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Test Id : CRUZI

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Trypanosoma cruzi (Chagas) Antibody Panel, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Highlights

Diagnostic testing for chronic Chagas disease requires serologic assessment using two assays based on different antigens and/or methods. Specimens with discordant results by these two assays should be evaluated at a public health laboratory or the CDC for resolution.

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

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
A short description of the method used to perform the test

CHAGS: Enzyme-Linked Immunosorbent Assay (ELISA)

CHAGL: Lateral Flow Assay (LFA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

T. cruzi (Chagas) Ab Panel, S

Aliases
Lists additional common names for a test, as an aid in searching

American trypanosomiasis

Chagas

Chagas disease

CHAGS

Kissing bug

Reduviid

T. cruzi

Triatoma

Trypanosoma

Trypanosomiasis

CRUZI

CHAGL

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt Aliquot Tube 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.75 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Frozen 14 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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 of 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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

 

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

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. Additional testing to resolve discordant results through a public health laboratory or the CDC is recommended.

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. Additional testing to resolve discordant results through a public health laboratory or the CDC is recommended.

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. Additional testing to resolve discordant results through a public health laboratory or the CDC is recommended.

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
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

False-positive results may occur in patients infected with Leishmania species or other Trypanosoma species, including Trypanosoma rangeli. Additionally, false-positive results with the T cruzi lateral flow assay have been detected in patients with hepatitis C, toxoplasmosis, or syphilis.

 

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
Recommendations for in-depth reading of a clinical nature

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
Describes how the test is performed and provides a method-specific reference

CHAGS:

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)

 

CHAGL:

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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 8 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 weeks

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
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Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86753 x2

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

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
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
CHAGS T. cruzi Total Ab, EIA, S 57320-4
CHAGL T. cruzi IgG, LFA, S 87994-0
CHAGI T. cruzi Interpretation 59464-8

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
New Test 2025-01-23