Hepatitis C Virus Genotyping

CERNER / EPIC MNEMONIC: HCV TYPE
CPT CODE:

87902

TEST INFORMATION: The test is used to determine the genotype, with subtype, of Hepatitis C Virus RNA.
DAYS PERFORMED: Wednesday
TURNAROUND TIME: 1-7 days
SPECIAL INSTRUCTIONS: The specimen MUST be frozen within 6 hours of specimen collection.
CONTAINER TYPE:

Red top Vacutainer® tube or SSTTM tube

SPECIMEN REQUIREMENTS: Blood (serum)
REJECTION CRITERIA: Excessive hemolysis, gross contamination of specimen, chylous serum, improper storage of specimen, specimen not frozen within 6 hours of collection, inappropriate specimen container, insufficient specimen volume.
MINIMUM VOLUME:

2 mL blood (1 mL serum)

HANDLING INSTRUCTIONS:

Serum MUST be separated and frozen at minus 20°C within 6 hours of specimen collection.

REFERENCE RANGE: The assay will identify the six major HCV genotypes and their subtypes.
LIMITATIONS OF TEST: The assay utilizes amplified HCV RNA. Specimens with insuffucient RNA levels CANNOT be genotyped. New genotypes and subtypes are continually being discovered. Specimens containing a genotype NOT identified by the assay will be referred for additional testing. An additional charge will be generated.
METHODOLOGY:

Polymerase Chain Reaction (PCR) combined with Voltammetry

ADDITIONAL INFORMATION:

This test was developed and its performance characteristics determined by Rush Medical Laboratories. This test has not been cleared or approved for commercial use by the U.S. Food and Drug Administration. The FDA has determined that FDA review is not required for such in-house assays.  (21 CFR 809.30(e)

LAST UPDATED:

9-13-2012

TEST SYNONYM(S):HCV Type