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Test ID MYCO Mycoplasma pneumoniae Antibodies, IgG and IgM, Serum


Ordering Guidance


Detection of IgM or IgG class antibodies to Mycoplasma pneumoniae provides exposure information. The preferred method of diagnosis of acute M pneumoniae infection is by molecular detection; order MPRP / Mycoplasma pneumoniae, Molecular Detection, PCR, Varies.



Specimen Required


Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Useful For

Screening for recent or past exposure to Mycoplasma pneumoniae

 

This test should not be used as a screening procedure for the general population.

Profile Information

Test ID Reporting Name Available Separately Always Performed
MYCOG M. pneumoniae Ab, IgG, S No Yes
MYCOM M. pneumoniae Ab, IgM, S No Yes
MYCON M. pneumoniae Ab Interpretation No Yes

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
MMYCO M. pneumoniae Ab, IgM, S by IFA No No

Testing Algorithm

If the Mycoplasma pneumoniae IgM result is reactive or equivocal, then M pneumoniae IgM by indirect immunofluorescence assay will be performed at an additional charge.

Method Name

MYCOG, MYCOM: Enzyme Immunoassay (EIA)

MMYCO: Indirect Immunofluorescence Assay (IFA)

MYCON: Interpretation

Reporting Name

M. pneumoniae Ab, IgG and IgM, S

Specimen Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
  Frozen  14 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Heat inactivated specimen Reject

Clinical Information

Mycoplasma 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. Central nervous system and cardiac manifestations are probably the most frequent extrapulmonary complications of infections due to M pneumoniae. The disease is usually self-limited, although severe disease has been reported in immunocompromised patients.

 

Identification of M pneumoniae by culture-based methods is time consuming and insensitive. Serology-based assays for M pneumoniae have several drawbacks. The development of IgM antibodies takes approximately 1 week, and the IgM response may be variable in adults or decreased in immunosuppressed individuals. Confirmation of the disease is dependent on the observation of a 4-fold rise in IgG antibody titers between acute and convalescent specimens, several weeks following the initial onset of illness, providing clinical utility only for retrospective testing. Real-time polymerase chain reaction offers a rapid and sensitive option for detection of M pneumoniae DNA from clinical specimens allows for diagnosis of acute or current infection.

Reference Values

IgG: Negative

IgM: Negative

IgM by indirect immunofluorescence: Negative

Interpretation

IgG ELISA result

IgM ELISA result

Interpretation

Positive

Negative

Results suggest past exposure.

Positive

 

Reactive

Prior exposure to Mycoplasma pneumoniae detected. Confirmatory testing for IgM to M pneumonia will be performed by an immunofluorescence assay.

Equivocal

Negative

Negative

No antibodies to M pneumoniae detected. Acute infection cannot be ruled out as antibody levels may be below the limit of detection.  If clinically indicated, a second serum should be submitted in 14 to 21 days.

Negative

Reactive

No prior exposure to Mycoplasma pneumoniae. Confirmatory testing for IgM to M pneumonia will be performed by an immunofluorescence assay..

Equivocal

Equivocal

Negative

Recommend follow-up testing in 10 to 14 days if clinically indicated.

Reactive

Confirmatory testing for IgM to M pneumonia will be performed by an immunofluorescence assay.

Equivocal

 

ELISA = Enzyme-linked immunosorbent assay

Cautions

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 clinical evaluation and the results of other diagnostic procedures (eg, molecular detection).

 

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 Mycoplasma genitalium and Mycoplasma 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.

Clinical Reference

1. Smith T: Mycoplasma pneumoniae infections: diagnosis based on immunofluorescence titer of IgG and IgM antibodies. Mayo Clin Proc. 1986 Oct;61(10):830-831

2. Holzman RS, Simberkoff MS, Leaf HL: Mycoplasma pneumoniae and atypical pneumonia. In Bennett JE, Dolin R, Blaser MJ, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 9th ed. Elsevier; 2020:2332-2339

Method Description

IgG:

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 IgG is added to the wells and incubated. The conjugate will react with the IgG antibody/antigen on the solid phase. The wells are washed to remove unreacted 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: M pneumoniae IgG Test System. Zeus Scientific Inc; Revision Date 12/2017)

 

IgM Enzyme Immunoassay:

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: M pneumoniae IgM Test System. Zeus Scientific, Inc; Revision Date 9/22/2016)

 

IgM Immunofluorescence Assay:

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 M pneumoniae is present, it will bind to the substrate. Fluorescein-labeled antihuman-IgM conjugate is added to the slide wells, 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; 09/2019)

Day(s) Performed

Monday through Friday

Report Available

Same day/1 to 3 days

Test Classification

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

86738 x 2-Mycoplasma pneumoniae by EIA

86738-Mycoplasma pneumoniae by indirect IFA (if appropriate)

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.