Search

With the present paper, the Working Group on Cells, Tissues and Organs and other experts of the Superior Health Council of Belgium aimed to provide stakeholders in material of human origin with advice on critical aspects of serological and nucleic acid test (NAT) testing, to improve virological safety of cell- and tissue and organ donation. The current paper focusses on a number of preanalytical variables which can be critical for any medical biology examination: (1) sampling related variables (type of samples, collection of the samples, volume of the sample, choice of specific tubes, identification of tubes), (2) variables related to transport, storage and processing of blood samples (transport, centrifugation and haemolysis, storage before and after centrifugation, use of serum versus plasma), (3) variables related to dilution (haemodilution, pooling of samples), and (4) test dependent variables (available tests and validation). Depending on the type of donor (deceased donor (heart-beating or non-heart beating) versus living donor (allogeneic, related, autologous), and the type of donated human material (cells, tissue or organs) additional factors can play a role: pre- and post-mortem sampling, conditions of sampling (e.g. morgue), haemodilution, possibility of retesting., SCOPUS: ar.j, info:eu-repo/semantics/published

We report on sample IS/17575 since it generated highly divergent results in the Belgian SARS-CoV-2 serology external quality assessment scheme. Sample IS/17575 was serum originating from a 30 years old male patient. 124 diagnostic laboratories analysed this sample. A total of 168 results was returned (including 5 doubles). Overall, 38 were positive. All tests against S1 were positive except the Euroimmun IgG ELISA and the Ortho clinical Diagnostics VITROS IgG CLIA. All tests against S1/S2 (Liaison, Diasorin) resulted in a signal above cutoff. Assays against RBD, mostly generate a negative result. An exception are the Wantai SARS-CoV-2 ELISA's. All tests targeting N protein were negative. The survey shows, when >6 months post-infection, assays targeting at least S1, and preferably S1 combined with S2, are the most sensitive. This finding accentuates the necessity of external quality assessment schedules and importance of antigenic composition of serologic SARS-CoV-2 assays., SCOPUS: ar.j, info:eu-repo/semantics/published

Background: We evaluated the quantitative DiaSorin Liaison SARS-CoV-2 antigen test in symptomatic and asymptomatic individuals consulting their general practioner (GP) during a period of stable intense virus circulation (213/100,000 habitants per day). Methods: Left-over RT-PCR positive (n=204) and negative (n=210) nasopharyngeal samples were randomly selected among fresh routine samples collected from patients consulting their GP. Samples were tested on Liaison XL according to the manufacturer’s instructions. Equivocal results were considered positive. Results: Overall sensitivity and specificity of the Liaison antigen test compared to RT-PCR were 67.7% [95% confidence interval (CI): 60.9%-73.7%] and 100% [CI: 97.8%-100%]. Sensitivity in samples with a viral load ≥10 5 ,≥10 4 and ≥10 3 copies/mL was 100% [CI: 96.3%-100.0%], 96.5% [CI: 91.8%-98.7%] and 87.4% [CI: 81.3%-91.5%], respectively. All samples ≤10 3 copies/mL were antigen negative. The ratio of antigen concentration to viral load in samples ≥10 3 copies/mL was comparable in symptomatic and asymptomatic individuals ( p =0.58). The proportion of RT-PCR positive participants with a high viral load (≥10 5 copies/mL) was not significantly higher in symptomatic than in asymptomatic participants (63.9% [CI: 54.9%-72.0%] vs. 51.9% [CI: 41.1%-62.6%], p =0.11), but the proportion of participants with a low viral load (<10 3 copies/mL) was significantly higher in asymptomatic than in symptomatic RT-PCR positive participants (35.4% [CI: 25.8%-46.4%] vs. 14.3% [CI: 9.0%-21.8%], p <0.01). Conclusions: Sensitivity and specificity in samples with a viral load ≥10 4 copies/mL was 96.5% and 100%. The correlation of antigen concentration with viral load was comparable in symptomatic and asymptomatic individuals., info:eu-repo/semantics/published

We evaluated the quantitative DiaSorin Liaison severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen test in symptomatic and asymptomatic individuals consulting their general practitioners (GPs) during a period of stable intense virus circulation (213/100,000 habitants per day). Leftover reverse transcription-PCR (RT-PCR) positive (n=204) and negative (n=210) nasopharyngeal samples were randomly selected among fresh routine samples collected from patients consulting their GPs. Samples were tested on Liaison XL according to the manufacturer's instructions. Equivocal results were considered negative. The overall sensitivity and specificity of the Liaison antigen test compared to RTPCR were 65.7% (95% confidence interval [CI], 58.9% to 71.9%) and 100% (CI, 97.8% to 100%). Sensitivity in samples with viral loads of ≥105, ≥104, and ≥103 copies/ml were 100% (CI, 96.3% to 100.0%), 96.5% (CI, 91.8% to 98.7%), and 87.4% (CI, 81.3% to 91.5%), respectively. All samples with ≤103 copies/ml were antigen negative. The ratio of antigen concentration to viral load in samples with ≥103 copies/ml was comparable in symptomatic and asymptomatic individuals (P=0.58). The proportion of RT-PCR-positive participants with a high viral load (≥105 copies/ml) was not significantly higher in symptomatic than in asymptomatic participants (63.9% [CI, 54.9% to 72.0%] versus 51.9% [CI, 41.1% to 62.6%]; P=0.11), but the proportion of participants with a low viral load (,103 copies/ml) was significantly higher in asymptomatic than in symptomatic RT-PCR-positive participants (35.4% [CI, 25.8% to 46.4%] versus 14.3% [CI, 9.0% to 21.8%]; P<0.01). Sensitivity and specificity in samples with a viral load of ≥104 copies/ml were 96.5% and 100%. The correlation of antigen concentration with viral load was comparable in symptomatic and asymptomatic individuals., SCOPUS: ar.j, info:eu-repo/semantics/published

