Ordering RecommendationRecommendations when to order or not order the test. May include related or preferred tests.
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.
MnemonicUnique test identifier.
HCV NS5A
MethodologyProcess(es) used to perform the test.
Polymerase Chain Reaction/Sequencing
PerformedDays of the week the test is performed.
Mon
ReportedExpected turnaround time for a result, beginning when ARUP has received the specimen.
10-13 days
New York DOH Approval StatusIndicates test has been approved by the New York State Department of Health.
Reference IntervalNormal range/expected value(s) for a specific disease state. May also include abnormal ranges.
By Report
Interpretive DataBackground information for test. May include disease information, patient result explanation, recommendations, details of testing, associated diseases, explanation of possible patient results.
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).
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.
Compliance Category
Laboratory Developed Test (LDT)
NoteAdditional information related to the test.
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.
Hotline History
N/A
CPT CodesThe American Medical Association Current Procedural Terminology (CPT) codes published in ARUP's Laboratory Test Directory are provided for informational purposes only. The codes reflect our interpretation of CPT coding requirements based upon AMA guidelines published annually. CPT codes are provided only as guidance to assist clients with billing. ARUP strongly recommends that clients confirm CPT codes with their Medicare administrative contractor, as requirements may differ. CPT coding is the sole responsibility of the billing party. ARUP Laboratories assumes no responsibility for billing errors due to reliance on the CPT codes published.
* 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.
AliasesOther names that describe the test. Synonyms.
Hepatitis C Virus (HCV) NS5A Drug Resistance by Sequencing
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