Human T-Lymphotropic Virus (HTLV) I/II EIA

Test Code: 30818

A special account is required to order pre-transplant testing. Contact Client Services or your account executive to set up a pre-transplant account to order this assay. Specimens should not be collected until after an account has been created.

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Clinical and Procedure
Clinical Utility

The Alinity s HTLV I/II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to human T-lymphotropic virus Type I and/or human T-lymphotropic virus Type II (anti-HTLV I/HTLV II) in human serum and plasma specimens on the Alinity s System.

The Alinity s HTLV I/II assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HTLV I/HTLV II. The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and

in testing serum specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens.

About HTLV

Human T-lymphotropic virus Type I (HTLV I) and Type II (HTLV II) are closely related but distinct retroviruses that can infect humans. HTLV I causes adult T-cell leukemia (ATL) and HTLV I-associated myelopathy/tropical spastic paraparesis (HAM/TSP).1 Although HTLV II is less pathogenic than HTLV I, it has been associated with

a neurological disease similar to HAM/TSP2, 3 and with chronic inflammatory arthropathy.1 HTLV I infection is endemic in south Japan4, the Caribbean5, in

some regions of Africa6, Central and South America7 and also found in Melanesia,8 the Middle East,9 and central and northern Australia.10, 11 HTLV II infection is endemic to a number of indigenous American Indian populations.7, 12 Both HTLV I and HTLV II are distributed worldwide.

HTLV I and HTLV II were the first discovered human retroviruses,13, 14 both viruses belonging to the oncovirus subfamily of retroviruses.15 Unlike HIV retroviruses, HTLV I and HTLV II show minimal genetic variation, mainly in the env, which defines the HTLV subtypes.16 HTLV I has six reported subtypes (subtypes A to F).17 HTLV II has four reported subtypes (subtypes A to D).18, 19 However, there is no reported association of a particular HTLV I or HTLV II subtype with a specific disease.19, 20 Transmission of HTLV I and HTLV II infection occurs via transfusion of infected cellular blood products,21-26 via breast feeding,27-30 sexual

contact,31 and sharing of contaminated needles and syringes by intravenous drug users.32, 33 Mother-to-child transmission of HTLV II has recently been reported.34

HTLV I and HTLV II antibodies develop within 4 to 8 weeks after infection. Most individuals infected with HTLV I and HTLV II are asymptomatic, and the infection is lifelong.35

HTLV I/HTLV II antibody assays are used to identify individuals infected with HTLV I or HTLV II and to prevent transmission of the virus to recipients of blood, blood components, and organs.

Procedure

This assay is a two-step immunoassay for the qualitative detection of antibodies to HTLV I and HTLV II in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology. Sample, HTLV I/HTLV II coated paramagnetic microparticles, and assay diluent are combined and incubated. The antibodies to HTLV I/HTLV II present in the sample bind to the HTLV I/HTLV II synthetic peptides and HTLV II recombinant antigen coated microparticles. The mixture is washed. HTLV I/HTLV II

synthetic peptides and HTLV I recombinant antigen acridinium labeled conjugate is added to create a reaction mixture and incubated. Following a wash cycle, Pre-Trigger and Trigger Solutions are added.

The resulting chemiluminescent reaction is measured as relative light units (RLU). There is a direct relationship between the amount of antibodies to HTLV I/HTLV II in the sample and the RLU detected by the system optics.

The presence or absence of antibodies to HTLV I/HTLV II in the sample is determined by comparing the chemiluminescent RLU in the reaction to the cutoff RLU determined from an active calibration.

Test performed by Eurofins DPT, 6933 S. Revere Parkway, Centennial, CO 80112.

This test has been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. See package insert for more information.

Turnaround Time

Within 24 hours from receipt of specimen.

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
Plasma (1) 30818 86687/86688 Yes

200 µL (min 100 µL)

Qualitative

Living

  • Collect whole blood in an EDTA, lavender top tube. Whole blood in ACD, Lithium Heparin, Sodium Citrate, or Sodium Heparin tubes are also accepted. Do not freeze whole blood.
  • Plasma shipped within 7 days ambient, 14 days refrigerated, or within 90 days frozen.
  • If not shipping original container, centrifuge and transfer 300 µL (min 150 µL) plasma to screw top tube.