Background: In Belgium, rubella serology is frequently requested in women of childbearing age, despite high vaccination coverage and a near-absence of congenital rubella cases. Different test kits are available and should be standardised by an international standard preparation. Aim: To analyse and compare rubella serology practices in Belgian laboratories. Methods: As part of the mandatory External Quality Assessment programme for rubella serology in Belgium, the national public health institute, Sciensano, sent a voluntary questionnaire concerning anti-rubella IgM/IgG analyses in women aged 15 to 45 years in 2017 to 130 laboratories. Results: The questionnaire response rate was 83.8% (109/130). The majority of 169,494 IgG analyses were performed on Roche (55%), Abbott (17%) and Diasorin (13%) analysers. Not all laboratories used the proposed international cut-off of 10 IU/mL. Assumed median seroprevalence ranged from 76.3% with Liaison (Diasorin) to 96.3% with Modular (Roche). Despite very low rubella incidence in Belgium, 93 laboratories performed 85,957 IgM analyses, with 748 positive and 394 grey zone results. The National Reference Centre for Measles, Mumps and Rubella virus and the National Reference Centre for Congenital infections did not confirm any positive rubella cases in 2017. Conclusion: This retrospective analysis shows that rubella serology results may differ considerably according to the assay used. It is therefore important to use the same test when comparing results or performing follow-up testing. The number of anti-rubella IgM analyses was very high. Incorrect use of IgM for screening women of childbearing age can lead to unwarranted anxiety and overuse of confirmation tests., SCOPUS: ar.j, info:eu-repo/semantics/published

Background: Cervical cancer claims 311,000 lives annually, and 90% of these deaths occur in low- and middle-income countries. Cervical cancer is a highly preventable and treatable disease, if detected through screening at an early stage. Governments have a responsibility to screen women for precancerous cervical lesions. Yet, national screening programmes overlook many poor women and those marginalised in society. Under-screened women (called hard-to-reach) experience a higher incidence of cervical cancer and elevated mortality rates compared to regularly-screened women. Such inequalities deprive hard-to-reach women of the full enjoyment of their right to sexual and reproductive health, as laid out in Article 12 of the International Covenant on Economic, Social and Cultural Rights and General Comment No. 22. Discussion: This article argues first for tailored and innovative national cervical cancer screening programmes (NCSP) grounded in human rights law, to close the disparity between women who are afforded screening and those who are not. Second, acknowledging socioeconomic disparities requires governments to adopt and refine universal cancer control through NCSPs aligned with human rights duties, including to reach all eligible women. Commonly reported- and chronically under-addressed- screening disparities relate to the availability of sufficient health facilities and human resources (example from Kenya), the physical accessibility of health services for rural and remote populations (example from Brazil), and the accessibility of information sensitive to cultural, ethnic, and linguistic barriers (example from Ecuador). Third, governments can adopt new technologies to overcome individual and structural barriers to cervical cancer screening. National cervical cancer screening programmes should tailor screening methods to under-screened women, bearing in mind that eliminating systemic discrimination may require committing greater resources to traditionally neglected

Congenital toxoplasmosis (CT) and cytomegalovirus (cCMV) infection can cause morbidity, lifelong disabilities and mortality. The main objective of this thesis was to unravel the burden of both congenital infections in terms of Disability-Adjusted Life Years (DALYs). To achieve this goal, we focused on available evidence, identified data gaps, and developed an up-to-date methodological framework for assessing disease incidence and burden of disease. The epidemiology and burden of CT and cCMV infection in Belgium and by extension of cCMV infection in the European Union were assessed. In addition, we estimated the toxoplasmosis sero-epidemiological status of pregnant women in Northern Vietnam. Although data gaps remain, CT and especially cCMV infection were shown to have an important impact on public health., (SP - Sciences de la santé publique) -- UCL, 2019

Background: In Vietnam, few studies have determined the epidemiological status of toxoplasmosis in pregnant women and no routine prenatal screening is in place. This study was conducted to evaluate the seroprevalence of this zoonotic parasitic infection in pregnant women in Northern Vietnam and to assess the association with awareness, risk factors and congenital toxoplasmosis. Methods: Approximately 800 pregnant women were included in the study from two hospitals, one in Hanoi and one in Thai Binh province, which is known to have a dense cat population. Serological immunoglobulin G (IgG) and immunoglobulin M (IgM) detection was performed to estimate the seroprevalence of toxoplasmosis and sero-incidence of maternal and congenital toxoplasmosis. In addition, a survey was conducted about awareness, clinical history, presentation of signs and symptoms relating to toxoplasmosis and to detect biologically plausible and socio-demographic risk factors associated with toxoplasmosis. Associations with seroprevalence were assessed using univariable and multivariable analysis. Results: The mean IgG seroprevalence after the full diagnostic process was 4.5% (95% confidence interval(CI): 2.7-7.0) and 5.8% (95% CI: 3.7-8.6) in Hanoi and Thai Binh hospital, respectively, and included one seroconversion diagnosed in Thai Binh hospital. Only 2.0% of the pregnant women in Hanoi hospital and 3.3% in Thai Binh hospital had heard about toxoplasmosis before this study. Conclusion: Since the percentage of seronegative, and thus susceptible, pregnant women was high and the awareness was low, we suggest to distribute information about toxoplasmosis and its prevention among women of child bearing age. Furthermore, future studies are recommended to investigate why such a low seroprevalence was seen in pregnant women in Northern Vietnam compared to other countries in South East Asia and globally

