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Xpert® CT/NG

Xpert® CT/NG

Xpert® CT/NG

Product catalog summary
Introduction
The document discusses the Xpert® CT/NG and Xpert® CT tests, which are in vitro diagnostic medical devices designed for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). These tests enable same-day consultation and treatment, addressing the rising rates of these infections.

The Need
The European Centers for Disease Control and Prevention (ECDC) reports a doubling of chlamydia infections over the last decade, with gonorrhea rates also increasing. Laboratories require accurate, reliable, and reproducible tests that allow for onsite consultation and treatment, reduce sample preparation time, and offer more test choices with fewer platforms.

The Solution
Xpert® CT/NG tests provide on-demand testing with results available in less than 90 minutes, facilitating same-day patient consultation and treatment. The test cartridges include controls to ensure integrity and performance, with features such as sample adequacy control and dual NG targets for increased confidence.

Impact on Patient Pathway
The "Test and Treat" approach allows for efficient use of resources, accelerating laboratory workflows and improving patient management. The system supports running other tests like GBS, MRSA, C. difficile, and Flu on the GeneXpert® System, enhancing overall laboratory service levels.

Clinical Performance
The Xpert® CT/NG Assay's clinical performance was validated in a multi-site study, showing high sensitivity and specificity for both CT and NG. The test controls for sample adequacy, processing, and reagent preparation, ensuring reliable results.

Workflow
The testing process involves three simple steps: obtaining a sample, transferring it to the cartridge, and starting the assay, with a total hands-on time of less than one minute.

Conclusion
The Xpert® CT/NG and Xpert® CT tests provide a rapid, reliable solution for the detection of CT and NG, supporting same-day diagnosis and treatment, which is crucial for effective infectious disease control.
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Catalog excerpts

Xpert® CT/NG-1

Xpert® CT/NG Xpert® CT Detect it in here. Stop it out there. The only tests for same-day consultation and treatment. In Vitro Diagnostic Medical Device

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Xpert® CT/NG-2

An on-demand test capable of delivering accurate results while patients are still present in the clinic provides a much-needed advantage in our efforts to control infectious diseases such as chlamydia and gonorrhea. Delays in treatment can lead to complications in about 1 in 25 infected women awaiting test results. In addition, the availability of results in less than 90 minutes is especially important for patients presenting to Emergency Departments and in managing patients who may not return for treatment.” Dr. Edward W. Hook III Professor of Medicine and Epidemiology at the University of Alabama,...

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Xpert® CT/NG-3

THE IMPACT Speed and single-test confidence to make the most efficient use of your highly trained resources. Accelerate your laboratory’s workflow with on-demand, random-access flexibility. Combine performance with the ability to run other tests (such as GBS, MRSA, C. difficile, and Flu) on the GeneXpert® System to achieve proven increase in overall laboratory level service. Shift your lab from reactive to proactive • Achieve same-day containment and improve patient management • Deliver same-day results to clinicians with a 90 minute, on-demand test • Contact patient faster • Help more patients...

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Xpert® CT/NG-4

Clinical performance characteristics of the Xpert® CT/NG Assay were determined in a multi-site prospective investigational study at 36 US and UK institutions by comparing the Xpert CT/NG Assay to a patient infected status (PIS) algorithm based on results from two currently marketed NAAT tests. Sensitivity Specificity Endocervical Swabs t Sensitivity Specificity All performance results at 95% confidence interval . For details, refer to Package Insert . At CONFIDENT AND IN CONTROL Each self-contained Xpert® cartridge controls for three specific failure modes: • Sample Adequacy Control (SAC) - Confirms...

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Xpert® CT/NG-5

REAL-WORLD SYSTEM THROUGHPUT* 628 Operational throughput per 8-hr shift based on CT/NG testing; internal analysis. GeneXpert Infinity Systems

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Xpert® CT/NG-6

3 EASY STEPS Total hands-on time: <1 Minute Obtain either Urine or Swab samples previously stored in the Cepheid Transport Reagent Transfer the sample to the cartridge Insert cartridge and start assay Xpert® CT/NG is a qualitative real-time PCR test for automated detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) CATALOG INFORMATION Xpert CT/NG (10 tests) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . GXCT/NG-CE-10 Xpert® CT is a qualitative real-time PCR test for automated detection of Chlamydia...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.