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HEPATITIS C RNA, QUANTITATIVE BY PCR WITH REFLEX TO HEPATITIS C GENOTYPING BY PCR AND LINE PROBE ASSAY

Mnemonic

HEPC QNTR

Synonym

HCV - Hep C - Hepatitis C Titer - HCV Quant PCR - HCV quantitative - HCV Viral Load - Hep C RNA - Nucleic Acid Amplification Test (NAT or NAAT) - Viral load monitoring - Hepatitis C viral load with reflex to Hepatitis C Genotype, HCV genotype

 

Guidelines

The HCV quantitative test is not intended for use as a screening test for the presence of HCV in blood or blood products. It is intended for use as an aid in the diagnosis of HCV infection and as an aid in the management of HCV-infected patients undergoing anti-viral therapy in conjunction with clinical and laboratory markers of infection. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection. 

If the HCV Quantitative PCR result is greater than or equal to 179 IU/mL (2.3 log IU/mL), the HCV Genotype by PCR and Line Probe assay will be added. Additional charges apply. This assay is used to determine the HCV Genotype to aid in prognosis and treatment selection.

 

 

Specimen Collection Requirements

Collect

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

Handling

Separate plasma or serum from cells within 6 hours of collection. Transfer 3.0 mL plasma or serum into plastic aliquot tube and freeze immediately.

Preferred Volume

3.0 mL

Minimum Volume

2.5 mL

Transport

Frozen

Rejection Criteria

Heparinized specimens, specimens past stability, 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

Hepatitis C RNA, Quantitative By PCR: 1-4 days

Hepatitis C Genotyping by PCR and Line Probe Assay: 4-7 days
 

Method

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.

Reference Values

Reference Values

Hepatitis C RNA, Quantitative By PCR: Not Detected

Hepatitis C Genotyping by PCR and Line Probe Assay: Interpretation provided

 


 

Comments

Though rare, mutations in the highly conserved regions of the viral genome covered by the COBAS® AmpliPrep/COBAS® TaqMan HCV Test, v2.0 primers and/or probes may result in under-quantification of or failure to detect the virus.

Due to inherent differences between quantitative methodologies, it is recommended that prior to changing methodologies a new baseline is established before making clinical decisions.
 

CPT Codes

HepC Quant: 87522; HepC Geno: 87902

Last Updated: Thursday, November 16, 2017 01:03:29 PM


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