Sentosa SA C. diff PCR Test v2.0

INTENDED USE

The Sentosa SA C. diff PCR Test v2.0 is a duplex, real-time polymerase chain reaction (PCR) based research use only test, targeting toxin B gene (tcdB) in the toxigenic Clostridium difficile strains, for the qualitative detection of C. difficile nucleic acids isolated and purified from liquid or soft stool.

This research use only test is configured for use on the Sentosa SX101 instrument, with the Sentosa SX Virus Total Nucleic Acid Kit v2.0, in conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument.

FEATURES AND BENEFITS

Supporting Decision Making

  • Sensitive and robust
  • Comprehensive information
  • Fast turn-around time

Providing Laboratory Efficiency

  • Can be run in combination with Sentosa SA Norovirus and Sentosa SA Rotavirus RT-PCR Tests
  • Highly automated workflow including lysis and PCR set-up
  • Automated result call-out within 2 mins
  • Test up to 184 clinical samples per day

Increasing Cost Effectiveness

  • Up to three tests from one extraction
  • Only 40 mins hands-on time per run (22 samples)
  • Comprehensive and fast result call-out to reduce patient management costs

WORKFLOW

SPECIFICATIONS

AttributeValue
Analytical Sensitivity (95% CI) 1.1 copies/μL
Analytical Reactivity 22 known strains of C. difficile was tested. All straing were correctly identified.
Analytical Specificity 31 common bacterial strains usually found in stool samples were tested. No cross-reactivity was observed.
Reproducibility 99.83%
Sample Type(s) Liquid or soft stool

ORDERING INFORMATION

ProductPack SizeItem Number
Sentosa SA C. diff PCR Test v2.0 (RUO) 4x24 300248
Sentosa SX Virus Total Nucleic Acid Kit v2.0 (RUO) 4x24 300044
Sentosa SX101 1 400089
Rotor-Gene® Q MDx 1 400046