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| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
Mycoplasma pneumoniae DNA, Qualitative Real-Time PCR
Test Code15498
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)
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.
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
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 |
