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Xpert® HPV

Xpert® HPV

Xpert® HPV

Product catalog summary
Introduction
Xpert® HPV is an in vitro diagnostic medical device designed for the reliable detection of high-risk HPV DNA, specifically genotyping HPV 16 and 18/45. It aims to help prevent cervical cancer by providing accurate and rapid results.

The Need
HPV is the most common sexually transmitted infection globally, with genotypes 16 and 18 linked to 71% of cervical cancer cases. Current HPV tests are often complex and delay results, impacting patient care. An ideal test should integrate easily into various environments and provide rapid results for effective patient risk stratification.

The Solution
Xpert® HPV, based on GeneXpert technology, automates the testing process, offering on-demand testing with results in 60 minutes. It enhances patient stratification by identifying high-risk HPV types and includes a sample adequacy control to ensure sample quality.

Clinical Performance
Clinical studies in the US and Europe demonstrated Xpert® HPV's high sensitivity and specificity compared to other HPV tests. It showed a sensitivity of 90.8% for ≥CIN2 disease status and 92.3% for ≥CIN3, with specificity rates of 42.6% and 40.0%, respectively.

Impact and Validation
Xpert® HPV has been clinically validated according to international guidelines, showing high accuracy and reproducibility. It supports improved patient care by enabling rapid risk stratification and same-day testing, adaptable to various clinical settings.

Workflow
The test involves two simple steps with less than one minute of hands-on time, allowing for high throughput in an 8-hour shift.

Contact Information
Corporate Headquarters: 904 Caribbean Drive, Sunnyvale, CA 94089 USA
European Headquarters: Vira Solelh, 81470 Maurens-Scopont France
Website: www.Cepheidinternational.com
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Catalog excerpts

Xpert® HPV-1

Accurately detect HPV infection. Help prevent cervical cancer. Reliable detection of high-risk HPV DNA with genotyping of HPV 16 and 18/45 In Vitro Diagnostic Medical Device

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Xpert® HPV-2

High-risk human papillomavirus (HPV) testing is a highly effective and reliable method of screening to prevent cervical cancer. An easy-to-use, rapid (~60 minutes to results), and scalable (1 to 80 tests per hour) HPV test with partial genotyping for the most important HPV types (HPV16 and HPV18/45) for risk stratification is transformative. It now will be possible to deploy centralized or point-of-care HPV testing for cervical cancer screening in all settings throughout the world using a wide range of clinical algorithms, including same-day screen-and-treat strategies.” Philip E. Castle, Ph.D.,...

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Xpert® HPV-3

© THE IMPACT Improve your laboratory workflow with simple, on-demand, random-access flexibility. Combine performance with the ability to run other tests (such as CT/NG, TV, HIV, HCV, and GBS) on the GeneXpert® System to achieve a proven increase in overall laboratory level service. Shift from reactive to proactive • Improved patient care: risk stratification in less than 60 minutes to support better clinical decisions. • Full ownership of patient results with same day cytology and HPV testing. • Optimal assay design for improved accuracy and reproducibility. • Adaptable: remote, near patient,...

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Xpert® HPV-4

WORKFLOW: 2 Easy Steps Total hands-on time: <1 minute * 1 Transfer 1 ml of appropriately collected cervical specimen to the cartridge*. System Throughput8-hr shift 16 GX-II References: 1. de Sanjose S, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010 Nov;11(11):1048-56. 2. Cox JT, et al. Comparison of cervical cancer screening strategies incorporating different combinations of cytology, HPV testing, and genotyping for HPV 16/18: results from the Athena HPV study. Am J Obstet Gynecol. 2013 Mar;208(3):184.e1-184.e11....

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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.