To ensure sample volume for all testing performed for donor screening, it is recommended to submit (2) Red Top Tubes and (1) EDTA Tube and ensure the tubes are filled completely
Serum (1) 30818 86687/86688 Yes

200 µL (min 100 µL)

Qualitative

Living

  • Collect whole blood in a gold, red, or red/gray tiger top tube. Do not freeze whole blood.
  • Sample sent in original vacutainer tube can be shipped within 7 days ambient, within 14 days, or within 90 days frozen.
  • If not shipping original container, centrifuge and transfer 300 µL (min 150 µL) serum/plasma to screw top tube.

Postmortem - Serum only

  • Collect whole blood in a gold, red, or red/gray tiger top tube. Do not freeze whole blood.
  • Sample sent in original vacutainer tube can be shipped within 3 days ambient, within 14 days, or within 90 days frozen.
  • If not shipping original container, centrifuge and transfer 300 µL (min 150 µL) serum to screw top tube.

To ensure sample volume for all testing performed for donor screening, it is recommended to submit (2) Red Top Tubes and (1) EDTA Tube and ensure the tubes are filled completely.
Shipping

All specimens must be labeled with patient's name and collection date. Please contact Client Services or your Account Executive for detailed shipping instructions.

Causes for Rejection

Whole blood frozen, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

Disclaimer

All Alinity s Platform individual assays have been FDA approved for Living and Cadaveric donor samples. All Alinity s Platform individual assays are CE marked. For more information, please use the FDA HCT/P Approved Testing link here.

