Elecsys® HTLV-I/II

Immunoassay for the qualitative determination of total antibodies to human T-lymphotropic virus I/II

The human T-lymphotropic viruses (HTLV) types I and II are retroviruses that have infected approximately 20 million people worldwide^1,2. The virus can be transmitted from mother to child via breastfeeding, through hetero- or homosexual intercourse, sharing contaminated needles, or via contaminated blood products.^3,4

As a result of infection via intravenous drug use and secondary sexual contact, HTLV-I / II have entered the general and blood donor populations.⁵ 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).^1,4

Contact

Elecsys^® Anti-HTLV-I/II

Systems

cobas e 411 analyzer, cobas e 601 module, cobas e 801 module
Testing Time

18 minutes
Test principle

One-step double-antigen sandwich immunoassay
Assay detects total IgG and IgM against viral recombinant antigens p24 and gp21
Calibration

2-point
Interpretation

COI <1.0 = non-reactive
COI ≥1.0 = reactive
Sample material

Serum collected using standard sampling tubes or tubes containing separating gel. Li‑heparin, Na‑heparin, K2‑EDTA, K3‑EDTA, ACD, CPD, CP2D, CPDA and Na‑citrate plasma. K2‑EDTA plasma tubes containing separating gel can be used.
cobas e flow

Duplicate repeat of initially reactive samples - cobas e 801 module
Sample volume

30 μL cobas e 411 analyzer, cobas e 601 module
18 μL cobas e 801 module
Onboard stability

28 days cobas e 411 analyzer, cobas e 601 module
16 weeks cobas e 801 module
Intermediate precision in positive samples

cobas e 411 analyzer: CV 3.3 – 7.2 %
cobas e 601 module: CV 1.8 – 2.3 %
cobas e 801 module: CV 1.7 – 2.7 %
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

References

Gessain, A., Mahieux, R. (2012). Tropical spastic paraparesis and HTLV-1 associated myelopathy: clinical, epidemiological, virological and therapeutic aspects. Rev Neurol 168, 257-69.
Proietti, F.A. et al. (2005). Global epidemiology of HTLV-I infection and associated diseases. Oncogene 24, 6058-68.
Szczypinska, E.M. et al. (2014). Human T-Cell Lymphotropic Viruses. Medscape. Available at: http://emedicine.medscape.com/article/219285.
Gonçalves, D.U. et al. (2010). Epidemiology, Treatment, and Prevention of Human T-Cell Leukemia Virus Type 1-Associated Diseases. Clin Microbiol Rev. 23, 577-89.
Roucoux, D.F., Murphy, E.L. (2004). The epidemiology and disease outcomes of human T-lymphotropic virus type II. AIDS Rev. 6, 144-54.

Elecsys® Anti-HTLV-I/II

Immunoassay for the qualitative determination of total antibodies to human T-lymphotropic virus I/II

Elecsys® Anti-HTLV-I/II

Elecsys^® Anti-HTLV-I/II

Elecsys^® Anti-HTLV-I/II