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artus CT/NG QS-RGQ Kit CE

For qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA
  • CE-IVD-compliant workflow on the QIAsymphony RGQ
  • High reliability through use of an internal control
  • Excellent detection limit for swabs and urine
The artus CT/NG QS-RGQ Kit is a ready-to-use real-time PCR assay for use on the QIAsymphony RGQ. The kit provides all necessary reagents optimized for the direct qualitative detection of Chlamydia trachomatis (CT) plasmid and genomic DNA and Neisseria gonorrhoeae (NG) genomic DNA for in vitro diagnostic use.
Cat No./ID: 4569365
artus CT/NG QS-RGQ Kit (2 x 48) CE
For 96 reactions: Master, Magnesium Solution, Positive/Negative Controls, Internal Control, NTC

The artus CT/NG QS-RGQ Kit CE is intended for in vitro diagnostic use in Europe.


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CE-IVD-marked.
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In vitro diagnostic medical device.
Performance

The diagnostic sensitivity and specificity of the CE-IVD-marked artus CT/NG QS-RGQ Kit were compared with the Abbott CT/NG assay. The artus CT/NG QS-RGQ Kit showed a diagnostic specificity of 99.8% and sensitivity of 98.1% for CT and a diagnostic specificity of 99.8% and sensitivity of 96.3% for NG compared to the Abbott CT/NG assay.

Excellent detection limit for swabs and urine

For swabs, the analytical detection limit (LOD) of the artus CT/NG QS-RGQ Kit, in consideration of the purification, was determined using a dilution series of C. trachomatis and N. gonorrhoeae cells spiked in eNAT medium in combination with the extraction on the QIAsymphony SP. The LOD gave a 95% probability that 5 EB/ml C. trachomatis and 3 CFU/ml of N. gonorrhoeae will be detected (see table below).

For urine, the LOD of the artus CT/NG QS-RGQ Kit, in consideration of the purification, was determined using a dilution series of C. trachomatis and N. gonorrhoeae cells spiked in urine samples containing eNAT as stabilization reagent. The LOD gave a 95% probability that 7.65 EB/ml C. trachomatis and 6.89 CFU/ml N. gonorrhoeae will be detected (see table below).

Excellent detection limit
Pathogen  Swabs Urine
C. trachomatis  5 EB/ml 8 EB/ml
N. gonorrhoeae  3 CFU/ml 7 CFU/ml

Principle

The artus CT/NG QS-RGQ Kit constitutes a ready-to-use system for the detection of C. trachomatis and N. gonorrhoeae DNA using real-time PCR on Rotor-Gene Q instruments with sample preparation and assay setup using QIAsymphony SP/AS instruments. The CT/NG RG Master contains reagents and enzymes for the specific amplification of an 86 bp region of the C. trachomatis cryptic plasmid, a 66 bp region of the C. trachomatis genome, and a 74 bp target of the N. gonorrhoeae genome for the direct detection of the specific amplicon in fluorescence channel Cycling Green and Cycling Orange of the Rotor-Gene Q.

The kit also provides a fourth heterologous amplification system to identify possible PCR inhibition. This is detected as an internal control (IC) in the fluorescence channel Cycling Yellow of the Rotor-Gene Q. The detection limit of the analytical CT/NG PCR is not reduced by this control. External positive/negative controls (Control CT+/NG– and Control NG+/CT–) and a no template control (NTC) are supplied.

Procedure

The QIAsymphony RGQ complete workflow solution for detection of C. trachomatis and N. gonorrhoeae DNA comprises the QIAsymphony SP and QIAsymphony DSP Virus/Pathogen Midi Kit for sample preparation, the QIAsymphony AS for assay setup, and the artus CT/NG QS-RGQ Kit on Rotor-Gene Q instruments. The system enables reliable pathogen DNA detection with a complete CE-IVD-compliant workflow.

The kit may also be used with Rotor-Gene AssayManager for automated interpretation of results.

Applications

The artus CT/NG QS-RGQ Kit enables rapid and sensitive detection of C. trachomatis plasmid and genomic DNA and N. gonorrhoeae genomic DNA from vaginal, cervical, and male urethral swabs and male and female urine samples.

The artus CT/NG QS-RGQ Kit is designed to be used with the QIAsymphony RGQ, providing a complete CE-IVD-compliant workflow, from sample to result.

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Application/Protocol Documents (20)

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Protocol Files (3)

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For use with QIAsymphony SP/AS instruments (software version 4.0)
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Assay profile for use with the artus basic plug-in V1.0.3 in combination with Rotor-Gene AssayManager
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Instrument Technical Documents (1)
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