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Legionella DNA, Qualitative Real-Time PCR

Test Summary

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.

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

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

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.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

  • Room temperature: 48 hours
  • Refrigerated: 14 days
  • Frozen: 30 days

Limitations

N/A

Other Acceptable Specimens

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

Unacceptable Specimens

Calcium alginate swabs

Order Code

LEGNQL

EPIC (Premier) Code

LAB4485

Includes

Legionella species and Legionella pneumophila

CPT Code

  • 87541
  • 87798

Billing Code

  • 671068
  • 671069

CPT Statement

Methodology

Real-Time Polymerase Chain Reaction (RT-PCR)

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 the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Reference Range

Legionella species Not detected
Legionella pneumophila Not detected

Setup Schedule / Expected Turnaround Time

Monday - Saturday; Report available: 2 - 3 days

Specimen Collection

Special Instructions

N/A

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

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.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

  • Room temperature: 48 hours
  • Refrigerated: 14 days
  • Frozen: 30 days

Limitations

N/A

Other Acceptable Specimens

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

Unacceptable Specimens

Calcium alginate swabs

Billing

CPT Code

  • 87541
  • 87798

Billing Code

  • 671068
  • 671069

CPT Statement

Result Information

Methodology

Real-Time Polymerase Chain Reaction (RT-PCR)

Testing Laboratory

N/A

Reference Range

Legionella species Not detected
Legionella pneumophila Not detected

Setup Schedule / Expected Turnaround Time

Monday - Saturday; Report available: 2 - 3 days