Assay Sheet

  

Test ID

5000 Atypical Pneumonia Panel (includes Chlamydophila pneumoniae and Mycoplasma pneumoniae)

CPT Code

87486, 87581

Clinical Utility

Chlamydophila pneumoniae is a common cause of pneumonia throughout the world and causes 7% to 10% of community-acquired pneumonia among adults. Symptoms of infection with C. pneumoniae are indistinguishable from other causes of pneumonia. A physical examination or chest x-ray does not typically provide information which allows for a definite diagnosis.  Culture of the organism is technically demanding and time-consuming.  Alternatively, molecular assays such as PCR allow for rapid testing of respiratory secretions for the presence C. pneumoniae DNA, thereby allowing a diagnosis to be established and therapy instituted quickly.

Mycoplasma pneumoniae is the pathogen most often associated with atypical pneumonia. Often indistinguishable from other viral and atypical bacterial pathogens, M. pneumoniae causes a wide range of respiratory infections, including pneumonia, tracheobronchitis, and upper respiratory tract infection.  Specialized laboratory tests are necessary to establish a definitive diagnosis due to the nonspecificity of atypical pneumonia clinical presentation.  Traditionally, culture and serological tests have been utilized.  However, culture is relatively insensitive for acute diagnosis and requires a long incubation period.  PCR technology to assess for M. pneumoniae nucleic acid has proven to be a sensitive and specific diagnostic tool.  Respiratory specimens are tested for the presence M. pneumoniae DNA, facilitating a rapid diagnosis which allows appropriate antimicrobial therapy to be instituted quickly.

Procedure

Extraction of C. pneumoniae DNA and M. pneumoniae DNA from respiratory specimens followed by amplification and detection of C. pneumoniae DNA and M. pneumoniae DNA using real-time, qualitative PCR. An internal control is added to ensure the extraction was performed correctly and the PCR reaction was not inhibited.

Specimens

Bronchial Lavage/Bronchial Wash: 1 to 3 ml, collected in sterile, screw-cap tube; ship ambient.

Sputum: 1 to 2 ml submitted in a sterile, screw-top tube; ship ambient.

Throat Gargle:  Instruct patient to gargle with 2 to 3ml sterile saline.  Expectorate into sterile cup, then transfer contents to sterile, screw-cap tube for shipment; ship ambient.

Upper respiratory aspirate (NP aspirate, nasal aspirate, tracheal aspirate, etc.): Instill 1 to 2 ml sterile saline into desired location and gently aspirate contents. Place collected fluid into sterile, screw-cap tube; ship ambient. 

Upper respiratory swab (NP swab, throat swab): Swab desired location with sterile, flexible shaft swab, preferably a flocked swab. Place swab into 1 to 2 ml sterile saline, M4, or viral transport media in sterile, screw-cap tube. Do not use calcium alginate swab or wood shafted swab; ship ambient.

All suction-type collection devices are inappropriate for specimen transport. Transfer specimen into sterile, leak proof tube for transport.

Other specimens may be accepted for testing; however the following comment will appear in the final report: "The clinical utility of this result has not yet been demonstrated in the peer reviewed literature and is therefore unknown." Call ViraCor for further information.

Causes for rejection

Wood shafted swab, calcium alginate swab. Call ViraCor at 800-305-5198 if specimen is greater than 96 hrs old.

Specificity

The Chlamydophila pneumoniae PCR assay was tested for cross reactivity against Bordetella pertussis, Bordetella parapertussis, Bordetella bronchiseptica, all relevant non-C. pneumoniae species of Chlamydophila, all relevant strains of Mycoplasma pneumoniae, and all relevant species of Legionella as well as human herpes viruses, polyoma viruses, hepatitis viruses, adenoviruses, parvovirus B19, Pneumocystis jirovecii and Toxoplasma gondii with no cross reactivity noted.

