Trypanosoma cruzi Antibody, IgG, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Diagnosis of Chagas disease (infection with Trypanosoma cruzi)
Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Trypanosoma cruzi Ab, IgG, S
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Preferred: Red top
Acceptable: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Mild OK; Gross reject
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Frozen (preferred)||14 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Chagas disease (American trypanosomiasis) is an acute and chronic infection caused by the protozoan hemoflagellate, Trypanosoma cruzi which 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 also has been transmitted by blood transfusion, organ transplantation, and apparently also by food ingestion. The acute febrile infection is most often undiagnosed and often resolves spontaneously. The actively motile (trypomastigote) form may be demonstrated in peripheral blood by stained smears during the acute phase. Chronic 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 Trypanosoma cruzi. The parasite is not seen in the blood during the chronic phase. Diagnosis at this time is made by serology or tissue biopsy. A positive serology is considered presumptive evidence of active infection. Serologically positive asymptomatic persons are capable of transmitting the infection.
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.
A positive serology is considered evidence of active infection.
Infected individuals usually begin producing antibodies to Trypanosoma cruzi during the first month following exposure to the parasite. Antibody levels may fluctuate during the chronic phase of the disease and may become undetectable after several months. Uninfected individuals are not expected to have detectable levels of antibodies to Trypanosoma cruzi.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
No significant cautionary statements
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Kirchhoff LV: American trypanosomiasis (Chagas' disease). In Topical Infectious Diseases. Edited by RL Guerrant et al. Philadelphia, Churchill Livingstone, 1999, pp 785-796
2. Umezawa ES, Stolf AM, Corbett CE, Shikanai-Yasuda MA: Chagas' disease. Lancet 2001;357:797-799
3. Leiby DA, Read EJ, Lenes BA, et al: Seroepidemiology of Trypanosoma cruzi, etiologic agent of Chagas' disease, in US blood donors. J Infect Dis 1997;176:1047-1052
4. Grant IH, Gold JW, Wittner M, et al: Transfusion-associated acute Chagas' disease acquired in the United States. Ann Intern Med 1989;111:849-851
Method Description Describes how the test is performed and provides a method-specific reference
The Hemagen Chagas Kit is a qualitative indirect enzyme-linked immunosorbent assay using purified antigens extracted from cultured Trypanosoma cruzi that have been attached to the surface of microplate wells. The presence of antibodies in the test serum is detected by an enzyme catalyzed color change in added 3,3', 5,5'-tetramethylbenzidine substrate. (Umezawa ES, Luquetti AO, Levitus G, et al: Serodiagnosis of chronic and acute Chagas' disease with Trypanosoma cruzi recombinant proteins: results of a collaborative study in six Latin American countries. J Clin Microbiol 2004;42:449-452)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Tuesday; 9 a.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Same day/1 day
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test has been cleared or approved by the U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|86159||Trypanosoma cruzi Ab, IgG, S||32725-4|