Mycoplasma pneumoniae DNA, Qualitative, Real-Time PCR

Test Code
15498


CPT Codes
87581

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


Minimum Volume
0.35 mL sputum or bronchial lavage/wash


Other Acceptable Specimens
Cerebrospinal fluid


Instructions
Nasopharyngeal and throat swab in M4, V-C-M (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 Container
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
Mon-sat


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 solely 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 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.