Test Code RP Respiratory Panel, PCR, Nasopharyngeal
Ordering Guidance
This assay is not predicted to detect severe acute respiratory syndrome (SARS)-associated coronavirus or Middle East respiratory syndrome (MERS)-coronavirus.
This test is not intended for otherwise healthy, immunocompetent patients who are likely to have a mild, self-limited respiratory infection. If testing is desired, these patients should be tested using the more targeted diagnostic assays based on their exposure history and clinical presentation.
-FLUNP / Influenza Virus Type A and Type B, and Respiratory Syncytial Virus (RSV), Molecular Detection, PCR, Nasopharyngeal Swab
-BPRPV / Bordetella pertussis and Bordetella parapertussis, Molecular Detection, PCR, Varies
-MPRP / Mycoplasma (Mycoplasmoides) pneumoniae with Macrolide Resistance Reflex, Molecular Detection, PCR, Varies
-COVID / Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Detection, PCR, Varies
It is not recommended that the following tests be concomitantly ordered when this test is ordered:
-FLUNP / Influenza Virus Type A and Type B, and Respiratory Syncytial Virus (RSV), Molecular Detection, PCR, Nasopharyngeal Swab
-LADV / Adenovirus, Molecular Detection, PCR, Varies
-LENT / Enterovirus, Molecular Detection, PCR, Varies
-BPRPV / Bordetella pertussis and Bordetella parapertussis, Molecular Detection, PCR, Varies
-MPRP / Mycoplasma (Mycoplasmoides) pneumoniae with Macrolide Resistance Reflex, Molecular Detection, PCR, Varies
-COVID / Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Detection, PCR, Varies
This test is appropriate for nasopharyngeal swabs only. For bronchoalveolar lavage or bronchial washings specimens, order RPB / Respiratory Panel, PCR, Varies.
Shipping Instructions
Specimens that cannot be shipped refrigerated to Mayo Clinic Laboratories within 3 days (72 hours) should be frozen prior to shipment. Specimens received older than 72 hours (refrigerated) or older than 30 days (frozen) will be canceled.
Specimen Required
Specimen Type: Nasopharyngeal swab
Supplies:
-Culture Swab - Liquid Stuarts/Single Swab (NP Swab) (T515)
-M4-RT (T605)
-Nasopharyngeal Swab (Nylon Mini-Tip Swab) (T861)
Collection Container/Tube: Swab. See Additional Information for acceptable swab.
Submission Container/Tube: Transport medium. See Additional Information for acceptable media.
Specimen Volume: Nasopharyngeal swab in minimum volume of 1 mL of transport media
Collection Instructions:
1. Nasopharyngeal swab specimens should be collected according to standard technique and immediately placed into transport media and submitted for testing.
2. Submit swab in original container.
Additional Information:
If any nasopharyngeal swab or transport media not listed below is utilized, testing may be canceled.
-Acceptable nasopharyngeal (NP) swabs are Copan Rayon Swabs, Copan Nylon Flocked Swabs, Copan Polyester Swabs, Puritan Calcium Alginate Swabs, SteriFlock NP Swab
-Acceptable transport media are Remel M4, Remel M4-RT, Remel M5, Remel M6, BD Universal Viral Transport Media (VTM), Copan Universal Transport Media (UTM), PrimeStore Molecular Transport Medium (MTM)
-Acceptable collection and transport systems are Sigma-Virocult Viral Collection and Transport System (Swab and transport medium), Copan ESwab Sample Collection and Delivery System (Swab and Liquid Amies Medium), and BD ESwab Collection Kit (Flocked swab and Liquid Amies Medium).
Secondary ID
609409Useful For
Rapid detection of respiratory infections caused by the following:
-Adenovirus
-Coronavirus (serotypes HKU1, NL63, 229E, OC43)
- SARS-CoV-2, the causative agent of COVID-19
-Human metapneumovirus
-Human rhinovirus/enterovirus
-Influenza A (H1, H1-2009, H3)
-Influenza B
-Parainfluenza virus (serotypes 1-4)
-Respiratory syncytial virus (RSV)
-Bordetella pertussis
-Bordetella parapertussis
-Chlamydia pneumoniae
-Mycoplasma pneumoniae
This test is not recommended as a test of cure.
Highlights
This test is a multiplex polymerase chain reaction (PCR) test capable of qualitatively detecting DNA or RNA of 22 pathogens (bacteria and viruses) in approximately 1 hour using nasopharyngeal swab specimens.
This test may diagnose infections caused by adenovirus, coronavirus (HKU1, NL63, 229E, OC43), SARS-CoV-2, human metapneumovirus, human rhinovirus/enterovirus, influenza A (H1, H1-2009, H3), influenza B, parainfluenza (1, 2, 3, 4), respiratory syncytial virus, Bordetella pertussis, Bordetella parapertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae.
