Test Information

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Legionella pneumophila Real-time PCR

Test Code: 5100

Cpt Code:

87541 (x1)

Clinical Utility

Legionella pneumophila is increasingly recognized as an important pathogen causing both community acquired pneumonia and nosocomial pneumonia. The mortality rate can be lowered if the disease is diagnosed rapidly and appropriate antimicrobial therapy is instituted.

Laboratory diagnosis is important since pneumonia caused by L. pneumophila is clinically indistinguishable from other pneumonias. A molecular method such as PCR is a useful diagnostic tool since it is more rapid than culture and does not depend on growth of a fastidious organism. PCR is utilized for detection of L. pneumophila in respiratory specimens, providing early, definitive diagnosis of infection. Moreover, the advantage of PCR includes its ability to detect all L. pneumophila serogroups which cause 80-90% of all Legionella infections.

Procedure

Extraction of L. pneumophila DNA from respiratory specimens followed by amplification and detection of known L. pneumophila strains 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 Legionella pneumophila PCR assay was tested for cross reactivity against Bordetella pertussis, Bordetella parapertussis, Bordetella bronchiseptica, all relevant species of Chlamydophila, all relevant strains of Mycoplasma pneumoniae, Legionella anisa, Legionella dumoffii, Leginella feeleii, Legionella longbeachae, Legionella maceachernii, Legionella micdadei, 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

5109 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.

5126 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.

5131 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.

5130 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.

5113 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.

5124 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.

5125 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.

5147 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.

5123 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.

5119 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.

5148 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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