Order before initiating treatment with NS5A inhibitors. Do not order prior to molecular confirmation of positive hepatitis C virus (HCV) screen and confirmation of genotype 1a or 1b.
Polymerase Chain Reaction/Sequencing
Lavender (EDTA), Pink (K2EDTA), Plasma Preparation Tube (PPT), or Serum Separator Tube (SST).
Separate from cells ASAP or within 2 hours of collection. Transfer 2 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 1 mL)
Ambient: Unacceptable; Refrigerated: 72 hours; Frozen: 4 months
This assay detects resistance-associated variants in NS5A codons 20-101 for HCV genotypes 1a and 1b. Variants in viral sub-populations below 20 percent of total may not be detected. For further information, please refer to drug package inserts for the applicable direct-acting antiviral drug and current HCV treatment guidelines (eg., AASLD/IDSA guidelines or EASL HCV treatment recommendations).
Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
This test may be unsuccessful if the HCV RNA viral load is less than log 3.4 or 2500 IU/mL and/or if the HCV RNA genotype is not 1a or 1b.
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