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Eurofins DPT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins DPT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References
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  2. Araujo A, Hall WW. Human T-lymphotropic virus type II and neurological disease. Ann Neurol 2004;56(1):10–19.
  3. Hjelle B, Appenzeller O, Mills R, et al. Chronic neurodegenerative disease associated with HTLV-II infection. Lancet 1992;339:645–646.
  4. The T- and B-Cell Malignancy Study Group. Statistical Analysis of Clinico-pathological, Virological and Epidemiological Data on Lymphoid Malignancies with Special Reference to Adult T-Cell Leukemia/ Lymphoma: A report of the Second Nationwide Study of Japan. Jap. J Clin Oncol 1985; 1593:517.
  5. Newton M, Cruickshank K, Miller D. et al. Antibody to Human T Lymphotropic Virus Type I in West-Indian Born UK Residents with Spastic Paraparesis. Lancet 1987; I:415.
  6. Saxinger W, Blattner WA, Levine PH, et al. Human T-cell leukemia virus (HTLV-I) antibodies in Africa. Science 1984;225:1473-1476.
  7. Maloney EM, Biggar RJ, Neel JV, et al. Endemic Human T-cell Lymphotropic Virus Type II Infection Among Isolated Brazilian Amerindians. J Infect Dis 1992; 166:100.
  8. Yanagihara R, Jenkins CL, Alexander SS, More CA, et al. Human T-lymphotropic Virus Type I Infection in Papua New Guinea: High Prevalence Among the Hagahai Confirmed by Western Blot Analysis. J. Infect. Dis 1990; 162:649.
  9. Safai B, Huang J-L, Boeri E, et al. Prevalence of HTLV type I infection in Iran: A serological and genetic study. AIDS Research and Human Retroviruses 1996;12(12):1185-1190.
  10. Bastian I, Gardner J, Webb D, Gardner I. Isolation of Human T-Lymphotropic Virus Type-I Strain from Australian Aboriginals. J. Virol. 1993; 67(2):843.
  11. Gessain A, Cassar O. Epidemiological aspects and world distribution of HTLV-1 infection. Frontiers in Microbiology 2012;3(388):1-23.
  12. Murphy EL, Mahieux R, de The G, et al. Molecular epidemiology of HTLV-II among United States blood donors and intravenous drug users: An age–cohort effect for HTLV-II RFLP type a0. Virology 1998;242:425–434.
  13. Poiesz BJ, Ruscetti FW, Gazdar AF, et al. Detection and isolation of type C retrovirus particles from fresh and cultured lymphocytes of a patient with cutaneous T-cell lymphoma. Proc Natl Acad Sci USA 1980;77(12):7415-7419.
  14. Poiesz BJ, Ruscetti FW, Reitz MS, et al. Isolation of a new type C retrovirus (HTLV) in primary uncultured cells of a patient with Sezarry T-cell leukemia. Nature (London) 1981;294:268-271.
  15. Centers for Disease Control and Prevention. Recommendations for counseling persons infected with human T-lymphotropic virus, types I and II. Recommendations on prophylaxis and therapy for disseminated Mycobacterium avium complex for adults and adolescents infected with human immunodeficiency virus. MMWR 1993;42(RR-9):1-13.
  16. Proietti FA, Carneiro-Proietti AB, Catalan-Soares BC, et al. Global epidemiology of HTLV-I infection and associated diseases. Oncogene 2005;24(39):6058-6068.
  17. Goncalves DU, Proietti FA, Ramos Ribas JG, et al. Epidemiology, treatment, and prevention of human T-cell leukemia virus type 1-associated diseases. Clinical Microbiology Reviews 2010;23(3):577-589.
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  19. Vandamme A-M, Salemi M, Van Brussel M, et al. African origin of human T-lymphotropic virus type 2 (HTLV-2) supported by a potential new HTLV-2d subtype in Congolese Bambuti Efe Pygmies. J Virol 1998;72(5):4327-4340.
  20. Ehrlich GD, Andrews J, Sherman MP, et al. DNA sequence analysis of the gene encoding the HTLV-I p21e transmembrane protein reveals inter- and intraisolate genetic heterogeneity. Virology. 1992;186(2):619-627.
  21. Donegan E, Pell P, Lee H, et al. Transmission of human T-lymphotropic virus type I by blood components from a donor lacking anti-p24: A case report. Transfusion 1992;32:68-71.
  22. Okochi K, Sato H, Hinuma Y. A retrospective study on transmission of adult T cell leukemia virus by blood transfusion: Seroconversion in recipients. Vox Sang 1984;46(5):245-253.
  23. Sato H, Okochi K. Transmission of human T-cell leukemia virus (HTLV-I) by blood transfusion: Demonstration of proviral DNA in recipients’ blood lymphocytes. Int J Cancer 1986;37(3):395-400.
  24. Kaplan JE, Litchfield B, Rouault C, et al. HTLV-I-associated myelopathy associated with blood transfusion in the United States: Epidemiologic and molecular evidence linking donor and recipient. Neurology 1991;41:192-197.
  25. Kleinman S, Swanson P, Allain JP, et al. Transfusion transmission of human T-lymphotropic virus types I and II: Serologic and polymerase chain reaction results in recipients identified through look-back investigations. Transfusion 1993;33(1):14-18.
  26. Saxton EH, Lee H, Swanson P, et al. Detection of human T-cell l Leukemia/lymphoma virus type I in a transfusion recipient with chronic myelopathy. Neurology 1989;39:841-844.
  27. Hino S, Yamaguchi K, Katamine S, et al. Mother-to-child transmission of human T-cell leukemia virus type I. Jpn J Cancer Res (GANN) 1985;76:474-480.
  28. Kusuhara K, Sonoda S, Takahashi K, et al. Mother-to-child transmission of human T-cell leukemia virus type I (HTLV-I): A fifteen-year follow-up study in Okinawa, Japan. Int J Cancer 1987;40:755-757.
  29. Ureta-Vidal A, Angelin-Duclos C, Tortevoye P, et al. Mother-to-child transmission of human T-cell-leukemia/lymphoma virus type I: Implication of high antiviral antibody titer and high proviral load in carrier mothers. Int J Cancer 1999;82:832-836.
  30. Takahashi K, Takezaki T, Oki T, et al. Inhibitory effect of maternal antibody on mother-to-child transmission of human T-lymphotropic virus type I. Int J Cancer 1991;49:673-677.
  31. Kajiyama W, Kashiwagi S, Ikematsu H, et al. Intrafamilial transmission of adult T cell leukemia virus. J Infect Dis 1986;154(5):851-857.
  32. Robert-Guroff M, Weiss SH, Giron JA, et al. Prevalence of antibodies to HTLV-I, -II, and -III in intravenous drug abusers from an AIDS endemic region. JAMA 1986;255(22):3133-3137.
  33. Centers for Disease Control and Prevention. Human T-lymphotropic virus type I screening in volunteer blood donors - United States, 1989. MMWR 1990;39(50): 915-924.
  34. Lal RB, Owen SM, Segurado AA, et al. Mother-to-child transmission of human T-lymphotropic virus type II (HTLV-II). Ann Intern Med 1994;120(4):300-301.
  35. 35. Parija SC. Retoviruses. In: Bhattacharya SM, Nasim S, Kumar S, editors. Microbiology & Immunology 2nd ed. Haryana, India: Elsevier; 2012:560-565.

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