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


Specimen Required


Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.7 mL

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


Useful For

Diagnosis of chronic Trypanosoma cruzi infection (Chagas disease)

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

T. cruzi Total Ab, EIA, S

Specimen Type

Serum

Specimen Minimum Volume

0.6 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Frozen 14 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject

Clinical Information

Chagas disease (American trypanosomiasis) is an acute and chronic infection caused by the protozoan hemoflagellate Trypanosoma cruzi. 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 infection is frequently undiagnosed and often resolves spontaneously. Diagnosis of acute T cruzi infection is most frequently 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 guidelines and the Centers of Disease Control and Prevention, serologic confirmation of chronic T cruzi infection requires positivity on 2 tests utilizing 2 different methodologies or 2 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

Negative

Reference values apply to all ages.

Cautions

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

 

Diagnosis of chronic Chagas disease requires both clinical evaluation (including exposure history) and laboratory testing. 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.

Day(s) Performed

Monday

Report Available

Same day/1 to 8 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