title: Lyme Borreliosis--the Utility of Improved Real-Time PCR Assay in the Detection of Borrelia burgdorferi Infections.
abstract: BACKGROUND
  Infections of Borrelia burgdorferi sensu lato reveal clinical manifestations affecting numerous organs and tissues. The standard diagnostic procedure of these infections is quite simple if a positive history of tick exposure or typical erythema migrans appears. Lack of unequivocal clinical symptoms creates the necessity for further evaluation with laboratory tests.
  
  
  OBJECTIVE
  This study discusses the utility of a novel, improved, well-optimized, sensitive and highly specific quantitative real-time PCR assay for the diagnostics of infections caused by Borrelia burgdorferi sensu lato.
  
  
  METHODS
  We designed an improved, specific, highly sensitive real-time quantitative polymerase chain reaction (RQ-PCR) assay for the detection and quantification of all Borrelia burgdorferi genotypes. A wide validation effort was undertaken to ensure confidence in the highly sensitive and specific detection of B. burgdorferi.
  
  
  RESULTS
  Due to high sensitivity and great specificity, as low as 1.6×10² copies of Borrelia per mL of whole blood could be detected. As much as 12 (3%) negative ELISA IgM results, 14 (2.8%) negative results of Line blot IgM, 11 (3.1%) and 7 (2.7%) of negative ELISA IgG and Line blot IgG results, respectively, were positive in real-time PCR.
  
  
  CONCLUSIONS
  The data in this study confirms the high positive predictive value of real-time PCR test in the detection of Borrelia infections.
authors.affiliation: Department of Clinical Chemistry, Wroclaw Medical University, Poland.
authors.forename: Iwona
authors.initials: I
authors.lastname: Bil-Lula
authors.affiliation: Euroimmun, Wrocław, Poland.
authors.forename: Patryk
authors.initials: P
authors.lastname: Matuszek
authors.affiliation: Euroimmun AG, Lubeck, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Pfeiffer
authors.affiliation: Department of Clinical Chemistry, Wroclaw Medical University, Poland.
authors.forename: Mieczysław
authors.initials: M
authors.lastname: Woźniak
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D025065:Borrelia burgdorferi / Q000145:classification / Q000235:genetics* / Q000276:immunology; D002138:Calibration; D004269:DNA, Bacterial / Q000235:genetics*; D004797:Enzyme-Linked Immunosorbent Assay; D005819:Genetic Markers; D006801:Humans; D015994:Incidence; D008193:Lyme Disease / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology / Q000382:microbiology; D011044:Poland / Q000453:epidemiology; D011237:Predictive Value of Tests; D012336:RNA, Ribosomal, 16S / Q000235:genetics*; D060888:Real-Time Polymerase Chain Reaction / Q000592:standards; D012015:Reference Standards; D015203:Reproducibility of Results; D021521:Ribotyping / Q000379:methods* / Q000592:standards; D012698:Serologic Tests
chemical_list: D000907:Antibodies, Bacterial; D004269:DNA, Bacterial; D005819:Genetic Markers; D012336:RNA, Ribosomal, 16S