JCM Accepts, published online ahead of print on 1 July 2009

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J. Clin. Microbiol. doi:10.1128/JCM.00567-09
Copyright (c) 2009, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Diagnosis of bacteremia in whole blood samples by a commercial universal 16S rDNA-based PCR and sequence analysis

Nele Wellinghausen, Anna-Julia Kochem, Claudia Disqué, Helge Mühl, Susanne Gebert, Juliane Winter, Jens Matten, and Samir G. Sakka^*

Institut für Medizinische Mikrobiologie und Hygiene, Universitätsklinikum Ulm, Albert-Einstein-Allee 23, D-89081 Ulm, Germany; and Dr. Gaertner & Partner Laboratories, Ravensburg, Germany; Kliniken der Stadt Köln gGmbH, Krankenhaus Merheim, Ostmerheimerstrasse 200, D-51109 Köln, Germany; Hochschule Bremerhaven, Institut für angewandte Mikrobiologie und Biotechnologie, An der Karlstadt 8, D-27568 Bremerhaven, Germany; MVZ Leverkusen, Abteilung Medizinische Mikrobiologie, Ostmerheimerstrasse 200, 51109 Köln, Germany

^* To whom correspondence should be addressed. Email: sakkas{at}kliniken-koeln.de.

In a prospective, multicenter study on 342 blood samples from 187 patients with systemic inflammatory response syndrome (SIRS), sepsis, or neutropenic fever, a new commercial PCR test (SepsiTest^TM, Molzym) was evaluated for rapid diagnosis of bacteremia. The test comprises a universal PCR from the 16S rRNA gene, with subsequent identification of bacteria from positive samples by sequence analysis of amplicons. Compared to blood culture (BC), the diagnostic sensitivity and specificity of the PCR was 87.0% and 85.8% respectively. Considering the 34 BC-positive patients, 28 were also PCR-positive in at least one of the samples, resulting in a patient-related sensitivity of 82.4%. The concordance of PCR and BC for both positive and negative samples was (47+247)/342, i.e. 86.0%. In total, 31 patients were PCR/sequencing-positive and BC-negative, in whom the PCR result was judged as possible or probable to true bacteremia in 25. In conclusion, the PCR approach facilitates the detection of bacteremia in blood samples within a few hours. Despite the indispensability of BC diagnostics, the rapid detection of bacteria by SepsiTest^TM appears to be a valuable tool, allowing earlier pathogen-adapted antimicrobial therapy in critically ill patients.

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