Ordering Recommendation

Detect presence of IgM antibodies to T. gondii. For male patients or nonpregnant female patients with equivocal or positive results, Toxoplasma gondii by PCR (0055591) may also be useful if a specimen can be collected from an affected body site.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum Separator Tube (SST).

Specimen Preparation

Allow specimen to clot completely at room temperature. Separate from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.5 mL) Parallel testing is preferred and convalescent specimens must be received within 30 days from receipt of the acute specimens.

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Contaminated, heat-inactivated, or grossly hemolyzed specimens.

Remarks

Label specimens plainly as "acute" or "convalescent."

Stability

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (Avoid repeated freeze/thaw cycles)

Methodology

Semi-Quantitative Chemiluminescent Immunoassay

Performed

Sun-Sat

Reported

Within 24 hours

Reference Interval

7.9 AU/mL or less: Not Detected.
8.0-9.9 AU/mL: Indeterminate - Repeat testing in 10-14 days may be helpful.
10.0 AU/mL or greater: Detected - Significant level of Toxoplasma gondii IgM antibody detected and may indicate a current or recent infection. However, low levels of IgM antibodies may occasionally persist for more than 12 months post-infection.

Interpretive Data

This test is performed using the DiaSorin LIAISON. As suggested by the CDC, any indeterminate or detected Toxoplasma gondii IgM result should be retested in parallel with a specimen collected 1-3 weeks later. Further confirmation may be necessary using a different test from another reference laboratory specializing in toxoplasmosis testing where an IgM ELISA should be ordered. Caution should be exercised in the use of IgM antibody levels in prenatal screening. Any Toxoplasma gondii IgM in pregnant patients that have also been confirmed by a second reference laboratory should be evaluated by amniocentesis and PCR testing for Toxoplasma gondii.

For male and non-pregnant female patients with indeterminate or detected Toxoplasma gondii IgM results, PCR may also be useful if a specimen can be collected from an affected body site.

This test should not be used for blood donor screening, associated re-entry protocols, or for screening Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P).

For additional information, refer to the CDC website: www.cdc.gov/parasites/toxoplasmosis/health_professionals/index.html.

The magnitude of the measured result is not indicative of the amount of antibody present.

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

86778

Components

Component Test Code* Component Chart Name LOINC
0050557 Toxoplasma gondii Ab, IgM 8040-8
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • parasite serology
  • T gondii Ab
  • T gondii IgG Ab
  • Toxoplasma Antibody, IgM, Serum
  • Toxoplasma IgM, ELISA, Serum
Toxoplasma gondii Antibody, IgM