Policy responses for Germany - HSRM

Germany


Policy responses for Germany

1.5 Testing

New test strategy and testing criteria in autumn and winter

The National Testing Strategy was updated on the basis of an ordinance on testing for SARS-CoV-2 which will enter into force on 15 October 2020. The overall objective of the National Testing Strategy remains the care for symptomatic COVID-19 cases, the protection of vulnerable groups and the prevention of the spread of the coronavirus SARS-CoV-2. The update includes the targeted use of antigen testing especially medical facilities such as hospitals and nursing homes and the extension of testing to more population groups (see also Section 1.4 COVID-19 in long-term facilities). The new rapid tests will be widely used in hospitals and nursing homes. This should help to better protect residents, staff and visitors. An infographic on the new test strategy can be found here: https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/C/Coronavirus/Nationale_Teststrategie_Grafik_131020.pdf 

As of December 2, a new Ordinance on the Distribution of Medical Devices (Medizinprodukte-Abgabeverordnung) regarding increased use of rapid antigen test in health and long-term care facilities and schools will come into force. The number of approved rapid antigen testing will be increased in nursing homes, hospitals and for office-based physicians for personal, patients and relatives. Health care providers need to develop a testing concept in order to apply for additional tests. Public health offices will decide on the number of tests reimbursed by the SHI funds. Each positive antigen test must be confirmed by a PCR test.

In future, up to 30 instead of 20 tests per month and resident or patient in residential facilities and hospitals will be possible. Increased testing will also be made available for ambulatory care providers, day care clinics and emergency medical services. The Ordinance also stipulates that schools and day care facilities can receive Antigen “rapid” tests for COVID-19 from pharmacies. Accordingly, after a case occurs in a class, the respective group, i.e. usually the class, should go into quarantine for five days. A rapid test should follow on day five. Children who test negative could then go back to school. A negative testing result will shorten the quarantine period for contact persons from 14 to 10 days. The costs of the tests are covered by the SHI funds. Further, rapid antigen testing will be made available for persons without symptoms, if the physician defines the patient as contact person. The federal states have the duty to organize and carry out the testing of children and personnel. As with previous regulations related to testing, reimbursement of costs is covered by the statutory health insurance companies.
The federal government and the states reached an agreement on January 5 to boost testing in care and retirement homes. While a policy of mandatory testing in these facilities has been in place since last year, they often lack the personnel to carry out testing on site. Thus, recruitment and training of volunteers to carry out the tests is now receiving major attention (see also Section 2.2 Second wave measures: workforce).

Testing for returnees from high-risk areas needs to paid out of pocket again from December 16 on. In addition, anyone who makes an "avoidable trip" to risk areas will no longer receive any compensation for loss of earnings for the time of the quarantine. Exceptions are “extraordinary circumstances”, such as the birth of one's own children or the death of close relatives.

New testing criteria

As of November 3, the RKI testing criteria are tightened to prevent overloading medical practices and laboratories. A SARS-CoV-2 test must be carried out by ambulatory physicians if at least one of the following criteria is met:
- Severe respiratory symptoms (e.g. acute bronchitis or pneumonia, respiratory distress or fever),
- Acute hypo- or anosmia or hypo- or ageusia (disturbance of the sense of smell and taste),
- Unexplained disease symptoms and close contact (less than 1,5 metres distance for at least 15 minutes) with a confirmed COVID-19 case or
- Acute respiratory symptoms of any severity and one of the following criteria: Membership in a risk group, work in nursing, medical practice, hospital, increased probability of exposure, contact in the household or in a cluster of persons with acute respiratory disease (ARD) of unknown cause and an increased COVID-19 7-day incidence (> 35/100,000 inhabitants) in the district, during the period of the symptoms there was the possibility (exposure setting) of further dissemination to many more persons, continued close contact with many people or with vulnerable risk patients, clinical deterioration with existing symptoms.
https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Massnahmen_Verdachtsfall_Infografik_DINA3.pdf?__blob=publicationFile

According to the Ordinance on eligibility for SARS-CoV-2 testing, in place since January 27, 2021, the following groups of people are tested for SARS-CoV-2 based on a PCR test at the expense of the SHI:
• Persons with COVID-19 symptoms
• Persons without symptoms who have had close contact with a person infected with the SARS-CoV-2
• Persons in facilities and accommodation (e.g. schools, day-care centres, refugee accommodation, emergency accommodation, correctional facilities) if a person infected with the SARS-CoV-2 coronavirus has been identified in the facility
• Patients, residents and staff in care facilities or hospitals if there has been an outbreak of the virus in the facility. This also applies, for example, to facilities for people with disabilities, rehabilitation, outpatient surgery or outpatient dialysis, as well as to medical and dental practices and other practices of human medical professionals, day clinics and the ambulance service.
• Patients or persons to be (re-) admitted to hospitals, residential facilities or outpatient care facilities.

