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Hepatitis B Antiviral Resistance LiPA

Test Code: 6100

Cpt Code:

87912 (x1)

Clinical Utility

Extended treatment of chronic hepatitis B with lamivudine, adefovir, telbivudine, and emtricitabine can result in the development of antiviral resistance. This process begins with a mutation in the viral genome that becomes selectively amplified by the pressure exerted by antiviral therapy. Assessment of resistance-associated mutations may be utilized to differentiate between non-adherence and drug-resistance. Moreover, early detection permits prompt initiation of therapy adjustment, and improved clinical outcomes.

Procedure

Extraction of nucleic acid from plasma or serum followed by amplification of portions of the HBV polymerase gene. Biotinylated PCR products are hybridized to immobilized oligonucleotide probes specific to the polymorphisms in the HBV polymerase gene which have been shown to confer resistance to lamivudine, adefovir, telbivudine, and emtricitabine.

Note: It is recommended that 6100 Hepatitis B Antiviral Resistance be ordered with 1100 Hepatitis B (HBV) Real-time qPCR. HBV Antiviral Resistance is performed following confirmation of adequate viral load to obtain a genotyping result. If the HBV viral load is less than 1,000 IU/mL, antiviral resistance testing may not be successful. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Assay Range

Mutations in the HBV polymerase gene will be reported as Resistant/None Detected. Interpretation of gene mutations and association with antiviral resistance, including lamivudine, adefovir, telbivudine, and emtricitabine will be provided with the report. See HBV AVR Reportable Mutations in the test information navigation (right side of webpage).

Causes For Rejection

Specimen types other than those listed, specimens containing HBV DNA levels too low to allow for antiviral drug resistance testing, or specimens beyond their acceptable length of time from collection as listed in the specimen handling.

Turnaround Time

Assay performed twice weekly on Mondays and Wednesdays with results reported Tuesdays and Thursdays

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-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086

Specimen Information

6101 plasma

4-5 mL collected in EDTA, ACD A or PPT. Separate plasma from cells by centrifugation. Transfer plasma to screw-cap tube for shipment. If specimen collected in PPT tube, the entire tube can be shipped following centrifugation. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

6110 serum

4-5 mL collected in red-top or SST. Separate serum from cells by centrifugation. Transfer serum to screw-cap tube for shipment. If specimen collected in SST tube, the entire tube can be shipped following centrifugation. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

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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