A fully integrated sample-to-answer molecular diagnostic platform for rapid identification of four major Aspergillus

Eun Hae Oh1, Jinseok Kang1, Dasol Jin1

  • 1iGENETECH R&D Center, iGENETECH Inc., Yongin, Republic of Korea.

Abstract

Insights

A new automated PCR platform rapidly identifies four key Aspergillus species in invasive pulmonary aspergillosis (IPA). This molecular tool overcomes limitations of traditional diagnostics for faster, more accurate patient care.

Area of Science:

  • Molecular diagnostics
  • Medical mycology
  • Infectious disease diagnostics

Background:

  • Invasive pulmonary aspergillosis (IPA) disproportionately affects immunocompromised individuals.
  • Current diagnostic methods for IPA suffer from low sensitivity, long turnaround times, and technical challenges.
  • Accurate and timely diagnosis is critical for effective IPA management.

Purpose of the Study:

  • To develop a fully automated, real-time PCR-based, sample-to-answer molecular diagnostic platform.
  • To enable simultaneous identification of four major Aspergillus species: A. fumigatus, A. flavus, A. niger, and A. terreus.
  • To provide a rapid and accurate diagnostic tool for suspected IPA cases.

Main Methods:

  • Optimized a sample-to-answer workflow using artificial bronchoalveolar lavage (BAL) samples spiked with Aspergillus species.
  • Evaluated analytical consistency against MALDI-TOF using 21 patient-derived culture isolates.
  • Assessed clinical feasibility using 22 clinical BAL specimens from patients with proven or probable IPA.

Main Results:

  • Achieved 95.2% overall agreement with MALDI-TOF for culture isolates (93.3% positive, 100% negative agreement).
  • In clinical validation, the platform detected 90.9% (10/11) of proven IPA samples with 100% species-level consistency.
  • Identified Aspergillus in 3 culture-negative probable IPA cases, adding crucial mycological evidence.

Conclusions:

  • The developed automated platform provides rapid and accurate species-level identification of Aspergillus.
  • This molecular assay overcomes limitations of conventional diagnostic methods for IPA.
  • The platform represents a significant advancement for clinical diagnostics in managing invasive aspergillosis.