Human T-Cell Lymphotropic Virus Types I and II Antibody Screen with Confirmation, Serum
Use
This test is used for the qualitative detection of human T-cell lymphotropic virus types I and II (HTLV-I and HTLV-II) specific antibodies. It includes confirmation and differentiation between HTLV-I and HTLV-II infection. Useful for diagnosing infections that are endemic in certain regions and can be associated with conditions like adult T-cell leukemia, HTLV-associated myelopathy, or tropical spastic paraparesis.
Special Instructions
This test is for serum specimens only. It should not be used to screen blood, human cells, tissues, or solid-organ donors and is not intended for use on cord blood specimens. If the antibody screen is reactive, an additional charge will apply for the confirmatory line immunoassay test.
Limitations
A negative result does not exclude the possibility of infection, especially in early stages where antibody levels might be undetectable. Confirmatory testing is necessary for initially reactive results due to potential low specificity, and to differentiate between HTLV-I and HTLV-II infections. Performance characteristics are not established for grossly lipemic, hemolyzed, icteric, particulate, or cadaveric specimens.
FDA ApprovedNew York Approved
Methodology
Immunoassay (ELISA)
Biomarkers
LOINC Codes
- 29901-6
- 29901-6
Result Turnaround Time
1-4 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1 mL
Minimum Volume
0.6 mL
Container
Preferred: Serum gel; Acceptable: Red top; Submission: Plastic vial
Collection Instructions
Centrifuge blood collection tube per manufacturer's instructions (e.g., centrifuge within 2 hours of collection for BD Vacutainer tubes). Aliquot serum into plastic vial.
Storage Instructions
Store frozen (preferred) for up to 28 days, or refrigerated for up to 7 days.
Causes for Rejection
Reject if gross hemolysis, lipemia, icterus, precipitated, or heat-treated specimens.
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 7 days |
| Frozen | 28 days |