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Elecsys® HTLV-I/II

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

Elecsys® HTLV-I/II

Immunoassay for the qualitative determination of 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 worldwide1,2. 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

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Elecsys HTLV-I/II

Elecsys® HTLV-I/II

  • Systems

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules, cobas e 402 / cobas e 801 analytical units

  • 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.

    Specimen collected from living patients, blood donors, or individual organ, tissue or call donors may be used, including samples obtained while the donor's heart is still beating, and cadaveric blood specimens (specimens collected post-mortem, non-heart-beating).

  • Sample volume

    30 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    18 μL cobas e 402 / cobas e 801 analytical units

  • Onboard stability

    28 days cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    16 weeks cobas e 402 / cobas e 801 analytical units

  • Intermediate precision in positive samples

    cobas e 411 analyzer: CV 4.6 – 6.3 %
    cobas e 601 / cobas e 602 modules: CV 2.3 – 3.2 %
    cobas e 402 / cobas e 801 analytical units: CV 1.7 – 3.1 %

  • 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

     

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    References

    1. Gessain A. Tropical spastic paraparesis and HTLV-1 associated myelopathy: clinical, epidemiological, virological and therapeutic aspects. Rev Neurol. 2012;168:257-69.
    2. Proietti FA, Carneiro-Proietti AB, Catalan-Soares BC, Murphy EL. Global epidemiology of HTLV-I infection and associated diseases. Oncogene 2005;24:6058–68.
    3. Yabes, JM. Human T-cell lymphotropic virus (HTLV) [Internet; updated 2019 Aug, cited 2022 Oct]. Available from: https://emedicine.medscape.com/article/219285-overview.
    4. Gonçalves DU, et al. Epidemiology, treatment, and prevention of human T-cell leukemia virus type 1-associated diseases. Clin Microbiol Rev. 2010 Jul;23:577-89.
    5. Roucoux DF, Murphy EL. The epidemiology and disease outcomes of human T-lymphotropic virus type II. AIDS Rev. 2004;6:144–54.
    6. Elecsys® HTLV-I/II Pack Inserts for 09015175190, 09015230190, 09015272190, 2021-11, V1.0.