Test Catalog

Test Id : MYCOG

Mycoplasma pneumoniae Antibodies, IgG, Serum

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

Screening for IgG antibodies in the indication of recent or past exposure to Mycoplasma pneumoniae

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, IgG, 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

Gross hemolysis Reject
Gross lipemia Reject
Heat inactivated specimen 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
Serum Refrigerated (preferred) 14 days
Frozen 14 days

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

Screening for IgG antibodies in the indication of 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 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 analysis 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
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

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
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 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 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.

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

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

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)

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
MYCOG M. pneumoniae Ab, IgG, S 45224-3
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.
MYCOG M. pneumoniae Ab, IgG, S 45224-3

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