artus T. vaginalis QS-RGQ Kit CE

For qualitative detection of Trichomonas vaginalis DNA

Products

The artus T. vaginalis QS-RGQ Kit (72) CE is intended for in vitro diagnostic use.

eNAT Screw Cap

Cat. No. / ID: 4670003

Optional screw cap for the eNAT collection tube if this requires closure

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eNAT Tube (empty)

Cat. No. / ID: 4670002

Empty 2 ml tube for use with a positive control

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Features

CE-IVD-compliant workflow on the QIAsymphony RGQ
Reliable diagnostic results
Highly sensitive detection of T. vaginalis
Well established clinical and analytical performance

Product Details

The artus T. vaginalis QS-RGQ Kit is an in vitro real-time PCR assay for the direct qualitative detection of Trichomonas vaginalis DNA purified from clinician-collected vaginal swabs, endocervical swabs, and urine samples (male and female) from symptomatic and asymptomatic subjects as an aid in the diagnosis of trichomoniasis.

This diagnostic test is configured for use with the QIAsymphony SP/AS and Rotor-Gene Q instruments for target amplification and detection.

Performance

The diagnostic sensitivity and specificity of the CE-IVD-marked artus T. vaginalis QS-RGQ Kit were compared with a composite reference method of wet mount microscopy and InPouch TV culture/microscopy (Biomed Diagnostics, Inc, White City, OR, USA) for female samples and a composite reference method of InPouch TV culture and a PCR method followed by bi-directional sequencing for the male samples. The artus T. vaginalis QS-RGQ Kit showed a sensitivity of 100.0% and a specificity of 98.0% for vaginal swabs and 100.0% and 99.0%, respectively, for endocervical swabs. For urine samples from female subjects, sensitivity was 97.7% and specificity was 98.8%, and for male subjects, the corresponding values were 94.3% and 99.4%, respectively.

The limit of detection (LoD) of theartus T. vaginalis QS-RGQ Kit (in combination with the QIAsymphony DSP Virus/Pathogen Midi Kit) was assessed by using two T. vaginalis strains, with one metronidazole-susceptible strain (ATCC 30001) and one metronidazole-resistant strain (ATCC 50143). For strain ATCC 30001, the LoD was 0.025 cells/ml for urine and 0.044 cells/ml for natural vaginal fluid. For strain 50143, the LoD was 0.021 cells/ml for urine and 0.265 cells/ml for natural vaginal fluid matrix. This indicates a ≥ 95% probability that T. vaginalis will be detected at the claimed LoD levels.
A total of 43 different T. vaginalis strains were tested by the kit and the results demonstrated 100% reactivity/inclusivity. A panel of over 60 bacteria, fungi, protozoa, and viruses were tested and the results showed no cross-reactivity and microbial interference.

Principle

The artus T. vaginalis QS-RGQ Kit constitutes a ready-to-use system for the detection of T. vaginalis DNA using real-time PCR on Rotor-Gene Q MDx instruments with sample preparation and assay setup using QIAsymphony SP/AS instruments. The artus T. vaginalis QS-RGQ Kit contains reagents and enzymes for the specific amplification and direct detection of a multiple repeat region within T. vaginalis genomic DNA. The T. vaginalis target is detected using the fluorescence channel Cycling Green on the Rotor-Gene Q MDx instrument.

In addition, the artus T. vaginalis QS-RGQ Kit contains an exogenous internal control (IC), which identifies possible PCR inhibition and monitors reagent integrity. The IC is detected in fluorescence channel Cycling Orange on the Rotor-Gene Q MDx instrument. This distinguishes the IC from the T. vaginalis target detected in fluorescence channel Cycling Green.

Procedure

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

For automated interpretation of results using the artus T. vaginalis QS RGQ Kit with Rotor-Gene AssayManager, the latest Epsilon Plug-in must be installed to your Rotor-Gene AssayManager. This kit is solely for use with Rotor-Gene MDx instruments.

Applications

The artus T. vaginalis QS-RGQ Kit enables efficient and sensitive detection of T. vaginalis DNA from clinician-collected vaginal swabs, endocervical swabs, and urine samples (male and female) from symptomatic and asymptomatic subjects.

The artus T. vaginalis QS-RGQ Kit is designed to be used with the QIAsymphony RGQ, providing a complete CE-IVD-compliant workflow, from sample to result, to aid in the diagnosis of trichomoniasis.