ViroKey™ SQ FLEX Genotyping Assay

Flexibility for virology, combine up to 4 assays (HIV-1, HCV, HBV, CMV) in one NGS run

DESCRIPTION

The ViroKey SQ FLEX Genotyping Assay (4x16) is a next generation sequencing-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 4 tests can be performed in one NGS run.

The  ViroKey SQ FLEX Genotyping Assay (4x16) is used in conjunction with the Sentosa SX Virus Total Nucleic Acid Plus (4x24) as well as the Sentosa SQ 318 Chip Kits, Sentosa ST Template Kits and the Sentosa SQ Sequencing Kits on the SentosaSX101, 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

Providing Assay Selection Flexibility:

  • Freedom to run up to 4 assays in one run
  • Genotype and resistance information in a single test

Providing Laboratory Efficiency and Effectiveness

  • No batching of samples required
  • Able to extract up to 16 samples (including controls) per run
  • Seamless sample traceability and network connectivity
  • Automated workflow, from samples to results in 2.5 days
  • Decreased hands-on time of 4 hours
  • 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

ORDERING INFORMATION

ProductPack SizeItem Number
Sentosa SQ Virus Testing Solutions (RUO) 4x24 300775
Sentosa SX Virus Total Nucleic Acid Plus Kit (RUO) 4x24 300155
ViroKey SQ CMV Positive Control Kit (8) (RUO) 8 301054
ViroKey SQ FLEX CMV Primer Set (96) (RUO) 96 300822
ViroKey SQ FLEX Genotyping Assay (4x16) (RUO) 4x16 690255
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 HBV Positive Control Kit (8) (RUO) 8 300761
ViroKey SQ HCV Positive Control Kit (8) (RUO) 8 300824
ViroKey SQ HIV-1 Positive Control Kit (8) (RUO) 8 300683