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Assay Sheet

Test ID

5000 Atypical Pneumonia Panel Qualitative PCR(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.

Specimen type & specimen handling 

Bronchial Lavage/Bronchial Wash: 2 mls collected in a sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.

Sputum: 2 mls collected in a sterile container, then transferred to sterile, screw top tube for shipment. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.

Throat Gargle:  2 mls collected in a sterile container then transferred to sterile, screw top tube for shipment. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.

Upper respiratory aspirate (NP aspirate, nasal aspirate/wash, tracheal aspirate, etc.): 2 mls collected in a sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.

Upper respiratory swab (NP swab, throat swab): 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.  Ship at ambient temperature Monday thru Friday.  Specimen must be received within 96 hrs of collection.

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

Wood shafted swab, calcium alginate swab.

Call ViraCor at 800-305-5198 if specimen is greater than 96 hrs old.

Specimen types other than those listed above that were sent without prior authorization.

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.

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