Test Information

  • Print
  • Download PDF

Hepatitis B Precore Mutations LiPA

Test Code: 6200

Cpt Code:

87912 (x1)

Clinical Utility

Mutations in the basal core promoter and precore regions can aid in the diagnosis of HBeAg-negative chronic HBV, and predict development of cirrhosis, hepatic decompensation, and hepatocellular carcinoma (HCC).1 The G1896A mutation in the precore region stops HBeAg production and the A1762T and G1764A dual mutation in the basal core promoter region down-regulates HBeAg production, both mechanisms lead to enhanced viral genome replication.2 Thus, mutations are valuable biomarkers to identify a subgroup of HBV infected individuals at extremely high risk for HCC.

Procedure

Extraction of nucleic acid from plasma or serum followed by amplification of portions of the basal core promotor and precore regions of the HBV polymerase gene. Biotinylated PCR products are hybridized to immobilized oligonucleotide probes specific to the polymorphisms in the basal core and precore region.

Note: It is recommended that 6200 Hepatitis B Precore Mutation be ordered with 1100 Hepatitis B (HBV) qPCR. HBV Precore Mutation LiPA is performed following confirmation of adequate viral load to obtain a result. If the HBV viral load is less than 1,000 IU/mL, analysis 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 in the basal core promoter region at nt1762 and 1764 and precore region at codon 28 will be reported as Detected/None detected.

Causes For Rejection

Specimen types other than plasma or serum, specimens containing HBV DNA levels too low to allow for precore mutation 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

6201 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.

6210 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.

References

1. Chu CJ, Keeffe EB, Han SH, et al. Prevalence of HBV precore/core promoter variants in the United States. Hepatology. 2003;38:619-628.

2. Chan HLY, Hussain M, Lok ASF. Different hepatitis B virus genotypes are associated with different mutations in the core promoter and precore regions during hepatitis Be antigen seroconversion. Hepatology. 1999;29:976-984.

<< Back to list