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HelpTest Code Billings Clinic: 4903 Mayo: HTLVL Human T-Cell Lymphotropic Virus Types I and II (HTLV-I/-II) Antibody Confirmation, Serum
Reporting Name
HTLV-I/-II Ab Confirmation, SPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Useful For
Confirmatory detection of human T-cell lymphotropic virus types I and II (HTLV-I and HTLV-II)-specific IgG antibodies in human serum specimens that are consistently reactive by initial screening tests
Differentiating between HTLV-I- and HTLV-II-specific IgG antibodies
Method Name
Line Immunoassay (LIA)
Ordering Guidance
This confirmatory assay should be ordered only on serum specimens that are consistently reactive by an antihuman T-cell lymphotropic virus 1 and 2 (anti-HTLV-I/-II) screening immunoassay. For an evaluation that includes screening and confirmation, order HTLVI / Human T-Cell Lymphotropic Virus Types I and II Antibody Screen with Confirmation, Serum.
For testing spinal fluid specimens, order HTLLC / Human T-Cell Lymphotropic Virus Types 1 and 2 (HTLV-1/-2) Antibody Confirmation, Spinal Fluid.
Necessary Information
Date of collection is required.
Specimen Required
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Collection Instructions:
1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot serum into plastic vial.
Specimen Type
Serum SSTSpecimen Minimum Volume
0.2 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum SST | Frozen (preferred) | ||
| Refrigerated | 7 days | ||
Reject Due To
| Gross hemolysis | OK |
| Gross lipemia | OK |
| Gross icterus | OK |
Reference Values
Negative
Interpretation
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) greater than or equal to 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.
Day(s) Performed
Tuesday
Report Available
2 to 15 daysTest Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
86689
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| HTLVL | HTLV-I/-II Ab Confirmation, S | 55162-2 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 83277 | HTLV-I/-II Ab Confirmation, S | 22362-8 |
| 23898 | HTLV-I/-II Bands | 61112-9 |
| 23899 | HTLV-I/-II Discrimination | 77744-1 |
Forms
If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.