Mobile Site ›
Normal View

Test ID: MYCPN
Mycoplasma pneumoniae Antibodies, IgG and IgM, Serum

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

Yes

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

An aid in the diagnosis of disease associated with Mycoplasma pneumoniae

Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test IDReporting NameAvailable SeparatelyAlways Performed
MYCGM. pneumoniae Ab, IgG, SNoYes
MYCMM. pneumoniae Ab, IgM, SNoYes

Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)

Test IDReporting NameAvailable SeparatelyAlways Performed
MMYCOM. pneumoniae Ab, IgM, S by IFANoNo

Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.

If Mycoplasma pneumoniae antibodies, IgM is positive or equivocal, then Mycoplasma pneumoniae antibodies, IgM by indirect immunofluorescence assay (IFA) will be performed at an additional charge.

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

MYCG, MYCM: Enzyme Immunoassay (EIA)

MMYCO: Indirect Immunofluorescence Assay (IFA)

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

M. pneumoniae Ab, IgG and 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 needed for testing

Serum

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Collection Container/Tube: 

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

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 laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
SerumRefrigerated (preferred)14 days
 Frozen 14 days

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.  

                                        

Mycoplasma 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).(1)

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.

IgG

< or =0.90 (negative)

0.91-1.09 (equivocal)

> or =1.10 (positive)

 

IgM

< or =0.90 (negative)

0.91-1.09 (equivocal)

> or =1.10 (positive)

 

IgM by IFA

Negative (reported as positive or negative)

Interpretation Provides information to assist in interpretation of the test results

Positive IgM results are consistent with acute infection, although false positives do occur (see Cautions).

 

A single positive IgG result only indicates previous immunologic exposure.

 

Negative results do not rule-out the presence of 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, IgG and/or IgM may not be detectable. If a Mycoplasma infection is clinically indicated, a second 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 should not be made on the basis of antimycoplasma results alone. Test results should be interpreted in conjunction with the clinical evaluation and the results of other diagnostic procedures.

 

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 Mycoplasma 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 Mycoplasma 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.

 

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

Supportive Data

The clinical study for this assay included 100 normal donor specimens that were tested for the presence of IgG and IgM class antibodies to Mycoplasma pneumoniae; 59% of the specimens contained IgG antibody and 4% displayed IgM antibody when tested with the EIA method.

Clinical Reference Provides recommendations for further 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

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: Mycoplasma IgG ELISA II. Wampole Laboratories, Princeton, NJ 2004)

 

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 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 anti-human 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)

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

No

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

Monday through Friday; 9 a.m.

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

Same day/1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

3 days

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

14 days

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

Rochester

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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

86738 x 2-Mycoplasma pneumoniae by EIA

86738-Mycoplasma pneumoniae by indirect IFA (if appropriate)

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
MYCGM. pneumoniae Ab, IgG, S5255-5
MYCMM. pneumoniae Ab, IgM, S5256-3