ObjectivesRegular hygiene trainings are an important way to refresh and improve knowledge about hygiene measures and the prevention of healthcare-associated infections. We aimed to develop an e-learning course to allow healthcare workers (HCWs) to learn these contents through a self-paced online format.MethodsWe developed an interactive hygiene training for HCWs of a tertiary care hospital using different content types of the HTML-5 package (H5P) plugin embedded into a Moodle-based learning management system. We evaluated the course using a short online questionnaire.ResultsWe present various suitable topics for online hygiene trainings as well as their implementation in an e-learning course. Examples include content on hand hygiene indications and techniques, information on multidrug-resistant organisms and other current topics in infection control. HCWs reported high overall satisfaction, perceived increase in knowledge, practical relevance as well as good usability and comprehensibility.DiscussionCurrently available commercial and non-commercial hygiene trainings present a number of specific advantages but also drawbacks. The presented approach combines the advantages of both approaches. The majority of the presented content can be readily adapted to suit various hospitals and care facilities or serve as inspiration for creating similar courses while remaining cost-effective.ConclusionH5P course presentations are a low-threshold, cost-effective way to implement digital hygiene trainings in a wide variety of clinical settings.
BackgroundHealthcare associated infections (HAI) pose a major threat to healthcare systems resulting in an increased burden of disease. Surveillance plays a key role in rapidly identifying these infections and preventing further transmissions. Alas, in German hospitals, the majority of surveillance efforts have been heavily relying on labour intensive processes like manual chart review. In order to be able to identify further starting points for future digital tools and interventions to aid the surveillance of HAI we aimed to gain an understanding of the current state of digitalisation in the context of the general surveillance organisation in German clinics across all care-levels. The end user perspective of infection prevention and control (IPC) professionals was chosen to identify digital interventions that have the biggest impact on the daily surveillance work routines of IPC professionals. Perceived impediments in the advancement of surveillance digitalisation should be explored.MethodsFollowing the development of an interview guideline, eight IPC professionals from seven German hospitals of different care levels were questioned in semi- structured interviews between December 2022 and January 2023. These included questions about general surveillance organisation, access to digital data sources, software to aid the surveillance process as well as current issues in the surveillance process and implementation of software systems. Subsequently, after full transcription, the interview sections were categorized in code categories (first deductive then inductive coding) and analysed qualitatively.ResultsResults were characterised by high heterogeneity in terms of general surveillance organisation and access to digital data sources. Software configuration of hospital and laboratory information systems (HIS/LIS) as well as patient data management systems (PDMS) varied not only between hospitals of different care levels but also between hospitals of the same care level. Outside research projects, neither fully automatic software nor solutions utilising artificial intelligence have currently been implemented in clinical routine in any of the hospitals.ConclusionsAccess to digital data sources and software is increasingly available to aid surveillance of HAI. Nevertheless, surveillance processes in hospitals analysed in this study still heavily rely on manual processes. In the analysed hospitals, there is an implementation and funding gap of (semi-) automatic surveillance solutions in clinical practice, especially in healthcare facilities of lower care levels.
