Test Catalog

Test ID: HCVDR    
Hepatitis C Virus Genotypic Antiviral Drug Resistance, Serum

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

This test utilizes the commercially available Sentosa SQ HCV Genotyping Assay, v 2.0, which is a next-generation sequencing assay based on a "sequencing by synthesis" method. The assay is designed to specifically amplify 4 sequences ranging from 600 to 1,100 bp in length, located in 3 different non-structural (NS) regions of the hepatitis C virus (HCV) genome: NS3 (67 RAS at 15 codon positions), NS5A (52 RAS at 13 codon positions), and NS5B (7 RAS at 4 codon positions). Clinical serum specimens are subjected to automated HCV RNA extraction and purification, followed by reverse-transcription (RT)-PCR of HCV target sequences, with both a system control and a positive control included in each assay run for quality control purposes. Automated DNA library preparation is performed using the amplified products, including enzymatic shearing, adapter ligation, purification, and normalization, prior to DNA template preparation and sequencing. Sequencing reactions are conducted with the Ion Personal Genome Machine (PGM) sequencer, and the assembled sequence data are analyzed using proprietary analysis and interpretive software applications. HCV genotype-specific antiviral drug-resistance interpretations are based on a combination of FDA-approved prescribing information for the drug and professional society practice guidelines using a 10% variant detection cutoff threshold.(Instruction manual: Vela Operations Singapore Pte Ltd. Sentosa SQ HCV Genotyping Assay v2.0 (4x16), Version 0.1; no. PS103375A; 06/2017)

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

No

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

Monday through Friday, 7 a.m.-11 p.m.

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

4 days

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Clinic Laboratories until the release of the test result

8 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

60 Days

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

Rochester