Session: P017 Challenges in diagnostic bacteriology

Category: 8d. Nosocomial infection surveillance & epidemiology

22 April 2017, 15:30 - 16:30

P0335

ELITe InGenius, a new CE-IVD sample-to-result solution for the molecular diagnostics
of healthcare associated infections

Audrey Estampes*1, Silvia Costa1, Marco Enrietto1, Salvatore Patanè1, Francesco Gorreta1,
Gulielmo Stefanuto1, Walt Mahoney1

1Elitechgroup Molecular Diagnostics

Background: ELITe InGenius™ (ELITechGroup Molecular Diagnostics) is a new and fully automated
cassette based sample-to-result solution combining a universal extraction and independently
controlled real-time PCR. The system was CE-IVD validated for the rapid diagnostic of Healthcare
Associated Infections (HAI) enabling the detection of: Carbapenem-Resistant Enterobacteriaceae
genes (CRE), Methicillin Resistant Staphylococcus Aureus (MRSA), Staphylococcus Aureus (SA),
toxinogenic Clostridium difficile. The validation studies were performed in combination with MRSA/SA,
C. difficile and CRE ELITE MGB® Kit real-time PCR assays (ELITechGroup Molecular Diagnostics)
respectively with nasal swab, stool and rectal swab samples. The present study describes the
performance obtained with these 3 assays in combination with ELITe InGenius and its advantages in
terms of workflow.

Material/methods: ELITe InGenius™ automatically performs nucleic acid extraction, amplification and
results analysis integrating in a single platform 12 extraction modules and 12 independently controlled
thermocyclers. MRSA/SA, C. difficile and CRE ELITE MGB® Kits are three multiplex real-time PCR
assays based on MGB technology. The validation plan for each parameter was based on (1) analytical
studies with efficiency, linearity, accuracy, repeatability and reproducibility testing to verify the PCR
performance; (2) target and internal control sensitivity study; and (3) system performance verification
using certified reference material (Qnostics Ltd.). Three clinical studies, including diagnostic sensitivity
and specificity assessment, were performed by testing: (1) 41 positive MRSA samples (including
mecA/mecC), 60 positive SA samples and 48 negative samples with MRSA/SA ELITe MGB® Kit, (2)
150 CRE positive samples and 52 negative CRE samples with CRE ELITe MGB® Kit, (3) 30 C. difficile
positive samples, 46 C. difficile negative samples with C. difficile ELITe MGB® Kit.

Results: MRSA/SA, C. difficile and CRE assays passed the validation criteria of analytical and clinical
studies. The clinical sensitivities were: 98%, 100% and 99% with MRSA/SA, C. difficile and CRE
ELITE MGB® Kits respectively after discrepant resolution. The clinical specificities were: 100%, 98%
and 100% with MRSA/SA, C. difficile and CRE ELITE MGB® Kits respectively after discrepant
resolution. In comparison to conventional PCR platforms and even other sample-to-result solutions,
the ELITe InGenius system enables the user a direct loading of samples in transport media without
pre-treatment limiting the hands-on time to few minutes, reducing the risk of errors and improving the
laboratory workflow.

Conclusions: The excellent results obtained support the CE-IVD marking of ELITe InGenius™
system in combination with MRSA/SA, C. difficile and CRE ELITe MGB® Kits. This new CE-IVD
molecular diagnostics solution can improve the detection of risk patient, and the control of HAI in
hospital settings.