ABSTRACTIntroductionDuring the COVID-19 pandemic, SARS-CoV-2 antigen rapid detection tests (RDTs) emerged as point-of-care diagnostics in addition to the RT-qPCR as the gold standard for SARS-CoV-2 diagnostics. Facing the course of the COVID-19 pandemic to an endemic characterised by several SARS-CoV-2 virus variants of concern (VOC) and an increasing public COVID-19 vaccination rate the aim of the study was to investigate the long-term test performance of SARS-CoV-2 RDT in large-scale, clinical screening use during and its influencing factors, above all SARS-CoV-2 VOC and COVID-19 vaccination.MethodsIn a prospective performance assessment conducted at a single centre tertiary care hospital, RDTs from three manufacturers (NADAL®, Panbio™, MEDsan®) were compared to RT-qPCR among individuals aged ≥ 6 month. The evaluation involved the determination of standardised viral load from oropharyngeal swabs as well as the evaluation of their influencing factors, especially the COVID-19 vaccination, for detecting SARS-CoV-2 in a clinical point-of-care environment spanning from 12 November 2020 to 30 June 2023 among patients, staff, and visitors of the hospital.ResultsAmong the 78,798 RDT/RT-qPCR tandems analysed, 2,016 (2.6%) tandems tested positive for SARS-CoV-2, with an overall sensitivity of 34.5% (95% CI 32.4-36.6%). A logistic regression revealed that typical COVID-19 symptoms significantly declined over the course of the study and throughout the COVID-19 pandemic, and that among the vaccinated, significantly fewer presented with an infection exhibiting typical symptoms. The employed lasso regression model indicated that only higher viral load and typical COVID-19 symptoms significantly increase the likelihood of a positive RDT result in the case of a SARS-CoV-2 infection directly.ConclusionOur findings indicate that only viral load and COVID-19 symptoms directly influence RDT performance while the obtained effects of COVID-19 vaccination and Omicron VOC both reducing RDT performance were mediated by these two factors. RDTs remain an adequate diagnostic tool for detecting SARS-CoV-2 in individuals showing respiratory symptoms. RDTs show promise beyond SARS-CoV-2, proving adaptable for detecting other pathogens like Influenza and RSV, highlighting their ongoing importance in infection control and prevention efforts.
BackgroundSurveillance is an acknowledged method to decrease nosocomial infections, such as surgical site infections (SSI). Electronic health care records create the opportunity for automated surveillance. While approaches for different types of surgeries and indicators already exist, only few exist for obstetrics and gynaecology.AimTo analyse sensitivity and workload reduction of semiautomated surveillance in obstetrics and gynaecology.MethodsIn this retrospective, single centre study at a 1438-bed tertiary care hospital in Germany, semiautomated SSI surveillance using the indicators antibiotic prescription, microbiological data and administrative data (diagnosis codes, readmission, post-hospitalisation care) was compared with manual analysing and categorizing all patient files. Breast surgeries (BS) conducted in the year 2018 and Caesarean sections (CS) fulfilling the inclusion criteria between May 2013 and December 2019 were included.The indicators were analysed for their sensitivity, the number of analysed procedures needed to identify one case (NNI), and potential workload reduction detecting SSI in comparison to the control group.FindingsThe reference standard showed nine SSI in 416 BS (2.2%). The sensitivities for the indicators antibiotic prescription, diagnosis code, microbiological sample taken and the combination “diagnosis code or microbiological sample” were 100%, 88.9%, 66.7% and 100% respectively.The reference standard showed 54 SSI in 3438 CS (1.6%). For collection of microbiological samples, diagnosis codes, readmission/post-hospitalisation care, and the combination of all indicators, the sensitivities were 38.9%, 27.8%, 85.2%, and 94.4%, respectively.ConclusionsSemiautomated surveillance systems may reduce workload by maintaining a high sensitivity depending on type of surgery, the local circumstances, and thorough digitalization.
