Declarations

Ethics approval and consent to participate

The study was conducted according to the principles of the Declaration of Helsinki and registered with the Ethics Committee of the Medical Faculty of Kiel University (D585/21).

Consent for publication

All authors have read the final manuscript and agree to publication.

Availability of data and materials

All data can be found in the manuscript or its supplement.

Competing interests

The authors have no conflicts of interest. DiaSorin played an important role in the preparation of the publication. The company supported this study by providing test kits and a financial grant. The first author, A.E., is employed by DiaSorin. This company had no influence on the selection of the samples, their testing and the interpretation of the results. The results of the tests were also communicated to Mikrogen GmbH.

Funding

The costs of the study were covered by DiaSorin.

Authors’ contributions

AE, AK and FN have planned the study. CB, FN, FS, IG and SM have tested the samples and collected the data. AK and FN have evaluated the data. AE, AK and FN wrote the manuscript. All authors have read the manuscript.

Acknowledgements

The authors would like to thank Dr. Thomas Lorentz (Labor Dr. Krause und Kollegen MVZ GmbH) for the support provided. Special thanks go to Mikrogen GmbH for the good and constructive cooperation.