Test Catalog

Test Id : HTLVI

Human T-Cell Lymphotropic Virus Types I and II Antibody Screen with Confirmation, Serum

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

Qualitative detection of human T-cell lymphotropic virus types I and II (HTLV-I and HTLV-II)-specific antibodies with confirmation and differentiation between HTLV-I and HTLV-II infection

 

This test is not intended for screening blood, human cells, tissues, or solid-organ donors.

 

This test is not intended for use on cord blood specimens.

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
HTLVL HTLV-I/-II Ab Confirmation, S Yes No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If this screen is reactive, then antibody confirmation by line immunoassay will be performed at an additional charge.

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

HTLV-I/-II Ab Screen, S

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

HTLV

HTLV-1

HTLV-2

HTLV Ab

HTLV antibody

HTLV-1 Antibody

HTLV-2 Antibody

HTLV-1 Ab

HTLV-2 Ab

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If this screen is reactive, then antibody confirmation by line immunoassay will be performed at an additional charge.

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

This test is for serum specimens only. For spinal fluid, order HTLVC / Human T-Cell Lymphotropic Virus Types 1 and 2 (HTLV-1/-2) Antibody Screen with Confirmation, Spinal Fluid.

Necessary Information

Date of collection is required.

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:

1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into plastic vial.

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

0.6 mL

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

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject
Heat-treated or precipitated specimens 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 (preferred) 28 days
Refrigerated 7 days

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

Qualitative detection of human T-cell lymphotropic virus types I and II (HTLV-I and HTLV-II)-specific antibodies with confirmation and differentiation between HTLV-I and HTLV-II infection

 

This test is not intended for screening blood, human cells, tissues, or solid-organ donors.

 

This test is not intended for use on cord blood specimens.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If this screen is reactive, then antibody confirmation by line immunoassay will be performed at an additional charge.

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

Human T-cell lymphotropic virus types I and II (HTLV-I and HTLV-II) are closely related exogenous human retroviruses. HTLV-I was first isolated in 1980 from a patient with a cutaneous T-cell lymphoma, while HTLV-II was identified from a patient with hairy cell leukemia in 1982.

 

HTLV-I infection is endemic in southwestern Japan, Caribbean basin, Melanesia, and parts of Africa, where HTLV-I seroprevalence rates are as high as 15% in the general population. In the United States, the combined HTLV-I and HTLV-II seroprevalence rate is about 0.016% among voluntary blood donors. About half of these infected blood donors are infected with HTLV-I, with most of them reporting a history of birth in HTLV-I-endemic countries or sexual contact with persons from the Caribbean or Japan. Smaller percentages report a history of either injection drug use or blood transfusion. Transmission of HTLV-I occurs from mother to fetus, sexual contact, blood transfusion, and sharing of contaminated needles. Two diseases are known to be caused by HTLV-I infection: adult T-cell leukemia or lymphoma, and a chronic degenerative neurologic disease known as HTLV-I-associated myelopathy or tropical spastic paraparesis. Cases of polymyositis, chronic arthropathy, panbronchiolitis, and uveitis also have been reported in HTLV-I-infected patients.

 

HTLV-II is prevalent among injection drug users in the United States and in Europe, and over 80% of HTLV infections in drug users in the United States are due to HTLV-II. HTLV-II also appears to be endemic in Native American populations, including the Guaymi Indians in Panama and Native Americans in Florida and New Mexico. HTLV-II-infected blood donors most often report either a history of injection drug use or a history of sexual contact with an injection drug user. A smaller percentage of infected individuals report a history of blood transfusion. HTLV-II is transmitted similarly to HTLV-I, but much less is known about the specific modes and efficiency of transmission of HTLV-II. The virus can be transmitted by transfusion of cellular blood products (whole blood, red blood cells, and platelets). HTLV-II infection has been associated with hairy-cell leukemia, but definitive evidence is lacking on a viral etiologic role. HTLV-II has also been linked with neurodegenerative disorders characterized by spastic paraparesis and variable degrees of ataxia.

