title: Evaluation of Altona Diagnostics RealStar Zika Virus Reverse Transcription-PCR Test Kit for Zika Virus PCR Testing.
abstract: With the emerging Zika virus (ZIKV) epidemic, accessible real-time reverse transcription-PCR (rRT-PCR) assays are needed to streamline testing. The commercial Altona Diagnostics RealStar ZIKV rRT-PCR test kit (Altona PCR) has been approved for emergency use authorization by the U.S. FDA. Our aim was to verify the Altona PCR by comparing it to the CDC-designed dual-target ZIKV rRT-PCR reference assay (reference PCR) and describe the demographics of patients tested for ZIKV by rRT-PCR in Ontario, Canada. A large set of clinical specimens was tested for ZIKV by the Altona PCR and the reference PCR. Positive or equivocal specimens underwent PCR and Sanger sequencing targeting the ZIKV NS5 gene. A total of 671 serum specimens were tested by the reference PCR: 58 (8.6%) were positive, 193 (28.8%) were equivocal, and 420 (62.6%) were negative. Ninety percent of the reference PCR-positive patients were tested in the first 5 days after symptom onset. The Altona PCR was performed on 284/671 specimens tested by the reference PCR. The Altona PCR was positive for 53/58 (91%) reference PCR-positive specimens and 16/193 (8%) reference PCR-equivocal specimens; the ZIKV NS5 PCR was positive for all 68 Altona PCR-positive specimens and negative for all 181 Altona PCR-negative specimens that underwent the NS5 PCR. The Altona PCR has very good sensitivity (91%) and specificity (97%) compared to the reference PCR. The Altona PCR can be used for ZIKV diagnostic testing and has less extensive verification requirements than a laboratory-developed test.
authors.affiliation: Hospital for Sick Children, Toronto, Ontario, Canada.
authors.forename: Arnaud G
authors.identifier: 0000-0001-9230-7285
authors.initials: AG
authors.lastname: L'Huillier
authors.affiliation: Public Health Ontario, Toronto, Ontario, Canada.
authors.forename: Ernesto
authors.initials: E
authors.lastname: Lombos
authors.affiliation: Public Health Ontario, Toronto, Ontario, Canada.
authors.forename: Elaine
authors.initials: E
authors.lastname: Tang
authors.affiliation: Public Health Ontario, Toronto, Ontario, Canada.
authors.forename: Stephen
authors.initials: S
authors.lastname: Perusini
authors.affiliation: Public Health Ontario, Toronto, Ontario, Canada.
authors.forename: Alireza
authors.initials: A
authors.lastname: Eshaghi
authors.affiliation: Public Health Ontario, Toronto, Ontario, Canada.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Nagra
authors.affiliation: Public Health Ontario, Toronto, Ontario, Canada.
authors.forename: Christine
authors.initials: C
authors.lastname: Frantz
authors.affiliation: Public Health Ontario, Toronto, Ontario, Canada.
authors.forename: Romy
authors.initials: R
authors.lastname: Olsha
authors.affiliation: Public Health Ontario, Toronto, Ontario, Canada.
authors.forename: Erik
authors.initials: E
authors.lastname: Kristjanson
authors.affiliation: National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.
authors.forename: Kristina
authors.initials: K
authors.lastname: Dimitrova
authors.affiliation: National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Safronetz
authors.affiliation: National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.
authors.forename: Mike
authors.initials: M
authors.lastname: Drebot
authors.affiliation: Hospital for Sick Children, Toronto, Ontario, Canada jonathan.gubbay@oahpp.ca.|Public Health Ontario, Toronto, Ontario, Canada.|University of Toronto, Toronto, Ontario, Canada.
authors.forename: Jonathan B
authors.initials: JB
authors.lastname: Gubbay
mesh_terms: D000328:Adult; D001769:Blood / Q000821:virology*; D002555:Cerebrospinal Fluid / Q000821:virology*; D003429:Cross Reactions; D003955:Diagnostic Tests, Routine / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D012367:RNA, Viral / Q000235:genetics*; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity; D014556:Urine / Q000821:virology*; D000071244:Zika Virus / Q000235:genetics*; D000071243:Zika Virus Infection / Q000175:diagnosis* / Q000821:virology
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic
keywords: PCR; Zika virus; diagnostic testing; flavivirus