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Test Id : BILHA

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Schistosoma species Antibody, IgG, Serum

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Overview

Test Catalog

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

Detection of antibodies to Schistosoma species

Highlights

This assay can be used as a screening test for detection of antibodies to Schistosoma species.

 

Positive results should be interpreted alongside clinical findings and suitable exposure history.

 

A single negative result should not be used to rule-out Schistosoma infection.

 

False-positive results may occur in individuals with other helminth infections.

Method Name
A short description of the method used to perform the test

Enzyme Immunoassay (EIA)

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

Schistosoma Ab, IgG, S

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

Schistosomiasis

Bilharzia

Bilharziasis

Katayama fever

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

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 plastic vial.

Forms

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

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

Gross hemolysis Reject
Gross lipemia Reject
Heat inactivated 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 Refrigerated (preferred) 30 days
Frozen 30 days

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

Detection of antibodies to Schistosoma species

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

Schistosoma species (class Trematoda) are flukes, characterized by their flat, leaf-like morphology as adults and use of gastropod mollusks (eg, snails) as an intermediate host. The schistosomes are also referred to as the "blood flukes" of which there are 5 species known to infect humans: Schistosoma mansoni, Schistosoma japonicum, Schistosoma haematobium, Schistosoma mekongi, and Schistosoma intercalatum. Among these S mansoni, S japonicum and S haematobium are most common.

 

These species have a defined geographic distribution, with S mansoni occurring throughout sub-Saharan Africa, the Middle East, and islands in the Caribbean; S haematobium found in much of the African continent and the Middle East; and S japonicum localized to China, Indonesia, and the Philippines.

 

Humans are definitive hosts for all Schistosoma species except for S japonicum, and infection begins with skin penetration of cercariae in contaminated water sources. The cercariae shed their bifurcated tails, becoming schistosomulae and migrate through the vascular system to the lungs, heart, and the portal venous system in the liver. There they mature to adults, pair off and migrate to the mesenteric venules of the bowel and rectum (S mansoni, S japonicum) or venus plexus of the bladder (S haematobium). Females will shed eggs, which are moved progressively towards the lumen of the intestine (S mansoni, S japonicum) and bladder (S haematobium) and are eliminated in the feces or urine, respectively. These eggs will hatch under ideal conditions, releasing miracidia, which penetrate specific snail (mollusk) intermediate hosts and develop into cercariae, continuing the life cycle.

 

While many infections are asymptomatic, acute schistosomiasis (Katayama fever), due to S mansoni or S japonicum, may occur weeks after initial infection. Symptoms include fever, cough, abdominal pain, diarrhea, hepatosplenomegaly, and eosinophilia. Central nervous system infection is uncommon; however, cerebral granulomatous disease may be caused by migration of Schistosoma eggs into the brain or spinal cord. Cystitis and ureteritis with hematuria are associated with S haematobium infection and can progress to bladder cancer.

 

Diagnosis of schistosomiasis can be made by detection of eggs in fecal or urine samples as appropriate for each species. Antibody detection can be useful for patients who reside in nonendemic areas but have recently traveled to regions where Schistosoma species are found and in whom eggs cannot be identified in fecal or urine examinations.

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

Interpretation
Provides information to assist in interpretation of the test results

Negative: No IgG antibodies to Schistosoma species detected.

 

Equivocal: Recommend follow-up testing in 10 to 14 days if clinically indicated.

 

Positive: IgG antibody to Schistosoma species detected. Differentiation between Schistosoma species is not possible by this assay. Serologic cross-reactivity may occur in individuals with other helminth infections, including Echinococcus or Taenia species.

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

This assay is designed to specifically detect IgG-class antibodies to Schistosoma mansoni, which are likely cross-reactive to other Schistosoma species.

 

Sensitivity for detection of antibodies to each of the Schistosoma species has not been evaluated for this assay.

 

Patients may remain seropositive by this assay following appropriate treatment and clearance of the infection.

 

Positive results should be confirmed with other laboratory findings (eg, ova and parasite examination), clinical symptoms, and suitable exposure history.

Supportive Data

The Mayo Clinic Infectious Disease Serology laboratory evaluated the accuracy of the NovaTec Schistosoma mansoni IgG enzyme-linked immunosorbent assay (ELISA) (as performed in our laboratory) using 64 serum samples that were previously tested by a fluorescent microsphere immunoassay at Focus Diagnostics. A comparison of the results is shown in Table 1.

 

Table 1. Accuracy of the NovaTec Schistosoma IgG assay compared to the Focus (Quest) Diagnostics assay

n = 64

Focus (Quest) Diagnostics FMI

Positive

Negative

NovaTec ELISA

Positive

31

1

Negative

1

20

Equivocal

5

6

 

Positive agreement (95% CI): 83.8% (68.5-92.6%)

Negative agreement (95% CI): 96.3% (80.2-100%)

Overall agreement (95% CI): 89.1% (82.6-97%)

 

The Mayo Clinic Infectious Disease Serology laboratory also evaluated the analytic specificity of the NovaTec S mansoni IgG ELISA using 36 serum samples positive for antibodies to other helminth and protozoa. The results are shown in Table 2 below.

 

Table 2. Analytical specificity studies

Specimen

No. of specimens tested

No. of sera positive or equivocal by the S mansoni IgG ELISA

Entamoeba histolytica IgG Ab

6

0

Echinococcus species IgG Ab

6

3

Strongyloides ratti IgG Ab

6

2

Taenia solium IgG Ab

6

2

Trichinella spiralis IgG Ab

6

3

Trypanosoma cruzi IgG Ab

6

1

 

The reference range for the NovaTec S mansoni IgG ELISA was established by testing serum from 50 normal donors; 47/50 (94%) of healthy individuals were negative by this ELISA.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Weerakoon KG, Gobert GN, Cai P, McManus DP: Advances in the diagnosis of human schistosomiasis. Clin Microbiol Rev. 2015 Oct;28(4):939-967

2. McManus DP, Dunne DW, Sacko M, Utzinger J, Vennervald BJ, Zhou XN: Schistosomiasis. Nat Rev Dis Primers. 2018 Aug;4(1):13

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

The qualitative immunoenzymatic determination of IgG-class antibodies against Schistosoma mansoni is based on the enzyme-linked immunosorbent assay (ELISA) technique.

 

Microtiter strip wells are precoated with Schistosoma mansoni antigens to bind corresponding antibodies of the specimen. After washing the wells to remove all unbound sample material, horseradish peroxidase-labelled protein A conjugate is added. This conjugate binds to antigen-antibody complexes. The immune complex formed by the bound conjugate is visualized by adding tetramethylbenzidine substrate, which gives a blue reaction product.

 

The intensity of this product is proportional to the amount of Schistosoma-specific IgG antibodies in the specimen. Sulfuric acid is added to stop the reaction. This produces a yellow endpoint color. Absorbance at 450 nm is read using an ELISA microwell plate reader.(Package insert: NovaLisa Schistosoma mansoni, NovaTec Immundiagnostica GmbH; 07/14/2020)

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.

Tuesday, Thursday

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 5 days

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

14 days

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

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

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  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

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 modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

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.

86682

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
BILHA Schistosoma Ab, IgG, S 33317-9
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.
BILHA Schistosoma Ab, IgG, S 33317-9

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 | PHP Pdf | CMS 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