CIN2+ detection of the HPV DNA Array genotyping assay in comparison with the Cobas 4800 HPV test and cytology

BACKGROUND: HPV DNA Array is an E1-targeting PCR genotyping test, with capability of distinguishing 18 high-risk (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82) and 11 low-risk HPV types (6, 11, 40, 42, 44, 54, 67, 69, 70, 85, 97). HPV DNA Array uses multiplex PCR for E1-gene sequence amplification. The amplicons are detected and genotyped by reverse hybridization to immobilized DNA probes spotted as triplets in single 96 well-plate wells and read by AID ELISPOT reader. METHODS: Aim of the study was to evaluate the clinical performance of the assay against internationally accepted and FDA approved Cobas 4800 HPV test (Roche Diagnostics). Study population comprised of 500 cervical samples. RESULTS: HPV DNA Array demonstrated a very high sensitivity of 100% for CIN2+ and 100% for CIN3+ detection, same as Cobas 4800. HPV DNA Array showed greater sensitivity for CIN2+ detection than cytology (100% vs. 13.6%). The agreement to Cobas 4800 for HPV detection, irrespective of type, was 81.4% with κ = 0.613. The agreement for HPV 16 was 92.8% (κ = 0.929), and for HPV 18 54.2% (κ = 0.681). CONCLUSION: HPV DNA Array demonstrated good clinical performance for detection of high-grade lesions, and may be considered for usage in a screening setting

Clinical performance of the HPV DNA Array genotyping assay in detection of CIN2+ lesions with BS GP5+/6+ MPG Luminex tested cervical samples

Human papillomavirus (HPV) detection is used for screening of cervical cancer and genotype-specific persistence has shown to be mandatory for dysplasia development. Aim of this study was to evaluate the clinical performance of HPV DNA Array for cervical intraepithelial neoplasia 2+ (CIN2+) lesion detection. HPV DNA Array is a polymerase chain reaction-based assay that targets E1 sequences of 29 HPV types (6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 44, 45, 51, 52, 53, 54, 56, 58, 59, 66, 67, 68, 69, 70, 73, 82, 85, and 97). The clinical evaluation was performed against the reference assay, BS-GP5+/6+ multiplex genotyping (MPG)-Luminex, with 600 cervical smear samples of a referral population. HPV DNA Array detected CIN2+ lesions with a sensitivity of 90.2%, identical to that of MPG-Luminex. Detection of CIN3+ lesions was with a sensitivity of 90.3%, as compared with 88.7% of MPG-Luminex. It demonstrated very good agreement for HPV detection, irrespective of type, of 91.5% (kappa = 0.832). HPV DNA Array is a simple and robust assay, with a short protocol of 4 hours hands-on time and automated readout by ELISpot AiDot software. It permits testing of up to 96 samples in one run and may be considered for use in organized screening programs and low resource settings

Auswirkungen der COVID-19-Krise auf Präventionsangebote zu durch Blut und sexuell übertragenen Infektionen bei Drogengebrauchenden

Im Rahmen einer Kurzbefragung zur aktuellen Situation in niedrigschwelligen Drogenhilfeeinrichtungen in der COVID-19-Krise wurden 41 Einrichtungen angeschrieben. Die zusammengefassten Rückmeldungen der niedrigschwelligen Einrichtungen der Drogenhilfe zeigen, dass es gravierende Einschränkungen hinsichtlich der Präventionsangebote für Blut- und sexuell übertragene Infektionskrankheiten durch die COVID-19-Krise gibt. Die Krise hat zeitweise zu einer vollständigen Schließung von Einrichtungen geführt, wobei viele mittlerweile unter Einhaltung der vorgeschriebenen Hygiene- und Abstandsregeln wieder öffnen konnten. Dies hat auch aktuell noch Auswirkungen auf die Beratungsmöglichkeiten, Testangebote, Konsum- und Aufenthaltsmöglichkeiten.Peer Reviewe

Estimates of Toxoplasmosis Incidence Based on Healthcare Claims Data, Germany, 2011–2016

Toxoplasmosis is a zoonotic infection contracted through Toxoplasma gondii–contaminated food, soil, or water. Seroprevalence in Germany is high, but estimates of disease incidence are scarce. We investigated incidences for various toxoplasmosis manifestations using anonymized healthcare claims data from Germany for 2011–2016. Patients with a toxoplasmosis diagnosis during the annual observational period were considered incident. The estimated incidence was adjusted to the general population age/sex distribution. We estimated an annual average of 8,047 toxoplasmosis patients in Germany. The average incidence of non–pregnancy-associated toxoplasmosis patients was 9.6/100,000 population. The incidence was highest in 2011, at 10.6 (95% CI 9.4–12.6)/100,000 population, and lowest in 2016, at 8.0 (95% CI 7.0–9.4)/100,000 population. The average incidence of toxoplasmosis during pregnancy was 40.3/100,000 pregnancies. We demonstrate a substantial toxoplasmosis disease burden in Germany. Public health and food safety authorities should implement toxoplasmosis-specific prevention programs.Peer Reviewe

