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Test Code CRUZI Trypanosoma cruzi (Chagas) Antibody Panel, Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube 5 mL (T914)

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.


Secondary ID

621062

Useful For

Diagnosis of chronic Trypanosoma cruzi infection (Chagas disease) using two different methods

Profile Information

Test ID Reporting Name Available Separately Always Performed
CHAGS T. cruzi Total Ab, EIA, S No Yes
CHAGL T. cruzi IgG, LFA, S No Yes
CHAGI T. cruzi Interpretation No Yes

Method Name

CHAGS: Enzyme-Linked Immunosorbent Assay (ELISA)

CHAGL: Lateral Flow Assay (LFA)

Specimen Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Frozen 14 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject

Reference Values

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.

Method Description

Trypanosoma cruzi Total Antibody:

The Wiener Chagatest ELISA 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)

 

Trypanosoma cruzi IgG:

The Chagas DetectTM Plus Rapid Test is a qualitative, membrane-based immunoassay for the detection of antibodies to Trypanosoma cruzi in human serum and whole blood matrices (venous and capillary [finger prick] whole blood). The rapid test membrane is precoated with a recombinant antigen on the test line region and utilizes a separate control to assure assay flow and performance. During testing, the sample and a proprietary blend of a stable liquid conjugate labeled with protein A are added to the sample pad. The conjugate and serum mixture migrates upward on the membrane (via capillary action) to react with recombinant T cruzi antigen on the membrane. If antibodies to the T cruzi antigen are present, a red line will appear at the test line. The red line at the control region should always appear if the assay is performed correctly. The presence of this red line verifies that proper flow has occurred and catastrophic failure of the conjugate has not occurred.(Package insert: Chagas Detect Plus Rapid Test. InBios; 01/05/2018)

Day(s) Performed

Monday

Report Available

Same day/1 to 8 days

Specimen Retention Time

2 weeks

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

86753 x2

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CRUZI T. cruzi (Chagas) Ab Panel, S 23785-9

 

Result ID Test Result Name Result LOINC Value
CHAGS T. cruzi Total Ab, EIA, S 57320-4
CHAGL T. cruzi IgG, LFA, S 87994-0
CHAGI T. cruzi Interpretation 59464-8

Forms

If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.