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Test Code CHAGS Trypanosoma cruzi Total Antibody, Enzyme-Linked Immunosorbent Assay, Serum


Specimen Required


Only orderable as part of a profile. For more information see CRUZI / Trypanosoma cruzi (Chagas) Antibody Panel, Serum.

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Secondary ID

615244

Useful For

Diagnosis of chronic Trypanosoma cruzi infection (Chagas disease)

Method Name

Only orderable as part of a profile. For more information see CRUZI / Trypanosoma cruzi (Chagas) Antibody Panel, Serum.

 

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

T. cruzi Total Ab, EIA, S

Specimen Type

Serum

Specimen Minimum Volume

0.4 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Frozen 14 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject

Clinical Information

Chagas disease (American trypanosomiasis) is caused by the protozoan hemoflagellate Trypanosoma cruzi and can lead to acute and chronic clinical manifestations of disease. T cruzi is endemic in many areas of South and Central America. The parasite is usually transmitted by the bite of reduviid (or "kissing") bugs of the genus Triatoma but may also be transmitted by blood transfusion, organ transplantation, food ingestion, and vertically from mother to fetus. The acute febrile stage of disease is frequently undiagnosed and often resolves spontaneously. Diagnosis of acute T cruzi infection is typically confirmed by microscopic identification of trypomastigotes in fresh preparations of anticoagulated blood or buffy coat or by molecular detection. Parasitemia decreases and is undetectable within approximately 90 days of infection.

 

Chronic T cruzi infections are often asymptomatic but may progress to produce disabling and life-threatening cardiac (cardiomegaly, conduction defects) and gastrointestinal (megaesophagus and megacolon) disease. These damaged tissues contain the intracellular amastigote of T cruzi. The parasite is not seen in the blood during the chronic phase. Diagnosis of chronic T cruzi infection relies on serologic detection of antibodies to this organism. However, no single serologic assay is sensitive and specific enough to be relied upon alone. Therefore, per current expert guidelines and the Centers for Disease Control and Prevention, serologic confirmation of chronic T cruzi infection requires positivity on 2 tests utilizing two different methodologies and/or two different T cruzi antigen preparations. When results are discordant, testing by a third assay is recommended to resolve the initial results or, alternatively, repeat testing on a new sample may be required.

Reference Values

Only orderable as part of a profile. For more information see CRUZI / Trypanosoma cruzi (Chagas) Antibody Panel, Serum.

 

Negative

Reference values apply to all ages.

Interpretation

CHAGS result

CHAGL result

Interpretive comment

Positive

Positive

Antibodies to Trypanosoma cruzi (Chagas disease) detected by two separate methods, suggesting current or past infection. Results should be interpreted alongside clinical presentation and exposure history.

Positive

Negative

Antibodies to Trypanosoma cruzi (Chagas disease) detected by one of two assays. Discordant results can be resolved through submission of a new sample for testing or through additional testing at a public health laboratory.

Positive

Invalid

Submission of a new sample is recommended to resolve discordant results.

Indeterminate

Positive

Antibodies to Trypanosoma cruzi (Chagas disease) detected by one of two assays. Discordant results can be resolved through submission of a new sample for testing or through additional testing at a public health laboratory.

Indeterminate

Negative

Submission of a new sample is recommended to resolve discordant results.

Indeterminate

Invalid

Submission of a new sample is recommended to resolve discordant results.

Negative

Positive

Antibodies to Trypanosoma cruzi (Chagas disease) detected by one of two assays. Discordant results can be resolved through submission of a new sample for testing or through additional testing at a public health laboratory.

Negative

Negative

No antibodies to Trypanosoma cruzi (Chagas disease) detected. False negative results may occur in patients tested within 4 weeks of infection.

Negative

Invalid

Submission of a new sample is recommended to resolve discordant results.

Cautions

False-positive results may occur in patients infected with Leishmania or other Trypanosoma species, including Trypanosoma rangeli.

 

A diagnosis of chronic Chagas disease requires both clinical evaluation (including exposure history) and laboratory results. Chagas disease should not be diagnosed based on a single serologic result alone.

 

A single negative result does not exclude the diagnosis of Chagas disease as antibodies to the pathogen may not yet be detectable. Sensitivity of the assay may be decreased in significantly immunosuppressed patients.

Clinical Reference

1. Bern C, Montgomery SP, Herwaldt BL, et al. Evaluation and treatment of Chagas disease in the United States: a systematic review JAMA. 2007;298(18):2171-2181

2. Bern C, Messenger LA, Whitman JD, Maguire JH. Chagas disease in the United States: A public health approach. Clin Microbiol Rev. 2019;33(1):e00023-19. doi:10.1128/CMR.00023-19

3. Forsyth CJ, Manne-Goehler J, Bern C, et al. Recommendations for screening and diagnosis of Chagas disease in the United States. J Infect Dis. 2022;225(9):1601-1610. doi:10.1093/infdis/jiab513

Method Description

The Wiener Chagatest ELISA (enzyme-linked immunosorbent assay) recombinante v.3.0 test kit is a qualitative technique for the detection of anti-Trypanosoma cruzi antibodies. The sample is diluted in the support in which the recombinant antigen (1, 2, 13, 30, 36, and SAPA) is immobilized (3rd generation method). These antigens are obtained by DNA recombinant techniques starting from specific proteins from the epimastigote and trypomastigote stages of the T cruzi corresponding to highly-conserved zones among different strains. The technology used allows us to ensure an antigenic mixture of known and permanent composition batch to batch, giving reproducible, specific, and highly-sensitive results. If the sample contains specific antibodies, these will form a complex with the antigens and will remain bound to the support. The unbound fraction is eliminated by washing, after which antihuman immunoglobulin antibodies conjugated to peroxidase are added. If a reaction is produced in the first step of the process, the conjugate is bound. After a new wash, the enzymatic substrate is added. If bound conjugate is present, a light-blue color is developed. The reaction is stopped by adding sulfuric acid, and the color changes to yellow.(Package insert: Chagatest ELISA recombinante v.3.0. Wiener Laboratorios S.A.I.C.; 801146000/00)

Day(s) Performed

Monday

Report Available

Same day/1 to 8 days

Specimen Retention Time

14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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.

CPT Code Information

86753

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CHAGS T. cruzi Total Ab, EIA, S 57320-4

 

Result ID Test Result Name Result LOINC Value
CHAGS T. cruzi Total Ab, EIA, S 57320-4