Safe blood supply and diagnostic excellence
- The human T-lymphotropic viruses (HTLV) types I and II are retroviruses that preferentially infect either CD4+ T-cells
(HTLV-I) or CD8+ T-cells (HTLV-II) of the human immune system.
- The viruses can be transmitted vertically from mother to child by breastfeeding, through hetero- or homosexual intercourse, by sharing contaminated needles, or via contaminated blood products.
- Approximately 20 million people worldwide are infected by HTLV-I/II in pockets of endemism.
- HTLV-I is the most clinically relevant of the two viruses and has been directly associated with the life-threatening disease adult T-cell leukemia/lymphoma (ATLL) and the life-debilitating condition HTLV-associated myelopathy/tropical spastic paraparesis (HAM/TSP).
- Automated serological assays like the Elecsys HTLV-I/II are the method of choice for screening of blood products and routine clinical samples.
|Assay time||18 min|
|Test principle||3rd generation one-step double-antigen sandwich immunoassay
Assay detects total IgG/IgM against viral recombinant antigens p24 and gp21
|Interpretation||Non-reactive: < 1.00 COI, Reactive: ≥ 1.00 COI|
|Sample material||Li-heparin, K2- and K3-EDTA, CPDA plasma as well as K2-EDTA|
|Sample volume||30 µL plasma tubes containing separating gel|
|Systems||cobas e 411 analyzer, cobas e 601/e 602 modules,
MODULAR® ANALYTICS <E 170>
|Intermediate precision in positive samples||cobas e 411 analyzers CV: 3.3 – 7.2 %
MODULAR® ANALYTICS <E 170> and cobas e 601/e 602 analyzers CV: 1.6 – 2.3 %
|Clinical sensitivity||100 % (n = 1,149)|
|Clinical specificity||99.95 % (n = 11,575 blood donors)
99.83 % (n = 2,399 diagnostic routine samples including pregnant women)
|Analytical specificity||100 % in a collective of 222 potentially cross-reacting samples|
Designed for high sensitivity and specificity
- High sensitivity and specificity minimizes the probability of missing true positives in all stages of infection and leads to less re-testing.
Clear interpretation of results
- Clear cut-off separation of positive and negative results
Efficient use of sample volume and time
- Only 30 uL sample volume required
- Result obtained in only 18 minutes
Efficiency for diagnostic use and blood donor screening
- Fully automated and integrated with other tests in the STD, TORCH and Blood Safety Solution portfolios