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HEPATITIS C GENOTYPING BY PCR AND LINE PROBE ASSAY

Mnemonic

HEPC GENO

Synonym

Hepatitis C Genotype

Specimen Collection Requirements

Collect

Plasma or Serum collected from lavender (EDTA) or serum separator top tubes (SST)

Handling

Separate plasma or serum from whole blood within 6 hours. Transfer 1.5 mL plasma or serum to a plastic aliquot tube and freeze immediately

Preferred Volume

1.5 mL

Minimum Volume

1.0 mL

Transport

Frozen

Rejection Criteria

Heparinized specimens, specimens past stability, specimens with a HCV viral load less than 179 IU/mL, specimens with inadequate volume for testing, or specimens tested in non-molecular labs.

Stability

On Cells - Ambient: 6 hours
After separation from cells – Ambient: Unacceptable; Refrigerated: 3 days; Frozen (preferred): 6 weeks

Testing Information

Note

Critical sterile. Samples cannot be shared with other laboratory departments unless molecular testing is performed first.

Performed

Mon - Fri, batched testing two times per week

Reported

4-7 days

Method

Method:

Reverse Transcription Polymerase Chain Reaction
and Line Probe Assay

Analytical Sensitivity / Specificity:

100% / 100% (n = 29)

Limit of Detection:

Typable down to 179 IU/mL

This test may yield an indeterminate result if the HCV viral load is less than the limit of detection. The HCV Genotype test will be cancelled for samples that also have a HCV Viral Load ordered that demonstrates a result below the limit of detection for this method.

Hepatitis C virus (HCV) is grouped into 6 genotypes (1-6) and each genotype is subcategorized based on phylogenetic analysis. Studies suggest that patient prognosis, disease course, and response to treatment may be genotype-dependent.

HCV RNA is assayed using reverse transcription polymerase chain reaction (RT-PCR) to amplify specific portions of the 5’ untranslated region (5’ UTR) and core region of the hepatitis C virus. Biotinylated DNA PCR product is hybridized to immobilized probes and resultant banding patterns are visualized and interpreted.

Legacy Laboratory Services has validated this test for the detection and reporting of genotypes 1, 2, 3, 4, and subtypes 1a, 1b, 2b, 2a or 2c, 3a, and 4a/4c/4d. Specimens yielding indeterminate reaction patterns, or reaction patterns correlating with less common genotypes (genotypes 5 and 6, and subtypes not shown above), will be referred for confirmatory testing at an outside laboratory.

This test, which uses Analyte Specific Reagents, was developed and its performance characteristics determined by Legacy Laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.

Reference Values

Reference Values

Interpretation provided.

CPT Codes

87902

Last Updated: Thursday, November 16, 2017 07:06:02 AM


Client Services: 503-413-1234