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EPIC CODE: LAB3189 Respiratory Panel by PCR to include Coronavirus

Additional Codes

Sunquest: RESP21

REGIONAL HOSPITAL PERFORMING

UPH Methodist Hospital

Collect

Nasopharyngeal Swab (NPS) collected accoridng to standard technique and immediately placed in 1-3 mL of viral transport media.  Other transport media inluding eSwabs is acceptable.

Stability (from collection to initiation)

Ambient (15-25° C): 4 hours

Refrigerated (2-8° C) Stability:(2-8° C):3 days

Frozen (< = 15° C or ≤70° C): 30 days

 

Unacceptable Conditions

Specimens not collected in Viral Transport Media or Saline. Non-nasopharyngeal specimens

Remarks

Performance of detecting Influenza A may vary if other influenza strains are circulating or a novel influenza A virus emerges. Due to genetic similarity between Rhinovirus and Enterovirus, the FilmArray RP2 cannot reliably differentiate them. A positive result should be followed up with an alternative method. Recent administration of nasal influenza vaccines (e.g. FluMist) prior to specimen collection could lead to accurate virus detetion by the FilmArray RP2.1

Methodology

Biofire

Components

Adenovirus

Coronavirus 229E

Coronavirus HKU1

Coronavirus NL63

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)

Human Metapneumovirus

Human Rhinovirus/Enterovirus

Influenza A, including Subtypes H1, H1-2009 and H3

Influenza B

Parainfluenza Virus 1-4

Respiratory Syncytial Virus (RSV)

Bordetella parapertussis

Bordetella pertussis

Chlymydia pneumoniae

Myocoplasma pneumoniae

Interpretive Data

The BioFire RP2.1 has not been validated for testing of specimens other than nasopharyngeal swab (NPS) specimens in transport medium and eSwabs.

The performance of the Biofire RP2.1 has not been established for specimens collected from individual without signs or symptoms of respirtory infection.

The detection of viral and bacterial nucleic acid is dependent upon proper specimen collection, handling, transportation, storage and preparation. Failure to observe proper procedures in any one of these steps can lead to incorrect results.

A negative BioFire RP2.1 result does not exclude the possibility of viral or bacterial infection.  Negative test results may occur from the presence of sequence variants (or mutation) in the region targeted by the assay, the presence of inhibitors, technical error, sample mix-up, an infection caused by an organism not detected by the panel, or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen.

CPT

0202U

Reference Values

Undetected (for all targets)