Test Information

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Atypical Pneumonia Real-time PCR Panel

Test Code: 5000

Cpt Code:

87486 (x1) 87581 (x1)

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 specimen 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. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

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 (Detected/Not Detected)

Causes For Rejection

Wood shafted swab, calcium alginate swab, specimens received in trap containers, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

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. A Viracor-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086

Specimen Information

5009 BAL

NY approved. 2 mL collected in a sterile, screw top tube. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

5026 bronch wash

NY approved. 2 mL collected in a sterile, screw top tube. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

5031 nasal asp

NY approved. 2 mL collected in a sterile, screw top tube. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

5030 nasal swab

NY approved. Sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube. Do not use calcium alginate swab or wood shafted swab. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

5013 nasal wash

NY approved. 2 mL collected in a sterile, screw top tube. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

5024 NP aspirate

NY approved. 2 mL collected in a sterile, screw top tube. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

5025 NP swab

NY approved. Sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube. Do not use calcium alginate swab or wood shafted swab. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

5047 NP wash

NY approved. 2 mL collected in a sterile, screw top tube. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

5023 throat gargle

NY approved. 2 mL collected in a sterile, screw top tube. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

5019 trach asp

NY approved. 2 mL collected in a sterile, screw top tube. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

5048 trach wash

NY approved. 2 mL collected in a sterile, screw top tube. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Viracor-IBT'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-IBT 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.

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