Human bocavirus (HBoV) has been detected primarily in children with acute lower respiratory tract disease (LRTD), but its occurrence, clinical profile, and role as a causative agent of RTD are not clear. The aim of this study was to investigate the prevalence and the potential clinical relevance of HBoV. Using molecular tests, we tested 1352 nasopharyngeal samples obtained between October 1, 2017 and April 30, 2018 from children up to the age of 16 with RTD for the presence of HBoV DNA and 20 other respiratory pathogens at three different hospitals in Belgium. HBoV was detected in 77 children with a median age of 10.6 months. Consecutive samples were available for 15 HBoV-positive children and showed persistent HBoV positivity in four of them. Monoinfection was observed in six infants. Four of them were born prematurely and were infected during hospitalization at the neonatal intensive care unit (NICU). Only one of these six monoinfected children was diagnosed with recurrent wheezing due to HBoV. This child was carried to term and had a high viral load. Coinfections, most frequently with rhinovirus (52.1%) and adenovirus (49.3%), were observed in 72 patients. In seventeen of them in which HBoV was present at high viral load or higher viral load than its copathogens, bronchi(oli)tis (n = 8), recurrent wheezing (n = 8) or episodic wheezing (n = 1) were diagnosed. Our results suggest that HBoV infection at high viral load in infants is associated with wheezing (P = 0.013, Cramer's V = 0.613)., info:eu-repo/semantics/published

37 p., ill., Le nombre de cas d'infections sexuellement transmissibles (IST) grimpe de manière alarmante en Belgique, comme dans le reste du monde. Chlamydia, gonorrhée et syphilis sont en tête du peloton, et deviennent de plus en plus difficiles à traiter en raison de leur résistance croissante aux antibiotiques. Le Centre fédéral d’Expertise des Soins de santé (KCE) a développé, en collaboration avec des praticiens de terrain, des scientifiques et des associations de patients, le premier guide de pratique clinique belge sur le diagnostic et le traitement de la gonorrhée et de la syphilis. Ce guideline, principalement destiné aux médecins généralistes, devrait permettre que le diagnostic et le traitement de ces infections se fassent de manière uniforme et scientifiquement fondée. Un outil en ligne gratuit sera également mis au point dans les mois à venir pour aider les médecins généralistes à aborder les questions de santé sexuelle avec leurs patients, 1 INTRODUCTION 6 -- 1.1 CONTEXTE 6 -- 1.2 SURVEILLANCE DES MALADIES INFECTIEUSES EN BELGIQUE 8 -- 1.3 OBJECTIFS ET CHAMP D’APPLICATION DU GUIDE DE PRATIQUE CLINIQUE 8 -- 2 MÉTHODOLOGIE 9 -- 2.1 LE GROUPE DE DÉVELOPPEMENT DES GUIDELINES (GUIDELINE DEVELOPMENT GROUP) 9 -- 2.2 QUESTIONS DE RECHERCHE CLINIQUE 9 -- 2.3 MÉTHODOLOGIE 10 -- 2.4 REVUE EXTERNE PAR DES EXPERTS ET CONSULTATION DES PARTIES CONCERNÉES 11 -- 2.5 VALIDATION FINALE 11 -- 3 RECOMMANDATIONS CLINIQUES POUR LA PRISE EN CHARGE DE LA GONORRHÉE 11 -- 3.1 DIAGNOSTIC DE LA GONORRHÉE 11 -- 3.1.1 Recommandations : Qui faut-il tester pour la gonorrhée 11 -- 3.1.2 Recommandations : Quels tests diagnostiques pour la gonorrhée 13 -- 3.1.3 Diagnostic de la gonorrhée : Avis de bonne pratique 16 -- 3.2 TRAITEMENT DE LA GONORRHÉE 16 -- 3.2.1 Recommandations : Informations et conseils au patient au sujet de la gonorrhée 16 -- 3.2.2 Recommandations : Tests et surveillance de la résistance de la gonorrhée aux médicaments 17 -- 3.2.3 Recommandations : Instauration d’un traitement de la gonorrhée 18 -- 3.2.4 Quand faut-il orienter le patient vers la seconde ligne : Avis de bonne pratique 19 -- 3.2.5 Recommandations : Traitement de la gonorrhée chez les femmes et les hommes, incluant les jeunes 19 -- 3.2.6 Traitement de la gonorrhée : Avis de bonne pratique 20 -- 3.2.7 Recommandations : Traitement de la gonorrhée chez les femmes enceintes 20 -- 3.2.8 Traitement de la gonorrhée chez les femmes enceintes : Avis de bonne pratique 21 -- 3.2.9 Traitement des patients allergiques aux céphalosporines : Avis de bonne pratique 21 -- 3.2.10 Recommandations : Traitement des co-infections gonorrhée-chlamydia 21 -- 3.3 TEST DE CONTRÔLE DE LA GUÉRISON ET FRÉQUENCE DES TESTS DE DÉPISTAGE DE LA GONORRHÉE 22 -- 3.3.1 Recommandations : Quand effectuer un test de contrôle de la guérison 22 -- 3.3.2 Recommandations : Fréquence des tests de dépistage de la gonorrhée 23 -- 3.4 DÉCLARATION OBLIGATOIRE DE LA GONORRHÉE 23 -- 4 RECOMMANDATIONS CLINI

