Epic Test Code LAB243 Mycoplasma (Mycoplasmoides) pneumoniae with Macrolide Resistance Reflex, Molecular Detection, PCR, Varies
Additional Codes
MML:MPRP
Useful For
Diagnosing infections due to Mycoplasma (Mycoplasmoides) pneumoniae
Assessing macrolide susceptibility
Reporting Name
M pneumoniae PCR + Macrolide ReflexSpecimen Type
VariesNecessary Information
Specimen source is required.
Specimen Required
The high sensitivity of amplification by polymerase chain reaction requires the specimen to be processed in an environment in which contamination of the specimen by Mycoplasma (Mycoplasmoides) pneumoniae DNA is unlikely.
Submit only 1 of the following specimens:
Specimen Type: Swab
Supplies:
-Culturette (BBL Culture Swab) (T092)
-BD E-Swab (T853)
-Nasopharyngeal Swab (Nylon Mini-Tip Swab) (T861)
-Culture Swab-Liquid Stuarts/Single Swab (NP Swab) (T515)
-M4-RT (T605)
Sources: Throat, nasal, or nasopharyngeal
Container/Tube:
Preferred: Culture swab transport system (Dacron or rayon swab with aluminum or plastic shaft with either Stuart or Amies liquid medium)
Acceptable: Culture transport swab (Stuart's media) or place swab in M4, M4-RT, M5, M6, universal transport media, or ESwab
Specimen Volume: Swab
Collection Instructions:
1. Collect specimen by swabbing back and forth over mucosa surface to maximize recovery of cells.
2. Place swab back into swab cylinder.
Specimen Type: Fluid
Sources: Pleural, pericardial, cerebrospinal
Container/Tube: Sterile container
Specimen Volume: 0.5 mL
Specimen Type: Respiratory
Sources: Bronchial washing, bronchoalveolar lavage, tracheal secretions, sputum
Container/Tube: Sterile container
Specimen Volume: 1 mL
Specimen Minimum Volume
Respiratory specimen: 0.5 mL
Other specimen types: See Specimen Required
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Varies | Refrigerated (preferred) | 7 days | |
Frozen | 7 days |
Reject Due To
Cotton or calcium alginate-tipped swab, wooden shaft swab, transport swab containing gel or charcoal Port-a-Cul tube Anaerobic fluid vials Dry swab (no pledget or sponge) Respiratory fluid specimens placed in VTM or placed on a swab and then into VTM (M4-RT, M4, or M5) Body fluid specimens placed in VTM or placed on a swab and then in VTM (M4-RT, M4, or M5) |
Reject |
Clinical Information
Mycoplasma (Mycoplasmoides) pneumoniae is a small bacterium transmitted via organism-containing droplets. It is a cause of upper respiratory infection, pharyngitis, and tracheobronchitis, particularly in children, and has been associated with approximately 20% of cases of community acquired pneumonia.(1) Central nervous system and cardiac manifestations are some of the extrapulmonary complications of infections due to M pneumoniae. The disease is usually self-limited although severe disease may occur, including in patients who are immunocompromised.(2)
Identification of M pneumoniae by culture-based methods is time consuming and insensitive. Serologic assays have drawbacks; the development of IgM antibodies takes approximately 1 week, and the IgM response in adults may be variable or may be decreased in immunosuppressed individuals.(3,4) Confirmation of the disease may be dependent on the observation of a 4-fold rise in IgG antibody titers between acute and convalescent specimens, only after several weeks following the initial onset of illness, only providing clinical application for retrospective testing and not individual patient care.(4) Real-time polymerase chain reaction (PCR) testing offers a rapid and sensitive option for detection of M pneumoniae DNA from clinical specimens.(5)
Macrolide resistance in M pneumoniae is increasingly reported. In a study performed at Mayo Clinic, 10% of M pneumoniae detections were associated with macrolide resistance.(6) Real-time PCR testing can be used to assess for common mutations associated with macrolide resistance in M pneumoniae.
Reference Values
Negative
Interpretation
A positive result indicates the presence of Mycoplasma (Mycoplasmoides) pneumoniae. If detected, common mutations associated with macrolide resistance in M pneumoniae may be assessed.
A negative result does not rule out the presence of M pneumoniae and may be due to the presence of inhibitors within the specimen matrix or the presence of target DNA below the limit of detection of the assay.
Cautions
This assay should only be used for testing of respiratory tract specimens (throat swabs, nasopharyngeal swabs, tracheal secretions, sputum, and bronchoalveolar lavage fluid) and pleural/chest fluid, pericardial fluid, and cerebrospinal fluid.
Supportive Data
Accuracy:
The assay was validated in a blinded manner using 30 Mycoplasma (Mycoplasmoides) pneumoniae-positive specimens received from a reference lab and 6 negative specimens. The M pneumoniae polymerase chain reaction (PCR) test had 100% sensitivity and specificity when compared to the Focus Diagnostics M pneumoniae primer pair PCR assay. Whole organism spiking studies (near the limit of detection of the assay) were also performed using the following specimens: bronchoalveolar lavage/bronchial wash, nasopharyngeal and throat swabs, sputum, pericardial/pleural fluid, and cerebrospinal fluid. These specimens were confirmed as being negative for M pneumoniae prior to spiking. The sensitivity and specificity of the spiked specimens combined for all the matrices were 99% (154/155) and 100% (57/57), respectively.
Limit of detection:
The limit of detection of the assay is less than 5 target copies/mcL for all validated specimen types.
Analytical specificity:
The assay was tested against a panel of 45 organisms consisting of bacteria and viruses representing normal respiratory flora and/or respiratory pathogens. There was no cross reactivity among these organisms, which included 16 other species of Mycoplasma (Mycoplasmoides).
Day(s) Performed
Monday through Sunday
Report Available
3 to 4 daysSpecimen Retention Time
7 daysPerforming Laboratory
Mayo Clinic Laboratories in RochesterCPT Code Information
87581
NY State Approved
YesMethod Name
Rapid Polymerase Chain Reaction (PCR) using Light Cycler and Fluorescent Resonance Energy Transfer (FRET)
Forms
If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.
Reflex Tests
Test ID | Reporting Name | Available Separately | Always Performed |
---|---|---|---|
RPMPM | M. pneumoniae Macrolide Resist PCR | Yes | No |
Testing Algorithm
If positive, Mycoplasma pneumoniae macrolide resistance will be performed at an additional charge.