LyteStar Enterovirus HFMD Typing RT-PCR Kit

For detection and subtyping of Human Enteroviruses, Enterovirus A71, Coxsackievirus A6 and Coxsackievirus A16 from human specimens

The LyteStar™ Enterovirus HFMD Typing RT-PCR Kit 1.0 is intended for the specific detection and subtyping of Enterovirus RNA in human throat, vesicles, lesions or rectal swabs in VTM, and blood and cerebrospinal fluid (CSF) specimens. The LyteStar™ Enterovirus HFMD Typing RT-PCR Kit 1.0 is a four-target assay comprising a screening assay targeting pan-Enterovirus 5’ UTR region, and a typing assay that further differentiates Enterovirus serotypes A71 (EV71), via targeting of the VP3–VP1 genes, and Coxsackievirus A16 (CVA16) and Coxsackievirus A6 (CVA6), via targeting the VP1 gene.

Specifications and Features

Multiplex kit for Detection and Differentiation:
Highest Analytical Sensitivity
Pan-Enterovirus specific; 5’UTR region
2.44 cp/μl
Enterovirus A71 specific; VP3-VP1-gene
1.79 cp/μl
Coxsackievirus A16 specific; VP1-gene
3.44 cp/μl
Coxsackievirus A6 specific; VP1-gene
4.79 cp/μl
Internal Control (IC); heterologous RNA

100% Analytical Specificity

  • The specificity of the kit was evaluated by testing genomic RNA/DNA extracted from other pathogens likely to be present in the same sample material as human Enteroviruses, or that cause similar symptoms to these viruses.
  • No cross reactivity was observed with human Rhinoviruses and other closely related pathogens, other than the intended target.

Clinically Validated

  • The clinical performance of the kit was evaluated through retrospective studies at various public health laboratories in comparison to the clinical site’s reference method.
  • The LyteStar™ Enterovirus HFMD Typing RT-PCR Kit 1.0 achieved 100% sensitivity and 100% specificity for the detection of EV71 and CVA6, 93.75% sensitivity and 100% specificity for pan-Enterovirus, 93.55% sensitivity and 93.10% specificity for CVA16.

Integrated Quality Monitoring

  • The kit includes a heterologous amplification system (Internal Control; IC) to identify possible RT-PCR inhibition and to confirm the integrity of the reagents of the kit. The IC may also be used to monitor nucleic acid extraction efficiency.
  • A Positive Control (PC) with in vitro transcripts of synthesized target genes of pan-Enterovirus, EV71, CVA16 and CVA6 confirms the integrity and performance of the kit components.
  • A Negative Control (PCR-grade water) monitors potential contamination and excludes false positive results.

Convenience and Efficiency

  • Harmonized cycling profiles with selected other AstronDX products to perform analysis of multiple targets concurrently in the same PCR run.
  • Validated for use with various extraction kits and PCR cyclers – Please always refer to latest Instructions for Use (IFU).
  • 96 rxn and 24 rxn kit sizes accommodate various throughput scenarios, with Master reagents being provided in multiple tubes to reduce freeze-thaw cycles.
  • Ready-to-use reagents and an intuitive, uncomplicated pipetting scheme to minimize errors and guarantee efficient workflows and routine procedures.

Order Information

Product Name
LyteStar Enterovirus HFMD Typing RT-PCR Kit 1.0

Cat. No.     /     Reactions
881303                   96
881301                   24

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Information

AstronDX Technologies Sdn Bhd

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    ​Selangor, Malaysia
  • +603 7931 6760
  • info@astrondx.com

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