Why is an example test required?

Questions and answers on quick and self-tests to prove SARS-CoV-2

What is the difference between PCR tests, rapid antigen tests, and self-tests?

PCR tests are the "gold standard" among the corona tests. The samples are taken by medical staff - the evaluation by laboratories.

Rapid antigen tests: Have their name because the result is available quickly. Can only be carried out by trained staff - a nasal or throat swab is taken for this, similar to the PCR test. In contrast to the PCR test, the evaluation takes place directly on site. Since March 8th, everyone has been entitled to at least one rapid test per week.

Self-tests: Have their name because anyone can do these tests themselves, e.g. at home. The self-tests are intended for use by private individuals. For this, the sampling and evaluation must be correspondingly simple. The test can be done with a nasal swab or saliva, for example. The Federal Institute for Drugs and Medical Devices, together with the Paul Ehrlich Institute, checks the quality and informative value of the tests.

Quick tests and self-tests have a higher error rate than the PCR tests. Therefore, a PCR test should always be carried out for confirmation after every positive rapid and self-test.

Which tests are suitable for what?

PCR tests as the gold standard of diagnostics are still used, for example, to clarify whether a person with symptoms is infected with SARS-CoV-2 or to verify a positive rapid or self-test. Rapid antigen tests are currently used in nursing homes, hospitals or schools to regularly test staff or residents. Since March 8, all citizens have been able to have a quick test tested at least once a week. The tests are carried out in the test centers of the local health authorities or by commissioned third parties (e.g. pharmacies, doctors). The federal government bears the costs. Self-tests can provide additional security in specific everyday situations - for example during a private visit or before going to the theater or cinema. They can also be used in schools and day-care centers as part of the test concepts of the federal states. If a quick test or self-test is positive, the result should definitely be confirmed by a PCR test.

Is there a right to a PCR test if the self-test is positive?

Yes. In the test centers, it should be possible to have the sample taken for a PCR test immediately after a positive rapid test. If you have tested yourself at home and received a positive result, you should make an appointment with your family doctor or call 116 117 to be tested with a PCR test. Until the confirmation test, you should stay at home and adhere to the AHA + L rule.

Who has to get the tests?

The federal states are responsible for procuring quick and self-tests for use in test centers, schools, nursing homes, etc. The federal government has secured quotas from various manufacturers so that enough tests are available for the German market. Certain institutions can procure rapid antigen tests themselves, use them and settle accounts with the associations of statutory health insurance physicians. These are, for example, care facilities, hospitals, medical practices, rehabilitation facilities or day clinics.

What is the newly established task force doing?

The task force headed by BMG and BMVI brought the providers of quick and self-tests together with the contact persons in the federal states and thus enabled the exchange of solutions for setting up country-specific logistics chains for the decentralized delivery of tests (e.g. for the delivery of schools and daycare centers). In this way, the task force has made a decisive contribution to ensuring that all federal states can provide themselves with sufficient quick and self-tests for the months of March and April and are then able to order and distribute the tests independently. In the last meeting of the task force, the federal and state governments determined that the task force had fulfilled its task and can go into stand-by mode; it will meet again at the request of a member.

Who pays what?

The federal states procure and organize the tests on site and, if necessary, set up or expand test centers for them. The federal states themselves pay for their facilities (daycare centers, schools). The federal government, on the other hand, bears the costs for the rapid tests that are carried out individually in test centers, pharmacies or medical practices. This is set at 18 euros per test for the test kit and the implementation of the test. When companies want their workforce or retailers and restaurants to test their customers, they pay for the costs themselves. Certain institutions have been able to procure and use rapid antigen tests themselves for a long time and settle accounts with the statutory health insurance associations. These are, for example, care facilities, hospitals, medical practices, rehabilitation facilities or day clinics.

How do the tests get to the citizen?

The federal states buy the tests for the test centers, schools and daycare centers. Pharmacies and medical practices can order tests directly from the manufacturers or from wholesalers. Citizens can find out about test options in their area, make an appointment and then have themselves tested.

How is the test result documented?

Every test center already has a documentation system. After a quick test, the person tested receives a certificate stating, among other things, who was tested by whom, when, and with what result. Pharmacies and medical practices provide similar certificates.

Are self-tests mandatory before going to school or daycare?

It is the task of the federal states to provide their schools and daycare centers with rapid tests. Self-tests can also be used as part of the federal states' testing strategy for daycare centers and schools.

Are there enough rapid antigen tests?

Compared to the self-tests, the task force was able to confirm that enough rapid tests are already available on the market. Last year, the BMG secured a contingent of 550 million rapid tests for 2021 with providers of rapid tests - this year, further contingents with a volume of almost 100 million rapid tests were secured. According to the providers, 150 million rapid tests could be ordered directly in March. In addition, the task force enables the countries to order a further 240 million rapid tests via a Joint Procurement Agreement with the EU Commission.

Are there enough self-tests?

In order to accelerate the start of the self-tests, the task force has arranged call contingents with a volume of more than 130 million tests for March and April 2021 (Roche: 70.5 million, Siemens: 62 million). In addition, the BMG has concluded agreements (MoU) on self-tests with several providers. These MoUs allow the countries to order at uniform offer conditions and help the providers with planning.

Is there a reporting requirement for rapid antigen tests?

Yes, positive results from PoC antigen rapid tests must be reported. People who use these tests on other people in schools or other facilities are also included in the reporting obligation under the Infection Protection Act.

Is there an obligation to report a positive self-test?

No. If you do a self-test that turns out positive, you should have it confirmed by a PCR test, just as with a positive rapid antigen test, and as a precaution go into isolation at home until the result is available. The AHA + L rules must still be observed. However, positive results from rapid antigen tests carried out by trained personnel must be reported.

Who can use rapid antigen tests?

Rapid antigen tests must be performed by trained personnel and appropriate occupational health and safety measures must be taken into account. It is particularly important that the nasal or throat swab is carried out correctly, in which infected tissue is removed from the mouth or nasal cavity with a swab. If the smear is taken incorrectly, the result of the rapid test may be falsified.

Which rapid tests are reimbursed?

The Federal Institute for Drugs and Medical Devices (BfArM) maintains a list of rapid tests that are reimbursed when they are used. The list is created using minimum criteria and based on manufacturer information. These minimum criteria are developed by the PEI in consultation with the RKI and adapted over the course of the year.

What do care facilities and hospitals have to do to request rapid antigen tests?

Nursing homes and other healthcare facilities can procure and use PoC antigen tests on their own responsibility as part of their facility or company-related test concept. The amount of tests that can be procured and used per month is limited. The amount of the limit depends on the one hand on the number of people who are treated, looked after, cared for or accommodated in the facility and on the other hand depends on the type of facility. For example, hospitals and inpatient care facilities may procure up to 30 PoC antigen tests per month for each person treated, cared for, cared for or accommodated, while this value is limited to up to 20 PoC antigen tests for outpatient care services. The facilities themselves are responsible for the procurement of the tests. The Federal Institute for Drugs and Medical Devices (BfArM) provides information on rapid antigen tests on its homepage and maintains a list of the rapid antigen tests that can be reimbursed. The tests can be obtained through the normal distribution channels, in particular from pharmacies, wholesalers or directly from the manufacturer.