Performance of PCR-REBA assay for screening and identifying pathogens directly in whole blood of patients with suspected sepsis

H. Y. Wang, J. Kim, S. Kim, S. D. Park, H. Y. Kim, H. K. Choi, Y. Uh, Hyeyoung Lee

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Aims: Rapid and accurate identification of a broad range of bacterial and fungal pathogens is the key to successful management of patients with bloodstream infections (BSIs). The aim of this study was to evaluate the diagnostic performance of PCR-REBA Sepsis-ID test for the detection of BSIs pathogens. Methods and Results: EDTA anticoagulated blood for REBA Sepsis-ID assay and blood culture samples from 882 patients with suspected sepsis were simultaneously collected from January 2014 to December 2014. Of 115 patients with positive blood culture, 64 (55·7%) were Gram-positive bacteria, 35 (30·4%) were Gram-negative bacteria, 1 (0·9%) was Candida albicans and 15 (13·0%) were polymicrobial infections. The concordance rate of blood culture system and PCR-REBA Sepsis ID test was 83·0% (95% confidence interval (CI), 79·8-84·8, P < 0·0001). Compared to blood culture, the diagnosis of bacterial proven pathogens by PCR-REBA revealed 81·0% (95% CI, 73·4-86·8, P < 0·0001) sensitivity, 83·4% (95% CI, 80·0-85·4, P < 0·0001) specificity, 80·9% positive and 95·8% negative predictive values respectively. In 10 cases with PCR-REBA positive but blood culture negative, the levels of C-reactive protein were significantly elevated 18·5 mg dl-1 (SD ± 13·7, 95% CI 1·8-41·9) and six cases has been proven to have pathogen by bacterial 16S rRNA sequencing. Although the sensitivity for pathogen identification was not significantly different between PCR-REBA and blood culture (P = 0·5), the combination of the two methods resulted in a significantly increased rate of pathogen detection (P = 0·002). The results of this study suggested that PCR-REBA may be helpful when added to blood culture in the diagnosis and management of sepsis. Conclusions: PCR-REBA Sepsis-ID test is a useful tool for the rapid identification of pathogenic isolates in whole blood to ensure adequate treatment for the causative agents of BSIs. Significance and Impact of the Study: Although the cost of molecular diagnostic assays is higher than the cost of conventional methods, clinical and economic cost-benefit analysis is still needed. PCR-REBA may provide essential information for accelerating therapeutic decisions to ensure effective treatment with antibiotics in the acute phase of pathogen infection.

Original languageEnglish
Pages (from-to)1433-1442
Number of pages10
JournalJournal of Applied Microbiology
Volume119
Issue number5
DOIs
Publication statusPublished - 2015 Nov 1

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Sepsis
Polymerase Chain Reaction
Confidence Intervals
Infection
Costs and Cost Analysis
Molecular Pathology
Gram-Positive Bacteria
Blood Culture
Gram-Negative Bacteria
Candida albicans
Coinfection
Edetic Acid
C-Reactive Protein
Cost-Benefit Analysis
Economics
Anti-Bacterial Agents

