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Differentiating between HTLV-I- and HTLV-II-specific IgG antibodies
A negative line immunoassay result does not preclude the possibility of exposure to human T-cell lymphotropic virus types I and II.
Results from this confirmatory assay should always be interpreted together with the reactive screening test result on a given specimen.
Line Immunoassay (LIA)
This test should be regarded as 'Research Use Only'. This test has not been cleared or approved by the U.S. Food and Drug Administration. It may not be covered by insurance and providers need to inform all patients of this prior to ordering.
For Medicare patients, an Advanced Beneficiary notice (ABN) is required; for Medicaid patients, a Noncovered Services Waiver is required, and for commercial payers, prior authorization should be obtained.
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, the 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 have also been reported in HTLV-I-infected patients.
HTLV-II is prevalent among injection drug users in the United States and in Europe, and more than 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 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 confirmatory test 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 (enzyme immunoassay) result with a negative or indeterminate confirmatory (line immunoassay) test result suggests either a false-reactive screening test result or a seroconverting HTLV infection. Repeat testing with a new specimen can clarify the final infection status. Persistently indeterminate confirmatory test results indicate absence of HTLV infection.
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) equal or greater than the sum of the gp46-I and p19-I band intensity.
Indeterminate 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 with a new specimen to determine final infection status.
Differentiation of HTLV-I and HTLV-II infection is not possible (ie, nontypeable HTLV antibodies) when the band intensity pattern does not meet the criteria of positive HTLV-I or HTLV-II antibody band intensity pattern.
Unreadable results indicate the presence of nonspecific background reactivity that is inhibiting the visualization of specific bands on the test strip. Repeat testing with a new specimen is recommended.
Invalid results indicate that nonspecific band reactivity is present. Submit another serum specimen for retesting, if clinically indicated.