The Mycoplasma pneumoniae PCR assay was tested for cross reactivity against Bordetella pertussis, Bordetella parapertussis, Bordetella bronchiseptica, all relevant species of Chlamydophila, all relevant species of Legionella as well as human herpes viruses, polyoma viruses, hepatitis viruses, adenoviruses, parvovirus B19, Pneumocystis jirovecii and Toxoplasma gondii with no cross reactivity noted.

Assay Range

Qualitative results (Positive/Not Detected)

Turnaround Time

Same day (within 12 to 18 hours of receiving specimen), Monday through Saturday

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to:

ViraCor Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086

The CPT codes provided are based on ViraCor's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. ViraCor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material. PCR tests are performed pursuant to a license agreement with Roche Molecular Systems, Inc. This assay was developed and the performance characteristics were determined at ViraCor Laboratories. This test is performed in a CLIA certified laboratory. FDA approval is not required for the performance of this test.

1009 V1

Pathogen Overview

 

About Chlamydophila pneumoniae

Chlamydophila pneumoniae is a small bacterium (0.2 to 1 micrometer) that undergoes several transformations during its life cycle.  In between hosts, the organism exists as an elementary body.  The elementary body is not biologically active, but it is resistant to environmental stresses and can survive outside of a host for a limited time.  The elementary body travels in small droplets from an infected person to the lungs of a non-infected person and is responsible for infection.  Once in the lungs, the elementary body is taken up into cells by phagocytosis.  However, the elementary body is not destroyed by fusion with lysosomes as is typical for phagocytosed material. Instead, it transforms into a reticulate body and begins to replicate within the endosome.  The reticulate bodies must utilize some of the host's cellular mechanisms to complete their replication.  The reticulate bodies then convert back to elementary bodies and are released back into the lung, often after causing the death of the host cell.  The elementary bodies are thereafter able to infect new cells, either in the same organism or in a new host.  Thus, the life cycle of C. pneumoniae is divided between the elementary body, which is able to infect new hosts but cannot replicate and the reticulate body, which replicates but is unable to cause new infection.

Clinical Manifestations

C. pneumoniae is a common cause of pneumonia throughout the world and is believed to cause 7% to 10% of community-acquired pneumonia among adults. C. pneumoniae is typically acquired by otherwise healthy people and is one form of community-acquired pneumonia.  Because treatment and diagnosis are different from historically recognized causes, such as Streptococcus pneumoniae, pneumonia caused by C. pneumoniae is categorized as an "atypical pneumonia."  Symptoms of infection with C. pneumoniae are indistinguishable from other causes of pneumonia.  Clinical manifestations include cough, fever, and difficulties in breathing. A slightly red, hard palate and a whitening of the back of the tongue are very common.  Patients infected with C. pneumoniae often have nasal congestion, chest pressure, and depression.  C. pneumoniae more often causes pharyngitis, laryngitis, and sinusitis than other causes of pneumonia; however, because many other causes of pneumonia results in these symptoms, differentiation is impossible. Likewise, a physical examination by a health provider does not typically provide information which allows for a definite diagnosis.

Diagnosis

Diagnosis of C. pneumoniae may be confounded by prior infections with this microorganism.  Chest x-rays of lungs infected with C. pneumoniae often show a small patch of increased shadow (opacity). However, many different patterns are common, and there is no appearance that allows for a specific diagnosis.  Examination of sputum or the secretions of the respiratory tract may reveal signs of the bacteria. Otherwise, examination of the blood may reveal antibodies against the bacteria. Interpretation may require a period of six weeks in order to reanalyze the antibodies and to determine whether the infection was new or old. Culture of the organism is technically demanding and time consuming.  Alternatively, molecular assays such as PCR allows for rapid testing of lower respiratory secretions for the presence C. pneumonia DNA, thereby allowing a diagnosis to be established quickly.

