Test Catalog

Test Id : FH1N5

Hepatitis C Viral RNA Genotype 1 NS5a Drug Resistance

Method Name
A short description of the method used to perform the test

Polymerase Chain Reaction (PCR); Sequencing

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

HCV RNA Genotype 1 NS5a Drug Resist

Aliases
Lists additional common names for a test, as an aid in searching

Daclatasvir resistance

HCV

HCV NS5a Subtype

Ledipasvir resistance

Ombitasvir resistance

Specimen Type
Describes the specimen type validated for testing

Varies

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Please submit one of the following:

 

Plasma:

Specimen Type: Plasma (Preferred)

Container/Tube: EDTA (lavender-top) tube(s).

Specimen volume: 2 mL

Collection Instructions: Draw blood in an EDTA (lavender-top) tube(s). (Plasma gel tube is acceptable.) Spin down and send 2 mL plasma refrigerated in a plastic vial.

 

Serum:

Specimen Type: Serum

Container/Tube: Red-top tube, serum gel is acceptable.

Specimen volume: 2 mL

Collection Instructions: Draw blood in a plain red-top tube(s). (Serum gel tube is acceptable.) Spin down and send 2 mL serum refrigerated in a plastic vial.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.6 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis Mild OK, Gross reject
Lipemia Mild OK, Gross reject
Icterus NA
Other Heparin plasma

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) 14 days
Frozen 42 days
Ambient 72 hours

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

The clinical significance of NS5a resistance associated variants for antiviral therapy may vary according to the clinical status and antiviral treatment experience of the HCV-infected patient.

 

Testing for NS5a resistance-associated variants prior to initiation of treatment with elbasvir plus grazoprevir in HCV genotype 1a infected patients is recommended.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

HCV NS5a Subtype:   Not Detected

Method Description
Describes how the test is performed and provides a method-specific reference

This assay is designed to amplify HCV genotypes 1a and 1b and may not successfully amplify other HCV genotypes.

 

This test utilizes RT-PCR and DNA sequencing to detect the presence of treatment-emergent HCV NS5a variants associated with NS5a inhibitor antiviral therapy.

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Daily

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

3 days - 5 – 7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Quest Diagnostics Infectious Disease

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics Infectious Disease. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87902

LOINC® Information

Test Id Test Order Name Order LOINC Value
FH1N5 HCV RNA Genotype 1 NS5a Drug Resist 82525-7
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip
Z4846 HCV NS5a Subtype 82380-7
Z4847 Daclatasvir Resistance 82379-9
Z4848 Ledipasvir Resistance 82377-3
Z4849 Ombitasvir Resistance 82378-1
Z4850 Elbasvir Resistance 82376-5
Z4851 Velpatasvir Resistance 82520-8

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports