Mycoplasma pneumoniae DNA, Qualitative Real-Time PCR [15498X]

Test Code
15498

CPT Codes
87581

Preferred Specimen
1 mL BAL/wash o sputum submitted in a sterile, plastic, leak-proof container

Minimum Volume
BAL/Wash, sputum, nasopharyngeal swab, throat swab : 0.3 mL
Pericardial fluid, CSF, or pleural fluid: 0.35 mL

Other Acceptable Specimens
3 mL nasopharyngeal or throat swab in M4 or VCM Transport Medium (green-cap) or equivalent (UTM) 1 mL pericardial or pleural fluid, submitted in a sterile, plastic, leak-proof container • Minimum: >3mm3 fresh tissue, submitted in a sterile, plastic, leak-proof container • 1 mL CSF, submitted in a sterile, plastic, leak-proof container

Instructions
Please note: Nasopharyngeal lavage/wash and tracheal lavage/wash specimens are no longer acceptable sample types.

Respiratory Samples in M4 or VCM Transport Medium: Use sterile vials containing 3 mL of sterile M4 or VCM Transport Medium. 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.

Sputum: Collect in a sputum collection kit or a sterile, plastic, container with a leak-proof cap.

Bronchial Lavage: Collect in a sterile, plastic, container with a leakproof cap.

Transport Temperature
Refrigerated (cold packs)

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

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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Mon-Sat a.m.; Report available: 1-2 days

Reference Range
Not detected

Clinical Significance
Mycoplasma pneumoniae DNA, PCR, is a highly sensitive method to detect the presence of Mycoplasma pneumoniae DNA in clinical specimens.
The diagnosis of Mycoplasma pneumoniae infection should not rely soley upon the result of a PCR assay. A positive result should be determined in conjunction with clinical presentation and additional established clinical tests. Moreover, this assay cannot differentiate between viable and nonviable organisms. A negative PCR result indicates the absence of Mycoplasma pneumoniae DNA at detectable levels in the sample tested and does not exclude the diagnosis of disease.

Performing Laboratory
Quest Diagnostics Infectious Disease, Inc 33608 Ortega Highway Building B San Juan Capistrano, CA 92675



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.