The availability of quality-assured, specific and sensitive tests for the detection of the pathogen and the protective immune response are essential for the diagnosis and management of an infection. Validated pathogen detection is the backbone for successful surveillance and efficient pandemic management. This must be complemented by methods to predict immune protection through antibodies from reinfection. These topics are therefore the focus of the Test Methods work package.

Work package 2 is structured into sub-work package 2a: Direct pathogen detection and sub-work package 2b: Antibody testing. Specific objectives of WP 2a are to test, adapt, and standardize new PCR-based methods that can be used without nucleic acid extraction, a robust medium- to high-throughput diagnostic protocol, a rapid point-of-care diagnostic test method, and a pipeline for monitoring pathogen evolution using viral sequencing. WP 2b addresses the validation and standardization of existing tests including their quality assurance as well as the validation of robust and broadly applicable tests for the deep characterization of the humoral immune response. Application and scaling will be done in direct collaboration with the application areas in this network. All results and protocols will be made available to all university hospitals and other interested parties in a timely manner via the common platform and consensus recommendations will be developed.

Successful surveillance management requires on the one hand criteria, which surveillance strategies can be used effectively and efficiently in which situations, and on the other hand comprehensive information technology support in order to collect the necessary surveillance data in a structured way and to combine and analyze them in real time.

The assignments in this work package therefore comprises two subsections, however they are closely linked:

Best Practice Surveillance and Surveillance Management

Based on the experiences of the last months, criteria for a targeted surveillance will be developed flanked by an effective surveillance management. These will be coordinated in an expert board. For this purpose the different surveillance methods and activities used by the project partners will be analyzed and processed and made available in the knowledge system CoSurv-Info.The aim is to provide a decision support system in the long term, with which recommendations for action and the best possible surveillance strategy can be derived for future pandemic situations.In particular, we are also investigating which information sources and data are particularly important for the early detection of new infections, hotspots and outbreaks and thus the choice of appropriate surveillance strategies to cope with the pandemic.

Surveillance Tools

On the basis of existing systems for the collection of the various relevant data on the occurrence of the infection, which were developed by the project partners during the COVID-19 pandemic, a modular and interoperable overall system is being developed, which brings together and analyzes this data in a structured manner and makes it available for pandemic management. This includes in particular the identification of infection courses in healthcare facilities, so-called nosocomial infections (CoSurv-SmICS) and the identification of criteria for test strategies (CoSurv-Test). The challenges here are to collect the data as efficiently as possible and to consolidate and analyze the data across institutions in compliance with the law. Due to the diversity of information systems in university hospitals, individual solutions for connecting the individual partners are necessary here. New findings on influencing and risk factors should be integrated into the system as soon as possible. All developments are carried out in close coordination with the Robert Koch Institute to guarantee an optimal connection to and supplementation of the nationwide surveillance systems.

Various concepts of surveillance (cross-section, cohorts, clusters) on the corona pandemic are followed at population level (not case-related) and in different approaches in four locations in Germany. For this purpose, flexible, scalable, digitally based methods are being either newly developed or further developed and implemented, taking into account various spread scenarios. In Heidelberg, a new, cluster-associated approach is being established in which people are tested for SARS-CoV-2 after a risk-based pre-selection by means of a screening app following self-sampling and postal dispatch. While in Cologne, using a self-sampling with selection from the population register will be implemented in Magdeburg particularly vulnerable people and blood donations will be additionally tested. In Lübeck, a cohort approach was started in May 2020 with repeated PCR and antibody tests carried out in a study centre. Accompanying app surveys are being further developed. A representative sample was generated from online registered members of the local population.

The pilot studies will test the feasibility of new innovative surveillance concepts with selected sample testing in regional population clusters and thus identify best practice models for the surveillance of people infected with Covid-19 and symptom-free infections.

In work package 5 (application area schools and day care centers) the acceptance and feasibility of regular tests for SARS-CoV-2, including with child-friendly test methods, is to be examined. The long-term goal is to prevent day care centers and schools from closing. The concept could be widely applied as a "rapid response tool" at other locations.

The project is coordinated by the University Hospital Cologne with the participation of the Düsseldorf, Heidelberg, Homburg and Munich (LMU) University Hospitals. The tests are carried out at 18 institutions (2 day care centres, 16 schools) and offered to approximately 7,500 children and adolescents and around 1,000 employees.

Children, adolescents and the staff of the institutions are tested several times a week over a period of three weeks. If a case of SARS-CoV-2 is found, the next steps will be coordinated in close cooperation with the responsible local health department. The aim is that all uninfected persons can continue to visit the facility under further close-knit testing.

A test phase is planned for autumn and a further one at the beginning of 2021. On October 26th, 2020, tests in the first test phase began.

(https://kinderklinik.uk-koeln.de/forschung/b-fast/)

In principle, the corona pandemic (COVID-19) in Germany has rapidly spread in five areas, while the spreading happened primarily via asymptomatic or oligosymptomatic infected persons in the past:

1. Nursing homes
2. Living situations
3. Cultural events
4. Work
5. Travel

The main aim of this Working Group is the piloting of strategies in the above-mentioned risk areas in order to achieve optimisations of previous methods at the following endpoints: acceptance, repeatability, scalability, costs, processing time, use of information, relation of costs to information benefit and containment, especially in winter when there is an increased incidence of other respiratory diseases, which complicates the differentiation to the early stage COVID-19-infection.

Furthermore, the measurement and modelling of the spreading of human aerosols and droplets should facilitate the development of recommendations for situational measures (Z-project).

While the containment of the current SARS-CoV-2 is the primary goal, the B-FAST network aims to establish a comprehensive surveillance and test strategy for future pandemics in a long-term and adaptable way.

Work package 7 is focusing on testing strategies and methods for patients, medical staff and visitors.

In this context, we want to provide best practice examples for hospitalized patients (e.g. admission testing and testing 1-2 days before admission) as well as testing in ambulatory patients and patients with intermittend hospital stay. We plan to the compare testing strategies in the light of various outcomes (balance between accuracy, velocity, side effects) and the associated consequences. In addition, an investigation is planned how admission testing results reflect the prevalence in the community. To optimize prevention measures for hospital staff, various concepts will be evaluated and immunity post COVID-19 will be investigated. Furthermore, we focus on the risk in special staff groups (e.g. with exposition to aerosol generating procedures) and want to provide useful communication strategies for medical staff. Finally, concepts to manage visitors and other external groups will be addressed.