GenomEra MRSA/SA, a fully automated homogeneous PCR assay for rapid detection of Staphylococcus aureus and the marker of methicillin resistance in various sample matrixes

Abstract

The GenomEra MRSA/SA assay (Abacus Diagnostica, Turku, Finland) is the first commercial homogeneous PCR assay using thermally stable, intrinsically fluorescent time-resolved fluorometric (TRF) labels resistant to autofluorescence and other background effects. This fully automated closed tube PCR assay simultaneously detects Staphylococcus aureus specific DNA and the mecA gene within 50 min. It can be used for both screening and confirmation of methicillin-resistant and -sensitive S. aureus (MRSA and MSSA) directly in different specimen types or from preceding cultures. The assay has shown excellent performance in comparisons with other diagnostic methods in all the sample types tested. The GenomEra MRSA/SA assay provides rapid assistance for the detection of MRSA as well as invasive staphylococcal infections and helps the early targeting of antimicrobial therapy to patients with potential MRSA infection.

Keywords::

• bacteremia
• closed-tube assay
• GenomEra MRSA/SA assay
• homogeneous PCR
• MRSA
• pathogen-specific PCR
• Staphylococcus aureus

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• • Faster diagnosis of bloodstream infections caused by Staphylococcus aureus and the detection of methicillin-resistance permits earlier implementation of appropriate antimicrobial treatment and can reduce morbidity and mortality.

• • Reliable detection of methicillin-resistant S. aureus (MRSA) is important in order to limit the transmission of this significant pathogen.

• • The GenomEra MRSA/SA assay is the first commercially available homogeneous PCR platform to use thermally stable, intrinsically fluorescent time-resolved labels resistant to autofluorescence and other background effects.

• • The GenomEra MRSA/SA assay simultaneously detects a S. aureus-specific gene and the mecA-gene.

• • The GenomEra MRSA/SA assay has a very high clinical sensitivity and specificity for the detection of methicillin-sensitive and -resistant S. aureus (MSSA and MRSA) in a variety of specimen types and a high clinical sensitivity and specificity for the preliminary screening of methicillin-resistant coagulase-negative staphylococci (MRCoNS) in blood culture samples.

• • Simple sample preparation, user-friendly application, fast turnaround time and scanty space requirement make the GenomEra MRSA/SA assays suitable for laboratories of any size and also for point-of-care settings.