title: Performance of PCR-REBA assay for screening and identifying pathogens directly in whole blood of patients with suspected sepsis.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors: Wonju Eco Environmental Technology Center, M&D, Inc., Wonju, Korea.
authors: H-Y
authors: HY
authors: Wang
authors: Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, Wonju, Korea.
authors: J
authors: J
authors: Kim
authors: Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, Wonju, Korea.
authors: S
authors: S
authors: Kim
authors: Department of Laboratory Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.
authors: S D
authors: SD
authors: Park
authors: Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.
authors: H Y
authors: HY
authors: Kim
authors: Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.
authors: H K
authors: HK
authors: Choi
authors: Department of Laboratory Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.
authors: Y
authors: Y
authors: Uh
authors: Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, Wonju, Korea.
authors: H
authors: H
authors: Lee
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006090:Gram-Negative Bacteria / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D006094:Gram-Positive Bacteria / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction / Q000295:instrumentation / Q000379:methods*; D011446:Prospective Studies; D012336:RNA, Ribosomal, 16S / Q000235:genetics; D012680:Sensitivity and Specificity; D018805:Sepsis / Q000097:blood / Q000382:microbiology*; D055815:Young Adult
chemical_list: D012336:RNA, Ribosomal, 16S
keywords: PCR-REBA; blood culture; molecular diagnosis; sepsis; whole blood