Female health-care providers' advocacy of self-sampling after participating in a workplace program for cervical cancer screening in Ghana: a mixed-methods study

Background: Cervical cancer is the second most common cancer among Ghanaian women and screening coverage is low. ACCESSING is a cross-sectional study investigating human papillomavirus (HPV) prevalence via self-sampling in rural communities of the North Tongu district in Ghana. Female health-care providers (HCPs) were invited to self-collect a cervicovaginal sample with a commercial sampler in order to acquaint themselves with the sampling method. Objective: This study set out to explore female HCPs' perceptions, advocacy for, and implications of self-sampling with the aim of enhancing self-sampling acceptability in the targeted screening population. Methods: A mixed-methods approach was used, consisting of (a) a survey among 52 female HCPs working in a district hospital and (b) 10 one-to-one semi-structured interviews with purposefully sampled HCPs. Results: The quantitative analysis of the survey (n = 52) showed that, among HCPs who took the sample themselves (50/52), all found it 'Easy' or 'Very Easy' and felt 'Very Comfortable' or 'Comfortable'. 82.7% indicated that they would undertake screening more often, and 98.1% indicated they would prefer self-sampling, if cervical cancer risk is as reliably determined as by clinician-directed cytobrush sampling. All interview participants (n = 10) indicated that they appreciated the program and would recommend the screening to their patients and/or family members and neighbours. Common reasons for preferring self-sampling were less (anticipated) pain compared to speculum examination and more privacy. Conclusions: Self-sampling for cervical cancer screening is highly acceptable to female HCPs. Setting up a workplace screening program that entails the option of self-sampling could create greater awareness and positive attitudes among HCPs to educating their patients, families, and neighbours on cervical cancer risks and motivate HCPs to advocate for women's participation in screening

Virushepatitis B und D im Jahr 2020

Infektionen mit Hepatitis-B-Viren (HBV) gehören zu den häufigsten Infektionskrankheiten weltweit. Hepatitis D ist ebenfalls weltweit verbreitet, auch wenn Deutschland zu den Niedrigprävalenzländern gehört. Sowohl die WHO als auch das Bundesministerium für Gesundheit haben Strategien zur Eindämmung von Hepatitis B veröffentlicht - die COVID-19-Pandemie stellt jedoch eine große Heraus¬forderung beim Erreichen der Eliminierungsziele bis 2030 dar. In Deutschland wurden im Jahr 2020 24% weniger HBV-Infektionen übermittelt als im Vorjahr. Wie das Epidemiologische Bulletin 29/2021 anlässlich des Welt-Hepatitis-Tages ausführt, sind die Gründe für die Re¬duktion übermittelter Fallzahlen vielfältig. Die COVID-19-Pandemie hat die Gesundheitsversor¬gung, den öffentlichen Gesundheitsdienst aber auch das Kontaktverhalten der Bevölkerung dras¬tisch verändert. Die Reduktion der Fallzahlen könnte aber auch durch die Änderungen im IfSG im Jahr 2017 begründet sein.Peer Reviewe

Increasing hepatitis B vaccination coverage and decreasing hepatitis B co-infection prevalence among people with HIV-1 in Germany, 1996–2019. Results from a cohort study primarily in men who have sex with men

Objectives Viral hepatitis co-infection among people living with HIV is known to accelerate the progression of liver disease and AIDS. An increased prevalence and incidence of hepatitis B virus (HBV) infection among people living with HIV demands continuous monitoring to adapt targeted prevention strategies to reach the global goals of eliminating viral hepatitis as a public health threat. Methods We determined the prevalence and incidence of HBV for the years 1996–2019 from yearly blood sample testing and questionnaire reports among people living with HIV belonging to a nationwide, multicentre observational, prospective cohort study. Results Among this study population of 3479 participants, the majority (87%) indicated that being men who have sex with men (MSM) was their likely HIV transmission route; 51% were recruited from Berlin. HBV prevalence for acute/chronic and resolved infections decreased from 4.1% and 45% in 1996–1999 to 1.3% and 16% in 2019, respectively. Simultaneously, participants with a serological status indicating HBV vaccination increased from 25% in 1996–1999 to 69% in 2019. Among vaccinated participants with relevant information (n = 1135), 38% received their first HBV vaccination after HIV infection. The HBV incidence rate in 565 eligible participants decreased from 6.9/100 person-years in 2004–2007 to 0.45/100 person-years in 2015. Conclusion Increasing vaccination coverage because of a general HBV vaccination recommendation and catch-up vaccination efforts among risk groups decreased HBV infection prevalence over time among this study population of people living with HIV, primarily MSM and from Berlin. Despite this success, the prevalence and incidence of HBV remains higher than in the general population in Germany. This emphasizes the need for continued HBV prevention by promoting HBV vaccination and HBV screening at regular intervals based on the individual risk behaviour.Peer Reviewe

Dynamics of genotype-specific HPV clearance and reinfection in rural Ghana may compromise HPV screening approaches

