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HelpTest Code LAB4903 Mycoplasma pneumoniae Detection by PCR
Additional Codes
LAB261
Performing Laboratory
Barnes-Jewish Hospital Molecular Infectious Disease Laboratory (BJH MID)
Methodology
Polymerase Chain Reaction (PCR).
Specimen Requirements
Acceptable Specimens
Nasopharyngeal (NP): 1 swab in universal transport medium (UTM)
Respiratory (bronchial alveolar lavage, bronchial washing, tracheal aspirate): ≥1 mL in a leakproof screw-capped, sterile container
Collection Procedure
Nasopharyngeal
1. Obtain a vial of universal transport medium (UTM) with collection swab.
2. Collect specimen using plastic shaft swab(s) provided.
3. Place swab(s) in vial, break or cut off shaft of swab(s), discard shaft, and tightly cap vial.
4. Maintain sterility and forward promptly.
5. If transport is delayed, refrigerate specimen.
Respiratory (Bronchial Alveolar Lavage, Bronchial Washing, Tracheal Aspirate)
1. Aseptically collect ≥1 mL of specimen.
2. Place in a leakproof screw-capped, sterile container.
3. Maintain sterility and forward promptly.
4. If transport is delayed, refrigerate specimen.
Note: Specimen source is required.
Day(s) Test Set Up
Monday through Sunday
Turnaround Time:
STAT: not available
Routine: 1- 3 days, Final report available the day of testing
Reference Values
Negative/Not Detected
Test Classification and CPT Coding
Test classification:
This assay utilizes ASR-s (analyte specific reagents) and is not FDA cleared. This test was developed and its performance has been evaluated by the Barnes Jewish Molecular Infectious Disease Laboratory for performance on NP swabs and lower respiratory specimens.
Assay Limit of Detection:
NP swabs: 1,000 genome copies/mL
Lower Respiratory Specimens: 1,000 genome copies/mL
Limitations:
-The detection of bacterial nucleic acid is dependent upon proper sample collection, transport, handling and storage. Failure to observe proper procedures in any one of these steps can lead to incorrect results.
-False-negative results may occur if the bacteria are present at a level that is below the analytical sensitivity of the assay or if the bacteria has genomic mutations, insertions, deletions, or rearrangements or if performed very early in the course of illness.
CPT Code:
87581
Additional Information
For BJH Laboratory Use Only
Minimum Volume:
Nasopharyngeal (NP): 1 swab in universal transport medium
Respiratory (bronchial alveolar lavage, bronchial washing, tracheal aspirate): 1 mL in a leakproof screw-capped, sterile container
Laboratory Processing Instructions
Testing performed in the BJH MID laboratory.
Specimen Transport Temperature
Nasopharyngeal Swab, Respiratory-Ambient/Refrigerate OK
Refrigerated specimens must be tested within 7 days
Frozen specimens must be tested within 30 days