Test Information

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Hepatitis B Genotyping LiPA

Test Code: 6000

Cpt Code:

87912 (x1)

Clinical Utility

Recent studies have provided evidence regarding the influence of HBV genotypes on liver disease, in both acute and chronic HBV infections. HBV can be classified into eight genotypes, A through H, which have been shown to influence HBeAg seroconversion, severity of liver disease, and predict response to therapeutic treatment.

Procedure

Extraction of nucleic acid from plasma or serum followed by amplification of the HBV polymerase gene domain B to C. Detection of hepatitis B genotypes A to H occurs through hybridization of biotinylated PCR products to immobilized oligonucleotide probes specific to the HBV genotypes.

Note: It is recommended that 6000 Hepatitis B Genotyping be ordered with 1100 Hepatitis B (HBV) qPCR. HBV Genotyping is performed following confirmation of adequate viral load to obtain a genotyping result. If the HBV viral load is <1,000 IU/mL, genotyping may not be successful. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

Detects all 8 HBV genotypes. The primers and probes used in this assay will distinguish HBV types A to H.

Assay Range

Genotypes: types A, B, C, D, E, F, G, and H.

Causes For Rejection

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

Turnaround Time

Specimens received Thursday - Monday, results reported on Tuesday. Specimens received Tuesday - Wednesday, results reported on Thursday.

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

6001 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.

6010 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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