Antigen tests

On February 24, the Federal Institute for Drugs and Medical Devices has approved the use of the first three COVID-19 self-administered rapid antigen tests for the German market. Testing samples are be obtained by swabbing the front of the nose. The Federal Institute for Drugs and Medical Devices has received nearly 30 approval requests so far. Every test is checked for technical functioning, but also in regard to safe use for laypeople and e.g. understandable operating instructions.In most federal states, teachers in child care and schools are eligible to get tested twice per week with antigen test performed in GPs practices or in schools by trained personel.

On the meeting between the chancellor and heads of the federal states on March 3 2021, the federal government and states agreed that regular Corona tests are an important building block to enable more normality. Testing concepts are to be implemented step by step by the beginning of April - in schools, child care or even in companies. All pupils and staff should receive at least one free rapid test per week. Companies are recommended to offer one free test per week to employees who are required to be present. Moreover, all asymptomatic citizens will be offered a free rapid test at least once a week. The federal and state governments form a joint task force on test logistics to ensure the greatest possible availability and speedy delivery of rapid tests, including self-tests.

There are more than 15,000 sites for free COVID-19 tests across Germany, according to the Federal Ministry of Health. The federal government began paying for the tests at the beginning of March 2021, while states and localities are responsible for setting up the various sites. The national average is at 37 testing sites per county/city.

Companies in Germany are obliged to offer employees a weekly COVID-19 test as of mid=April 2021. However, the tests are voluntary from the employee side and the employers are not allowed to monitor the results due to data protection reasons. Business associations have lodged complaints against the obligation, citing bureaucratic burdens. A survey from the Hans Böckler Foundation's Institute of Economic and Social Research on companies offering COVID-19 rapid tests in Germany has shown that 73% of companies were offering employees at least one test per week during the second half of April 2021. The obligation to offer testing came into effect on April 20th and the survey also showed a jump from 46% respondent satisfaction with company rapid testing management in March to 87% in April.

Source: https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/C/Coronavirus/Verordnungen/Coronavirus-TestV_BAnz_27.01.2021_V2.pdf
https://www.ndr.de/nachrichten/niedersachsen/Ab-heute-gilt-Ein-Corona-Test-pro-Woche-vom-Arbeitgeber,testpflicht132.html

New test strategy and testing criteria in autumn and winter

The National Testing Strategy was updated on the basis of an ordinance on testing for SARS-CoV-2 which will enter into force on 15 October 2020. The overall objective of the National Testing Strategy remains the care for symptomatic COVID-19 cases, the protection of vulnerable groups and the prevention of the spread of the coronavirus SARS-CoV-2. The update includes the targeted use of antigen testing especially medical facilities such as hospitals and nursing homes and the extension of testing to more population groups (see also Section 1.4 COVID-19 in long-term facilities). The new rapid tests will be widely used in hospitals and nursing homes. This should help to better protect residents, staff and visitors. An infographic on the new test strategy can be found here: https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/C/Coronavirus/Nationale_Teststrategie_Grafik_131020.pdf 

As of November 3, the RKI testing criteria are tightened to prevent overloading medical practices and laboratories. A SARS-CoV-2 test must be carried out by ambulatory physicians if at least one of the following criteria is met:

- Severe respiratory symptoms (e.g. acute bronchitis or pneumonia, respiratory distress or fever),
- Acute hypo- or anosmia or hypo- or ageusia (disturbance of the sense of smell and taste),
- Unexplained disease symptoms and close contact (less than 1,5 metres distance for at least 15 minutes) with a confirmed COVID-19 case or
- Acute respiratory symptoms of any severity and one of the following criteria: Membership in a risk group, work in nursing, medical practice, hospital, increased probability of exposure, contact in the household or in a cluster of persons with acute respiratory disease (ARD) of unknown cause and an increased COVID-19 7-day incidence (> 35/100,000 inhabitants) in the district, during the period of the symptoms there was the possibility (exposure setting) of further dissemination to many more persons, continued close contact with many people or with vulnerable risk patients, clinical deterioration with existing symptoms.
https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Massnahmen_Verdachtsfall_Infografik_DINA3.pdf?__blob=publicationFile

People with respiratory infection (cough, runny nose, sore throat) can ask to be tested for COVID-19 if the following conditions apply: 1) if they have had contact with a laboratory-confirmed COVID-19 patient during the last two weeks; 2)  if there is a pre-existing condition or the respiratory infection gets worse (develop high fever, cough etc.); 3) if there is contact with individuals who are considered vulnerable during work or voluntary work (e.g. in hospitals or elderly care). Prior to test results, these persons should self-isolate (stay at home, avoid contacts with distance less than 2-meter, respect hand hygiene and use a mask during contact to others (if available).

