Test Catalog

Test Id : MYCOM

Mycoplasma pneumoniae Antibodies, IgM, Serum

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

Screen for recent or past exposure to Mycoplasma pneumoniae

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
MMYCO M. pneumoniae Ab, IgM, S by IFA No No

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

Only orderable as part of a profile. For more information see MYCO / Mycoplasma pneumoniae Antibodies, IgG and IgM, Serum.

 

Enzyme Immunoassay (EIA)

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 Ab, IgM, S

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

M. pneumoniae

Mycoplasma Serology

Specimen Type
Describes the specimen type validated for testing

Serum

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

Only orderable as part of a profile. For more information see MYCO / Mycoplasma pneumoniae Antibodies, IgG and IgM, Serum.

 

Collection Container/Tube: 

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

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

Hemolysis Mild reject; Gross reject
Lipemia Mild reject; Gross reject
Icterus NA
Other NA

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
Serum Refrigerated (preferred) 14 days
Frozen 14 days

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

Screen for recent or past exposure to Mycoplasma pneumoniae

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

Mycoplasma pneumoniae is an important respiratory tract pathogen. Several syndromes have been associated with the infection including pharyngitis, tracheobronchitis, pneumonia, and inflammation of the tympanic membrane presenting as bullous myringitis. 

                       

M pneumoniae accounts for approximately 20% of all cases of pneumonia. Classically, it causes a disease that has been described as primary atypical pneumonia. The disease is of insidious onset with fever, headache, and malaise for 2 to 4 days before the onset of respiratory symptoms. Most cases do not require hospitalization. Symptomatic infections attributable to this organism most commonly occur in children and young adults (ages 2-19 years).

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.

Only orderable as part of a profile. For more information see MYCO / Mycoplasma pneumoniae Antibodies, IgG and IgM, Serum.

 

Negative

Interpretation
Provides information to assist in interpretation of the test results

Positive IgM results are consistent with recent infection, although false-positives may occur (see Cautions).

 

Negative results do not rule out the presence of acute or ongoing Mycoplasma pneumoniae-associated disease. The specimen may have been drawn before the appearance of detectable antibodies. If testing is performed too early following primary infection, IgM may not be detectable. If a Mycoplasma infection is clinically suspected, a second, convalescent specimen should be submitted in 14 to 21 days.

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

A diagnosis of  Mycoplasma pneumoniae infection should not be solely based on results of serologic testing for this agent. Test results should be interpreted in conjunction with the clinical evaluation and the results of other diagnostic procedures (eg molecular detection).

 

The use of hemolytic, lipemic, bacterially contaminated, or heat-inactivated specimens should be avoided as erroneous results may occur.

 

Assay performance characteristics have not been established for matrices other than serum.

 

The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.

 

Testing should not be performed as a screening procedure for the general population. Testing should only be done when clinical evidence suggests the diagnosis of M pneumoniae-associated disease.

 

The performance of this test has not been established on neonates and immunocompromised patients.

 

Performance of the IgM assay has not been tested with specimens known to be positive for antibodies to organisms that are known to be associated with lower respiratory illness (ie, influenza A and B, cytomegalovirus, Chlamydophila pneumoniae, parainfluenza), and closely related serovars known to cross-react with M pneumoniae, such as M genitalium, and M hominis, as well as various Ureaplasma species. Cross-reactivity studies with such organisms have not been performed with this assay.

 

The IgG removal system included with the IgM test system has been shown to functionally remove the IgG from specimens containing total IgG levels ranging from 300 to 600 mg/mL. The effectiveness of this removal system at IgG levels exceeding 600 mg/mL has not been established.

 

The prevalence of Mycoplasma IgM antibody is relatively low, which affects the assay's predictive value.

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

Smith T: Mycoplasma pneumoniae infections: diagnosis based on immunofluorescence titer of IgG and IgM antibodies. Mayo Clin Proc 1986;61:830-831

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

IgM EIA:

Test sera are diluted with the sample diluent provided. The sample diluent contains antihuman IgG that precipitates and removes IgG and rheumatoid factor from the sample, leaving IgM free to react with immobilized antigen. Diluted sera are incubated in antigen-coated microwells. Any antigen-specific antibody in the samples will bind to the immobilized antigen. The plate is washed to remove unbound antibody and other serum components. Peroxidase conjugated goat-antihuman IgM (chain specific) is added to the wells and incubated. The conjugate will react with the IgM antibody/antigen on the solid phase. The wells are washed to remove unbound conjugate. The microwells containing immobilized conjugate are incubated with peroxidase substrate solution. Hydrolysis of the substrate by peroxidase produces a color change. After a period of time the reaction is stopped by the addition of diluted acid, and the color changes are measured photometrically. The color intensity of the solution depends on the antibody concentration in the serum sample.(Package insert: Mycoplasma IgM ELISA II. Wampole Laboratories, Princeton, NJ 2004)

 

IgM Immunofluorescence Assay (IFA):

Mycoplasma pneumoniae antigenic substrate is fixed onto microscope slide wells. Serum that has been pretreated to remove IgG antibodies is incubated with the substrate. If IgM antibody to Mycoplasma pneumoniae is present, it will bind to the substrate. Fluorescein-labeled antihuman IgM conjugate is added to the slide well(s) and the slide is incubated. If antibody is present, it can be observed as a characteristic positive, bright, apple-green fluorescent reaction when the slide is read on a fluorescence microscope.(Package insert: Mycoplasma pneumoniae IgM IFA Antibody Test System. Zeus Scientific, Inc., Raritan, NJ 2004)

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 Friday

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.

Same day/1 to 3 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 Regional Manager. 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 has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test 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.

86738

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
MYCOM M. pneumoniae Ab, IgM, S 5257-1
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.
MYCOM M. pneumoniae Ab, IgM, S 5257-1

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