HTLV I/II Antibody with Reflex to Confirmatory Assay
Use
This test is intended to aid in the clinical diagnosis of Human T‑lymphotropic Virus Type I (HTLV‑1) or Type II (HTLV‑II) infection by detecting antibodies using an ELISA screening assay. Reactive specimens reflex to a supplemental line immunoassay (LIA) for confirmation and differentiation of HTLV‑I and HTLV‑II type. Low‐titer specimens or early seroconverters may yield false‐negative results, thus repeat testing or nucleic acid amplification testing should be considered when clinical suspicion persists or results are indeterminate.
Special Instructions
Not provided.
Limitations
While the ELISA has high sensitivity, specimens with low antibody titers or early seroconversion may yield false‑negative results. Indeterminate reflex results warrant further evaluation, including repeat serology after approximately 3 months or use of nucleic acid amplification tests (NAAT) to detect infection in the window period prior to antibody development.
Methodology
Immunoassay (Other)
Biomarkers
Result Turnaround Time
3-9 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1 mL
Minimum Volume
1 mL
Container
SST
Storage Instructions
If transport temperature will be frozen, centrifuge the red/lavender‑top and transfer the serum/plasma into a plastic, screw‑cap vial labelled with specimen type and two unique identifiers. Do not send original tube if submitting aliquot.
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 14 days |
| Frozen | 30 days |