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HelpTest Code HTLVL Human T-Cell Lymphotropic Virus Types I and II (HTLV-I/-II) Antibody Confirmation, Serum
Reporting Name
HTLV-I/-II Ab Confirmation, SUseful 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
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
Serum SSTOrdering 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 Minimum Volume
0.2 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum SST | Frozen (preferred) | ||
| Refrigerated | 7 days | ||
Reference Values
Negative
Day(s) Performed
Tuesday
Test 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 |
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.
Clinical Reference
1. 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. doi:10.1016/j.neurol.2011.12.006
2. Mahieux R, Gessain A. Adult T-cell leukemia/lymphoma and HTLV-I. Curr Hematol Malig Rep. 2007;2(4):257-264. doi:10.3390/v8060161
3. Yamano Y, Sato T. Clinical pathophysiology of human T-lymphotropic virus-type I-associated myelopathy/tropical spastic paraparesis. Front Microbiol. 2012;3:389. doi:10.3389/fmicb.2012.00389
4. Marrero Rolon RM, Yao JDC. Laboratory diagnosis of HTLV-1-associated myelopathy. Clin Microbiol Newslett. 2020;42(16)129-134. doi:10.1016/j.clinmicnews.2020.07.004
Report Available
2 to 15 daysMethod Name
Line Immunoassay (LIA)
Forms
If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.