Respiratory Pathogen Panel by PCR (BioFire RP2.1) - Laboratory Technical Bulletin
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Announces verification and implementation of a new multiplex PCR respiratory pathogen panel (BioFire RP2.1) performed on nasopharyngeal specimens; describes organisms detected, specimen requirements, and operational/ordering notes for clinicians and laboratory staff within McLaren facilities.
A new test, Respiratory Pathogen Panel by PCR (BioFire RP2.1), has been verified and implemented effective November 19, 2024.
The BioFire RP2.1 assay identifies 19 viral and bacterial respiratory pathogens and subtypes.
Specimen collection, storage, and transport requirements for nasopharyngeal swabs are specified (volume, temperatures, and acceptable durations).
Coverage Criteria and Intended Use
The BioFire Respiratory Panel v2.1 (Respiratory Pathogen Panel by PCR, RPP) is intended to expand detection of potential respiratory pathogens from a single nasopharyngeal specimen using a multiplex real-time PCR approach. It is not intended to replace routine, targeted on-site PCR assays for SARS-CoV-2, Influenza, or RSV when used for routine testing of patients with uncomplicated upper respiratory symptoms; those targeted assays remain the standard for uncomplicated cases run on-site at McLaren hospitals and clinics.
Identification of respiratory viral and selected bacterial pathogens — covered indication
Covered when ALL of the following are met:
ALL of the following
- Specimen is a nasopharyngeal swab submitted for respiratory pathogen testing.
- Testing is ordered using the test name 'Respiratory Pathogen Panel by PCR' (RPP by PCR) or equivalent laboratory order code.
- Broad pathogen detection is clinically indicated — i.e., the clinician requires identification of multiple potential viral or selected bacterial respiratory pathogens from a single nasopharyngeal specimen to inform diagnosis or management rather than a single-target assay.
- Order is not intended as a routine replacement for targeted SARS‑CoV‑2, influenza, or RSV PCR testing for patients with uncomplicated upper respiratory symptoms; continue to use on‑site targeted assays per local testing algorithms when appropriate.
ALL of the following
- The testing modality is the BioFire Respiratory Panel v2.1 (RP2.1), a multiplex real‑time PCR assay performed as a send‑out to ARUP by McLaren Medical Laboratory.
- The panel detects the 19 viral and bacterial respiratory pathogens and subtypes listed in the laboratory bulletin (see organism list).
ALL of the following
- Specimen collection, transport, and labeling meet laboratory requirements (nasopharyngeal swab placed in 1–3 mL viral transport media or saline and labeled with collection time to confirm transport/storage windows).
- Specimen meets stability/temperature requirements for acceptance (adhere to room temperature, refrigerated, or frozen time limits as specified by the laboratory).
ALL of the following
- Clinical indication includes need to identify one or more of the pathogens on the panel such as adenovirus; human metapneumovirus; parainfluenza viruses 1–4; human rhinovirus/enterovirus; influenza A (including H1, H1‑2009, H3) and influenza B; respiratory syncytial virus; coronaviruses 229E, HKU1, NL63, OC43; SARS‑CoV‑2; Bordetella pertussis and parapertussis; Chlamydia pneumoniae; Mycoplasma pneumoniae.
This test should not be used as a routine replacement for targeted SARS-CoV-2, Influenza, or RSV PCR assays for uncomplicated upper respiratory infections; continue to use on-site targeted assays per local testing algorithms for routine cases.
Laboratory Test Code
| RPP by PCR | Test code for Respiratory Pathogen Panel by PCR (as listed in the bulletin) |
Ordering, Specimen Handling, and Provider Guidance
Prior authorization
No payer prior authorization guidance is provided in this bulletin; ordering follows standard laboratory ordering processes within McLaren facilities.
Testing algorithm note
The panel is not intended to replace routine targeted SARS‑CoV‑2, Influenza, or RSV PCR assays for uncomplicated upper respiratory symptoms; continue to use on‑site targeted assays per local testing algorithms when clinically appropriate.
Ordering and specimen labeling
Order the test using the name 'Respiratory Pathogen Panel by PCR (Test code: RPP by PCR)'. Collect a nasopharyngeal (NP) swab placed in 1–3 mL of viral transport media (VTM) or saline and label the specimen with collection time to confirm adherence to transport/storage windows.
- Order name: Respiratory Pathogen Panel by PCR; Test code: RPP by PCR.
- Specimen: NP swab placed in 1–3 mL viral transport media or saline.
- Labeling: include collection time to verify temperature/time stability during transport/storage.
Specimen acceptance risk
Specimens that do not meet the listed collection, volume, or storage/transport temperature and time requirements may yield invalid or unsatisfactory results and risk rejection.
- Acceptable volumes: NP swab in 1–3 mL VTM or saline.
- Temperature/time limits: room temp 15–25°C up to 4 hours; refrigerated 2–8°C up to 3 days; frozen (≤‑15°C or ≤‑70°C) up to 30 days.
How to Order and Submit Specimens
Ordering requirements: test name, code, NP swab in 1–3 mL VTM/saline and transport/storage windows
Place orders using the test name 'Respiratory Pathogen Panel by PCR' (Test code: RPP by PCR). Collect a nasopharyngeal swab in 1–3 mL viral transport media or saline and follow the specified transport and storage conditions (room temperature up to 4 hours; refrigerated 2–8°C up to 3 days; frozen per bulletin up to 30 days).
- Test name and code: Respiratory Pathogen Panel by PCR — RPP by PCR.
- Specimen: NP swab in 1–3 mL VTM or saline; adhere to timing and temperature windows specified in the bulletin.
Key Definitions
Background and Operational Notes
The BioFire® Respiratory Panel v2.1 is a multiplex real-time PCR assay that qualitatively detects multiple viral and bacterial respiratory pathogens from a single nasopharyngeal swab. The assay identifies a panel of respiratory organisms to help broaden etiologic identification beyond single-target tests and supports clinical decision-making when expanded pathogen detection is indicated.
Operationally, the Respiratory Pathogen Panel by PCR is performed as a send-out test to ARUP. It is intended to expand pathogen detection from a single swab and reduce overall turnaround time for broader testing; it is explicitly not intended to replace routine targeted on-site PCR assays for SARS-CoV-2, Influenza, or RSV in uncomplicated cases.
The BioFire RP2.1 assay qualitatively identifies 19 viral and bacterial respiratory pathogens and subtypes, including adenovirus; human metapneumovirus; parainfluenza viruses 1–4; human rhinovirus/enterovirus; influenza A (including H1, H1-2009, H3) and influenza B; respiratory syncytial virus; coronaviruses (229E, HKU1, NL63, OC43); SARS-CoV-2; and selected atypical bacterial agents such as Bordetella pertussis, Bordetella parapertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae.
Collect a nasopharyngeal swab in 1–3 mL of viral transport media or saline and place at 2–8°C within 4 hours of collection. Specimen stability and transport windows are: room temperature (15–25°C) for up to 4 hours; refrigerated (2–8°C) for up to 3 days; and frozen (≤-15°C or ≤-70°C) for up to 30 days.
Policy Changes
McLaren Medical Laboratory completed verification and implemented the BioFire Respiratory Panel v2.1 (Respiratory Pathogen Panel by PCR, send-out to ARUP) effective November 19, 2024.
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