 

Infection by these viruses results in the appearance of specific antibodies against the viruses that can be detected by serologic tests such as enzyme immunoassay (EIA). For accurate diagnosis of HTLV-I or HTLV-II infection, all initially screening test-reactive results should be verified by a confirmatory test, such as Western blot or line immunoassay.

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 screening results indicate the absence of both human T-cell lymphotropic virus types I and II (HTLV-I- and HTLV-II)-specific IgG antibodies in serum.

 

A reactive screening test result is suggestive of infection with either HTLV-I or HTLV-II. However, this result does not confirm infection (eg, low specificity), and it cannot differentiate between HTLV-I and HTLV-II infection.

 

Specimens with reactive screening test results will be tested automatically by the line immunoassay (LIA) confirmatory test. Positive LIA results provide confirmatory evidence of infection with HTLV-I or HTLV-II.

 

A reactive screening result with a negative or indeterminate confirmatory test result suggests either a false-reactive screening test result or a seroconverting HTLV infection. Repeat testing in 1 to 2 months can clarify the final infection status. Persistently indeterminate confirmatory test results indicate absence of HTLV infection.

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

This test is not offered as a screening or confirmatory test for serum specimens from blood, human cells, tissues, or solid organ donors.

 

A negative test result does not exclude the possibility of exposure to human T-cell lymphotropic virus types I and II (HTLV-I or HTLV-II). Levels of total antibodies to these viruses may be undetectable in early infection.

 

Performance characteristics have not been established for the following specimen characteristics:

-Grossly icteric (total bilirubin level of >20 mg/dL)

-Grossly lipemic (triolein level of >3000 mg/dL)

-Grossly hemolyzed (hemoglobin level of >3051 mg/dL)

-Containing particulate matter

-Cadaveric specimens

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

1. Araujo A, Hall WW: Human T-lymphotropic virus type II and neurological disease. Ann Neurol. 2004;56(1):10-19

2. Mahieux R, Gessain A: Adult T-cell leukemia/lymphoma and HTLV-I. Curr Hematol Malig Rep. 2007;2(4):257-264

3. Yamano Y, Sato T: Clinical pathophysiology of human T-lymphotropic virus-type I-associated myelopathy/tropical spastic paraparesis. Front Microbiol. 2012;3:1-10

4. Gessain A, Mahieux R: Tropical spastic paraparesis and HTLV-I associated myelopathy: clinical, epidemiological, virological, and therapeutic aspects. Rev Neurol (Paris). 2012;168(3):257-269

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

The Avioq HTLV-I/II Microelisa System is an enzyme-linked immunosorbent assay in which the solid phase (microwells) is coated with a purified human T-cell lymphotropic virus types I (HTLV-I) viral lysate, a purified HTLV-II viral lysate, and a recombinant HTLV-I p21E antigen. With the addition of a diluted test sample containing antibodies to either HTLV-I or HTLV-II, complexes are formed by the interaction of the antibodies in the sample and the solid phase antigens. Following incubation, the sample is aspirated and the well is washed with buffer. Subsequently, antihuman immunoglobulin (goat) conjugated with horseradish peroxidase (HRP) is added, which binds the antibody-antigen complex during a second incubation. Following a wash and incubation with TMB (tetramethylbenzidine) substrate, a blue color is produced. The enzyme reaction is stopped by the addition of a sulfuric acid solution, which changes the color to yellow. The amount of HTLV-I / HTLV-II specific antibodies present in the sample is proportional to the color intensity.(Package insert: Avioq HTLV-I/II Microelisa System. Avioq, Inc; 05/2019)

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 through Friday

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.

1 to 4 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.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. 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 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.

86790

86689 (if appropriate)

LOINC® Information

Test Id Test Order Name Order LOINC Value
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.
HTLVI HTLV-I/-II Ab Screen, S 29901-6
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.
9539 HTLV-I/-II Ab Screen, S 29901-6

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 | Create a 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