ViroKey® SQ FLEX Genotyping Assay

Flexibility for virology, combine up to four assays (HIV-1, HCV, HBV, CMV) in one NGS run

DESCRIPTION

The ViroKey SQ FLEX Genotyping Assay is a next-generation sequencing (NGS)-based test intended for the detection of genomic mutations of the Human Immunodeficiency virus (HIV-1), Hepatitis C virus (HCV), Hepatitis B virus (HBV) and Cytomegalovirus (CMV) that confer resistance to specific types of antiviral drugs from human plasma / serum. Up to four tests can be performed in one NGS run.

The  ViroKey SQ FLEX Genotyping Assay is used in conjunction with the Sentosa® SX Virus Total Nucleic Acid Plus Kit and Sentosa SQ Virus Testing Solutions on the Sentosa SX101 instrument, as well as the Sentosa ST Template Kit, Sentosa SQ 318 Chip Kit and Sentosa SQ Sequencing Kit on the Sentosa ST401 and Sentosa SQ301 instruments.

GENOTYPES AND SUBTYPES

TargetTarget GenesTarget Genotypes and Subtypes
HIV-1

Reverse Transcriptase, Protease and Integrase regions of pol gene

Group M subtypes

HCV

 NS3, NS5A, NS5B

Genotyping: Genotypes 1 to 6, subtypes 1a/1b2

 Detecting mutations:  Subtypes 1a/1b, Genotype 3

HBV

Reverse Transcriptase, Surface gene, Basal Core Promoter, PreCore and Core regions.

NA

CMV

UL54, UL97, UL56, UL51, UL27, UL 89

NA

FEATURES AND BENEFITS

Supporting Clinical Research:

  • Up-to-date databases: Stanford, ANRS, REGA, EASL and AASLD Guidelines, DAA IFU
  • Provides drug resistance intepretation report
  • Solution for low volume testing

Assay Selection Flexibility:

  • Freedom to run up to four assays in one run
  • Genotype and resistance information in a single test
  • Easy menu expansion to add new assays

Laboratory Efficiency and Effectiveness

  • Able to extract up to 16 samples (including controls) per run
  • Seamless sample traceability and network connectivity
  • Automated workflow, from sample-to-results in 2.5 days and less than 4 hours of hands-on time
  • Automated data analysis and result reporting

WORKFLOW

SPECIFICATIONS

AttributeValue
Sample Input

730 μl Plasma for HIV, HCV, HBV, CMV
730 μl Serum for HCV, HBV

Sample Throughput Up to 16 samples/run (assay dependent)
Analytical Sensitivity 1,000 copies/mL for HIV-1
1,000 IU/mL for HCV, HBV, CMV

PRODUCT FLYERS

ViroKey & Sentosa FLEX Flyer RUO EN

 

ORDERING INFORMATION

ProductPack SizeItem Number
Sentosa SQ Virus Testing Solutions (4x24) RUO 4x24 300775
ViroKey SQ CMV Positive Control Kit (8) (RUO) 8 301054
ViroKey SQ FLEX CMV Primer Set (96) RUO 96 300822
ViroKey SQ FLEX HBV Primer Set (96) RUO 96 300821
ViroKey SQ FLEX HCV Primer Set (96) RUO 96 300820
ViroKey SQ FLEX HIV-1 Primer Set (96) RUO 96 300819
ViroKey SQ FLEX Library Prep Reagents (4x16) RUO 4x16 300823
ViroKey SQ HCV Positive Control Kit (8) RUO 8 300824
ViroKey SQ HIV-1 Positive Control Kit (8) RUO 8 300683