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Legionella pneumophila Real-time PCR

Test Code: 5100
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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.

Same day (within 12-18 hours from receipt of specimen), Monday through Saturday.

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
BAL 5109 87451 Yes 2 mL (min. 0.5 mL) Detected/Not Detected
  • Collect 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.
bronch wash 5126 87451 Yes 2 mL (min. 0.5 mL) Detected/Not Detected
  • Collect 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.
nasal asp 5131 87451 Yes 2 mL (min. 0.5 mL) Detected/Not Detected
  • Collect 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.
nasal swab 5130 87451 Yes 2 mL Detected/Not Detected
  • Place 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.
nasal wash 5113 87451 Yes 2 mL (min. 0.5 mL) Detected/Not Detected
  • Collect 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.
NP aspirate 5124 87451 Yes 2 mL (min. 0.5 mL) Detected/Not Detected
  • Collect 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.
NP swab 5125 87451 Yes 2 mL Detected/Not Detected
  • Place 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.
NP wash 5147 87451 Yes 2 mL (min. 0.5 mL) Detected/Not Detected
  • Collect 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.
throat gargle 5123 87451 Yes 2 mL (min. 0.5 mL) Detected/Not Detected
  • Collect 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.
trach asp 5119 87451 Yes 2 mL (min. 0.5 mL) Detected/Not Detected
  • Collect 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.
trach wash 5148 87451 Yes 2 mL (min. 0.5 mL) Detected/Not Detected
  • Collect 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.
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 Eurofins test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 1001 NW Technology Dr, Lee's Summit, MO 64086

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.

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 Eurofins' 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 Eurofins 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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