Medical
Masks
For private home use, only antigen tests, often called rapid tests, that are declared for private use may be used explicitly. Since these tests must meet certain requirements in terms of application, comprehensibility of the instructions for use and evaluation.
For example, in the case of a medical PCR test, it is not to be expected that a layperson would carry out the unpleasant swabbing depth in the nasopharyngeal swab of 8 to 10 cm. Which is why a PCR test carried out by laypersons has no medical significance, as the deep-seated covid pathogens may not have been reached.
This is why Corona rapid tests have a much simpler handling and evaluation for laypersons. For rapid tests, a so-called nasal drill test is often sufficient, which requires a more comfortable dressing depth of 2 to 4 cm.
A list of all antigen tests approved for lay use can be found on the BfArM website.
The manufacturers of in vitro diagnostics specify in the instructions for use for which their test is intended. A deviation from this intended use can be associated with liability risks for institutions and users, as the manufacturers have only tested and proven the performance of their tests for an application in accordance with the intended use. The manufacturers will not accept responsibility for errors (e.g. false-negative results) that occur when the test is not used for its intended purpose.
Facilities as operators must check on a case-by-case basis whether a particular nursing assistant with appropriate training is sufficiently qualified to use the test in question. As a precaution, the process of instruction should be documented. So who was instructed, by whom, when and what was trained.
It is suggested that the selection of personnel (group of users) should also be documented.
Before antigen tests are carried out by non-medical staff, training by a medical doctor is always required. This training can also be provided by a public health service, but is now also offered by many companies such as DEKRA or Johanniter.