38 p., ill., Het aantal gevallen van seksueel overdraagbare infecties (SOI’s) neemt in België, net als in de rest van de wereld, onrustwekkend toe. Chlamydia, gonorroe en syfilis zijn daarbij de sterkste stijgers. Door de toenemende antibioticaresistentie wordt het ook steeds moeilijker om ze te behandelen. In samenwerking met clinici, wetenschappers en patiëntenverenigingen ontwikkelde het Federaal Kenniscentrum voor de Gezondheidszorg (KCE) de eerste wetenschappelijke Belgische richtlijn voor de diagnose en behandeling van gonorroe en syfilis, een primeur voor ons land. De richtlijn, vooral bestemd voor huisartsen, moet ervoor zorgen dat de opsporing en aanpak van deze infecties op een uniforme, wetenschappelijk onderbouwde manier gebeurt. In de komende maanden zal er ook een gratis online tool beschikbaar zijn, om huisartsen te begeleiden bij het ter sprake brengen van seksuele gezondheid., 1 INLEIDING 6 -- 1.1 ACHTERGROND 6 -- 1.2 SURVEILLANCE VAN INFECTIEZIEKTEN IN BELGIË .8 -- 1.3 DOELSTELLINGEN EN REIKWIJDTE VAN DE RICHTLIJN 8 -- 2 METHODOLOGIE.9 -- 2.1 DE ‘GUIDELINE DEVELOPMENT GROUP’ (GDG-RICHTLIJNONTWIKKELINGSGROEP) 9 -- 2.2 KLINISCHE ONDERZOEKSVRAGEN 9 -- 2.3 METHODOLOGIE 10 -- 2.4 EXTERNE REVIEW DOOR EXPERTEN EN STAKEHOLDERBEVRAGING 11 -- 2.5 FINALE VALIDATIE11 -- 3 KLINISCHE AANBEVELINGEN VOOR DE AANPAK VAN GONORROE .11 -- 3.1 DIAGNOSE VAN GONORROE 11 -- 3.1.1 Aanbevelingen wie er moet getest worden op gonorroe 11 -- 3.1.2 Aanbevelingen: Diagnostische testen voor gonorroe 13 -- 3.1.3 Diagnose van gonorroe: Advies voor goede praktijkvoering 16 -- 3.2 BEHANDELING VAN GONORROE 16 -- 3.2.1 Aanbevelingen over informatie en advies aan de patiënt over gonorroe 16 -- 3.2.2 Aanbevelingen voor het testen op en de surveillance van gonorroe geneesmiddelenresistentie. 17 -- 3.2.3 Aanbeveling bij het opstarten van de gonorroe behandeling 18 -- 3.2.4 Wanneer doorverwijzen naar de tweede lijn bij gonorroe: Advies voor goede praktijkvoering 19 -- 3.2.5 Aanbeveling voor de behandeling van vrouwen en mannen met gonorroe, inclusief jongeren 19 -- 3.2.6 De behandeling van gonorroe: Advies voor goede praktijkvoering 20 -- 3.2.7 Aanbeveling voor de behandeling van zwangere vrouwen met gonorroe.20 -- 3.2.8 De behandeling van zwangere vrouwen met gonorroe: Advies voor goede praktijkvoering 21 -- 3.2.9 Behandeling van gonorroe bij patiënten met een cefalosporineallergie: Advies voor goede praktijkvoering .21 -- 3.2.10 Aanbevelingen voor de behandeling van een co-infectie gonorroe-chlamydia 21 -- 3.3 TEST OP GENEZING EN FREQUENTIE VAN TESTEN OP GONORROE 22 -- 3.3.1 Aanbevelingen over het uitvoeren van een test op genezing bij gonorroe 22 -- 3.3.2 Aanbevelingen over de frequentie van testen op gonorroe 23 -- 3.4 MELDINGSPLICHT VAN GONORROE 23 -- 4 KLINISCHE AANBEVELINGEN VOOR SYFILIS 24 -- 4.1 DIAGNOSE VAN SYFILIS 24 -- 4.1.1 Aanbevelingen wie er moet getest worden op s

13 p., ill., Het Federaal Kenniscentrum voor de Gezondheidszorg (KCE) ontwikkelde een online tool voor het opsporen, behandelen en opvolgen van chlamydia, gonorroe, syfilis, HIV en hepatitis A, B en C. De tool werd samen met mensen van het terrein ontwikkeld en is bedoeld voor zorg- en hulpverleners van de eerste lijn (vooral huisartsen), om te gebruiken tijdens de consultatie. Hij kan gratis worden geraadpleegd via www.soa.kce.be., VOORWOORD 1 -- SYNTHESE 2 -- 1. INLEIDING 4 -- 2. STAPPEN IN DE ONTWIKKELING VAN DE INTERACTIEVE TOOL 5 -- 2.1. LITERATUURONDERZOEK OVER BESTAANDE TOOLS 5 -- 2.2. WETENSCHAPPELIJKE INHOUD 6 -- 2.2.1. Hoe opent u het gesprek over de seksuele gezondheid van de patiënt en hoe schat u in of -- de patiënt bereid is om zich te laten testen op SOI’s? 6 -- 2.2.2. Hoe schat u in of de patiënt risico loopt op een SOI, en op welke SOI dan specifiek? 6 -- 2.2.3. Welk staal is er nodig voor welke SOI? 10 -- 2.2.4. Welke aanbevolen behandeling voor welke SOI? 10 -- 2.2.5. Wat is de aanbevolen opvolging voor de patiënt? 10 -- 2.2.6. Hoe de partner(s) van de patiënt informeren? 10 -- 3. ONTWIKKELING VAN DE TOOL 11 -- 3.1. TECHNISCHE SPECIFICATIES 11 -- 3.2. ONTWIKKELING VAN DE ENGELSE, FRANSE EN NEDERLANDSE VERSIE 12 -- 3.2.1. Eerste iteratieve fase: alfaversie 12 -- 3.2.2. Voorlopige evaluatie van de tool: betaversie 12 -- 3.3. EVALUATIE VAN DE NIEUWE VERSIE VAN DE TOOL 12 -- 3.4. ONTWIKKELING VAN DE DUITSTALIGE VERSIE 13 -- 4. CONCLUSIE 13