Background SARS-CoV-2 antigen rapid detection tests (RDTs) emerged as point-of-care diagnostics alongside reverse transcription polymerase chain reaction (RT-qPCR) as reference. Methods In a prospective performance assessment from 12 November 2020 to 30 June 2023 at a single centre tertiary care hospital, the sensitivity and specificity fi city (primary endpoints) of RDTs from three manufacturers (NADAL (R), (R) , PanbioTM, TM , MEDsan (R)) (R) ) were compared to RT-qPCR as reference standard among patients, accompanying persons and staff aged >= six month in large-scale, clinical screening use. Regression models were used to assess influencing fl uencing factors on RDT performance (secondary endpoints). Findings Among 78,798 paired RDT/RT-qPCR results analysed, overall RDT sensitivity was 34.5% (695/2016; 95% CI 32.4-36.6%), - 36.6%), specificity fi city 99.6% (76,503/76,782; 95% CI 99.6-99.7%). - 99.7%). Over the pandemic course, sensitivity decreased in line with a lower rate of individuals showing typical COVID-19 symptoms. The lasso regression model showed that a higher viral load and typical COVID-19 symptoms were directly significantly fi cantly correlated with the likelihood of a positive RDT result in SARS-CoV-2 infection, whereas age, sex, vaccination status, and the Omicron VOC were not. Interpretation The decline in RDT sensitivity throughout the pandemic can primarily be attributed to the reduced prevalence of symptomatic infections among vaccinated individuals and individuals infected with Omicron VOC. RDTs remain valuable for detecting SARS-CoV-2 in symptomatic individuals and offer potential for detecting other respiratory pathogens in the post-pandemic era, underscoring their importance in infection control efforts. Copyright (c) 2024 The Author(s). Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
OBJECTIVE:The number of hospitalized patients with severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) does not differentiate between patients admitted due to coronavirus disease 2019 (COVID-19) (ie, primary cases) and incidental SARS-CoV-2 infection (ie, incidental cases). We developed an adaptable method to distinguish primary cases from incidental cases upon hospital admission. DESIGN:Retrospective cohort study. SETTING:Data were obtained from 3 German tertiary-care hospitals. PATIENTS:The study included patients of all ages who tested positive for SARS-CoV-2 by a standard quantitative reverse-transcription polymerase chain reaction (RT-PCR) assay upon admission between January and June 2022. METHODS:We present 2 distinct models: (1) a point-of-care model that can be used shortly after admission based on a limited range of parameters and (2) a more extended point-of-care model based on parameters that are available within the first 24-48 hours after admission. We used regression and tree-based classification models with internal and external validation. RESULTS:In total, 1,150 patients were included (mean age, 49.5±28.5 years; 46% female; 40% primary cases). Both point-of-care models showed good discrimination with area under the curve (AUC) values of 0.80 and 0.87, respectively. As main predictors, we used admission diagnosis codes (ICD-10-GM), ward of admission, and for the extended model, we included viral load, need for oxygen, leucocyte count, and C-reactive protein. CONCLUSIONS:We propose 2 predictive algorithms based on routine clinical data that differentiate primary COVID-19 from incidental SARS-CoV-2 infection. These algorithms can provide a precise surveillance tool that can contribute to pandemic preparedness. They can easily be modified to be used in future pandemic, epidemic, and endemic situations all over the world.
Objectives: Antigen rapid diagnostic tests (RDTs) for SARS coronavirus 2 (SARS-CoV-2) are quick, widely available, and inexpensive. Consequently, RDTs have been established as an alternative and additional diagnostic strategy to quantitative reverse transcription polymerase chain reaction (RT-qPCR). However, reliable clinical and large-scale performance data specific to a SARS-CoV-2 virus variant of concern (VOC) are limited, especially for the Omicron VOC. The aim of this study was to compare RDT performance among different VOCs. Methods: This single-centre prospective performance assessment compared RDTs from three manufacturers (NADAL, Panbio, MEDsan) with RT-qPCR including deduced standardized viral load from oropharyngeal swabs for detection of SARS-CoV-2 in a clinical point-of-care setting from November 2020 to January 2022.
The incidence has been widely used to assess the epidemiological situation during the COVID-19 pandemic and guide health policy. As testing requirements changed during the pandemic, more SARS-CoV-2 infections may have remained undetected. This study aims to evaluate the use of different indicators for estimating unreported SARS-CoV-2 infections. Monthly SARS-CoV-2 incidences in the general Bavarian population were compared with three indicators: incidence in healthcare workers (HCWs), incidence of patients, and incidence in visitors. Based on this, the number of unreported SARS-CoV-2 cases in the Bavarian population was estimated. The incidence from the visitors correlated moderately with the official incidences (r = 0.63). The general population incidence and the inpatient incidence are highly correlated (r = 0.91), as are the general population incidence and the HCWs incidence (r = 0.94). Between April 2020 and June 2023, the general population incidence was on average higher than the average incidence of the three indicators, after which the relationship reversed. The reversal of the relationship between the data series of the Bavarian population and the chosen indicators in June 2022 suggests that SARS-CoV-2 infections were underreported. Inpatient screening incidence and HCWs’ incidence in settings with low-threshold test accessibility are suitable indicators of current epidemiology in the general population.
