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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, 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 >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 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 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.
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 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
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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