Hepatitis C Quantitative:
Method: Quantitative Reverse Transcription Polymerase Chain Reaction
Analytical Sensitivity: 98% (n = 1760 across reportable range)
Analytical Specificity: No cross reactivity was observed in samples spiked with other common pathogenic viruses, bacteria, or yeast.
Limit of Detection: 10 IU/mL
Quantitative Range: 15 - 100,000,000 IU/mL (1.2 - 8.0 Log)
A negative result (“Not Detected”) does not rule out the presence of HCV below the limit of detection of the assay or the presence of inhibitory substances. HCV viral loads detected at less than 15 IU/mL are not quantitated. Assay is the FDA-approved Roche AmpliPrep/COBAS® TaqMan® HCV Test, v2.0.
Hepatitis C Genotype:
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.