Treatment and Prognosis

Typically, treatment for pneumonia is initiated before the causative microorganism is identified. This empiric therapy includes an antibiotic active against the atypical bacteria, including C. pneumoniae. The most common type of antibiotic used is a macrolide, such as azithromycin or clarithromycin. If testing reveals that C. pneumoniae is the causative agent, therapy may be switched to doxycycline, which is slightly more effective against the bacteria. In some cases, a quinolone antibiotic, such as levofloxacin, may be started empirically. This antibiotic group is not as effective against C. pneumoniae. Treatment is typically continued for 10 to 14 days for known infections.  If the patient history involves symptoms for a prolonged period of time (> 6 months), the course of treatment should be a minimum of three weeks.

Selected References

Benson R, Tondella ML, Bhatnagar J, Carvalho M, Sampson JS, Talkington DF, Whitney AM, Mothershed E, McGee L, Carlone G, McClee V, Guarner J, Zaki S, Dejsiri S, Cronin K, Han J, Fields BS. Development and evaluation of a novel multiplex PCR technology for molecular differential detection of bacterial respiratory disease pathogens. J Clin Microbiol. 2008;46(6):2074-2077.

Cunha BA. The atypical pneumonias: clinical diagnosis and importance. Clin Microbiol Infect. 2006;12 (Suppl 3):12-24. 

Dowell SF, Peeling RW, Boman J, Carlone GM, Fields BS, Guarner J, et al. Standardizing Chlamydia pneumoniae assays: recommendations from the Centers for Disease Control and Prevention (USA) and the Laboratory Centre for Disease Control (Canada). Clin Infect Dis. 2001;33(4):492-503. 

Ewig S, Torres A. Is Chlamydia pneumoniae an important pathogen in patients with community-acquired pneumonia?. Eur Respir J.  2003;21(5):741-742. 

Ginevra C, Barranger C, Ros A, Mory O, Stephan JL, Freymunth F, Joannès M, Pozzetto B, Grattard F. Development and evaluation of Chlamylege, a new commercial test allowing simultaneous detection and identification of Legionella, Chlamydophila pneumoniae, and Mycoplasma pneumoniae in clinical respiratory specimens by multiplex PCR. J Clin Microbiol. 2005;43(7):3247-3254.

Kauppinen M, Saikku P. Pneumonia due to Chlamydia pneumoniae: prevalence, clinical features, diagnosis, and treatment. Clin Infect Dis. 1995;21 (Suppl 3):S244-S252. 

Kumar S, Hammerschlag MR. Acute respiratory infection due to Chlamydia pneumoniae: current status of diagnostic methods. Clin Infect Dis. 2007;44(4):568-576. 

Loens K, Beck T, Ursi D, Overdijk M, Sillekens P, Goosens H, Ieven M. Development of Real-Time multiplex nucleic acid sequence-based amplification for detection of Mycoplasma pneumoniae, Chlamydophila pneumoniae, and Legionella spp. in respiratory specimens. J Clin Microbiol. 2008;46(1):185-191.

Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007;44:Suppl 2:S27-S72. 

Nolte FS. Molecular diagnostics for detection of bacterial and viral pathogens in community-acquired pneumonia. Clin Infect Dis. 2008;47:S123-S126.

Schneeberger PM, Dorigo-Zetsma JW, van der Zee A, van Bon M, van Opstal JL. Diagnosis of atypical pathogens in patients hospitalized with community-acquired respiratory infection. Scand J Infect Dis. 2004;36(4):269-273. 

Thibodeau KP, Viera AJ. Atypical pathogens and challenges in community-acquired pneumonia. American Family Physician. 2004;69(7):1699-1706.

Tondella MLC, Talkintong DF, Holloway BP, Dowell SF, Cowley K, Soriano-Gabarro M, Elkind MS, Fields BS. Development and evaluation of real-time PCR-based fluorescence assays for detection of Chlamydia pneumoniae. J Clin Microbiol. 2002;40(2):575-583.