title: Evaluation of RealStar Reverse Transcription-Polymerase Chain Reaction Kits for Filovirus Detection in the Laboratory and Field.
abstract: Diagnosis of Ebola virus (EBOV) disease (EVD) requires laboratory testing.
  
  
  
  The RealStar Filovirus Screen reverse transcription-polymerase chain reaction (RT-PCR) kit and the derived RealStar Zaire Ebolavirus RT-PCR kit were validated using in vitro transcripts, supernatant of infected cell cultures, and clinical specimens from patients with EVD.
  
  
  
  The Filovirus Screen kit detected EBOV, Sudan virus, Taï Forest virus, Bundibugyo virus, Reston virus, and Marburg virus and differentiated between the genera Ebolavirus and Marburgvirus The amount of filovirus RNA that could be detected with a probability of 95% ranged from 11 to 67 RNA copies/reaction on a LightCycler 480 II. The Zaire Ebolavirus kit is based on the Filovirus Screen kit but was optimized for detection of EBOV. It has an improved signal-to-noise ratio at low EBOV RNA concentrations and is somewhat more sensitive than the Filovirus kit. Both kits show significantly lower analytical sensitivity on a SmartCycler II. Clinical evaluation revealed that the SmartCycler II, compared with other real-time PCR platforms, decreases the clinical sensitivity of the Filovirus Screen kit to diagnose EVD at an early stage.
  
  
  
  The Filovirus Screen kit detects all human-pathogenic filoviruses with good analytical sensitivity if performed on an appropriate real-time PCR platform. High analytical sensitivity is important for early diagnosis of EVD.
authors.affiliation: Department of Virology, Bernhard Nocht Institute for Tropical Medicine.
authors.forename: Toni
authors.initials: T
authors.lastname: Rieger
authors.affiliation: Department of Virology, Bernhard Nocht Institute for Tropical Medicine.
authors.forename: Romy
authors.initials: R
authors.lastname: Kerber
authors.affiliation: altona Diagnostics.
authors.forename: Hussein
authors.initials: H
authors.lastname: El Halas
authors.affiliation: Department of Virology, Bernhard Nocht Institute for Tropical Medicine German Center for Infection Research, Hamburg, Germany.
authors.forename: Elisa
authors.initials: E
authors.lastname: Pallasch
authors.affiliation: Department of Virology, Bernhard Nocht Institute for Tropical Medicine.
authors.forename: Sophie
authors.initials: S
authors.lastname: Duraffour
authors.affiliation: Department of Virology, Bernhard Nocht Institute for Tropical Medicine German Center for Infection Research, Hamburg, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Günther
authors.affiliation: altona Diagnostics.
authors.forename: Stephan
authors.initials: S
authors.lastname: Ölschläger
mesh_terms: D029043:Ebolavirus / Q000235:genetics / Q000302:isolation & purification*; D016563:Filoviridae / Q000235:genetics / Q000302:isolation & purification*; D018702:Filoviridae Infections / Q000175:diagnosis* / Q000821:virology; D019142:Hemorrhagic Fever, Ebola / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D057089:Pathology, Molecular; D012367:RNA, Viral / Q000032:analysis / Q000235:genetics; D011933:Reagent Kits, Diagnostic; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic
keywords: Ebola virus disease; Filovirus; commercial RT-PCR kit; molecular diagnostics; sensitivity