Criteria for possible cases requiring testing has changed throughout the course of the pandemic. Initially people who returned from a high-risk area were also tested to identify possible cases. On March 25, the stay in a high-risk area was taken from the list of criteria for testing.

Persons who have had personal contact with someone confirmed as carrying SARS-CoV-2 should immediately, and irrespective of symptoms, contact their competent health office, get in touch with the doctor or call the 116117 non-emergency medical on-call service (directing patients to medical assistance when the need is urgent but not life-threatening) – and stay at home. In general, hospitals and family physicians decide who will be tested. They base their decision on the recommendations of the RKI. Also, public health offices provide information on COVID-19 testing and provide appointments.

The RKI launched a nationwide laboratory survey to determine the number of laboratory tests being performed for COVID-19 in Germany. This survey is supplemented by three further data collections from the Network for Respiratory Diseases (RespVir, RKI), the national network for the surveillance of antibiotic resistance in Germany (ARS, RKI) and the Association of Accredited Medical Laboratories in Germany (ALM e.V.). From the response of 174 laboratories, a total of at least 483 295 samples were tested up to and including week 12/2020, most in calendar week 11 (127 457 samples) and week 12 (348 619 samples). According to the Professional Association of German Laboratory Doctors 40 000 tests are currently performed per day in Germany with increasing tendency.

After the first COVID-19 PCR test was developed by the German Center for Infection Research (DZIF) at Charité Berlin, German scientists are currently preparing to carry out a test in April to find out who has already developed antibodies to fight off the COVID-19.

According to the RKI situation report of April 8, a total of 1,317 887 tests have been performed in Germany up to calendar week 14 of which 100,901 (7.7%) have been tested positive on COVID-19. There are currently 143 testing laboratories, of which 132 reported a cumulative testing capacity of 116,665 per day according to the RKI (calendar week 14). However, 30 laboratories stated a backlog of 7,185 samples to be analyzed and 59 laboratories reported difficulties in the supply of reagents.

On April 8, the Charité, Germany's largest university hospital based in Berlin, announced to start stepwise large-scale COVID-19 testing and a voluntary antibody testing for employed medical personal to better assess infection rates among medical personal.

On April 9, the Robert-Koch-Institute announced the launch of a large-scale COVID-19 antibody study to better assess infection rates and monitor the spread of the virus more effectively. The study entails three serological tests: (1) as of early April samples of about 5,000 blood donors will be examined every 14 days, (2) as of mid-April antibody tests will be conducted in a representative sample of 2,000 people in each of four areas that had seen large outbreaks of the virus, and (3) a representative study of the broader population (15,000 people) will be carried out in 150 study locations across Germany as of mid-May (with first results expected in June).

Until April 21, a total of 2,072,669 tests were performed in Germany. The number of weekly performed tests recently declined to 323,449 (calendar week 16) even though the number of laboratories increased to 161. In calendar week 16, 21,538 (6,7%) of these tests were positive. Test capacity however was further increased to 136,064 tests per day or 818,426 per week according to the RKI.

Until June 28, 5,873,563 laboratory tests were performed in Germany of which 229,240 have been tested positive for SARS-CoV-2. To assess the test numbers, data from university hospitals, research institutions as well as clinical and outpatient laboratories throughout Germany are merged weekly at the RKI. These are transmitted via an internet-based RKI test laboratory survey, via the network for respiratory viruses (RespVir), via the laboratory-based SARS-CoV-2 Surveillance established at the RKI (an extension of the Antibiotic Resistance Surveillance (ARS)) and via the enquiry of a professional association of laboratory medicine.

Sources:
https://www.aerzteblatt.de/nachrichten/111346/RKI-Aufenthalt-in-COVID-19-Risikogebiet-nicht-mehr-Kriterium-fuer-Test-auf-SARS-CoV-2
https://www.bundesgesundheitsministerium.de/en/press/2020/coronavirus.html
https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Situationsberichte/2020-03-26-en.pdf?__blob=publicationFile
https://www.charite.de/service/pressemitteilung/artikel/detail/erster_test_fuer_das_neuartige_coronavirus_in_china_entwickelt/
https://www.rki.de/DE/Content/Service/Presse/Pressemitteilungen/2020/05_2020.html
https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Situationsberichte/2020-04-08-de.pdf?__blob=publicationFile
https://www.aerzteblatt.de/nachrichten/111826/Charite-startet-Testung-tausender-Mitarbeiter-auf-SARS-CoV-2
https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Testzahl.html
https://www.tagesschau.de/inland/antikoerpertests-roche-corona-101.html
https://www.aerzteblatt.de/nachrichten/112785/PCR-Testkapazitaeten-nicht-ausgeschoepft-Antikoerpertests-nehmen-zu