Method Name
Multiplex Polymerase Chain Reaction (PCR)
Reporting Name
Respiratory Panel, PCR, NPSpecimen Type
VariesSpecimen Minimum Volume
See Specimen Required
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Varies | Refrigerated (preferred) | 72 hours | |
Frozen | 30 days | ||
Ambient | 4 hours |
Reject Due To
Swabs other than NP swab (eg, any thick shafted swab such as an oropharyngeal swab or nasal swab) Any transport media or NP swab type not listed in Specimen Required |
Reject |
Clinical Information
Respiratory infections are common and generally cause self-limited illnesses in healthy, immunocompetent hosts. Viruses account for a significant percentage of respiratory diseases, but bacteria can be associated with respiratory infections. Although respiratory illnesses are frequently mild, viruses may cause significant morbidity and mortality in immunocompromised hosts (eg, transplant recipients, patients with underlying malignancies).
Influenza viruses (types A and B) and respiratory syncytial virus (RSV) are 2 common causes of viral respiratory illness, with peak incidence in the winter and spring months in the Northern hemisphere. Both viruses can cause a clinically indistinguishable syndrome characterized by fever, cough, headache, and general malaise. RSV is a leading cause of respiratory illness in young children. Early diagnosis of influenza and RSV is important so necessary infection control precautions can be taken if the patient is hospitalized, and antiviral therapy can be considered if the patient is hospitalized or considered at high-risk for severe disease.(1) Human metapneumovirus is also a cause of respiratory illness in both children and adults.
Human rhinovirus and coronavirus serotypes HKU1, NL63, 229E, and OC43 are the causative agents of the common cold, with symptoms including runny nose, sore throat, and malaise. Infections with rhinovirus and coronaviruses are extremely common, due to the large number of serotypes of these viruses. Most infections are mild and self-limiting; however, immunocompromised individuals may suffer more severe illnesses, including lower respiratory tract disease.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an RNA virus that causes COVID-19. Like other coronaviruses that infect humans, SARS-CoV-2 can cause both upper and lower respiratory tract illness. Symptoms can range from mild (eg, the common cold) to severe (eg, pneumonia) in both healthy and immunocompromised patients. SARS-CoV-2 transmission occurs primarily via respiratory droplets. During the early stages of COVID-19 disease, the symptoms may be nonspecific and resemble other common respiratory infections, such as influenza.
Parainfluenza viruses and adenovirus are also common causes of viral infection, especially in young children. Parainfluenza viruses are most common during the spring, summer, and fall months, with symptoms including fever, runny nose, and cough. However, parainfluenza viruses may also cause more severe lower respiratory disease, such as croup or pneumonia. Adenoviruses may infect a range of organ systems, with sequelae ranging from cold-like symptoms (sore throat) to pneumonia, conjunctivitis (pink eye), or diarrhea. Similar to the viruses described above, parainfluenza viruses and adenoviruses generally cause mild, self-limited infections but may cause severe disease in immunosuppressed patients.
Respiratory infections may also be caused by bacterial pathogens, including Bordetella pertussis, Bordetella parapertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae. B pertussis is the causative agent of pertussis, or whooping cough, a disease characterized by a prolonged cough that may be associated with an inspiratory whoop and post-tussive vomiting. B parapertussis causes a similar, but generally less severe, illness. M pneumoniae is a cause of upper respiratory infection, pharyngitis, tracheobronchitis, and pneumonia. C pneumoniae is a rare cause of pneumonia.
Reference Values
Undetected (for all targets)
Interpretation
Results are intended to aid in the diagnosis of illness and are meant to be used in conjunction with other clinical and epidemiological findings.
A negative result should not rule out infection in patients with a high pretest probability for a respiratory infection. The assay does not test for all potentially infectious agents of respiratory disease. Specimens collected too early or too late in the clinical course may not yield the organism causing disease. Negative results should be considered in the context of a patient's clinical course and treatment history, if applicable.
For patients who are immunocompromised and have a negative FilmArray respiratory panel test from a nasopharyngeal sample but a high suspicion for infection, there may be additional value in testing a bronchoalveolar lavage specimen (RPB / Respiratory Panel, PCR, Varies).
Positive results do not distinguish between a viable or replicating organism and the presence of a nonviable organism or nucleic acid, nor do they exclude the potential for coinfection by organisms not included in the panel. Nucleic acid may persist in some patients for days to weeks, even following appropriate therapy. Detection of 1 or more organisms included in this test suggests that the virus or bacteria is present in the clinical sample; however, the test does not distinguish between organisms that are causing disease and those that are present but not associated with a clinical illness. Coinfections (eg, detection of multiple viruses or bacteria or viruses and bacteria) may be observed with this test. In these situations, the clinical history and presentation should be reviewed thoroughly to determine the clinical significance of multiple pathogens in the same specimen.
