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HEPATITIS C RNA, QUANTITATIVE BY PCR

Mnemonic

HEPC QNT

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

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.  

Specimen Collection Requirements

Collect

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

Handling

Separate plasma or serum from cells within 24 hours of collection. Transfer 3.0 mL plasma or serum into plastic aliquot tube and freeze immediately.

Preferred Volume

3.0 mL

Minimum Volume

1.5 mL

Transport

Frozen

Rejection Criteria

Heparinized specimens, specimens past stability, specimens tested in non-molecular labs or specimens with inadequate volume for testing.

Stability

ON CELLS - Ambient or Refrigerated:  24 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

Tue and Fri (AM)

Reported

1-4 days

Method

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.

Reference Values

Reference Values

Not Detected

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

87522

Last Updated: Friday, November 10, 2017 06:49:30 AM


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