181 p., ill., SCIENTIFIC REPORT 14 -- 1 INTRODUCTION .14 -- 1.1 BACKGROUND 14 -- Etiology, transmission, clinical features and epidemiological trends .14 -- Notification of infectious diseases in Belgium . 21 -- 1.2 THE NEED FOR A NATIONAL GUIDELINE .22 -- 1.3 SCOPE .23 -- 1.4 REMIT OF THE GUIDELINE .24 -- Overall objectives .24 -- Patient-centred care 24 -- Policy relevance and target users of the guideline .24 -- 1.5 STATEMENT OF INTENT 25 -- 1.6 FUNDING AND DECLARATION OF INTEREST 25 -- 2 METHODOLOGY 26 -- 2.1 THE GUIDELINE DEVELOPMENT GROUP 26 -- 2.2 INTERNATIONAL COLLABORATION .26 -- 2.3 GENERAL APPROACH AND CLINICAL RESEARCH QUESTIONS 26 -- General approach 26 -- Research questions 28 -- 2.4 SEARCH FOR GUIDELINES AND QUALITY APPRAISAL 34 -- Databases and date limits 34 -- Search strategy 34 -- Quality appraisal 36 -- 2.5 ADDITIONAL LITERATURE SEARCH: DIAGNOSTIC TESTS FOR GONORRHOEA 36 -- Diagnostic tests of choice for diagnosis of gonorrhoea in primary care 36 -- Quality appraisal 37 -- 2.6 ADDITIONAL LITERATURE SEARCH: TREATMENT FOR GONORRHOEA 38 -- Treatment for gonorrhoea in primary care 38 -- Quality appraisal 39 -- 2.7 ADDITIONAL LITERATURE SEARCH: DIAGNOSTIC TESTS FOR SYPHILIS 39 -- Search strategy .39 -- Quality appraisal 40 -- 2.8 ADDITIONAL LITERATURE SEARCH: TREATMENT FOR SYPHILIS .40 -- Treatment for syphilis in primary care 40 -- Quality appraisal 42 -- 2.9 DATA EXTRACTION .43 -- 2.10 STATISTICAL ANALYSES .43 -- 2.11 GRADING EVIDENCE .44 -- 2.12 FORMULATION OF RECOMMENDATIONS 47 -- 2.13 EXTERNAL REVIEW 49 -- 2.14 FINAL VALIDATION 50 -- 3 CLINICAL RECOMMENDATIONS 51 -- 3.1 ASSESSMENT OF RISK FOR GONORRHOEA 51 -- 3.2 DIAGNOSIS OF GONORRHOEA 52 -- Recommendations from international guidelines .53 -- Additional literature search: Diagnosis of gonorrhoea 56 -- Recommendations: Who to test for gonorrhoea 76 -- Recommendations: Diagnostic tests for gonorrhoea in men .77 -- Recommendations: Diagnostic tests for gonorrhoea in women 78 -- Diagnosis of gonorrhoea: Good pra

72 p., ill., LIST OF TABLES 3 -- LIST OF FIGURES 4 -- LIST OF ABBREVIATIONS 5 -- SCIENTIFIC REPORT 7 -- 1 INTRODUCTION 7 -- 2 DEVELOPMENT OF THE SCIENTIFIC CONTENT 8 -- 2.1 GENERAL APPROACH AND CLINICAL RESEARCH QUESTIONS 8 -- 2.2 SEARCH FOR GUIDELINES, GUIDANCE INSTRUMENTS AND QUALITY APPRAISAL 10 -- 2.2.1 Search strategy 10 -- 2.2.2 Identification and selection of guidance documents 10 -- 2.2.3 Quality appraisal 12 -- 2.3 SCIENTIFIC CONTENT 12 -- 2.3.1 How to start a conversation about sexual health 12 -- 2.3.2 How to assess if the patient is ready for STI testing and if there is a need for testing 16 -- 2.3.3 How to define the patient’s risk or risk group for an STI 17 -- 2.3.4 How to define which STI should be tested for by groups at risk 20 -- 2.3.5 Which is the correct sample for each STI 23 -- 2.3.6 How should the STI be treated 26 -- 2.3.7 The follow-up of a patient with an STI 28 -- 2.3.8 How often should a patient with an STI be re-tested 30 -- 2.3.9 Tracing partners of a patient with an STI 30 -- 2.3.10 How are partners best contacted 31 -- 2.3.11 Notification of infectious diseases 33 -- 3 DEVELOPMENT OF THE TOOL 33 -- 3.1 THE CHOICE OF TECHNICAL SPECIFICATIONS REQUIRED FOR THE DEVELOPMENT AND FOR THE UPDATE OF THE TOOL 33 -- 3.2 THE DEVELOPMENT OF THE TOOL INTEGRATING THE CONTENT IN ENGLISH, FRENCH AND DUTCH 34 -- 3.2.1 Iterative first phase: alpha version 34 -- 3.2.2 A preliminary assessment of the tool: beta version 34 -- 3.2.3 Feedback from KCE experts and NGC 35 -- 3.3 A TEST OF THE REVISED VERSION OF THE TOOL 35 -- 3.3.1 Testing via an online survey 35 -- 3.3.2 Feedback from HCPs, GDG members and patients’ representatives 35 -- 4 DISSEMINATION OF THE ONLINE TOOL 36 -- 4.1 KCE COMMUNICATION STRATEGY 36 -- 4.1.1 Website 36 -- 4.1.2 Press 37 -- 4.1.3 Social media and newsletters 37 -- 4.2 EBPNET COMMUNICATION 37 -- 5 CONCLUSION 37 -- APPENDICES 38 -- APPENDIX 1. GUIDANCE DOCUMENTS AND CONSULTATION ALGORITHMS 38 -- APPENDIX 2. STARTING A SEXUAL HEALTH CONVERSATION

