Legionella DNA, Qualitative, Real-Time PCR

Test Code
15062


CPT Codes
87541, 87798

Includes
Legionella species and Legionella pneumophila


Preferred Specimen
1 mL bronchoalveolar lavage (BAL) or bronchial wash collected in a sterile plastic leak-proof container or
1 mL sputum collected in a sputum collection kit or a sterile plastic leak-proof container


Minimum Volume
0.3 mL


Other Acceptable Specimens
Throat or nasopharyngeal swab collected in 3 mL M4 media or VCM medium (green-cap) or equivalent (UTM) tube


Instructions
Throat, nasopharyngeal (NP) swabs: Use sterile vials containing 3 mL of sterile VCM, M4, or equivalent (UTM) media. If using swabs, use only sterile dacron or rayon swabs. Do not use calcium alginate swabs, as they may contain substances that inhibit PCR testing. Break applicator sticks off near the tip to permit tightening of the cap.


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Room temperature: 48 hours
Refrigerated: 14 days
Frozen: 30 days


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Calcium alginate swabs



Methodology
Real-Time Polymerase Chain Reaction

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Mon-Sat; Report available: 2-3 days


Reference Range
Legionella species Not detected
Legionella pneumophila Not detected


Clinical Significance
This test is intended for the qualitative detection of DNA from Legionella pneumophila and other pathogenic Legionella species in patients at risk for legionellosis.

Most species of the bacteria Legionella are pathogenic and can cause respiratory infections that present as either Legionnaires? disease or Pontiac fever, which are collectively referred to as legionellosis. Transmission most commonly occurs via inhalation of aerosolized water containing the bacteria. Risk factors include age ≥50, smoking, chronic lung disease, immune system disorders due to illness or medication, a recent stay outside the home, systemic malignancy, underlying illnesses such as diabetes or renal failure, and exposure to hot tubs (1).

A detected Legionella pneumophila result is consistent with the presence of DNA from any serotype of L. pneumophila, while the presence of DNA above the limit of detection from most species of clinically relevant Legionella species, including but not limited to L. pneumophila, L. longbeachae, L. micdadei, L. dumoffii, L. feeleii and L. bozemanii, will cause a detected Legionella species result.

This test is faster and generally more sensitive than culture-based tests, and it allows for the detection of a wider range of targets as compared to urine antigen tests, which typically only detect specific serotypes of L. pneumophila. It does not, however, detect all species of Legionella and may not detect L. jordanis and L. oakridgensis.


Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.