Ordering Recommendation

Order before initiating treatment with NS5A inhibitors. Use to determine HCV type 1-6 after molecular confirmation of positive HCV screen. If genotype “1a or 1b” is determined, testing will reflex to HCV NS5A for genotype differentiation and drug resistance by sequencing.

Mnemonic
HCV RFX 5A
Methodology

Polymerase Chain Reaction/Sequencing

Performed

Sun-Sat

Reported

13-19 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Lavender (EDTA), Pink (K2EDTA), Plasma Preparation Tube (PPT), or Serum Separator Tube (SST).

Specimen Preparation

Separate from cells ASAP or within 2 hours of collection. Transfer 2 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 1.5 mL)

Storage/Transport Temperature

Frozen.

Unacceptable Conditions

Heparinized specimens.

Remarks
Stability

Ambient: Unacceptable; Refrigerated: 72 hours; Frozen: 4 months

Reference Interval

By report

Interpretive Data

Refer to report.

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.

Note

This test may be unsuccessful if the HCV RNA viral load is less than log 3.6 or 4000 IU/mL. If initial result is Type "1a or 1b", then HCV NS5A Drug Resistance by Sequencing will be added. Additional charges apply.

Hotline History
N/A
CPT Codes

87902; if reflexed, add 87902

Components
Component Test Code* Component Chart Name LOINC
0055593 HCV Genotype by Sequencing 32286-7
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
Hepatitis C Virus (HCV) Genotype with Reflex to HCV NS5A Drug Resistance by Sequencing