Xpert
HPV
Accurately detect HPV infection. Help prevent cervical cancer.
Xpert HPV ®
Reliable detection of high-risk HPV DNA with
genotyping of HPV 16 and 18/45
A better way.
In Vitro Diagnostic Medical Device
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., MPH
Co-Founder and Executive Director, Global Coalition
Against Cervical Cancer (Arlington, VA USA) and
Professor of Epidemiology and Population Health,
Albert Einstein College of Medicine (Bronx, NY USA)
the need the solution
Human papillomavirus (HPV) infection is the most Now both cytology and molecular laboratories can run a HPV
common sexually transmitted infection worldwide. On a test with confidence. Based on the GeneXpert technology,
global basis, HPV genotypes 16 and 18 are associated Xpert® HPV automates the test process including DNA extraction,
with approximately 71% of all cases of cervical cancer, and amplification, and detection in one fully integrated cartridge. ONE
HPV genotype 45 is associated with approximately 6% of test for all screening algorithm options.
additional cases of cervical cancer.1
On-demand HPV testing — a next generation solution:
Cervical cancer screening programs vary, based upon • Highest risk HPV 16 and HPV 18/45 call-outs enhances patient
local guidance that consider testing algorithms, resources, stratification
skill set and infrastructure.
• Optimized detection of 14 hrHPV reported as: HPV16, HPV18/45
Most HPV Nucleic Acid Amplification Tests (NAAT) are or other hrHPV (31, 33, 35, 52, 58; 51, 59; 39, 56, 66, 68)
complicated to use and batch testing can delay results • E6/E7 oncogenes target eliminates concerns in case of L1
critical for scheduling patient consultations for follow-up gene deletion3
testing or colposcopy.
• Sample adequacy control (SAC) confirms patient sample
The ideal HPV test can flexibly integrate easily into most contains human DNA
environments, and enable physicians to effectively risk • Reporting of hrHPV DNA in captured cervical cells for improved
stratify patients based on cytology and high-risk HPV performance
status. Further, rapid HPV results that include integrated
• HPV results in 60 minutes for same-visit clinician/patient consult,
high risk HPV 16 and HPV 18 genotyping support quality
minimizes need for repeat visits
decision making for colposcopy referral.2
• Scalable platform automation delivers on-demand results,
eliminating delays associated with batch testing
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, in a cytology center, or in a molecular laboratory.
Clinical performance
Clinical performance characteristics of Xpert® HPV were established in multi-site, prospective investigational studies at
US and European institutions. These studies included both a colposcopy referral population and a general cervical cancer
screening population. Performance of Xpert HPV was established relative to cervical disease status and/or in comparison
to two currently marketed HPV (NAAT) tests.4
Table 1. Clinical Performance Relative to ≥ CIN2^ Disease Status
Xpert HPV cobas® Roche hc2 (Qiagen)
Sensitivity 90.8% 90.8% 81.6%
95%CI (84.7-95.0%) (84.7-95.0%) (74.2-87.6%)
Specificity 42.6% 39.6% 47.7%
95%CI (38.5-46.9%) (35.5-43.8%) (43.4-51.9%)
Table 2. Clinical Performance Relative to ≥ CIN3^ Disease Status
Xpert HPV cobas® Roche hc2 (Qiagen)
Sensitivity 92.3% 92.3% 80.2%
95%CI (84.8-96.9%) (84.8-96.9%) (70.6-87.8%)
Specificity 40.0% 37.2% 45.0%
95%CI (36.1-44.0%) (33.3-41.2%) (40.9-49.0%)
^ Preinvasive precursor lesions or dysplasia (often referred to as “CIN”, for cervical intraepithelial neoplasia), are graded into histological grades of
mild (CIN1), moderate (CIN2) or severe (CIN3). Lesions often regress and do not progress to invasive cancer.5
Clinical VALIDATION
Clinical validation of the Xpert HPV test according to the international guidelines6 was established in multi-site,
investigational studies at European institutions. Xpert HPV demonstrated sufficient accuracy for use in cervical cancer
screening.7,8 Additionally, Xpert HPV showed excellent overall intra-laboratory reproducibility with an agreement of 96.9%
[95% CI, 95.4 to 98.4%]. The inter-laboratory test also showed an excellent agreement of 97.8% [95% CI, 96.6 to 99.1%].*
*Publication pending
WORKFLOW:
2 Easy Steps System Throughput# 596
Total hands-on time: <1 minute 8-hr shift
365
1 Transfer 1 ml of appropriately 126
collected cervical specimen to
the cartridge*. 16 32
GX-II GX-IV GX-XVI Infinity-48 Infinity-80
# Operational throughput per 8-hr shift based on HPV testing, internal analysis.
2 Insert cartridge and start test.
Results in less than 60 minutes.
Xpert® HPV is a qualitative real-time PCR test for automated and rapid detection of Human
Papillomaviruses (HPV).
Catalog Information
Xpert HPV (10 tests) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . GXHPV-CE-10
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.
3. Tjalma WA, et al. Cervical cancer screening: which HPV test should be used-L1 or E6/E7? Eur J Obstet Gynecol Reprod Biol. 2013 Sep;170(1):45-6.
4. Einstein MH, et al. Clinical evaluation of the cartridge-based GeneXpert human papillomavirus assay in women referred for colposcopy. J Clin Microbiol. 2014 Jun;52(6):2089-95.
5. Solomon D, et al. The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA. 2002 Apr 24;287(16):2114-9.
6. Meijer C, et al. Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older. Int J Cancer. 2009 Feb 1;124(3):516-20.
7. Arbyn M, et al. VALGENT: A protocol for clinical validation of human papillomavirus assay. J Clin Virol. 2016 Mar;76 Suppl 1:S14-S21.
8. Cuzick J, et al. Performance of the Xpert HPV assay in women attending for cervical screening. Papillomavirus Research. 2015 Dec 1:32-7.
* Refer to Xpert HPV package insert for instruction on collection of ThinPrep (PreservCyt) specimen
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