Method Description
The FilmArray Respiratory Panel is a closed system that performs all the chemistry required to isolate, amplify, and detect nucleic acid from multiple viral and bacterial respiratory pathogens within a single nasopharyngeal swab specimen. The panel contains reagents in freeze-dried form and is divided into discrete segments where the required chemical processes are carried out. Patient sample and hydration fluid are drawn by vacuum into the panel and then placed into the FilmArray instrument. The detection process operations are automated (nucleic acid purification, first stage polymerase chain reaction [PCR], second stage PCR, and melt analysis) and complete in about 45 minutes in this closed system.
Nucleic Acid Purification:
The sample is lysed by a combination of chemical and mechanical mechanisms and the liberated nucleic acid is captured, washed, and eluted using magnetic bead technology.
First-Stage PCR:
A reverse transcription step is performed to convert viral RNA into complementary DNA prior to amplification. The purified nucleic acid solution is combined with a preheated master mix to initiate the reverse transcription step and subsequent thermocycling for multiplex PCR.
Second-Stage PCR:
Products of first-stage PCR are diluted and mixed with fresh PCR reagents, which is distributed over the second stage PCR array. The individual wells of the array contain primers for different assays (in triplicate) that target specific nucleic acid sequences from each of the pathogens detected, as well as control template material.
DNA Melting Analysis:
Temperature is slowly increased and fluorescence in each well of the array is monitored and analyzed to generate a melt curve.
Analysis of Melt Curves:
The software evaluates the DNA melt curve for each well to determine if a PCR product was present in that well. If the melt profile indicates the presence of a PCR product, then the analysis software calculates the melting temperature of the curve, which is then compared against the expected range for the assay. When the software determines that the melt curve falls inside the assay-specific melt temp range, it is called positive. When it determines that the melt curve is not in the appropriate range, it is called negative.
Analysis of Replicates:
Melt curves of each of the 3 replicates for each assay are evaluated to determine the assay result. For an assay to be called positive, at least 2 of the 3 associated melt curves must be called positive, and the melting temperature (Tm) for at least 2 of the 3 positive melt curves must be similar (within 1 degree C). Assays that do not meet these criteria are called negative.(Instruction manual: FilmArray Respiratory Panel 2.1 (RP2.1). BioFire Diagnostics, LLC; VFR0000-8303 05/2020)
Performing Laboratory
Mayo Clinic Laboratories in RochesterTest Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
0202U
LOINC Code Information
Test ID | Test Order Name | Order LOINC Value |
---|---|---|
RP | Respiratory Panel, PCR, NP | 82159-5 |
Result ID | Test Result Name | Result LOINC Value |
---|---|---|
SS021 | Specimen Source | 31208-2 |
609644 | Adenovirus | 82160-3 |
609645 | Coronavirus 229E | 82163-7 |
609646 | Coronavirus HKU1 | 82161-1 |
609647 | Coronavirus NL63 | 82162-9 |
609648 | Coronavirus OC43 | 82164-5 |
609649 | SARS Coronavirus-2 | 94565-9 |
609651 | Human Metapneumovirus | 82165-2 |
609650 | Human Rhinovirus/ Enterovirus | 82175-1 |
609652 | Influenza A | 82166-0 |
609653 | Influenza B | 82170-2 |
609654 | Parainfluenza Virus 1 | 82171-0 |
609655 | Parainfluenza Virus 2 | 82172-8 |
609656 | Parainfluenza Virus 3 | 82173-6 |
609657 | Parainfluenza Virus 4 | 82174-4 |
609658 | Respiratory Syncytial Virus | 82176-9 |
609659 | Bordetella parapertussis | 87621-9 |
609660 | Bordetella pertussis | 82179-3 |
609661 | Chlamydia pneumoniae | 82178-5 |
609662 | Mycoplasma pneumoniae | 82177-7 |
609663 | Interpretation | 59464-8 |
Testing Algorithm
If positive for Mycoplasma pneumoniae, M pneumoniae macrolide resistance will be performed at an additional charge.
For more information see Coronavirus Disease 2019 (COVID-19), Influenza, and Respiratory Syncytial Virus Testing Algorithm.
Special Instructions
Day(s) Performed
Monday through SundayForms
If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.
Reflex Tests
Test ID | Reporting Name | Available Separately | Always Performed |
---|---|---|---|
RPMPM | M. pneumoniae Macrolide Resist PCR | Yes | No |