Respiratory Pathogen Panel (RP2.1) molecular assay with 22 pathogens, including SARS-CoV-2, Nasopharyngeal

CPT Code(s)

CPT 0202U

Synonym(s)

Adenovirus, Coronavirus, Metapneumovirus, Rhinovirus, Enterovirus, Influenza A, H1N1, H3, H1, Influenza B, Parainfluenza, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, COVID-19, SARS-COV-2, FLU A, FLU B, Respiratory Syncytial Virus, Influenza

Performed

Molecular Diagnostics Laboratory

Clinical Indication and Relevance

The assay is useful to detect adenovirus, coronavirus 229E or HKU1 or NL63 or OC43, human metapneumovirus, human rhinovirus/enterovirus, influenza A including subtypes H1 or H3 or H1-2009, influenza B, parainfluenza virus 1 or 2 or 3 or 4, COVID-19/SARS-COV-2, respiratory syncytial virus, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and/or Mycoplasma pneumoniae.

Methodology

The assay uses polymerase chain reaction (PCR) on the BioFire FilmArray Torch System RP 2.1.

Minimum Specimen Requirements

Sample type

Collect a nasopharyngeal (NP) swab according to instructions provided with the kit
in either viral transport media (VTM) or universal transport media (UTM).

Specimen Labeling

The specimen must be labeled with two identifiers at the time of collection. Examples of acceptable identifiers include but are not limited to: patient name, date of birth, hospital medical record number, accession number. A location (e.g., hospital room number) is not an acceptable identifier. Collection date and collector’s identifier are required.

A completed requisition form should be submitted with every sample and, at minimum, the following is required: ordering physician name, phone number, fax number, and patient’s name, identifying number of patient, patient sex, patient date of birth specimen type, collection date, tests requested, provisional diagnosis or clinical rationale for test, and billing information.

Transport

Specimens can contain extremely high levels of virus or other organisms. Specimens
must be shipped and transported in accordance with applicable local, national and international transportation regulations. Maintain proper storage conditions of 2-8°C during shipping to ensure integrity of the specimen.

Stability

After collection, store samples at 2-8°C up to 7 days before testing.

Unacceptable Samples

Improperly labeled or incorrect patient identification, specimen leaked,
incorrect media, insufficient volume (less than 700 ul), no swab, bloody or grossly mucoid, specimen does not meet transport, storage or date of collection requirements.

Turnaround time

1-2 business days.