Background:
The Microbiology Division will implement the ePlex® Respiratory Pathogen Panel 2 (ePlex RP2 Panel) to be used in nasopharyngeal swabs (NPS) from patients with signs and symptoms of respiratory tract infection. The ePlex RP2 Panel is only for use under the Food and Drug Administration’s Emergency Use Authorization (EUA).
Important consideration:
- Due to the limited supply of reagents, ePlex RP2 is limited to inpatients only and will require approval through the Antibiotic Approving Attending on-call (ID and BMT physicians are exempted from approval). As the supply increases, these approval processes may be eliminated.
Effective date: Nov. 24, 2020
Methodology and limitations:
The ePlex Respiratory Pathogen Panel 2 (ePlex RP2 Panel) is a multiplexed nucleic acid in vitro diagnostic test intended for use for the simultaneous qualitative detection and differentiation of nucleic acids from multiple respiratory viral and bacterial organisms. The panel includes the following viruses and bacteria: adenovirus, coronavirus (229E, HKU1, NL63, OC43), SARS-CoV-2, human metapneumovirus, human rhinovirus/enterovirus, influenza A, influenza A H1, influenza A H1-2009, influenza A H3, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, respiratory syncytial virus (RSV) A, respiratory syncytial virus (RSV) B, Chlamydia pneumoniae, and Mycoplasma pneumoniae.
Due to the genetic similarity between human rhinovirus and enterovirus, this test cannot reliably differentiate them. If clinically significant, an ePlex RP2 Panel Rhinovirus/Enterovirus positive result should be followed-up using an alternate method. At concentrations greater than 1% weight/volume in the sample, tobramycin was found to inhibit assay performance.
Specimen requirements:
Collect: Nasopharyngeal swab in viral transport media (VTM)
Stability: Ambient: Acceptable if received immediately; Refrigerated: 3 days; Frozen: 1 month.
Minimum volume: 1 nasopharyngeal swab containing 1 ml of VTM
Turnaround time (TAT): 3 hours
Test code: SRP2
Rejection criteria:
Specimens that exceed stated stability, unlabeled/mislabeled/mismatched specimens, specimens submitted in leaking containers, swabs with wooden shafts, dry swabs not in transport media, non-sterile containers, bloody samples.
A summary of all tests offered by our laboratory services can be found here: http://www.pathology.uci.edu/services/index.asp
Sincerely,
Cassiana Bittencourt, MD
Director
Division of Clinical Microbiology
Edwin S. Monuki, MD, PhD
Chair
Department of Pathology & Laboratory Medicine |
