Molecular Detection of Streptococcus pyogenes by Strand Invasion Based Amplification Assay

Sonja Elf1, Jenni Olli1, Sanna Hirvonen1

  • 1Research and Development, Orion Diagnostica Oy, P. O. BOX 83, 02101, Espoo, Finland.

Abstract

Insights

A new strand invasion based amplification (SIBA) assay rapidly and accurately detects Streptococcus pyogenes (GAS) DNA. This method offers a sensitive and specific alternative for diagnosing GAS infections, improving patient care.

Area of Science:

  • Microbiology
  • Molecular Diagnostics
  • Infectious Diseases

Background:

  • Streptococcus pyogenes (group A Streptococcus, GAS) causes highly communicable infections, leading to significant sore throat hospital visits.
  • Accurate and prompt diagnosis of GAS is crucial for effective patient care and antibiotic stewardship.

Purpose of the Study:

  • To develop and evaluate a novel nucleic acid amplification method for the rapid and specific diagnosis of GAS.
  • To assess the performance of the developed assay against an established GAS polymerase chain reaction (PCR) method.

Main Methods:

  • Development and evaluation of a strand invasion based amplification (SIBA) assay for GAS detection.
  • Comparison of the GAS SIBA assay's performance with a standard GAS PCR assay using clinical specimens.

Main Results:

  • The GAS SIBA assay demonstrated rapid detection of S. pyogenes DNA (ten copies) within 13 minutes.
  • Achieved 100% sensitivity and specificity for detecting S. pyogenes in clinical specimens, with results obtained in approximately 8 minutes.
  • Optimized reaction conditions, including magnesium concentration and temperature, contributed to the assay's speed.

Conclusions:

  • The GAS SIBA assay provides a rapid, sensitive, and specific method for diagnosing GAS infections.
  • Its ability to perform at low, constant temperatures makes it suitable for both laboratory and point-of-care settings.
  • The assay has the potential to enhance patient care and reduce unnecessary antibiotic prescriptions.

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