14 p., ill., Le Centre Fédéral d’Expertise des Soins de Santé (KCE) a développé un outil en ligne pour le diagnostic, le traitement et le suivi de la gonorrhée, la syphilis, la chlamydia, le VIH et les hépatites A, B et C. Cet outil a été élaboré en collaboration avec les associations de terrain ; il est prévu pour servir de support pour les intervenants de première ligne – principalement les médecins généralistes – lorsqu’ils abordent les questions relatives à la santé sexuelle. Il est disponible gratuitement sur www.ist.kce.be., PRÉFACE 1 -- SYNTHÈSE 2 -- 1. INTRODUCTION 4 -- 2. ÉTAPES DE DÉVELOPPEMENT DE L’OUTIL INTERACTIF 5 -- 2.1. RECHERCHE DE LITTÉRATURE SUR LES OUTILS EXISTANTS 5 -- 2.2. CONTENU SCIENTIFIQUE 6 -- 2.2.1. Comment entamer une conversation sur la santé sexuelle et estimer si le patient est disposé à effectuer des tests de dépistage ? 6 -- 2.2.2. Comment estimer si le patient est à risque d’IST et pour quelles IST en particulier ? 6 -- 2.2.3. Quel est le prélèvement adéquat pour chaque IST ? 10 -- 2.2.4. Quel est le traitement recommandé pour chaque IST ? 10 -- 2.2.5. Quel est le suivi recommandé pour chaque patient ? 10 -- 2.2.6. Comment avertir le(s) partenaire(s) du patient ? 11 -- 3. DÉVELOPPEMENT DE L’OUTIL 12 -- 3.1. SPÉCIFICATIONS TECHNIQUES 12 -- 3.2. DÉVELOPPEMENT DES VERSIONS ANGLAISE, FRANÇAISE ET NÉERLANDAISE 12 -- 3.2.1. Première phase itérative : version alpha 12 -- 3.2.2. Évaluation préliminaire de l'outil : version bêta 12 -- 3.3. ÉVALUATION DE LA VERSION RÉVISÉE DE L’OUTIL 13 -- 3.4. DÉVELOPPEMENT D’UNE VERSION EN ALLEMAND 13 -- 4. CONCLUSION 14

45 p., ill., 1 INTRODUCTION 7 -- BACKGROUND 7 -- REMIT OF THE GUIDELINE 9 -- 1.2.1 Objectives of the guideline 9 -- 1.2.2 Patient-centered care 9 -- 2 METHODOLOGY 10 -- THE GUIDELINE DEVELOPMENT GROUP 10 -- CLINICAL RESEARCH QUESTIONS 10 -- GENERAL APPROACH 11 -- QUALITY ASSESSMENT OF STUDIES 11 -- FORMULATION OF RECOMMENDATIONS 12 -- EXTERNAL REVIEW 12 -- FINAL VALIDATION 12 -- 3 CLINICAL RECOMMENDATIONS FOR MANAGEMENT OF GONORRHOEA 14 -- GONORRHOEA DIAGNOSIS 14 -- 3.1.1 Recommendations: Who to test for gonorrhoea 14 -- 3.1.2 Recommendations: Diagnostic tests for gonorrhoea 16 -- 3.1.3 Diagnosis of gonorrhoea: Good practice statements 18 -- GONORRHOEA TREATMENT 19 -- 3.2.1 Recommendations regarding information and advice for the patient 19 -- 3.2.2 Recommendations regarding testing and surveillance for resistance 20 -- 3.2.3 Recommendation regarding initiation of therapy 20 -- 3.2.4 Referral to the second line for gonorrhoea: Good practice statements 21 -- 3.2.5 Recommendation for treatment of gonorrhoea in women and men including young people 21 -- 3.2.6 Treatment of gonorrhoea: Good practice statements 22 -- 3.2.7 Recommendation for treatment of gonorrhoea in pregnant women 22 -- 3.2.8 Treatment of gonorrhoea in pregnant women: Good practice statements 23 -- 3.2.9 Treatment of gonorrhoea in people with an allergy to cephalosporin: Good practice statement 23 -- 3.2.10 Recommendations for treatment of chlamydia and gonorrhoea co-infection 24 -- GONORRHOEA TEST OF CURE AND FREQUENCY OF TESTING 25 -- 3.3.1 Recommendations regarding a test of cure for gonorrhoea 25 -- 3.3.2 Recommendations regarding testing frequency for gonorrhoea 26 -- MANDATORY NOTIFICATION OF GONORRHOEA 26 -- 4 CLINICAL RECOMMENDATIONS FOR MANAGEMENT OF SYPHILIS 27 -- SYPHILIS DIAGNOSIS 27 -- 4.1.1 Recommendations: Who to test for syphilis 27 -- 4.1.2 Recommendations: Which sample to take for syphilis 28 -- 4.1.3 Recommendation: Which tests to use for syphilis 29 -- 4.1.4 Choice of tests for syphilis diagnosis

