Human papillomavirus (HPV) infection is the most common sexually transmitted infection1
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.2,3
HPV Nucleic Acid Amplification Tests (NAAT) can be complicated to use and batch testing can delay results critical for the mangement of hrHPV postive women.4
Rapid HPV results that include integrated high-risk HPV 16 and HPV 18 genotyping support more efficient colposcopy referrall.5
WHO recommends using a screen-and-treat approach.6
1 CDC. Sexually Transmitted Infections (STIs). About Genital HPV Infection. https://www.cdc.gov/sti/about/about-genital-hpv-infection.html#:~:text=HPV%20is%20the%20most%20common,these%20health%20problems%20from%20happening. 2 de Martel C, et al. Worldwide burden of cancer attributable to HPV by site, country and HPV type. Int J Cancer. 2017;141(4):664–70. doi:10.1002/ijc.30716 3 Chen, A et al. Human Papillomavirus 45 Genetic Variation and Cervical Cancer Risk Worldwide. J Virol. 2014 Apr;88(8):4514-21 4 Kundrod, K et al. Advances in technologies for cervical cancer detection in low-resource settings. Expert Rev Mol Diagn. 2019 Aug;19(8):695-714. 5 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. 6 WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, second edition. Geneva: World Health Organization; 2021
Rozwiązanie
The Xpert HPV v2 test, is an automated, qualitative, in vitro test for the detection of the E6/E7 region of the viral DNA genome from 14 high risk HPV in patient specimens.
Xpert HPV v2 specifically identifies types HPV 16 and HPV 18/45 in two distinct detection channels, and reports 11 other high-risk types in a pooled result
The Xpert HPV v2 test can be used with a Pap specimen or as a first-line primary screening test.
Wpływ
Enhanced Patient Management: Xpert HPV v2 provides partial genotyping, with individual call-outs for high-risk HPV types 16 and 18/45, for primary screening of women who are at risk of developing cervical cancer.7
Rapid Results: HPV results in around 60 minutes for same-visit clinician/ patient consult, minimizes the need for repeat visits, and follows the WHO screen-and-treat approach.6
Zdolność do adaptacji: in a decentralized setting in a laboratory environment, in a cytology center, or in a molecular laboratory.
7 Vassilakos, P et al. A cross-sectional study exploring triage of human papillomavirus (HPV)-positive women by visual assessment, manual and computer-interpreted cytology,and HPV-16/18-45 genotyping in Cameroon. Int J Gynecol Cancer. 2021 Jun;31(6):808-816. 6 WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, second edition. Geneva: World Health Organization; 2021
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