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Survey results on nucleic acid tests of infectious diseases: Present status and need for rapid and patient near diagnostics

Jörg Neukammer, Martin Hussels, A. Kummrow, Alison Devonshire, Carole Foy, Jim Huggett, Helen Parkes, Jana Zel, Mojca Milavec, Heinz Schimmel, Wolfgang Unger, Müslüm Akgoz, Timothy Mchugh, Viktorija Tomic, Hans-Peter Grunert, Heinz Zeichhardt
Published February 2015
DOI: 10.3205/lab000016

Link to publication: http://www.egms.de/static/en/journals/lab/2015-6/lab000016.shtml

Abstract

This survey discusses current and emerging isothermal and rapid polymerase chain reaction (PCR) based nucleic acid amplification methods for near-patient diagnostics.

To assess the clinical need of rapid diagnostics for infectious diseases based on nucleic acid tests (NATs) we performed and analysed a questionnaire among laboratories participating in corresponding INSTAND ring trials for external quality assurance. The questions concerning new amplification technologies like isothermal nucleic acid amplification, potentially suited to significantly decrease turnaround times, were complemented by questions to evaluate the present status of NATs. Besides end-users, companies were also addressed by sending out a manufacturer specific questionnaire.

Analysis of the answers from 48 laboratories in 14 European countries revealed that a much shorter turnaround time is requested for selected pathogens compared to about 2 h or longer when applying temperature cycling amplification, i.e. PCR. In this context, most frequently mentioned were methicillin-resistant Staphylococcus aureus (MRSA), norovirus, influenza A and B viruses, cytomegalovirus (CMV) as well as hepatitis B virus (HBV) and hepatitis C virus (HCV). At present, 8% of the laboratories having participated in this survey apply isothermal amplification of nucleic acids to identify infectious pathogens.

 

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