Evaluation of Altona Diagnostics RealStar Zika Virus Reverse Transcription-PCR Test Kit for Zika Virus PCR Testing
| Autor: | Erik Kristjanson, Arnaud G L'Huillier, Sandeep Nagra, David Safronetz, Stephen Perusini, Romy Olsha, Kristina Dimitrova, Jonathan B. Gubbay, Christine Frantz, Ernesto Lombos, Elaine Tang, Mike Drebot, Alireza Eshaghi |
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| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Microbiology (medical) Adult Male Emergency Use Authorization Demographics 030106 microbiology Cross Reactions Urine Real-Time Polymerase Chain Reaction Sensitivity and Specificity Zika virus 03 medical and health sciences symbols.namesake 0302 clinical medicine Virology Medicine Humans 030212 general & internal medicine Symptom onset Cerebrospinal Fluid Sanger sequencing biology business.industry Diagnostic Tests Routine Zika Virus Infection Diagnostic test Zika Virus biology.organism_classification Reverse transcription polymerase chain reaction Flavivirus Blood symbols RNA Viral Female Reagent Kits Diagnostic business |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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