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Human T-Lymphotropic Virus (HTLV) I/II Qualitative Real-time PCR

Test Code: 5916
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Clinical Utility

Human T-Lymphotropic Virus (HTLV) I/II Qualitative Real-Time PCR assay detects and distinguishes HTLV-1 virus, which can cause adult T-cell leukemia/lymphoma and other serious conditions, and HTLV-2 virus. HTLV-2 virus currently is not definitively known to cause specific disease. HTLV proviral DNA is integrated into the genomes of human T-lymphocytes; therefore all U.S. donors of blood, blood derived products, hematopoietic stem cells, living organ donors and, in some cases, organs rich in leukocytes should be screened by serological testing. This PCR assay is not cleared or approved for in vitro diagnostic use and should be used in conjunction with clinical evaluation to aid in diagnosis.

Procedure

Extraction of viral DNA from whole blood followed by amplification and detection using real-time, qualititative PCR. The real-time PCR assay is designed to detect and distinguish HTLV-1 and/or HTLV-2 proviral DNA (that is, viral DNA copies integrated into the genomes of human T-lymphocytes). An internal control is added to ensure the extraction was performed correctly and the PCR reaction was not inhibited. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

Detects 5 HTLV-1 subtypes (1a, 1b, 1c, 1f and 1g) and 3 HTLV-2 subtypes (2a, 2b and 2d) in one assay. The primers and probes used in this assay are specific and inclusive for all 8 subtypes listed. Additionally, potential cross-reactivity was evaluated with various pathogens that could cause similar symptoms or pathogens related to HTLV due to sequence identity.

Same day (within 8 - 12 hours from receipt of specimen), Monday through Saturday.

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
whole blood 5916 87798 No 2 mL (min. 0.5 mL) Detected/Not Detected
  • Collect in EDTA tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs of collection.

Detected/Not Detected

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor Eurofins test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 1001 NW Technology Dr, Lee's Summit, MO 64086.

Causes for Rejection

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 Viracor 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. Viracor Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

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