TEST CATALOG ORDERING & RESULTS SPECIMEN HANDLING CUSTOMER SERVICE EDUCATION & INSIGHTS
Test Catalog

Test ID: RESPM    
Respiratory Pathogen Panel, PCR, Nasopharyngeal

Useful For Suggests clinical disorders or settings where the test may be helpful

Rapid detection of respiratory infections caused by the following:

-Adenovirus

-Coronavirus (serotypes HKU1, NL63, 229E, OC43)

-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

-Chlamydophila pneumoniae

-Mycoplasmoides pneumoniae

 

This test is not recommended as a test of cure.

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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 may 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 (type A and type 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 that 1) necessary infection control precautions can be taken if the patient is hospitalized, and 2) 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, 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 hosts may suffer more severe illnesses, including lower respiratory tract disease.

 

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. Similarly 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, Chlamydophila pneumoniae, and Mycoplasmoides pneumoniae (previously Mycoplasma pneumoniae). Bordetella pertussis is the causative agent of pertussis, or whooping cough, a disease characterized by prolonged cough that may be associated with an inspiratory whoop and post-tussive vomiting. Bordetella parapertussis causes a similar, but generally less severe illness. Mycoplasmoides pneumoniae is a cause of upper respiratory infection, pharyngitis, tracheobronchitis, and pneumonia. Chlamydophila pneumoniae is a rare cause of pneumonia.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative (for all targets)

Interpretation Provides information to assist in interpretation of the test results

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 potential 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 immunocompromised patients who 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 (RESLR / Respiratory Pathogen 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.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The detection of microbial DNA or RNA is dependent upon proper sample collection, handling, transportation, storage, and preparation. There is a risk of false-negative results due to the presence of strains with sequence variability or genetic rearrangements in the target regions of the assays.

 

Repeat testing should not be performed on samples collected less than 7 days apart.

 

Adenovirus:

Assay may show variable detection with no-respiratory serotypes within species A, D, F, and G.

 

Influenza A:

Performance characteristics were established when influenza A H1-2009, A H1, and A H3 were the predominant influenza A viruses in circulation. Performance of detecting influenza A may vary if other influenza A strains are circulating or a novel influenza A virus emerges. The performance of the FilmArray respiratory panel has not been established in individuals who received influenza vaccine. Recent administration of a nasal influenza vaccine may cause false-positive results for influenza A or influenza B. Some strains of human, swine, or avian origin are predicted to react with influenza A assays leading to an Influenza A (no subtype detected) result.

 

Assay detects and differentiates commonly occurring influenza A hemagglutinin subtypes based on only the hemagglutinin gene, through the use of 2 influenza A assays and 3 subtyping assays for the hemagglutinin gene. Results are reported as "detected" when at least 1 of the influenza A assays and 1 of the subtyping assays are both positive. If both of the influenza A assays are positive without a hemagglutinin subtype, results are reported as influenza A (no subtype detected). Equivocal results are reported following repeat testing in 2 scenarios: 1) Neither of the influenza A assays are positive, but a hemagglutinin gene is positive, 2) One of the influenza A assays is positive, and hemagglutinin genes are negative. The assay does not detect or differentiate the influenza A neuraminidase gene.

 

Rhinovirus/Enterovirus group:

Due to the genetic similarity of these viruses, the assay is unable to reliably differentiate them.

 

Bordetella pertussis:

Some acellular vaccines contain polymerase chain reaction (PCR)-detectable DNA. Contamination of specimens with vaccine can cause false-positive Bordetella pertussis PCR results. Specimens should not be collected or processed in areas that are exposed to B pertussis vaccine material. Assay targets the single-copy promoter region of the pertussis toxin gene. Results of this assay may not be concordant with commonly used Bordetella PCR assays, which target the multicopy insertions sequences (IS481). Cross reactivity could occur with high levels or rare sequence variants of other species such as Bordetella bronchiseptica and Bordetella parapertussis.

 

Coronavirus:

Coronavirus OC43 assay may cross-react with coronavirus HKU1. As a result, when both HKU1 and OC43 are detected in the same patient specimen, the result may be due to assay cross-reactivity. A coinfection with these 2 viruses is also possible.

Supportive Data

This test is FDA-approved on nasopharyngeal (NP) swabs; the manufacturer has evaluated the clinical performance data of this sample type. The Clinical Bacteriology Laboratory at Mayo Clinic conducted a verification of the FilmArray Respiratory Panel 2 (RP2) assay using 4 pools of known target analytes from a commercially-available verification panel. The assay demonstrated an overall agreement of 100% with expected results. The Clinical Bacteriology Laboratory also tested 35 clinical NP samples side by side on the RP2 and compared the results to those of prior testing on the FilmArray Respiratory Panel (RP). The percent positive agreement was above 95% for all targets tested, with the exception of Human Rhinovirus/ Enterovirus for which it was 75%, as a result of one missed detection compared to the four detected with RP assay. Some targets were not represented in the clinical NP sample set, including Coronavirus 229E, Coronavirus NL63, Human Metapneumovirus, Influenza B, and Parainfluenza virus 1-4.

Clinical Reference Recommendations for in-depth reading of a clinical nature

1. Lee N, Lui GC, Wong KT, et al: High morbidity and mortality in adults hospitalized for respiratory syncytial virus infections. Clin Infect Dis. 2013:57(8):1069-1077

2. Miliander C, Espy M, Binnicker MJ: Evaluation of the BioFire FilmArray for the detection of respiratory viruses in clinical samples. Clinical Virology Symposium Annual Meeting, Daytona, Florida, April 2013

3. Ramanan P, Bryson AL, Binnicker MJ, Pritt BS, Patel R: Syndromic panel-based testing in clinical microbiology. Clin Microbiol Rev. 2017 Nov 15;31(1):e00024-17. doi: 10.1128/CMR.00024-17