Test Catalog

Test Id : MPRP

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Mycoplasma (Mycoplasmoides) pneumoniae with Macrolide Resistance Reflex, Molecular Detection, PCR, Varies

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Diagnosing infections due to Mycoplasma (Mycoplasmoides) pneumoniae

 

Assessing macrolide susceptibility

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
RPMPM M. pneumoniae Macrolide Resist PCR Yes No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If positive, Mycoplasma pneumoniae macrolide resistance will be performed at an additional charge.

Method Name
A short description of the method used to perform the test

Rapid Polymerase Chain Reaction (PCR) using Light Cycler and Fluorescent Resonance Energy Transfer (FRET)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

M pneumoniae PCR + Macrolide Reflex

Aliases
Lists additional common names for a test, as an aid in searching

Mycoplasma pneumoniae

Mycoplasmoides pneumoniae

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If positive, Mycoplasma pneumoniae macrolide resistance will be performed at an additional charge.

Specimen Type
Describes the specimen type validated for testing

Varies

Necessary Information

Specimen source is required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
SRCMP Specimen Source

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

Respiratory specimen: 0.5 mL

Other specimen types: See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

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

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) 7 days
Frozen 7 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Diagnosing infections due to Mycoplasma (Mycoplasmoides) pneumoniae

 

Assessing macrolide susceptibility

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If positive, Mycoplasma pneumoniae macrolide resistance will be performed at an additional charge.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Interpretation
Provides information to assist in interpretation of the test results

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
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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).

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Waites KB, Taylor-Robinson D: Mycoplasma and Ureaplasma. In. Versalovic J, Carroll K, Funke G, et al, eds. Manual of Clinical Microbiology. ASM Press; 2011:970-985

2. Jensen JS, Heilmann C, Valerius NH. Mycoplasma pneumoniae infection in a child with AIDS. Clin Infect Dis. 1994;19(1):207

3. Daxboeck F, Krause R, Wenisch C. Laboratory diagnosis of Mycoplasma pneumoniae infection. Clin Microbiol Infect. 2003;9(4):263-273

4. Waites KB, Talkington DF. Mycoplasma pneumoniae and its role as a human pathogen. Clin Microbiol Rev. 2004;17(4):697-728

5. Schmitt BH, Sloan LM, Patel R. Real-time PCR detection of Mycoplasma pneumoniae in respiratory specimens. Diagn Microbiol Infect Dis. 2013;77(3):202-205

6. Rothstein TE, Cunningham SA, Rieke RA, Mainella JM, Mutchler MM, Patel R. Macrolide resistance in Mycoplasma pneumoniae, Midwestern United States, 2014 to 2021. Antimicrob Agents Chemother. 2022;66(4):e0243221

Method Description
Describes how the test is performed and provides a method-specific reference

Throat swabs, nasopharyngeal swabs, sputum, bronchoalveolar lavage fluid, pericardial/pleural/chest fluid, and cerebrospinal fluid specimens are processed according to specimen type. Nucleic acid is extracted by the MagNA Pure 96 automated instrument (Roche Applied Science). A specific target sequence from Mycoplasma (Mycoplasmoides) pneumoniae is targeted by primers and fluorescence resonance energy transfer hybridization probes. The LightCycler 480 II instrument (Roche Applied Science) amplifies and monitors the development of target nucleic acid sequences after the annealing step during polymerase chain reaction (PCR) cycling. Detection of the M pneumoniae target is performed through melting curve analysis using the LightCycler software.(Schmitt BH, Sloan LM, Patel R. Real-time PCR detection of Mycoplasma pneumoniae in respiratory specimens. Diagn Microbiol Infect Dis. 2013 Nov;77[3]:202-205)

 

If M pneumoniae is detected, a reflexive PCR is performed to assess the 23S ribosomal RNA gene region of M pneumoniae and predict macrolide resistance based on the most common, high-level point mutations at positions 2064 and 2063 via melting curve analysis. While the wildtype genotype will display a stable melting temperature, the designed primer and probe combinations will be highly sensitive to single nucleotide mutations resulting in a cooler (left shift) melting temperature value.(Rothstein TE, Cunningham SA, Rieke RA, Mainella JM, Mutchler MM, Patel R. Macrolide resistance in Mycoplasma pneumoniae, Midwestern United States, 2014 to 2021. Antimicrob Agents Chemother. 2022 Apr 19;66[4]:e0243221)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

3 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87581

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
MPRP M pneumoniae PCR + Macrolide Reflex 29257-3
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
SRCMP Specimen source 31208-2
62394 M. pneumoniae PCR 29257-3

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
Test Changes - Specimen Information 2023-10-10
File Definition - Algorithm 2023-09-12