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HEPATITIS C RNA, QUANTITATIVE BY PCR

Mnemonic

HEPC QNT

Synonym

Hep C - HCV - Hepatitis C Viral Load - Hepatitis C RNA Quantitation - Hepatitis C Titer - Hepatitis C Nucleic Acid Amplification Test (NAT or NAAT) - Hepatitis C Screen Confirmation

Guidelines

This test is intended to aid in the diagnosis and management of HCV infection.

Specimen Collection Requirements

Collect

Serum or Plasma, one 8.5 mL gold (SST) or two 4.0 mL lavender (EDTA) top tube

Handling

Separate serum or plasma from cells within 24 hours of collection and transfer 1.5 mL into each of two plastic aliquot tubes. Freeze immediately.

Preferred Volume

3.0 mL

Minimum Volume

1.5 mL

Transport

Frozen

Rejection Criteria

Heparin samples

Stability

ON CELLS - Ambient: 24 hours

AFTER SEPARATION FROM CELLS - Ambient: Unacceptable; Refrigerated: 72 hours; Frozen (preferred): 6 weeks

Testing Information

Note

Due to stability requirements, this test cannot be added on to specimens that were received for non-molecular testing, such as serology or chemistry.

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

CPT Codes

87522

Last Updated: Thursday, January 5, 2017 03:41:12 AM


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