Persistent Human Papillomavirus (HPV) infection is a prerequisite for cervical cancer development. Few studies investigated clearance of high-risk HPV in low-and-middle-income countries. Our study investigated HPV clearance and persistence over four years in women from North Tongu District, Ghana. In 2010/2011, cervical swabs of 500 patients were collected and HPV genotyped (nested multiplex PCR) in Accra, Ghana. In 2014, 104 women who previously tested positive for high-risk HPV and remained untreated were re-tested for HPV. Cytobrush samples were genotyped (GP5+/6+ PCR & Luminex-MPG readout) in Berlin, Germany. Positively tested patients underwent colposcopy and treatment if indicated. Of 104 women, who tested high-risk HPV+ in 2010/2011, seven (6,7%; 95%CI: 2.7-13.4%) had ≥1 persistent high-risk-infection after ~4 years (mean age 39 years). Ninety-seven (93,3%; 95%CI: 86.6-97.3%) had cleared the original infection, while 22 (21.2%; 95%CI: 13.8-30.3%) had acquired new high-risk infections with other genotypes. Persistent types found were HPV 16, 18, 35, 39, 51, 52, 58, and 68. Among those patients, one case of CIN2 (HPV 68) and one micro-invasive cervical cancer (HPV 16) were detected. This longitudinal observational data suggest that single HPV screening rounds may lead to over-referral. Including type-specific HPV re-testing or additional triage methods could help reduce follow-up rates

Zur Situation bei wichtigen Infektionskrankheiten in Deutschland – Virushepatitis C im Jahr 2020

Die Anzahl übermittelter HCV-Infektionen im Jahr 2020 ist im Vergleich zu den Vorjahren 2018 und 2019 deutlich abgefallen. Die Meldedaten von 2020 sind nach den grundsätzlichen Änderungen des Surveillancesystems und der Meldepflicht nur bedingt mit den Vorjahren vergleichbar und der beobachtete deutliche Rückgang der Infektionen kann durch mehrere Faktoren beeinflusst worden sein. Die COVID-19-Pandemie hat durch die Belastung des Öffentlichen Gesundheitsdienstes auch erhebliche Auswirkungen auf die Erfassung, Meldung und Übermittlung von anderen meldepflichtigen Infektionskrankheiten. Ob es sich daher um einen tatsächlichen Abfall der Hepatitis-C-Neudiagnosen handelt oder ob dieser artifiziell bedingt ist durch Untererfassung und Rückgang der Diagnostik, lässt sich erst im Laufe der nächsten Jahre bewerten. Der Jahresbericht zur Virushepatitis C anlässlich des diesjährigen Welt-Hepatitis-Tages gibt einen Überblick u. a. über die epidemiologische Situation weltweit, in Europa und in Deutschland sowie die Therapie der Hepatitis C in den Jahren 2018-2020.Peer Reviewe

Characterization of Human Papillomavirus prevalence and risk factors to guide cervical cancer screening in the North Tongu District, Ghana

Introduction: This population-based study aimed to fill the knowledge gap on Human Papillomavirus (HPV) prevalence and associated sociodemographic risk factors of the general population in the North Tongu District, Ghana. These results are needed to guide cervical cancer prevention efforts, as the leading type of female cancers. Methods: A cross-sectional study including 2002 women in the North Tongu District, Ghana investigated HPV prevalence and associated sociodemographic risk factors. Women were recruited by geographical distribution through the local community-based health system and samples collected using a self-sampling device. For HPV genotyping BSGP5+/6+-PCR with Luminex-MPG readout was used. Multivariate logistic regression analyzed sociodemographic risk factors for HPV positivity. Results: Of 2002 self-collected samples, 1943 were eligible, contained sufficient DNA and provided valid HPV genotyping results. Prevalence of single high risk HPV types was 32.3% and of multiple high risk types 9.7%. The five most common detected HPV types were HPV16 (7.4%; 95%CI: 6.3–8.7), HPV52 (7.2%; 95%CI: 6.1–8.5), HPV35 (4.8%; 95%CI: 3.9–5.8), HPV59 (4.7%; 95%CI: 3.8–5.8), HPV56 (3.9%; 95%CI: 3.1–4.8). Highest prevalence was observed among women aged 18–24 years, while age 25–54 years was inversely associated with high risk HPV positivity in multivariate analysis. Sociodemographic risk factors identified were i) having any sexual partner, ii) more partners increased the odds for high risk HPV positivity, iii) independently from this marital status, in particular not being married. Discussion & conclusion: Most importantly, the high risk HPV prevalence detected from this study is higher than estimates reported for Western Africa. This needs be considered, when deciding on the cervical cancer screening algorithms introduced on a wider scale. Follow-up and triage, depending on the methods chosen, can easily overburden the health system. Self-sampling worked well and provided adequate samples for HPV-based screening. Women with increasing number of sexual partners and not being married were found to have higher odds of being high risk HPV positive, therefore could be a higher prioritized screening target group