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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 account has been created.

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Clinical Utility

Avioq HTLV-I/II Microelisa System is a qualitative enzyme-linked Immunosorbent assay (ELISA) for the detection of antibodies to Human T-Lymphotropic Virus Type I (HTLV-I) and/or Human T-Lymphotropic Virus Type II (HTLV-II) in human serum or plasma samples. It is intended for screening 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, and for use as an aid in clinical diagnosis of HTLV-I or HTLV-II infection and related diseases. It is not intended for use on cord blood specimens. In addition to being used as a Manual assay, the assay is also intended for use with the ORTHO® Summit System (OSS) for screening blood donors.

About HTLV

HTLV-I, a human type C retrovirus, has been etiologically associated with Adult T-Cell Leukemia (ATL)1-4 and with a demyelinating neurologic disorder termed Tropical Spastic Paraparesis, and/or HTLV-I Associated Myelopathy (TSP/HAM). Antibodies to HTLV-I are found with high frequency in persons affected with these disorders. However, it is well established in studies from viral endemic areas that virus negative ATL and TSP/HAM are seen. More recently, HTLV-I infection has been shown to be associated with B- and T-cell chronic lymphatic leukemia (CLL),5,6 multiple myeloma,7 some cases of non-Hodgkin’s lymphoma (NHL),8 polymyositis,9 arthritis,10,11 Kaposi’s sarcoma,12 uveitis,13 strongyloidiasis5 and mycosis fungoides.14,15 HTLV-I is endemic in some Caribbean countries, Southern Japan, and possibly in some areas of Africa.16-21 In the United States, HTLV-I has been identified in ATL patients, intravenous drug abusers, and in healthy individuals. HTLV-II, a related virus, is endemic in several Amerindian tribes,22-25 but has not been unequivocally proven to be a pathogen. A high rate of HTLV-II seropositives has been observed among intravenous drug abusers.26-28 The first reported patients with HTLV-II infections presented with an atypical T-cell variant of hairy cell leukemia. More recent observations led to the assumption that HTLV-II may be associated with large granular lymphocyte leukemia (LGL),29 leukopenic chronic T-cell leukemia,30 T-prolymphocytic leukemia,31 mycosis fungoides14 and chronic neurodegenerative diseases32,33 like myelopathy,34 and spastic ataxia.35 Antibodies to HTLV-II are significantly cross-reactive to HTLV-I antigens. Transmission of HTLV-I and HTLV-II infections to transfusion recipients of infected cellular blood products is well documented. Other known modes of transmission include breast milk, sexual contact, and sharing of contaminated needles and syringes by intravenous drug abusers. Perinatal transmission is suspected but remains unproven.

Procedure

Avioq HTLV-I/II Microelisa System is an enzyme-linked immunosorbent assay in which the solid phase (Microwells) is coated with a purified HTLV-I viral lysate, a purified HTLV-II viral lysate, and a recombinant HTLV-I p21E antigen.

With the addition of a diluted test sample containing antibodies to either HTLV-I or HTLV-II, complexes are formed by the interaction of the antibodies in the sample and the solid phase antigens. Following incubation, the sample is aspirated and the well is washed with buffer. Subsequently, goat anti-human immunoglobulins conjugated with horseradish peroxidase (HRP) are added which bind the antibodyantigen complex during a second incubation. Following a wash and incubation with TMB (Tetramethylbenzidine) substrate, a blue color is produced. The enzyme reaction is stopped by the addition of a sulfuric acid solution which changes the color to yellow. The amount of HTLV-I/or HTLV-II specific antibodies present in the sample is proportional to the color intensity.

Test performed by VRL Eurofins, 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.

Within 24 hours from receipt of specimen.

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
Plasma 30818 86687/86688 Yes

200 µL (min 100 µL)

Qualitative

  • Collect whole blood in an EDTA, lavender top tube. Lithium Heparin, Sodium Citrate, or Sodium Heparin tubes are also accepted. Do not freeze whole blood.
  • Sample sent in original vacutainer tube can be shipped at ambient or refrigerated temperature, must be received within 14 days.
  • If not shipping in original container, centrifuge and transfer 200 µL (min 100 µL) plasma to screw top tube. Specimens shipped at ambient or refrigerated temperature must be received within 14 days of collection, or frozen.
Serum 30818 86687/86688 Yes

200 µL (min 100 µL)

Qualitative

  • Collect whole blood in an gold, red, or red/gray tiger top tube. Do not freeze whole blood.
  • Sample sent in original vacutainer tube can be shipped at ambient or refrigerated temperature, must be received within 14 days.
  • If not shipping in original container, centrifuge and transfer 200 µL (min 100 µL) serum to screw top tube. Specimens shipped at ambient or refrigerated temperature must be received within 14 days of collection, or frozen.
Shipping

All specimens must be labeled with patient's name and collection date. A Viracor/VRL Eurofins Pre-Transplant test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: VRL Eurofins, 6933 S. Revere Parkway, Centennial, CO 80112.

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.

Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on VRL Eurofins' 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. VRL Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

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