Evaluation of the Loop-Mediated Isothermal Amplification Assay (LAMP) Eazyplex<sup>®</sup> <i>Pneumocystis jirovecii</i>

A commercially available loop-mediated isothermal amplification assay (LAMP) for the detection of <i>Pneumocystis jirovecii</i> (<i>P. jirovecii</i>) has been evaluated for the diagnosis of <i>Pneumocystis</i> pneumonia (PcP) in critically ill patients. Altogether...

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Bibliographic Details
Main Authors: Ulrike Scharmann, Lisa Kirchhoff, Jan Buer, Franziska Schuler, Annerose Serr, Susann Rößler, Jürgen Held, Tobias Szumlanski, Joerg Steinmann, Peter-Michael Rath
Format: Article
Language:English
Published: MDPI AG 2025-04-01
Series:Journal of Fungi
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Online Access:https://www.mdpi.com/2309-608X/11/4/300
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Summary:A commercially available loop-mediated isothermal amplification assay (LAMP) for the detection of <i>Pneumocystis jirovecii</i> (<i>P. jirovecii</i>) has been evaluated for the diagnosis of <i>Pneumocystis</i> pneumonia (PcP) in critically ill patients. Altogether, 109 lower respiratory tract specimens from 95 patients with a positive <i>P. jirovecii</i> test in routine diagnostics were collected from five distinct university hospitals in Germany. All samples were tested with a qPCR and eazyplex<sup>®</sup> LAMP assay. qPCR was set as the gold standard and was evaluated beforehand with samples from 100 patients categorized to have proven, probable, and possible PcP according to the EORTC/MSGERC guidelines. The sensitivity, specificity, and positive and negative predictive value (PPV and NPV) of the LAMP were assessed. Sensitivity was 68%, specificity was 86%, and PPV and NPV were 99% and 16%, respectively. All patients with proven PcP were positive in the LAMP. There was a weak correlation between the time to positivity and the fungal load (squared Pearson correlation coefficient (r<sup>2</sup>) = 0.5653). A positive result in the LAMP indicates a PcP. Because of the low sensitivity, negative results do not rule out an infection and should be clarified with further molecular methods. The LAMP should be used in patients in whom a PcP is expected, not for screening only.
ISSN:2309-608X