Rational clinical use of near-patient analytical systems for molecular detection of infectious agents

Luppa PB, Rabenau HF, GÃssler N, Huzly D, Nauck M, Reischl U, Schoerner C, Zeichhardt H (2021)

Publication Type: Journal article

Publication year: 2021

Journal

Journal of Laboratory Medicine de Gruyter

DOI: 10.1515/labmed-2021-0035

Abstract

Tests for diagnosing infectious diseases (ID-POCT) play a special role among the available point-of-care testing (POCT) methods. A systematic literature search was performed in PubMed. Based on this literature review and our own experience, aspects associated with using molecular biological methods in the diagnostic amplification of pathogen DNA/RNA (nucleic acid testing = NAT) and/or signal amplification were discussed in an interdisciplinary manner. This resulted in the following recommendations for the near-patient use of NAT methods. Due to the current rise in the use of near-patient NAT testing (e.g., using disposable cartridges), recommendations are made for their implementation and appropriate clinical use in the hospital setting. Particular emphasis is placed on the analytical quality of the results. Furthermore, internal best-practice rules and selection criteria are proposed to ensure rapid diagnosis. Equally important are a medically valid interpretation of results and compliance with hygiene requirements. These recommendations emphasize that near-patient NAT should always be procured in conjunction with a (preferably) multidisciplinary institution responsible for POCT and knowledge of the test specifications and risks, as well as quality assurance need to be in place before they are carried out. These recommendations are intended to improve patient safety and to avoid economically questionable expenditures.

Involved external institutions

Technische Universität München (TUM) DE Germany (DE) Universitätsklinikum Frankfurt am Main (KGU) DE Germany (DE) St. Bernward Krankenhaus DE Germany (DE) Universitätsklinikum Freiburg DE Germany (DE) Universitätsmedizin Greifswald / Universitätsklinikum Greifswald DE Germany (DE) Universitätsklinikum Regensburg DE Germany (DE) IQVD GmbH DE Germany (DE)

How to cite

APA:

Luppa, P.B., Rabenau, H.F., GÃssler, N., Huzly, D., Nauck, M., Reischl, U.,... Zeichhardt, H. (2021). Rational clinical use of near-patient analytical systems for molecular detection of infectious agents. Journal of Laboratory Medicine. https://doi.org/10.1515/labmed-2021-0035

MLA:

Luppa, Peter B., et al. "Rational clinical use of near-patient analytical systems for molecular detection of infectious agents." Journal of Laboratory Medicine (2021).

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