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Viral Respiratory Panel NPSW
MessagePerformed at BUMCT
Test Code
Viral Respiratory Panel NPSW
Alias/See Also
Respiratory, Virus, Qualitative, RT-PCR, Tucson
CPT Codes
0115U
Preferred Specimen
Nasopharyngeal (NP) Flexible Minitip Flocked swab collected in 3mL Universal Transport Media (UTM red-cap).
Minimum Volume
0.5 mL
Transport Temperature
Refrigerated (if transport will be delayed)
Specimen Stability
Refrigerated 7 days
Methodology
GenMark ePlex
FDA Status
This test was developed, and its performance characteristics determined by Banner Health/Laboratory Sciences of Arizona. It has been cleared or approved by the U.S. Food and drug Administration (FDA).
Setup Schedule
Daily
Report Available
Turnaround time is 6 hours
Clinical Significance
NOTE: THIS ASSAY DOES NOT DETECT SEVERE ACUTE RESPIRATORY SYNDROME (SARS), MIDDLE EAST RESPIRATORY SYNDROME (MERS), OR SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-CoV-2)
This test is an automated qualitative nucleic acid multiplex in vitro diagnostic test for simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPSW) collected in universal transport media (UTM). The test detects the following viral and bacterial targets: Adenovirus (A,B,C,D,E,F), Coronavirus (229E, HKU1, NL63, OC43), Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A H1 virus, Influenza A 2009 H1N1 virus, Influenza A H3 virus, Influenza B virus, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Parainfluenza 4, Respiratory Syncytial virus A, Respiratory Syncytial virus B, Chlamydia pneumoniae, and Mycoplasma pneumoniae in nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory infection.
Sensitivity of >95% and Specificity of >99%, depending on target.
This test is an automated qualitative nucleic acid multiplex in vitro diagnostic test for simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPSW) collected in universal transport media (UTM). The test detects the following viral and bacterial targets: Adenovirus (A,B,C,D,E,F), Coronavirus (229E, HKU1, NL63, OC43), Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A H1 virus, Influenza A 2009 H1N1 virus, Influenza A H3 virus, Influenza B virus, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Parainfluenza 4, Respiratory Syncytial virus A, Respiratory Syncytial virus B, Chlamydia pneumoniae, and Mycoplasma pneumoniae in nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory infection.
Sensitivity of >95% and Specificity of >99%, depending on target.
