Mycoplasma pneumoniae DNA, Qualitative Real-Time PCR
Test Summary
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.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
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
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.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Refrigerated. Tissue should be sent frozen.
Specimen Stability
- Room temperature: 48 hours
- Refrigerated: 7 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
1 mL CSF collected in a sterile leak-proof container
Unacceptable Specimens
Calcium alginate swabs
Order Code
MYCPLS
EPIC (Premier) Code
LAB5202
Includes
N/A
CPT Code
- 87581
Billing Code
- 670982
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
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Testing
Reference Range
Not detected
Setup Schedule / Expected Turnaround Time
Monday - Saturday; Report available: 1 - 2 days
Specimen Collection
Special Instructions
N/A
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
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.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Refrigerated. Tissue should be sent frozen.
Specimen Stability
- Room temperature: 48 hours
- Refrigerated: 7 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
1 mL CSF collected in a sterile leak-proof container
Unacceptable Specimens
Calcium alginate swabs
Result Information
Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)
Testing Laboratory
N/A
Reference Range
Not detected
Setup Schedule / Expected Turnaround Time
Monday - Saturday; Report available: 1 - 2 days