In mid-October the Federal Ministry of Health in Germany announced the introduction of rapid antigen testing to reduce the risk of infection with Sars-Cov-2 in care homes and to enable homes to stay open to visitors.
The Federal Ministry of Health acknowledges that rapid antigen tests may be less reliable than PCR tests, but emphasises that rapid testing has the advantage to be able to identify infection in real-time, with test results being available within 15-20 minutes. The Ministry issued a new “Directive on the entitlement to be tested for Coronavirus SARS-Cov-2”, which widens the Federal Government’s testing strategy to introduce point-of-care testing and to include people without symptoms or a known exposure to the virus into the testing strategy. The directive requires social insurance funds to reimburse antigen testing in priority settings such as care homes, hospitals, doctors’ offices and rehabilitation facilities as part of the Federal Government’s new testing strategy.
Guidelines developed by the Robert-Koch-Institute recommend point-of-care testing to be made available in care homes and other facilities that deliver health services (e.g. hospital, day surgery facility, dialysis centre) or provide care to vulnerable groups (care home for older people and people with disabilities, domiciliary care providers), if they are located in an area with an infection rate of 50 or over per 100,000 population over the last seven days. The testing strategy recommends regularly testing care staff, service users, and their visitors. However, it is in the care homes’ discretion to decide whether and how they organise antigen testing. If residents or staff develop symptoms or there is a known case of infection in the home, the strategy continues to recommend a PCR test.
To be able to test residents and others, and receive compensation, care homes are required to produce a ‘testing concept’. This involves defining the groups to be tested; the frequency of testing; the processes involved in administering tests (including the procurement of the tests, training requirements, the need for personal protective equipment); and a definition of cases in which an antigen test should be replaced by a PCR test (see example). Care homes have to procure the testing kits themselves. Tests have to meet a set of minimum requirements set out by the Paul Ehrlich Institute and the Federal Office for Pharmaceuticals and Medical Products has published a list of tests available in the market that meet these minimum standards.
The home’s testing concept has to be approved by the local health authority in its area, as a condition of reimbursement. Care homes are eligible to receive 7 Euro per test if they procure the test themselves, for up to 20 tests per resident per month, covering all testing requirements of staff, residents and visitors. Care homes can receive funding for a larger number of tests, if this has been approved by the local health authority as part of the testing concept. Reimbursement is organised through regional associations of office-based doctors (Kassenärztliche Vereinigungen); these organisations routinely organise the reimbursement of services provided by office-based doctors to patients under social health insurance.
Politicians, care associations and relatives of people in care homes have long demanded care homes to remain open to visitors as much as possible to avoid the detrimental effects of social isolation on residents’ mental and physical health. There is also debate as to whether shielding residents by closing homes to visitors entirely is a violation of residents citizens and essential human rights. Thus, the testing strategy is a welcome avenue to ease the burden of Covid-19 on care homes and reduce the risk of infection to their residents.
However, while there is whole-hearted support for point-of-care testing and some rapid action from the Ministry, the implementation of the new strategy continues to be challenging.
There are many different antigen tests commercially available now. However, there have been reports that some care homes have had difficulty procuring tests due to supply shortages, ending up in a situation not unlike the shortage of personal protective equipment experienced in Spring. The high demand is also reflected in increased prices of tests, which smaller homes can find more difficult to navigate than those that can purchase larger quantities individually or as a group. There has also been concern about variation in quality of tests, which can create another uncertainty for care homes required to purchase tests themselves.
Care homes need to develop their own testing concept, which is time consuming for both the homes and the local health authorities required to review and approve them. Again, larger organisations such as the Arbeiter-Samariter Bund or Caritas that operate a large number of homes, may have an advantage over smaller entities with less capacity to allocate resources to develop concepts. There have also been reports of local authorities struggling to approve testing concepts at pace, with the city of Bremen bringing in the Medical Service of Social Insurance (MDK) to help.
The testing itself can be done quickly if considering a single test, but doing hundred or thousands of them per week require substantial addition staffing and resource. Testing also requires appropriate documentation, which also draws on tight resources. Some care homes have managed to employ additional staff to conduct the testing; however others reported that they have not been able to employ more staff and that existing staff is already too stretched to engage in additional tasks. There is a general shortage of care personnel in Germany, in both health and long-term care, so it is unlikely that supply will easily match demand. While staff administering tests do not have to be fully medically trained, bespoke training needs to be in place if no medically trained staff is available.
The ministry has recommended that staff in care homes should be tested every one to two weeks. Some care homes are testing staff every day before the beginning of a shift, however this means that staff need to start work 30 minutes early and the care needs to pay for the extra time. Other homes have reported that they residents only, with no tests available for staff or relatives. Others plan to test all staff once per week and only test residents if there is cause for concern.
There is now a call for the Government to support implementation more comprehensively and the Ministry of Health has announced to produce an implementation guideline for care homes, but this will not be available before December 2020. As rapid testing is voluntary for care homes, it would be surprising if the availability of tests and the practice of testing would not remain highly variable.
Rates of infection are rising again in care homes. In Germany, there is no official statistic of infection rates in care homes available. Even Covid-19 deaths are only recorded for a number of institutional settings in combination (e.g. care homes, asylum seekers’ accommodation, prisons) as per legislation. A survey of state ministries of health, conducted by two regional state broadcasters, WDR and NDR, and the broadsheet Süddeutsche Zeitung, found that currently one in four care homes in the state of Hesse have reported one or more Sars-Cov-2 infections as have one in five homes in Rhineland-Palatine and Hamburg, one in six in North Rhine-Westphalia and one in ten in Brandenburg.
Dr Stefanie Ettelt is an Honorary Associate Professor at the London School of Hygiene and Tropical Medicine.