•SARS-CoV-2 rapid antigen detection tests (RDT) were evaluated among children.•9760 oropharyngeal samples in paediatric patients were enrolled.•RDT sensitivity was 44.7% compared to RT-qPCR.•SARS-CoV-2 virus variant of concern and COVID-19 vaccination status did not have a significant impact of RDT sensitivity.
Background: Antigen rapid diagnostic tests (RDT) for SARS-CoV-2 are quick, widely available, and inexpensive. Consequently, RDT have been established as an alternative and additional diagnostic strategy to quantitative reverse transcription polymerase chain reaction (RT-qPCR). However, reliable SARS-CoV-2 virus variant of concern (VOC) specific clinical and large-scale performance data is limited, especially for Omicron VOC.Methods: This single-centre prospective performance assessment compares RDT from three manufacturers (NADAL®, Panbio™, MEDsan®) with RT-qPCR including deduced standardised viral load from 35,479 oropharyngeal swabs for detection of SARS-CoV-2 in a clinical point-of-care setting.Findings: RDT sensitivity compared to RT-qPCR was 38·50% (95% CI 34·00%–43·20%) with an overall specificity of 99·67% (95% CI 99·60%–99·72%). RDT sensitivity depended clearly on viral load with decreasing sensitivity accompanied by descending viral load. VOC dependent sensitivity assessment showed 42·86% (95% CI 32·82%–53·52%) for wild-type SARS-CoV-2 , 43·42% (95% CI 32·86%–54·61%) for Alpha VOC, 37·67% (95% CI 30·22%–45·75%) for Delta VOC, and 33·67% (95% CI 25·09%–43·49%) for Omicron VOC. Sensitivity in samples with high viral loads was significantly lower in Omicron VOC (50·00%, 95% CI 36·12%–63·88%) compared to wild-type virus (79·31%, 95% CI 61·61%–90·15%, p=0·015).Interpretation: RDT sensitivity for detection of the Omicron VOC is reduced in infectious individuals with high viral load, which curtails the effectiveness of RDT. This aspect further limits RDT use although RDT are still an irreplaceable diagnostic tool for rapid, economic, point-of-care and extensive SARS-CoV-2 screening use.Funding: Federal Ministry for Education and Science (BMBF), Free State of Bavaria. Declaration of Interest: None of the authors has any conflict of interest.Ethical Approval: The Ethics committee of the University of Wuerzburg considered the study protocol and waived the need to formally apply for ethical clearance due to the study design (File N 20210813 01).
Background: Antigen rapid diagnostic tests (RDT) for SARS-CoV-2 are fast, broadly available, and inexpensive. Despite this, reliable clinical performance data from large field studies is sparse. Methods: In a prospective performance evaluation study, RDT from three manufacturers (NADAL (R), Panbio (TM), MEDsan (R), conducted on different samples) were compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 5 068 oropharyngeal swabs for detection of SARS-CoV-2 in a hospital setting. Viral load was derived from standardised RT-qPCR Cycle threshold (C-t) values. The data collection period ranged from November 12, 2020 to February 28, 2021. Findings: The sensitivity of RDT compared to RT-qPCR was 42.57% (95% CI 33.38%-52.31%). The specificity was 99.68% (95% CI 99.48%-99.80%). Sensitivity declined with decreasing viral load from 100% in samples with a deduced viral load of >= 10(8) SARS-CoV-2 RNA copies per ml to 8.82% in samples with a viral load lower than 10(4) SARS-CoV-2 RNA copies per ml. No significant differences in sensitivity or specificity could be observed between samples with and without spike protein variant B.1.1.7. The NPV in the study cohort was 98.84%; the PPV in persons with typical COVID-19 symptoms was 97.37%, and 28.57% in persons without or with atypical symptoms. Interpretation: RDT are a reliable method to diagnose SARS-CoV-2 infection in persons with high viral load. RDT are a valuable addition to RT-qPCR testing, as they reliably detect infectious persons with high viral loads before RT-qPCR results are available. (C) 2021 The Authors. Published by Elsevier B.V.
