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

Test Code
15498

CPT Codes
87581

Preferred Specimen
1 mL sputum, or bronchial lavage/wash collected in a sterile, leak-proof plastic container, or
3 mL throat or nasopharyngeal swab collected in a M4 media or VCM medium (green-cap) tube or equivalent (UTM)

Minimum Volume
0.35 mL sputum • 0.35 mL bronchial lavage/wash • 0.35 mL throat/nasopharyngeal swab • 0.35 mL CSF

Other Acceptable Specimens
1 mL CSF collected in a sterile leak-proof container

Instructions
Nasopharyngeal and Throat swab in M4, VCM (UTM) Media (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, leak-proof plastic container.
Bronchial Lavage: Collect in a sterile, leak-proof plastic container.



Transport Temperature
Refrigerated (cold packs)

Specimen Stability
Room temperature: 48 hours
Refrigerated: 7 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 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.