iCassette – MRSA Detection Kit

What is in the MRSA Detection Kit

The MRSA Detection Kit includes primers and probes targeting:

• mecA gene – the genetic determinant of methicillin resistance (FAM channel)

• spa gene – a conserved gene in Staphylococcus aureus used for identification (CY5 channel)

• Internal control (HEX) – ensures PCR quality and flags inhibited or invalid results

Each kit contains 12 MRSA iCassettes, preloaded with:

• Magnetic beads for extraction

• Lysis, wash, and elution buffers

• Lyophilized dNTPs, enzymes, primers, and probes

• Positive and negative controls (pseudovirus with gene fragments)

• NaOH pretreatment solution and enhancer for sputum processing

Samples are processed with minimal handling, directly within the sealed cassette system.

Role of mecA and spa Genes in MRSA Infections

Methicillin-resistant Staphylococcus aureus (MRSA) is a significant cause of hospital- and community-acquired infections. Its resistance is conferred by the mecA gene, encoding PBP2a, which alters penicillin-binding affinity and confers resistance to β-lactam antibiotics.

The spa gene, encoding staphylococcal protein A, is universally present in S. aureus strains and is a reliable target for pathogen identification.

Together, detecting mecA-positive and spa-positive samples allows differentiation between:

• MRSA-positive (mecA+, spa+)

• Methicillin-sensitive SA (mecA–, spa+)

• Negative or inhibited samples via internal control

This dual-target approach supports precise infection control, especially in respiratory surveillance and outbreak settings.

About the Staphylococcus aureus and MRSA Drug-Resistance Gene Detection Kit

The Staphylococcus aureus and MRSA Drug-Resistance Gene Detection Kit by Igenesis is a CE-marked, professional-use-only test designed for enclosed, automated molecular diagnostics. It is compatible with Galaxy Nano, Neo, Lite, and Pro qPCR instruments.

Key specifications:

• 12 single-use iCassettes per kit

• Validated for sputum, throat, and nasal swabs

• No cross-reactivity with other major respiratory pathogens

• LoD: 10³ copies/mL (molecular), 10³ CFU/mL (culture)

• Precision: CV ≤ 5%

The kit includes all necessary reagents, controls, and instructions for direct sample-to-answer workflows. Once the cassette is loaded with sample and placed in the instrument, the process is fully automated from extraction to amplification and result output.

Principle and Workflow

This MRSA PCR panel applies real-time multiplex PCR in a fully enclosed format. The test workflow includes:

1. Sample Preparation

   • Throat/nasal swabs: No pretreatment

   • Sputum: Mix with NaOH-based pretreatment solution + enhancer, liquefy fully

2. Cassette Loading & Ultrasonic Lysis

   • Add 1000 µL of sample into the iCassette

   • Sonicate for 20 seconds (or skip if using Galaxy Neo)

3. Automated PCR Run

   • Insert cassette → Scan QR code → Start run

   • Instrument auto-runs nucleic acid extraction, PCR, and fluorescence detection

4. Fluorescence Channels

   • FAM: mecA gene (MRSA)

   • CY5: spa gene (SA)

   • HEX: Internal control

5. Result Interpretation

   • Ct ≤ 37 = positive

   • HEX must be positive in negative samples

   • Invalid runs are automatically flagged by the system

Result output includes Ct values, amplification curves, and full interpretation summary directly in the software.

Clinical Application

The MRSA Detection Kit supports use in:

• Hospital microbiology labs for infection screening and outbreak control

• ICU and emergency settings for rapid antimicrobial decision-making

• Pre-surgical and admission screening for MRSA carriage

• Infection prevention teams monitoring MRSA prevalence and colonization

• Molecular diagnostics labs implementing closed-system, contamination-free workflows

Its dual-target design improves diagnostic clarity by distinguishing colonization from resistance, offering faster isolation decisions and improved patient outcomes.