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Multicentre study discloses advantages of SepsiTest diagnostics in relation to blood culture diagnostics
 
Original article:
Wellinghausen N., Kochem A.J., Disqué C., Mühl H., Gebert S., Winter J., Matten J., Sakka S.G. (2009) Diagnosis of bacteremia in whole-blood samples by use of a commercial universal 16S rRNA gene-based PCR and sequence analysis. J. Clin. Microbiol. 47: 2759-2765.
 
  Blood culture
 PCR positive negative total
 positive 47  41 88
 negative 7 247 254
 Total 54288
342
 Concordance (%) *$
86.0
  
 Sensitivity (%) $
87.0
  
 Specificity (%) $85.8
  
 Pos. Predictive Value (%) $
53.4
  
 Neg.Predictive Value (%) $97.2
  
*  positive and negative samples (47+247)/342)  
$  related to blood culture results

Abstract: 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™, 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™ appears to be a valuable tool, allowing earlier pathogen-adapted antimicrobial therapy in critically ill patients. 

 
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