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Avioq HTLV-I/II Microelisa

Test Code: 5219299

Performed at multiple locations.

Cpt Code:

86790 (x1)

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. 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 also intended for use in testing serum specimens to screen organ donors when specimens are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens.

Procedure

Avioq HTLV‐I/II Microelisa System is an enzyme‐linked immunosorbent assay in which the Microwells are 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 antibody-antigen complex during a second incubation. Following a wash and incubation with TMB 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.

Specificity

Based on an assumed zero prevalence of HTLV-I and HTLV-II antibodies in normal human donors, the overall estimated specificity of this assay is 99.95%.

Assay Range

Qualitative. NonReactive/Reactive

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.

Turnaround Time

Same day as specimen receipt, Monday through Friday.

Shipping

Lee's Summit Lab: Ship Monday through Friday.
Ship specimens FedEx Priority Overnight® to:

Viracor-IBT Laboratories
1001 NW Technology Dr
Lee's Summit, MO 64086
Ph: (800) 305-5198

Los Angeles Lab: Ship Monday through Friday.
Ship specimens FedEx Priority Overnight® to:

Viracor-IBT Serology
2100 West 3rd Street, Suite 301
Los Angeles, CA 90057
Ph: (213) 229-3654

Label Friday shipments with Saturday delivery. All specimens must be labeled with patients name and collection date. A Viracor-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen.

 

Specimen Information

5219299 serum (Lee's Summit, MO)- NY approved
521929 serum (Los Angeles, CA)

 

Collect 3-5 mL whole blood in a gel separator tube (SST). Centrifuge specimen within 2 hours of draw to pellet cells below the gel.  Specimen can be stored refrigerated at 2 to 8°C for up to 14 days or preferably stored frozen. Specimen should be shipped on dry ice for overnight delivery to Viracor-IBT

Disclaimer

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

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