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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.
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.