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Accelerating Candidozyma auris colonization diagnosis: an evaluation of a new molecular point-of-care test for rapid diagnostic responses
Background
Introduction
C. auris is an emerging, multi-drug-resistant pathogen, implicated in hospital outbreaks.
Colonization screening is a key strategy for transmission and outbreak prevention in healthcare facilities.
Aim
Assessment of the clinical performance of the novel point-of-care Vivalytic C.auris PCR assay.
C. auris colonization status on admission and weekly of hospitalized patients in the ICU of the University Hospital of Heraklion, Crete, Greece.
Methods
110 nasal plus composite bilateral axilla and groin swabs
85 ICU patients between July and October 2025
Standard-of-care protocol (SOC)= enrichment culture, ID of suspicious colonies via MALDI-TOF MS (VITEK-MS): Reference method
Rapid diagnostic testing= Vivalytic C.auris assay: point-of-care, qualitative real-time PCR, C.auris ITS2 gene
Results
In total, 14 positive and 96 negative swabs
Vivalytic Sensitivity: 92.86%, 66.13%-99.82%, (95% CI)
Vivalytic Specificity: 95.51%, 88.89%-98.76%, (95% CI)
31 ICU patients subjected to serial swabbing due to long hospitalization
5 patients colonized over time
2 patients: a change in colonization status was detected by the Vivalytic system one week earlier than by SOC.
Conclusions
Vivalytic C.auris demonstrated high concordance and improved time-to-result when compared to SOC processing.
Its ease-of-use concept serves to enhance screening efficiency.
Its rapid turnaround time potentially improves infection control practices by enabling timelier patient isolation.
