Test ID: HTLVI    
Human T-Cell Lymphotropic Virus Types I and II (HTLV-I/-II) Antibody Screen with Confirmation, Serum

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.

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 (ATL), and a chronic degenerative neurologic disease known as HTLV-I-associated myelopathy (HAM) or tropical spastic paraparesis (TSP). 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 >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 immunoassays (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.

Negative

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.

-Positive results for HTLV-I antibodies indicate the confirmed presence of HTLV-I IgG antibodies in serum, based on 2 visible antibody bands that include gp21-I/-II band, or 3 or more bands, and the sum of the gp46-I and p19-I band intensity is greater than the gp46-II band intensity.

-Positive results for HTLV-II antibodies indicate the confirmed presence of HTLV-II IgG antibodies in serum, based on 2 visible antibody bands that include gp21-I/-II band, or 3 or more bands, and the gp46-II band intensity is a) greater than the gp46-I band intensity and b) > or =the sum of the gp46-I and p19-I band intensity.

Indeterminate LIA results indicate the presence of gp21-I/-II band only or combination of any 2 bands without a detectable gp21-I/-II band. Patients with indeterminate test results with known risk factors for HTLV-I or HTLV-II infection should undergo repeat confirmatory antibody testing in 1 to 2 months to determine final infection status.

When the LIA band intensity pattern does not meet the criteria of a positive HTLV-I- or HTLV-II-antibody band intensity pattern, differentiation of HTLV-I and HTLV-II infection is not possible (ie, nontypeable HTLV antibodies).

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.

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

This test is not intended for screening 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 serum specimens that are hemolyzed, lipemic, icteric, or contain particulate matter.

1. Centers for Disease Control and Prevention: Guidelines for counseling persons infected with human T-lymphotropic virus type I (HTLV-I) and type II (HTLV-II). MMWR Morb Mortal Wkly Rep 1993;42(RR-9):1-13

2. Murphy E, Roucoux D: The epidemiology and disease outcome of human T-lymphotropic virus type II. AIDS Rev 2004;6:144-154

3. Projetti FA, Carneiro-Projetti AB, Catalan-Soares BC, et al: Global epidemiology of HTLV-I infection and associated diseases. Oncogene 2005;24:6058-6068