All Science Journal Classification (ASJC) codes

  • Biotechnology
  • Applied Microbiology and Biotechnology

Cite this

Wang, H. Y. ; Kim, J. ; Kim, S. ; Park, S. D. ; Kim, H. Y. ; Choi, H. K. ; Uh, Y. ; Lee, Hyeyoung. / Performance of PCR-REBA assay for screening and identifying pathogens directly in whole blood of patients with suspected sepsis. In: Journal of Applied Microbiology. 2015 ; Vol. 119, No. 5. pp. 1433-1442.
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abstract = "Aims: Rapid and accurate identification of a broad range of bacterial and fungal pathogens is the key to successful management of patients with bloodstream infections (BSIs). The aim of this study was to evaluate the diagnostic performance of PCR-REBA Sepsis-ID test for the detection of BSIs pathogens. Methods and Results: EDTA anticoagulated blood for REBA Sepsis-ID assay and blood culture samples from 882 patients with suspected sepsis were simultaneously collected from January 2014 to December 2014. Of 115 patients with positive blood culture, 64 (55·7{\%}) were Gram-positive bacteria, 35 (30·4{\%}) were Gram-negative bacteria, 1 (0·9{\%}) was Candida albicans and 15 (13·0{\%}) were polymicrobial infections. The concordance rate of blood culture system and PCR-REBA Sepsis ID test was 83·0{\%} (95{\%} confidence interval (CI), 79·8-84·8, P < 0·0001). Compared to blood culture, the diagnosis of bacterial proven pathogens by PCR-REBA revealed 81·0{\%} (95{\%} CI, 73·4-86·8, P < 0·0001) sensitivity, 83·4{\%} (95{\%} CI, 80·0-85·4, P < 0·0001) specificity, 80·9{\%} positive and 95·8{\%} negative predictive values respectively. In 10 cases with PCR-REBA positive but blood culture negative, the levels of C-reactive protein were significantly elevated 18·5 mg dl-1 (SD ± 13·7, 95{\%} CI 1·8-41·9) and six cases has been proven to have pathogen by bacterial 16S rRNA sequencing. Although the sensitivity for pathogen identification was not significantly different between PCR-REBA and blood culture (P = 0·5), the combination of the two methods resulted in a significantly increased rate of pathogen detection (P = 0·002). The results of this study suggested that PCR-REBA may be helpful when added to blood culture in the diagnosis and management of sepsis. Conclusions: PCR-REBA Sepsis-ID test is a useful tool for the rapid identification of pathogenic isolates in whole blood to ensure adequate treatment for the causative agents of BSIs. Significance and Impact of the Study: Although the cost of molecular diagnostic assays is higher than the cost of conventional methods, clinical and economic cost-benefit analysis is still needed. PCR-REBA may provide essential information for accelerating therapeutic decisions to ensure effective treatment with antibiotics in the acute phase of pathogen infection.",
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Performance of PCR-REBA assay for screening and identifying pathogens directly in whole blood of patients with suspected sepsis. / Wang, H. Y.; Kim, J.; Kim, S.; Park, S. D.; Kim, H. Y.; Choi, H. K.; Uh, Y.; Lee, Hyeyoung.

In: Journal of Applied Microbiology, Vol. 119, No. 5, 01.11.2015, p. 1433-1442.

Research output: Contribution to journalArticle

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AU - Kim, J.

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AU - Lee, Hyeyoung

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N2 - Aims: Rapid and accurate identification of a broad range of bacterial and fungal pathogens is the key to successful management of patients with bloodstream infections (BSIs). The aim of this study was to evaluate the diagnostic performance of PCR-REBA Sepsis-ID test for the detection of BSIs pathogens. Methods and Results: EDTA anticoagulated blood for REBA Sepsis-ID assay and blood culture samples from 882 patients with suspected sepsis were simultaneously collected from January 2014 to December 2014. Of 115 patients with positive blood culture, 64 (55·7%) were Gram-positive bacteria, 35 (30·4%) were Gram-negative bacteria, 1 (0·9%) was Candida albicans and 15 (13·0%) were polymicrobial infections. The concordance rate of blood culture system and PCR-REBA Sepsis ID test was 83·0% (95% confidence interval (CI), 79·8-84·8, P < 0·0001). Compared to blood culture, the diagnosis of bacterial proven pathogens by PCR-REBA revealed 81·0% (95% CI, 73·4-86·8, P < 0·0001) sensitivity, 83·4% (95% CI, 80·0-85·4, P < 0·0001) specificity, 80·9% positive and 95·8% negative predictive values respectively. In 10 cases with PCR-REBA positive but blood culture negative, the levels of C-reactive protein were significantly elevated 18·5 mg dl-1 (SD ± 13·7, 95% CI 1·8-41·9) and six cases has been proven to have pathogen by bacterial 16S rRNA sequencing. Although the sensitivity for pathogen identification was not significantly different between PCR-REBA and blood culture (P = 0·5), the combination of the two methods resulted in a significantly increased rate of pathogen detection (P = 0·002). The results of this study suggested that PCR-REBA may be helpful when added to blood culture in the diagnosis and management of sepsis. Conclusions: PCR-REBA Sepsis-ID test is a useful tool for the rapid identification of pathogenic isolates in whole blood to ensure adequate treatment for the causative agents of BSIs. Significance and Impact of the Study: Although the cost of molecular diagnostic assays is higher than the cost of conventional methods, clinical and economic cost-benefit analysis is still needed. PCR-REBA may provide essential information for accelerating therapeutic decisions to ensure effective treatment with antibiotics in the acute phase of pathogen infection.

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