Recommendations for the implementation of near-patient analytical systems for the molecular detection of infectious agents in the clinical setting

Summary

Background: Among the available point-of-care testing (POCT) methods, methods for the diagnosis of infectious pathogens (ID-POCT) play a special role.

Methods: A selective literature search was performed in PubMed. Based on the literature review and our own experience, the aspects associated with the use of molecular biological methods for the diagnostic amplification of pathogen DNA/RNA (nucleic acid testing = NAT) and signal amplification were discussed on an interdisciplinary basis. This resulted in the present recommendations for the patient-oriented use of NAT methods.

Results: As NAT procedures (e.g. using disposable cartridges) that can be applied close to the patient are currently being used increasingly, recommendations are given for their implementation and appropriate clinical use in hospitals. Particular emphasis is placed on the quality of results. Furthermore, internal best practice rules and selection criteria are proposed to ensure rapid diagnostics. Equally important are a medically valid interpretation of results and compliance with hygiene requirements. These recommendations emphasize that NAT-POC tests should always be procured in conjunction with a (preferably) multidisciplinary facility responsible for POCT and should only be operated with knowledge of the test specifications, risks and quality assurance.

Conclusion: The recommendations are intended in particular to improve patient safety and avoid economically questionable expenditure.
Abstract

Background: Among the available point-of-care testing (POCT) methods, tests for the diagnosis of infectious agents (ID-POCT) play a special role.

Methods: A selective literature search in PubMed was performed. Based on the literature review and own experience, the aspects associated with the application of molecular biological methods for the diagnostic amplification of pathogen DNA/RNA (Nucleic Acid Testing = NAT) or signal amplification were discussed on an interdisciplinary basis. This resulted in the present recommendations for the patient-oriented use of NAT methods.

Results: Since NAT methods (e.g., using disposable cartridges) that can be applied patient-near are currently being increasingly used, recommendations are given for their implementation and meaningful clinical use in the hospital setting. Particular emphasis is placed on the analytical quality of results. Furthermore, internal best-practice-rules and selection criteria are proposed to ensure rapid diagnosis. Equally important are medically valid interpretation of results and compliance with hygiene requirements. These recommendations emphasize that NAT-POC tests should always be purchased with a connection to a (preferably) multidisciplinary institution responsible for POCT and should only be operated under consideration of knowledge of test specifications, risks and quality assurance.

Conclusion: The recommendations are especially intended to improve patient safety and to avoid economically questionable expenditures.

Introduction

The timeliness of these recommendations can be seen in the events of the SARS-CoV-2 pandemic of 2020: Specific RNA amplification protocols for the detection of the novel coronavirus SARS-CoV-2 have been available since January 2020, initially as Laboratory Developed Test (LTD), meanwhile also numerous as CE-certified test systems. For near-patient laboratory diagnostics, compact, automated Nucleic Acid Testing (NAT) systems have also been available since April 2020. The reaction sequences are carried out as isothermal processes or according to the PCR principle and include extraction, reverse transcription of the viral RNA as well as amplification and detection (1).

The POCT section of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL), in collaboration with the German Society for Hygiene and Microbiology (DGHM), Society of Virology e.V. (GfV), the German Association for the Control of Viral Diseases e. V. (DVV) and the Professional Association of Physicians for Microbiology, Virology and Infection Epidemiology (BÄMI e.V.) has developed the following recommendations for the implementation of near-patient analysis systems for the molecular detection of infectious agents in the clinical setting.

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Author

Peter B. Luppa, Holger F. Rabenau,, Daniela Huzly, Matthias Nauck, Norbert Gässler, Udo Reischl, Christoph Schoerner, Heinz Zeichhardt for the participating professional societies

German Society for Clinical Chemistry and Laboratory Medicine (DGKL), Section POCT:

Prof. Dr. med. Peter B. Luppa, Institute for Clinical Chemistry and Pathobiochemistry, Klinikum rechts der Isar of the TU Munich

Prof. Dr. rer. nat. Norbert Gässler, Centre for Laboratory Diagnostics, St. Bernward Hospital, Hildesheim

Prof. Dr. med. Matthias Nauck, Institute for Clinical Chemistry and Laboratory Medicine, University Medical Centre Greifswald

German Society for Hygiene and Microbiology (DGHM):

Prof. Dr. rer. nat. Udo Reischl, Institute for Clinical Microbiology and Hygiene, University Hospital Regensburg

Dr. med. Christoph Schoerner, Microbiological Institute - Clinical Microbiology, Immunology and Hygiene, University Hospital Erlangen

Society of Virology e.V. (GfV); German Association for the Control of Viral Diseases e. V. (DVV):

Prof. Dr. rer. med. Holger F. Rabenau, Institute for Medical Virology, University Hospital Frankfurt/Main

Prof. Dr. rer. nat. Heinz Zeichhardt, IQVD GmbH - Institute for Quality Assurance in Virus Diagnostics, Berlin

Professional Association of Physicians for Microbiology, Virology and Infection Epidemiology (BÄMI e.V.):

Dr. med. Daniela Huzly, Institute of Virology, University Hospital Freiburg

Sources

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