305 p., ill., 1. COMPOSITION OF THE GUIDELINE DEVELOPMENT GROUP 12 -- 1.1. COMPOSITION OF THE GUIDELINE DEVELOPMENT GROUP 12 -- 1.2. COMPOSITION OF THE KCE EXPERT TEAM 13 -- 1.3. EXTERNAL RESEARCHERS INVOLVED IN THE GUIDELINE DEVELOPMENT 13 -- 2. SEARCH STRATEGIES 14 -- 2.1. GENERAL LITERATURE SEARCH 14 -- 2.1.1. Ovid MEDLINE 14 -- 2.1.2. Cochrane 15 -- 2.1.3. Embase 17 -- 2.1.4. Study flow for general literature search 21 -- 2.2. ADDITIONAL SEARCH FOR DIAGNOSIS OF GONORRHOEA 22 -- 2.2.1. Medline 22 -- 2.2.2. Central 22 -- 2.2.3. Study flow of selection of primary studies 22 -- 2.2.4. Excluded studies 24 -- 2.3. ADDITIONAL SEARCH FOR TREATMENT OF GONORRHEA 28 -- 2.3.1. Medline 28 -- 2.3.2. Embase 29 -- 2.3.3. Cochrane 30 -- 2.3.4. Study flow of selection of primary studies 31 -- 2.3.5. Excluded studies 33 -- 2.4. ADDITIONAL SEARCH FOR DIAGNOSIS OF SYPHILIS 35 -- 2.4.1. Medline 35 -- 2.4.2. Cochrane 36 -- 2.4.3. Study flow of selection of systematic reviews and primary studies 37 -- 2.4.4. Excluded studies 38 -- 2.5. ADDITIONAL SEARCH FOR TREATMENT OF SYPHILIS 39 -- 2.5.1. Medline 39 -- 2.5.2. Embase 40 -- 2.5.3. Cochrane 40 -- 2.5.4. Pubmed 41 -- 2.5.5. Excluded studies 43 -- 3. GUIDELINES IDENTIFIED 44 -- 3.1. TOPIC: DIAGNOSIS AND/OR MANAGEMENT OF GONORRHOEA 44 -- 3.2. TOPIC: DIAGNOSIS AND/OR MANAGEMENT OF SYPHILIS 45 -- 4. GUIDANCE DOCUMENTS AND CONSULTATION ALGORITHMS FOR THE TOOL 46 -- 5. GUIDANCE DOCUMENTS FOR PARTNER MANAGEMENT 48 -- 6. QUALITY APPRAISAL 50 -- 6.1. QUALITY APPRAISAL TOOLS 50 -- 6.1.1. Guidelines 50 -- 6.1.2. Diagnostic accuracy studies 54 -- 6.1.3. Primary studies for therapeutic interventions 59 -- 7. EVIDENCE TABLES BY CLINICAL QUESTION 73 -- 7.1. DIAGNOSIS OF GONORRHEA 73 -- 7.1.1. Nucleic acid amplification Tests (NAATs) and culture 73 -- 7.2. TREATMENT OF GONORRHOEA 136 -- 7.2.1. Sexually active women and men including adolescents 136 -- 7.2.2. Pregnant women 144 -- 7.2.3. People with an allergy to cephalosporin 150 -- 7.3. DIAGNOSIS OF SYPHILIS 150

This paper on the biological tests carried out on serum/plasma samples from donors of human body material (HBM) is the result of a project of the working Group of Superior Health Council of Belgium formed with experts in the field of HBM and infectious serology. Indeed, uncertainty about the interpretation of biological test results currently leads to the sometimes unjustified cancelling of planned donations or the rejection of harvested HBM, whilst more sophisticated diagnostic algorithms would still allow the use of organs or HBM that would otherwise have been rejected. NAT tests will not be discussed in this publication. In the first part some general aspects as the need for a formal agreement between the Tissue Establishment l and the laboratory responsible for the biological testing, but also some specifications regarding testing material, the choice of additional biological tests, and some general aspects concerning interpretation and reporting are discussed. In a second part, detailed information and recommendations concerning the interpretation are presented for each of the mandatory tests (human immunodeficiency virus, hepatitis B virus, hepatitis C virus and syphilis) is presented. A number of not mandatory, but regularly used optional serological tests (e.g. for the detection of antibodies to Toxoplasma gondii, Epstein-Barr virus, human T cell leukemia virus and cytomegalovirus) are also extensively discussed. Although the project was meant to provide clarification and recommendations concerning the Belgian legislation, the majority of recommendations are also applicable to testing of donors of tissues and cells in other (European) countries.

BACKGROUND: The knowledge of circulating HCV genotypes and subtypes in a country is crucial to guide antiviral therapy and to understand local epidemiology. Studies investigating circulating HCV genotypes and their trends have been conducted in Belgium. However they are outdated, lack nationwide representativeness or were not conducted in the general population. METHODS: In order to determine the distribution of different circulating HCV genotypes in Belgium, we conducted a multicentre study with all the 19 Belgian laboratories performing reimbursed HCV genotyping assays. Available genotype and subtype data were collected for the period from 2008 till 2015. Furthermore, a limited number of other variables were collected: some demographic characteristics from the patients and the laboratory technique used for the determination of the HCV genotype. RESULTS: For the study period, 11,033 unique records collected by the participating laboratories were used for further investigation. HCV genotype 1 was the most prevalent (53.6%) genotype in Belgium, with G1a and G1b representing 19.7% and 31.6%, respectively. Genotype 3 was the next most prevalent (22.0%). Further, genotype 4, 2, and 5 were responsible for respectively 16.1%, 6.2%, and 1.9% of HCV infections. Genotype 6 and 7 comprise the remaining <1%. Throughout the years, a stable distribution was observed for most genotypes. Only for genotype 5, a decrease as a function of the year of analysis was observed, with respectively 3.6% for 2008, 2.3% for 2009 and 1.6% for the remaining years. The overall M:F ratio was 1.59 and was mainly driven by the high M:F ratio of 3.03 for patients infected with genotype 3. Patients infected with genotype 3 are also younger (mean age 41.7 years) than patients infected with other genotypes (mean age above 50 years for all genotypes). The patients for whom a genotyping assay was performed in 2008 were younger than those from 2015. Geographical distribution demonstrates that an important

