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.
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