Accessories and Controls

Accessories and Controls

Your quality needs are covered with our range of positive, negative, and control materials. Designed to run with corresponding PlexPCR® and ResistancePlus® kits.

ResistancePlus® GC Control

Neisseria gonorrhoea wild-type and mutant amplification controls.

Accessory Features

Each positive control vial contains synthetic DNA designed to simulate wild type Neisseria gonorrhoeae genes and mutant genes including:

  • porA
  • opa
  • gyrA S91 wildtype
  • gyrA S91F mutant

A negative control vial is also provided.

Resources

Compatibility

Compatible for use with the ResistancePlus® GC kit.

 

Regulatory status

CE-IVD, TGA cleared, Class I 510(k) Exempt

Product Size Catalogue Compatible
ResistancePlus® GC Control 10 reactions 95003 All platforms

ResistancePlus® MG Positive Control

Mycoplasma genitalium wild-type and mutant amplification controls.

Accessory Features

Each positive control vial contains fragments of synthetic DNA designed to simulate wild type M. genitalium or mutant M. genitalium including:

  • MG, 23S rRNA wild type
  • MG, 23S rRNA A2058G
  • MG, 23S rRNA A2059G
  • MG, 23S rRNA A2058T
  • MG, 23S rRNA A2058C
  • MG, 23S rRNA A2059C

Resources

Compatibility

Compatible for use with the ResistancePlus® MG kit.

 

Regulatory status

CE-IVD, TGA cleared, Health Canada cleared, Class I 510(k) Exempt

Product Size Catalogue Compatible
ResistancePlus® MG Positive Control 10 reactions 95001 All platforms

ResistancePlus® MG S2A Positive Control

Mycoplasma genitalium wild-type and mutant amplification controls for sample to answer (S2A) systems.

Accessory Features

Each positive control vial contains fragments of synthetic DNA designed to simulate wild type M. genitalium or mutant M. genitalium including:

  • MG, 23S rRNA wild type
  • MG, 23S rRNA A2058G
  • MG, 23S rRNA A2059G
  • MG, 23S rRNA A2058T
  • MG, 23S rRNA A2058C

Resources

Compatibility

Compatible for use with the ResistancePlus® MG FleXible kit.

 

Regulatory status

CE-IVD, TGA cleared

Product Size Catalogue Compatible
ResistancePlus® MG S2A Positive Control* 2 tests per positive control S2A-95004 Cepheid GeneXpert®

*Not for sale in the US.

PlexPCR® RespiVirus Positive Control

Respiratory virus amplification controls.

Accessory Features

Each positive control vial contains synthetic DNA to simulate 11 different respiratory virus targets, including:

  • Influenza A (FluA)
  • Influenza B (FluB)
  • Rhinoviruses (RhV)
  • Respiratory Syncytial Viruses A and B (RSV)
  • Human metapneumovirus (HMPV)
  • Adenoviruses B and C (AdV)
  • Human parainfluenza viruses 1, 2, 3
  • 4 x (HPIV 1-4) targets

Resources

Compatibility

Compatible for use with the PlexPCR® RespiVirus kit.

 

Regulatory status

CE-IVD, TGA cleared

Product Size Catalogue Compatible
PlexPCR® RespiVirus Positive Control* 10 reactions 95002 All platforms

*Not for sale in the US.

PlexPCR® Amplification Control

Heterologous control DNA for use as an amplification control for reflex testing workflows.

Accessory Features

Contains heterologous control DNA for use as an amplification control to for use with sample extracts and lysates.

Resources

Compatibility

Compatible for use with the ResistancePlus® GC, ResistancePlus® MG and ResistancePlus® MG FleXible kits.

 

Regulatory status

CE-IVD, TGA cleared, Class I 510(k) Exempt

Product Size Catalogue Compatible
PlexPCR® Amplification Control 25 reactions 90002 All platforms

PlexPCR® Colour Compensation

Universal SpeeDx test calibration dyes.

Accessory Features

For the generation of a PlexPCR® Colour Compensation file on Roche LightCycler instruments.

Resources

Compatibility

Compatible for use with LC480 I, LC480 II and z480 instruments.

 

Regulatory status

CE-IVD, TGA cleared, Health Canada cleared, Class I 510(k) Exempt

Product Size Catalogue Compatible
PlexPCR® Colour Compensation 2 reactions 90001 LC480 I, LC480 II, z 480

Supplied upon request. This kit is only required for initial set-up to establish calibration of PlexPCR® kits on the LC480 instrument.

Contact SpeeDx for more information about these accessories and controls.