Toxoplasma gondii Antibody, IgM and IgG, Serum

Message
Sendout, Mayo test code: TXPAB


Test Code
LAB5210348


Alias/See Also
T. gondii Toxoplasma gondii Toxoplasma IgG & IgM Antibody Assays Toxoplasma, IgG Antibody, Serum Toxoplasma, IgM Antibody, Serum Toxoplasmosis TXPAB


CPT Codes
86778, 86777

Includes
Toxoplasma Ab, IgG, IgM S Toxoplasma IgG Value


Preferred Specimen
0.7 mL serum from a gold serum gel tube


Minimum Volume
0.7 mL


Other Acceptable Specimens
Red tube


Instructions
Centrifuge and aliquot serum into a plastic vial.


Transport Container
Plastic vial


Transport Temperature
Refrigerated


Specimen Stability
Refrigerated (preferred): 21 days
Ambient: 72 hours
Frozen:90 days


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis: Reject
Gross lipemia: Reject
Heat-inactivated specimen: Reject


Methodology
Electrochemiluminescence Immunoassay (ECLIA)

FDA Status
Approved

Setup Schedule
Monday through Saturday


Report Available
Same day/1 to 3 days


Limitations
Diagnosis of recent or active infection by Toxoplasma gondii can only be established based on a combination of clinical and serological data. The result of a single serum sample does not constitute sufficient proof for diagnosis of recent infection. Elevated IgM can persist from an acute infection that may have occurred as long ago as 1 year.
 
To differentiate between a recently acquired and past infection in patients who are IgM and IgG positive for Toxoplasma antibodies, Toxoplasma IgG avidity testing should be considered. A high avidity index for IgG antibodies indicates that the infection occurred at least 4 months ago. No clinical interpretation can be deduced from a low avidity result.
 
A negative Toxoplasma IgM result in combination with a positive IgG result does not completely rule out the possibility of an acute infection with Toxoplasma.
 
Elevated anti-IgM or IgG titers may be absent in patients who are immunocompromised. Results should be interpreted with caution in patients who are either HIV-positive, receiving immunosuppressive therapy, or have other disorders leading to immunosuppression.
 
A suspected diagnosis of central nervous system or congenital toxoplasmosis should be confirmed by detection of Toxoplasma gondii DNA by polymerase chain reaction (PCR) analysis of cerebrospinal fluid or amniotic fluid specimens, respectively (PTOX / Toxoplasma gondii, Molecular Detection, PCR, Varies).
 
If a serum specimen was collected too soon after infection, antibodies to T gondii may be absent. If this is suspected, a second serum specimen should be collected 2 to 3 weeks later, and the test repeated.
 
Heterophile antibodies in the patient specimens may interfere with IgM assay performance.
 
The performance of these assays has not been established for cord blood testing.
 
Specimens should not be collected from patients receiving therapy with high biotin doses (ie, >5 mg/day) until at least 8 hours following the last biotin administration.
 
As with any low prevalence analyte, there is the increased possibility that a positive result may be false, reducing the assay's positive predictive value. Per the Public Health Advisory (7/25/1997), the US Food and Drug Administration suggests that sera found to be positive for Toxoplasma gondii IgM antibodies should be submitted to a Toxoplasma reference laboratory.


Reference Range
Included with report


Clinical Significance
Qualitative detection of IgM and quantitative detection of IgG antibodies to Toxoplasma gondii in human serum


Performing Laboratory
Mayo Clinic Laboratories, Rochester, Minnesota

Additional Information
Toxoplasma gondii Antibody, IgM and IgG, Serum


The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.