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Mycoplasma pneumoniae DNA, Qualitative Real-Time PCR [15498X]
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Test Code
MYCPLS
Alias/See Also
15498
CPT Codes
87581
Preferred Specimen
1 ML BRONCHIAL LAVAGE/WASH OR SPUTUM
OTHER ACCEPTABLE SPECIMENS:
THROAT SWAB OR NASOPHARYNGEAL SWAB IN 3 ML M4 MEDIA OR
VCM MEDIUM (GREEN-CAP) TUBE OR EQUIVALENT (UTM)
1 ML PLEURAL FLUID, PERICARDIAL FLUID, CSF
>3 MM (3) TISSUE
OTHER ACCEPTABLE SPECIMENS:
THROAT SWAB OR NASOPHARYNGEAL SWAB IN 3 ML M4 MEDIA OR
VCM MEDIUM (GREEN-CAP) TUBE OR EQUIVALENT (UTM)
1 ML PLEURAL FLUID, PERICARDIAL FLUID, CSF
>3 MM (3) TISSUE
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
RESPIRATORY SAMPLES IN M4 MEDIA: USE STERILE VIALS
CONTAINING 3 ML OF STERILE M4 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.
SPUTUM: COLLECT IN A SPUTUM COLLECTION KIT OR A STERILE,
PLASTIC CONTAINER WITH A LEAK-PROOF CAP.
BRONCHIAL LAVAGE: COLLECT IN A STERILE CONTAINER WITH A
LEAK-PROOF CAP.
TISSUE: TISSUE SAMPLES MUST BE SUBMITTED FROZEN.
CONTAINING 3 ML OF STERILE M4 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.
SPUTUM: COLLECT IN A SPUTUM COLLECTION KIT OR A STERILE,
PLASTIC CONTAINER WITH A LEAK-PROOF CAP.
BRONCHIAL LAVAGE: COLLECT IN A STERILE CONTAINER WITH A
LEAK-PROOF CAP.
TISSUE: TISSUE SAMPLES MUST BE SUBMITTED FROZEN.
Transport Temperature
Refrigerated. Tissue should be sent frozen.
Specimen Stability
Room temperature: 48 hours
Refrigerated: 7 days
Frozen: 30 days
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; 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.
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 |
Last Updated: November 30, 2021