In total, 20 severe acute respiratory coronavirus virus 2 (SARS-CoV-2) clusters were analyzed in a tertiary-care hospital from the beginning of the pandemic until July 2021. After the second pandemic wave, the number of clusters decreased with increasing vaccination rates and community infections increased again. These findings should motivate healthcare workers to participate in SARS-CoV-2 vaccination campaigns.
Background Rapid antigen detection tests (RDT) are an easily accessible, feasible, inexpensive, and point-of-care method in SARS-CoV-2 diagnostics – established in adults as well as in children and adolescents. Despite this, large-scale data of clinical performance in the paediatric population especially regarding the influence of SARS-CoV-2 virus variants of concern (VOC) and COVID-19 vaccination on test accuracy is rare.Methods This single-centre prospective diagnostic study evaluates three RDT (NADAL®, Panbio™, MEDsan®) in comparison to quantitative reverse transcription polymerase chain reaction (RT-qPCR). 9,760 oropharyngeal screening samples regarding SARS-CoV-2 VOC and COVID-19 vaccination in paediatric hospitalised patients aged younger than 18 years were enrolled.Findings RDT sensitivity was 44·7% (157/351, 95% CI 39·6%–50·0%) compared to the reference standard RT-qPCR, specificity 99·8% (9,392/9,409, 95% CI 99·7%–99·9%). Most SARS-CoV-2 infections considered were caused by Omicron VOC. Diagnostic accuracy of RDT depended on specimen containing viral load with a decreasing RDT sensitivity by descending viral load, corresponding with a significantly impaired sensitivity in asymptomatic children. A sensitivity of 71·0% was obtained for a viral load higher than 106 SARS-CoV-2 RNA copies per ml suggested as infectivity threshold. No significant differences in RDT sensitivity could be observed regarding gender, symptoms, COVID-19 vaccination status, and VOC.Interpretation In a paediatric population, RDT have proven to reliably detect potentially highly infectious patients with a viral load of at least 106 SARS-CoV-2 RNA copies per ml. Due to the low sensitivity in asymptomatic individuals, the usefulness of RDT seems limited in large-scale SARS-CoV-2 screening programs.Funding Federal Ministry for Education and Science (BMBF), Free State of Bavaria### Competing Interest StatementManuel Krone receives honoraria from Abbott outside the submitted work. None of the other authors has any conflicts of interests to declare.### Funding StatementThis study was funded by the Federal Ministry for Education and Science (BMBF) via a grant provided to the University Hospital of Wuerzburg by the Network University Medicine on COVID-19 (B-FAST, grant-No 01KX2021), by the Bavarian Staten Ministry of Health and Care via Bay-VOC as well as by the Free State of Bavaria with COVID-research funds provided to the University of Wuerzburg, Germany. Nils Petri is supported by the German Research Foundation (DFG) funded scholarship UNION CVD. ### Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:The Ethics committee of the University of Wuerzburg considered the study protocol and waived the need to formally apply for ethical clearance due to the study design (File 20220602 01).I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesIndividual participant data that underlie the results reported in this article after deidentification is available on request immediately following publication ending 5 years following article publication to researchers who provide a methodological sound proposal to achieve aims in the approved proposal. Proposals should be directed to krone_m@ukw.de.