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Xpert® HPV
Reliable Detection of High-Risk HPV DNA with Genotyping of HPV 16 and 18/45
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GXHPV-CE-10
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The Need
Human papillomavirus (HPV) infection is the most common sexually transmitted infection worldwide. On a global basis, HPV genotypes 16 and 18 are associated with approximately 71% of all cases of cervical cancer, and HPV genotype 45 is associated with approximately 6% of additional cases of cervical cancer.1
Cervical cancer screening programs vary, based upon local guidance that consider testing algorithms, resources, skill set and infrastructure.
Most HPV Nucleic Acid Amplification Tests (NAAT) are complicated to use and batch testing can delay results critical for scheduling patient consultations for follow-up testing or colposcopy.
The ideal HPV test can flexibly integrate easily into most environments, and enable physicians to effectively risk stratify patients based on cytology and high-risk HPV status. Further, rapid HPV results that include integrated high risk HPV 16 and HPV 18 genotyping support quality decision making for colposcopy referral.2
Cervical cancer screening programs vary, based upon local guidance that consider testing algorithms, resources, skill set and infrastructure.
Most HPV Nucleic Acid Amplification Tests (NAAT) are complicated to use and batch testing can delay results critical for scheduling patient consultations for follow-up testing or colposcopy.
The ideal HPV test can flexibly integrate easily into most environments, and enable physicians to effectively risk stratify patients based on cytology and high-risk HPV status. Further, rapid HPV results that include integrated high risk HPV 16 and HPV 18 genotyping support quality decision making for colposcopy referral.2
(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.
(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.
The Solution
Now both cytology and molecular laboratories can run a HPV test with confidence. Based on the GeneXpert® technology, Xpert HPV automates the test process including DNA extraction, amplification, and detection in one fully integrated cartridge.
On-demand HPV testing — a next generation solution:
- Highest risk HPV 16 and HPV 18/45 call-outs enhances patient management
- Optimized detection of 14 hrHPV reported as: HPV16, HPV18/45 or other hrHPV (31, 33, 35, 52, 58; 51, 59; 39, 56, 66, 68)
- E6/E7 oncogenes target eliminates concerns in case of L1 gene deletion3
- Sample adequacy control (SAC) confirms patient sample contains human DNA
- HPV results in around 60 minutes for same-visit clinician/patient consult, minimizes need for repeat visits
(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.
The Impact
Xpert HPV is an accurate, fast, on-demand PCR test that provides actionable results in about an hour
Shift Your Lab From Reactive to Proactive
- Improved patient care: in around 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: near patient, in a cytology center, or in a molecular laboratory.
- Opportunity to run other tests (such as CT/NG, TV, HIV, HCV, GBS, and MG) on the GeneXpertSystem
* Rompalo A, et al. Point-of-care tests for sexually transmissible infections: what do 'end users' want? Sex Health. 2013 Dec; 10(6): 541–545
(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.
(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.
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