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Test Code LAB4903 Mycoplasma pneumoniae Detection by PCR

Performing Laboratory

Barnes-Jewish Hospital Molecular Infectious Disease Laboratory

Methodology

Polymerase Chain Reaction (PCR) performed on the DiaSorin Liaison MDX.                  

Specimen Requirements

Acceptable Specimens

Nasopharyngeal (NP): 1 swab in viral transport medium
Respiratory (bronchial alveolar lavage, bronchial washing, tracheal aspirate): ≥1 mL in a leakproof screw-capped, sterile container

 

Collection Procedure

Nasopharyngeal 
1. Call Barnes-Jewish Hospital Laboratory Customer Service at 314-362-1470 to obtain Viral Transport Medium Collection Kit.

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. 
Note: Specimen source is required.

 

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

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

Reference Values

Negative

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

Additional Information

 

For BJH Laboratory Use Only

Minimum Volume: 
Nasopharyngeal (NP): 1 swab in viral transport medium

Respiratory (bronchial alveolar lavage, bronchial washing, tracheal aspirate): 1 mL in a leakproof screw-capped, sterile container

 Laboratory Processing Instructions    

    BJH Microbiology will forward to the performing laboratory.