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

Background: Tests for diagnosing infectious diseases (ID-POCT) play a special role among the available point-ofcare testing (POCT) methods. 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 interdisciplinarymanner. This resulted in the following recommendations for the near-patient use of NAT methods. Results: 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 nearpatient NAT should always be procured in conjunctionwith 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. Conclusions: These recommendations are intended to improve patient safety and to avoid economically questionable expenditures.     «

Background: Tests for diagnosing infectious diseases (ID-POCT) play a special role among the available point-ofcare testing (POCT) methods. 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 interdisciplinarymanner. This resulted in the f...     »