original. We found more studies that evaluated the test in a different population than in a similar one. Conclusion: Not every diagnostic accuracy study is validated. Diagnostic tests are more often repeated in different populations. [Copyright &y& Elsevier]