title: Comparison of the Simplexa HSV1 & 2 Direct kit and laboratory-developed real-time PCR assays for herpes simplex virus detection.
abstract: BACKGROUND
  Rapid detection and differentiation of herpes simplex viruses (HSV) is important for patient management and treatment, especially in HSV meningoencephalitis.
  
  
  OBJECTIVE
  Results of Simplexa HSV1 & 2 Direct kit (Focus Diagnostics), an FDA-cleared sample-to-result method providing results in ∼ 75 min, were compared to those of laboratory-developed real-time PCR assays (LDT) for detection of HSV1 and HSV2.
  
  
  METHODS
  Samples tested included 168 cerebral spinal fluid (CSF) collected prospectively and 150 tested retrospectively: 81 from clinical testing and 69 from subjects in a neonatal herpes study; and 53 plasma and sera. Each sample was tested by both methods on the same day.
  
  
  RESULTS
  Three of 318 CSF had invalid Simplexa Direct results and negative LDT results. Three neonatal samples with low HSV viral loads by LDT could not be typed; two were HSV2 positive and one was negative by Simplexa Direct. Of 312 CSF with valid, type-specific results, HSV1 was detected in 16 by LDT and in 17 by Simplexa Direct; HSV2 was detected in 48 by LDT and in 49 by Simplexa Direct. Concordance rates were 98.4% (κ 0.84) and 97.1% (κ 0.89) for HSV1 and HSV2, respectively. Positive percent agreements were 87.5% for HSV1 and 91.7% for HSV2. Two and four CSF were positive only by LDT and three and five were positive only by Simplexa Direct for HSV1 and HSV2, respectively.
  
  
  CONCLUSIONS
  Simplexa HSV1 & 2 assay performed well compared to an established LDT. The faster turn-around-time compared to LDT will allow for more rapid antiviral treatment and better patient management.
authors.affiliation: Department of Laboratory Medicine, University of Washington Medical Center, Seattle, WA, USA; Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. Electronic address: kuypers@uw.edu.
authors.forename: Jane
authors.initials: J
authors.lastname: Kuypers
authors.affiliation: Department of Laboratory Medicine, University of Washington Medical Center, Seattle, WA, USA.
authors.forename: Gregory
authors.initials: G
authors.lastname: Boughton
authors.affiliation: Department of Laboratory Medicine, University of Washington Medical Center, Seattle, WA, USA.
authors.forename: Jina
authors.initials: J
authors.lastname: Chung
authors.affiliation: Department of Laboratory Medicine, University of Washington Medical Center, Seattle, WA, USA.
authors.forename: Lindsay
authors.initials: L
authors.lastname: Hussey
authors.affiliation: Department of Laboratory Medicine, University of Washington Medical Center, Seattle, WA, USA; Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors.forename: Meei-Li
authors.initials: ML
authors.lastname: Huang
authors.affiliation: Department of Laboratory Medicine, University of Washington Medical Center, Seattle, WA, USA; Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Cook
authors.affiliation: Department of Laboratory Medicine, University of Washington Medical Center, Seattle, WA, USA; Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors.forename: Keith R
authors.initials: KR
authors.lastname: Jerome
mesh_terms: D006561:Herpes Simplex / Q000175:diagnosis* / Q000821:virology*; D018259:Herpesvirus 1, Human / Q000235:genetics*; D018258:Herpesvirus 2, Human / Q000235:genetics*; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000592:standards; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods* / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: Herpes simplex virus detection; Point of care testing; Rapid polymerase chain reaction