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HelpTest Code TXM; SQ: TOXOM Toxoplasma gondii Antibody, IgM, Serum
Secondary ID
39856Useful For
Detecting recent infection with Toxoplasma gondii
Highlights
Detection of IgM-class antibodies to Toxoplasma gondii may be useful as a screen for recent infection with T gondii.
Per the US Food and Drug Administration, IgM-positive results by a screening assay should be confirmed, for example, by a Toxoplasma reference laboratory.
A single negative result by this assay does not rule-out toxoplasmosis as the specimen may have been collected too early following infection, prior to development of detectable antibodies.
Method Name
Multiplex Flow Immunoassay (MFI)
Reporting Name
Toxoplasma Ab, IgM, SSpecimen Type
SerumSpecimen 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.
Specimen Minimum Volume
0.8 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
Toxoplasma gondii is an obligate intracellular protozoan parasite capable of infecting a variety of intermediate hosts, including humans. Infected definitive hosts (cats) shed oocysts in feces that rapidly mature in the soil and become infectious.(1) Toxoplasmosis is acquired by humans through ingestion of food or water contaminated with cat feces or through eating undercooked meat containing viable oocysts. Vertical transmission of the parasite through the placenta can also occur, leading to congenital toxoplasmosis. Following primary infection, T gondii can remain latent for the life of the host; the risk for reactivation is highest among individuals who are immunosuppressed.
Seroprevalence studies performed in the United States indicate approximately 6.7% of individuals between the ages of 12 and 49 have antibodies to T gondii.(2)
Infection of immunocompetent adults is typically asymptomatic. In symptomatic cases, patients most frequently present with lymphadenopathy and other nonspecific constitutional symptoms, making definitive diagnosis difficult to determine.
Severe-to-fatal infections can occur among patients with AIDS or individuals that are otherwise immunosuppressed. These infections are thought to be caused by reactivation of latent infections and commonly involve the central nervous system.(3)
Transplacental transmission of the parasites resulting in congenital toxoplasmosis can occur during the acute phase of acquired maternal infection. The risk of fetal infection is a function of the time at which acute maternal infection occurs during gestation.(4) The incidence of congenital toxoplasmosis increases as pregnancy progresses; conversely, the severity of congenital toxoplasmosis is greatest when maternal infection is acquired early during pregnancy. A majority of infants infected in utero are asymptomatic at birth, particularly if maternal infection occurs during the third trimester, with sequelae appearing later in life. Congenital toxoplasmosis results in severe generalized or neurologic disease in about 20% to 30% of the infants infected in utero; approximately 10% exhibit ocular involvement only, and the remainder are asymptomatic at birth. Subclinical infection may result in premature delivery and subsequent neurologic, intellectual, and audiologic defects.
Reference Values
Negative
Reference values apply to all ages.
Interpretation
Active toxoplasmosis is suggested by the presence of IgM-class antibodies, but elevated anti-IgM titers may be absent in patients who are immunocompromised. In addition, elevated IgM can persist from an acute infection that may have occurred as long ago as 1 year. A suspected diagnosis of acute toxoplasmosis should be confirmed by detection of Toxoplasma gondii DNA by polymerase chain reaction (PCR) analysis of cerebrospinal fluid or amniotic fluid specimens (PTOX / Toxoplasma gondii, Molecular Detection, PCR, Varies).
For confirmation of toxoplasmosis, the US Food and Drug Administration issued a Public Health Advisory (07/25/1997) that recommends sera found to be positive for Toxoplasma gondii IgM antibodies should be sent to a Toxoplasma reference laboratory.
A single negative result should not be used to rule-out toxoplasmosis, and repeat testing is recommended for patients at high risk for infection.
Method Description
The BioPlex 2200 Toxoplasma gondii IgM assay uses multiplex flow immunoassay technology. Briefly, Toxoplasma antigen-coated fluorescent beads are mixed with an aliquot of patient sample and sample diluent and then incubated at 37° C. During this time, IgM anti-Toxoplasma antibodies in the specimen will bind to the Toxoplasma antigen on the beads. After a wash cycle, a fluorescently-labeled antihuman-IgM antibody conjugate is added to the mixture and incubated at 37° C. Following a wash step to remove unbound conjugate, the bead mixture is passed through a detector that identifies the bead based on dye fluorescence and determines the amount of antibody captured by the antigen based on fluorescence of the antihuman-IgM conjugate. Raw data is calculated in relative fluorescence intensity and is converted to an antibody index for interpretation.
Three additional dyed beads: an internal standard bead, a serum verification bead, and a reagent black bead are present in each reaction mixture to verify detector response, the addition of serum to the reaction vessel, and the absence of significant nonspecific binding in serum, respectively.(Package insert: BioPlex 2200 System, ToRC IgM. Bio-Rad Laboratories; 08/2017)
Day(s) Performed
Monday through Saturday
Performing Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
86778
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| TXM | Toxoplasma Ab, IgM, S | 40678-5 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| TXM | Toxoplasma Ab, IgM, S | 40678-5 |
Test Classification
This test has been cleared, approved, or is exempt by the US 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.Forms
If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.