Ordering Recommendation

Aid in the diagnosis of exposure and chronic phase Chagas disease (T. cruzi).

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

  Plain red or serum separator tube.

Specimen Preparation

  Separate serum from cells ASAP or within 2 hours of collection. Transfer 0.5 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 of the acute specimens. Mark specimens plainly as "acute" or "convalescent."

Storage/Transport Temperature

  Refrigerated. Also acceptable: Room temperature or frozen.

Unacceptable Conditions

  Plasma. Bacterially contaminated, heat-inactivated, hemolyzed, icteric, lipemic, or turbid specimens.

Remarks
Stability

  After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year

Methodology

  Semi-Quantitative Enzyme-Linked Immunosorbent Assay (ELISA)

Performed

Mon, Wed, Fri

Reported

    1-6 days

Reference Interval

Test Number
Components
Reference Interval
  T. cruzi IgG, Recombinant Antigen 0.8 S/Co or less
  T. cruzi IgG, Purified Antigen 1.0 IV or less

Interpretive Data

  According to the CDC, at least two different serologic tests should be used to make the laboratory diagnosis of chronic Chagas Disease, as no single serologic test is sufficiently sensitive and specific. If results between the two assays are discrepant, repeat testing or testing by a third method may be helpful.
This assay should not be used for blood donor screening or associated re-entry protocols, or for screening Human Cell and Cellular Tissue-Based Products (HCT/Ps).


Component Unit Of Measure Interpretation
T. cruzi IgG, Recombinant Antigen 0.8 S/Co or less
0.9 to 1.1 S/Co
1.2 S/Co or greater
Negative - No significant level of Trypanosoma cruzi IgG antibody detected.
Equivocal - Questionable presence of Trypanosoma cruzi IgG antibody detected. Repeat testing in 10-14 days may be helpful.
Positive - IgG antibodies to Trypanosoma cruzi detected which may suggest current or past infection.
T. cruzi IgG, Purified Antigen 1.0 IV or less
1.1 IV
1.2 IV or greater
Negative - No significant level of Trypanosoma cruzi IgG antibody detected.
Equivocal - Questionable presence of Trypanosoma cruzi IgG antibody detected. Repeat testing in 10-14 days may be helpful.
Positive - IgG antibodies to Trypanosoma cruzi detected which may suggest current or past infection.

Compliance Category

FDA

Note

  T. cruzi IgG , Recombinant Antigen assay is performed using the Wiener Chagatest ELISA recombinante v.3.0.
T. cruzi IgG , Purified Antigen assay is performed using the Hemagen Chagas Kit.

Hotline History

N/A

CPT Codes

86753 x2

Components

Component Test Code* Component Chart Name LOINC
0051076 T. cruzi IgG, Purified Antigen 59387-1
3020059 T. cruzi IgG, Recombinant Antigen 59387-1
* 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

  • Chagas Antibody, IgG
  • Chagas disease
  • Trypanosomiasis
Trypanosoma cruzi Antibody, IgG Panel