Lower Resp Tract Multiplex PCR Panel

Message

Performed at BUMCT

Test Code

LRTRESPLEX

Alias/See Also

Respiratory, Virus, Qualitative, PCR, RT-PCR, Tucson

CPT Codes
0115U

Preferred Specimen

Bronchoalveolar lavages, bronchial washes, and tracheal aspirates. Respiratory specimens (>0.5mL) are collected in a sterile container.

Minimum Volume

0.5mL

Transport Temperature

Refrigerated-STAT

Methodology
GenMark ePlex

FDA Status
This test is performed using the GenMark ePlex Respiratory Pathogen Panel. This test has been modified by this laboratory to allow for testing on lower respiratory specimens, including bronchoalveolar lavage, bronchial washings, and endotracheal aspirates. The performance characteristics were determined by Banner Health/Laboratory Sciences of Arizona. These sources have not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary since the laboratory is approved under CLIA for high complexity testing.

Setup Schedule

Daily (9 am cutoff)

Report Available

1 Day

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 bronchoalveolar lavages, bronchial washes, and tracheal aspirates collected in sterile containers. 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.

Last Updated: December 3rd, 2020

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.