Elecsys® HTLV-I/II


Map showing in color endemic areas fro HTLV-I and HTLV-II infections

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
Calibration 2-point
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,
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