General information on diagnostics in the ZBS 1 special laboratory and Consultant Laboratory for Poxviruses

Laboratory methods for detecting a viral infection can either detect the virus itself (direct detection) or the immune system's response to the infection (indirect detection). In direct pathogen detection, components of the virus are detected in biological sample material (e.g., smear, blood, urine). In this case, sections of the genetic material of the virus are detected by means of polymerase chain reaction (PCR) or viral proteins, e.g. by means of antigen detection. The genetic material of the person examined is not decoded when these methods are used. While PCR and antigen/protein testing detect only virus components, the cultivation of viruses in cell culture enables the detection of complete viruses capable of replication. Virus cultivation can therefore be used to investigate whether a sample could lead to an infection with the virus. In indirect pathogen detection, so-called serological tests detect antibodies that are produced by the immune system after infections or vaccinations and recognize components of the virus. Serological tests are thus used to detect a past infection and/or a successful vaccination, but can only provide indications of protection against an infection if there is sufficient scientific data. In certain cases, serological tests can also detect an acute infection. However, PCR is usually performed to detect an acute infection. An antigen/protein test can serve as confirmation of PCR or replace it in certain cases, for example, when the sample material is unsuitable for PCR.

After primary diagnostics have been completed, and if the patient has given appropriate consent, the test results and the remains of the samples can be used in pseudonymized form to answer scientific questions that are important for public health. This includes questions related to laboratory methods (e.g., Is a particular newly developed method better or worse than methods currently used for diagnosis?), characterization of infection (e.g., In what sample material can the virus be most reliably detected?), and characterization of immune response (e.g., How well does a vaccination or a past infection protect against further infection?). Answering such questions can serve to improve diagnostics and patient care, as well as prevent future infections. Other important questions concern the modification (mutation) of the virus, which may be associated with better adaptation to humans, with more severe courses of disease or increased contagiousness. To this end, the genome of the virus is sequenced and analyzed according to the current state of the art.

Data processing for scientific purposes takes place in pseudonymized form, and publication of the scientific findings obtained takes place in anonymized and often aggregated (i.e. grouped) form. The pseudonymization of samples takes place in the course of sample acquisition in the laboratory by assigning a laboratory number, which is used instead of the personal name (i.e. as a pseudonym) to identify the sample and assign test results. From this point on personal data could only be assigned to a natural person by very few authorized persons or with a disproportionately high effort. For anonymization for the purpose of publishing research results, the laboratory numbers are deleted from the corresponding data sets. The assignment of personal data to a natural person is then no longer possible.