This paper on the biological tests carried out on serum/plasma samples from donors of human body material (HBM) is the result of a project of the working Group of Superior Health Council of Belgium formed with experts in the field of HBM and infectious serology. Indeed, uncertainty about the interpretation of biological test results currently leads to the sometimes unjustified cancelling of planned donations or the rejection of harvested HBM, whilst more sophisticated diagnostic algorithms would still allow the use of organs or HBM that would otherwise have been rejected. NAT tests will not be discussed in this publication. In the first part some general aspects as the need for a formal agreement between the Tissue Establishment l and the laboratory responsible for the biological testing, but also some specifications regarding testing material, the choice of additional biological tests, and some general aspects concerning interpretation and reporting are discussed. In a second part, detailed information and recommendations concerning the interpretation are presented for each of the mandatory tests (human immunodeficiency virus, hepatitis B virus, hepatitis C virus and syphilis) is presented. A number of not mandatory, but regularly used optional serological tests (e.g. for the detection of antibodies to Toxoplasma gondii, Epstein–Barr virus, human T cell leukemia virus and cytomegalovirus) are also extensively discussed. Although the project was meant to provide clarification and recommendations concerning the Belgian legislation, the majority of recommendations are also applicable to testing of donors of tissues and cells in other (European) countries., SCOPUS: ar.j, SCOPUS: er.j, info:eu-repo/semantics/published

Background The knowledge of circulating HCV genotypes and subtypes in a country is crucial to guide antiviral therapy and to understand local epidemiology. Studies investigating circulating HCV genotypes and their trends have been conducted in Belgium. However they are outdated, lack nationwide representativeness or were not conducted in the general population. Methods In order to determine the distribution of different circulating HCV genotypes in Belgium, we conducted a multicentre study with all the 19 Belgian laboratories performing reimbursed HCV genotyping assays. Available genotype and subtype data were collected for the period from 2008 till 2015. Furthermore, a limited number of other variables were collected: some demographic characteristics from the patients and the laboratory technique used for the determination of the HCV genotype. Results For the study period, 11,033 unique records collected by the participating laboratories were used for further investigation. HCV genotype 1 was the most prevalent (53.6%) genotype in Belgium, with G1a and G1b representing 19.7% and 31.6%, respectively. Genotype 3 was the next most prevalent (22.0%). Further, genotype 4, 2, and 5 were responsible for respectively 16.1%, 6.2%, and 1.9% of HCV infections. Genotype 6 and 7 comprise the remaining <1%. Throughout the years, a stable distribution was observed for most genotypes. Only for genotype 5, a decrease as a function of the year of analysis was observed, with respectively 3.6% for 2008, 2.3% for 2009 and 1.6% for the remaining years. The overall M:F ratio was 1.59 and was mainly driven by the high M:F ratio of 3.03 for patients infected with genotype 3. Patients infected with genotype 3 are also younger (mean age 41.7 years) than patients infected with other genotypes (mean age above 50 years for all genotypes). The patients for whom a genotyping assay was performed in 2008 were younger than those from 2015. Geographical distribution demonstrates that an important num, SCOPUS: ar.j, info:eu-repo/semantics/published

Congenital toxoplasmosis (CT) and cytomegalovirus infection (cCMV) may cause significant morbidity and even fetal or neonatal mortality. We aimed to quantify the disease burden of CT and cCMV in Belgium in terms of disability-adjusted life years (DALYs) and identify data gaps. The public health impact of CT and cCMV in Belgium in 2013 was 188 (95% uncertainty interval [UI], 43-419) and 1976 (95% UI, 757-4067) DALYs, respectively. The major data gaps identified were representative Belgian studies; information on important sequelae, intrauterine mortality, and termination of pregnancy; and late onset sequelae. A scenario analysis showed important increases in years of life lost when the burden due to fetal losses was included and decreases in DALYs when comprehensive CT prevention measures were conducted. Addressing the key data gaps identified may allow generation of the data needed to break the vicious circle of underrecognition.

Marusya Lieveld,1 Elizaveta Padalko,2,3 Marleen Praet,4 Davy Vanden Broeck1 1Department of Uro/gynaecology, Ghent University Hospital, Ghent, Belgium; 2Department of Clinical Chemistry, Microbiology and Immunology, Ghent University Hospital, Ghent, Belgium; 3School of Life Sciences, Hasselt University, Diepenbeek, Belgium; 4N. Goormaghtigh Institute of Pathology, Ghent University Hospital, Ghent, BelgiumZappacosta et al1 recently published a case report concerning a human papillomavirus (HPV)-positive invasive cervical cancer in a 79-year-old women who had a history of normal Pap smears. In this article, Anyplex II HPV28 (Seegene) is used for HPV genotyping of formalin-fixed paraffin embedded (FFPE) tissue, liquid based cytology (LBC) specimens and urine samples. It is suggested that HPV53 is present exclusively in the cervical cancer cells, lymph node metastases, and atypical urinary cells of one single case while the surrounding CIN2+ tissue revealed ten different HPV strains. Unfortunately, the HPV genotype results for lymph nodes and urinary cells are not presented while these results underline the potential role of HPV53 in oncogenesis. Moreover, it is generally accepted that one lesion is caused by one HPV infection, detection of multiple HPV types thus indicates the presence of multiple infections,2 suggesting that this patient may have several lesions. Read the original article &nbsp

Poster de conférence republié - 12th Annual ESCV Meeting, info:eu-repo/semantics/published