HPV testing in combination with liquid-based cytology in primary cervical screening (ARTISTIC): a randomised controlled trial

Kitchener, Henry C; Almonte, Maribel; Thomson, C; Wheeler, Philip M.; Sargent, Alexandra; Stoykova, Boyka; Gilham, Clare; Baysson, Hélène; Roberts, Christopher; Dowie, Robin; Desai, M.; Mather, Jean; Bailey, A. S.; Turner, Andrew; Moss, Sue; Peto, Julian

doi:10.1016/s1470-2045(09)70156-1

Cited by 340 publications

(288 citation statements)

References 16 publications

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“…Overall, the number of cases of CIN3 lesions or cancers did not differ between trial arms, suggesting that initial co-testing may detect significant lesions earlier but not any more effectively than conventional cytologic screening (58). Similar results were obtained in a large study conducted in England (59).…”

Section: Hpv Triage: Molecular Screening For Cervical Cancersupporting

confidence: 73%

Evidence-Based Cervical Cancer Screening: The Modern Evolution of the Pap Smear

Lappen¹,

Gossett²

2012

Evidence Based Medicine - Closer to Patients or Scientists?

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Section: Hpv Triage: Molecular Screening For Cervical Cancersupporting

confidence: 73%

Evidence-Based Cervical Cancer Screening: The Modern Evolution of the Pap Smear

Lappen¹,

Gossett²

2012

Evidence Based Medicine - Closer to Patients or Scientists?

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“…6,51,52 We used only a single co-test, while the importance of assessing screening over at least two rounds has been suggested. 53 Additionally, because all tests were conducted in a high-functioning health care system, test sensitivity may be superior to other settings. Finally, because we used surrogate outcomes, we could not estimate the cost per case of cervical cancer prevented or life years saved.…”

Section: Discussionmentioning

confidence: 99%

Cost-Effectiveness of Primary HPV Testing, Cytology and Co-testing as Cervical Cancer Screening for Women Above Age 30 Years

et al. 2016

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BACKGROUND: Cervical cancer screening guidelines for women aged ≥30 years allow for co-testing or primary cytology testing. Our objective was to determine the test characteristics and costs associated with Cytology, HPV and Co-testing screening strategies. MAIN METHODS: Retrospective cohort study of women undergoing cervical cancer screening with both cytology and HPV (Hybrid Capture 2) testing from 2004 to 2010 in an integrated health system. The electronic health record was used to identify women aged ≥30 years who had cotesting. Unsatisfactory or unavailable test results and incorrectly ordered tests were excluded. The main outcome was biopsy-proven cervical intraepithelial neoplasia grade 3 or higher (CIN3+). KEY RESULTS: The final cohort consisted of 99,549 women. Subjects were mostly white (78.4 %), married (70.7 %), never smokers (61.3 %) and with private insurance (86.1 %). Overall, 5121 (5.1 %) tested positive for HPV and 6115 (6.1 %) had cytology ≥ ASCUS; 1681 had both and underwent colposcopy and 310 (0.3 %) had CIN3+. Sensitivity for CIN3+ was 91.9 % for Primary Cytology, 99.4 % for Co-testing, and 94.8 % for Primary HPV; specificity was 97.3 % for Co-testing and Primary Cytology and 97.9 % for Primary HPV. Over a 3-year screening interval, Primary HPV detected more cases of CIN3+ and was less expensive than Primary Cytology. Co-testing detected 14 more cases of CIN3+ than Primary HPV, but required an additional 100,277 cytology tests and 566 colposcopies at an added cost of $2.38 million, or $170,096 per additional case detected. CONCLUSIONS: Primary HPV was more effective and less expensive than Primary Cytology. Primary HPV screening appears to represent a cost-effective alternative to Co-testing.

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“…[6] The identification of high-risk human papillomavirus (hrHPV) types (the cause of cervical cancer) offers the prospect of improving cervical screening programmes through the introduction of hrHPVbased screening tests. Studies from developed countries provide convincing evidence that hrHPV DNA-based screening algorithms are cost-effective and clinically sensitive for the detection of precancerous lesions [7][8][9] and invasive cervical cancer [10] compared with cytology-based screening in women older than 30. Recently, this finding has also been confirmed in India, a developing country with a low human immunodeficiency virus (HIV) prevalence.…”

mentioning

confidence: 99%

Age-specific prevalence of cervical human papillomavirus infection and cytological abnormalities in women in Gauteng Province

et al. 2013

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Background. Women accessing the public health system in Gauteng province, South Africa are largely unscreened for cervical cancer and have a high background prevalence of human immunodeficiency virus (HIV) infection. Objectives. This cross-sectional study describes the age-specific prevalence of human papillomavirus (HPV) infection and cytological abnormalities among this urban and peri-urban population. Method. Over the period March 2009 -September 2011, 1 524 women attending public sector primary healthcare clinics were invited to participate in a cervical cancer screening study. All participants were screened with conventional cytology and HPV testing undertaken using the HPV linear array genotyping kit (Roche Molecular Systems). Results. Of 1 472 women with valid cytology results, abnormalities were detected in 17.3% (n=255), of which 9.1% (n=134) were high-grade squamous intraepithelial lesions, and 0.5% (n=8) suggestive of squamous carcinoma. Of the 1 445 women with complete data, the overall and high-risk HPV DNA prevalences were 74.6% (n=1 078) and 54.3% (n=784), respectively. HPV type 16 and/or 18 were detected in 19.5% (n=282) of women. Age-specific prevalence of HPV showed a plateau-shaped curve. Conclusions. The prevalences of HPV infection and abnormal cytology were much higher than previously reported in general populations in South Africa and elsewhere. Higher age-specific prevalence and similar plateau-like age-specific epidemiological curves have previously only been described in studies among HIV-positive women. These findings have implications for planning and development of cervical screening programmes in developing countries with largely unscreened populations with a high background prevalence of HIV. Specimen collection and testingAll participants were screened with conventional cytology (Pap smear) as per national protocol. Cytopathology reports were based on the Bethesda system. [13] Specimens for HPV genotyping were either healthcare worker-collected dry cervical swabs (N=951) or patientcollected tampon specimens (N=573). Tampons were placed in a phosphate buffered saline and 10% methanol solution directly after collection. DNA extraction was performed in batches on washed cell pellets of the tampon specimens or directly on the dry swab specimens using the DNA Isolation Kit (Roche Molecular Systems, Branchburg, NJ) on the MagNA Pure automated extraction system. HPV genotyping was done using the HPV linear array (LA) genotyping kit (Roche Molecular Systems, Branchburg, NJ). The pool of primers is designed to amplify HPV DNA from 15 high-risk genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73 and 82), 3 probable high-risk genotypes (26, 53 and 66) and 19 low/undetermined-risk types (6,11, 40, 42, 54, 55, 61, 62, 64, 67, 69, 70, 71, 72, 81, 83, 84, IS39 and CP6108). The β-globin gene was amplified concurrently to assess cellular adequacy, extraction and amplification for each individually processed specimen. Strict procedures were followed to avoid contamination, with ne...

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HPV testing in combination with liquid-based cytology in primary cervical screening (ARTISTIC): a randomised controlled trial

Cited by 340 publications

References 16 publications

Evidence-Based Cervical Cancer Screening: The Modern Evolution of the Pap Smear

Evidence-Based Cervical Cancer Screening: The Modern Evolution of the Pap Smear

Cost-Effectiveness of Primary HPV Testing, Cytology and Co-testing as Cervical Cancer Screening for Women Above Age 30 Years

Age-specific prevalence of cervical human papillomavirus infection and cytological abnormalities in women in Gauteng Province

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