Результаты тестирования на вирус папилломы человека при самостоятельном и врачебном заборе материала
Результаты тестирования на вирус папилломы человека при самостоятельном и врачебном заборе материала
Белокриницкая Т.Е., Фролова Н.И., Туранова О.В. и др. Результаты тестирования на вирус папилломы человека при самостоятельном и врачебном заборе материала. Гинекология. 2017; 19 (1): 56–62.
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Belokrinitskaya T.E., Frolova N.I., Turanova O.V. et al. Results of human papillomavirus testing on self-collected versus clinician-collected samples. Gynecology. 2017; 19 (1): 56–62.
Результаты тестирования на вирус папилломы человека при самостоятельном и врачебном заборе материала
Белокриницкая Т.Е., Фролова Н.И., Туранова О.В. и др. Результаты тестирования на вирус папилломы человека при самостоятельном и врачебном заборе материала. Гинекология. 2017; 19 (1): 56–62.
________________________________________________
Belokrinitskaya T.E., Frolova N.I., Turanova O.V. et al. Results of human papillomavirus testing on self-collected versus clinician-collected samples. Gynecology. 2017; 19 (1): 56–62.
Цель исследования – выявить распространенность вируса папилломы человека высокого канцерогенного риска (ВПЧ-ВКР) у женщин репродуктивного возраста, дать оценку результативности и приемлемости обследования при самостоятельном и врачебном заборе вагинального отделяемого для ВПЧ-теста. Материалы и методы. Проведено одномоментное кросс-секционное исследование с участием 200 женщин в возрасте 18–45 лет (средний возраст 32,7±6,9 года), обратившихся в поликлинику медосмотров для получения допуска к работе. Забор вагинального отделяемого для исследования на ВПЧ-ВКР методом полимеразной цепной реакции проведен дважды: самостоятельно с помощью прибора Qvintip и врачом из цервикального канала. Приемлемость взятия образцов двумя сравниваемыми методами оценена по результатам опроса пациенток об удобстве, болезненности, конфиденциальности, эмоциональных ощущениях при заборе материала для ВПЧ-теста. Результат. ВПЧ-ВКР выявлен у 42% обследованных. Результативность обследования с помощью устройства Qvintip была выше, чем при заборе материала врачом: 38% vs 27,5% (отношение шансов – ОШ 1,6; pχ2=0,025). Использование только устройства Qvintip повышает шанс выявления ВПЧ-ВКР в 5 раз: 36,3% vs 9,5% (ОШ 5,0; pχ2=0,0001). Частота выявления ВПЧ 16-го типа была наибольшей (17,7%), реже идентифицированы ВПЧ 56 (16,3%), 39 (13,6%), 31 (10,9%), 33 и 51 (по 8,2%), 58 (7,5%), 52 (6,1%), 45 (5,4%), 18 (4,1%), 35 (1,4%), 59-го типа (0,7%). У 51,2% ВПЧ-позитивных женщин обнаружены несколько типов ВПЧ-ВКР: 2 – у 34,5%, 3 – 9,5%, 4 – 6%, 5 – 1,2%. При оценке комплаентности 64% пациенток отдали предпочтение методу самостоятельного забора материала для ВПЧ-теста с помощью устройства Qvintip, 36% – взятию образца врачом (p<0,001). Большая часть женщин отметили, что метод самозабора более комфортный (75% vs 22,2%, р<0,001), менее болезненный (70,3% vs 22,2%, р<0,001), вызывал меньшее смущение (25,8% vs 1,4%, р<0,001). Единственной причиной предпочтения взятия образца врачом является большая уверенность, что материал взят правильно (10,1% vs 84,7%, р<0,001). В будущем предпочтут самостоятельно производить забор материала для ВПЧ-теста 96% женщин, поскольку это просто и не требует визита к врачу. Заключение. У организованных женщин репродуктивного возраста высока распространенность ВПЧ-ВКР-инфицирования (42%). Устройство Qvintip для самостоятельного взятия образца ДНК ВПЧ обладает высокой диагностической эффективностью, простое и удобное в использовании. Высокая комплаентность пациенток к самостоятельному взятию образцов ДНК ВПЧ может повысить численность женщин, участвующих в программах цервикального скрининга. Ключевые слова: вирус папилломы человека высокого канцерогенного риска, ВПЧ-тест, самозабор, шейка матки, Qvintip.
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Objective – to evaluate the prevalence of high-risk human papillomavirus infection (HR HPV), the efficiency and acceptability on self-collected using the Qvintip device versus clinician-collected samples in vaginal discharge. Subjects and methods. A cross-sectional study involving 200 women attituded to an employer’s outpatient clinic for periodic/annual medical examination. The mean age of the patients was 32.7±6.9 (range: 18–45 years). Vaginal discharge was collected using a Qvintip device and vaginal smear from the cervical canal was taken by a physician for a further HR HPV PCR test. A face-to-face interviews using to assess acceptability of the compared methods. Patients evaluated comfort, pain, privacy and embarrassment using the rating «yes» or «no». Results. 42% of all patients were HR HPV positive. The efficiency of the survey using the self-collected Qvintip device was higher than the clinician-taken samples: 38% vs 27.5% (OR=1.6; pχ2=0.025). The use of the Qvintip device only increased a chance to detect HR-HPV by 5 times: 36.3% vs 9.5% (OR=5.0; pχ2=0.0001). HPV-16 was the most frequently encountered HPV type (17.7%), followed by HPV-56 (16.3%), HPV-39 (13.6%), HPV-31 (10.9%), HPV-33 and HPV-51 (8.2%), HPV-58 (7.5%), HPV-52 (6.1%); HPV-45 (5.4%), HPV-18 (4.1%); HPV-35 (1.4%), HPV-59 (0.7%). 51.2% of HPV-positive women were infected with several types of HR HPV. Two types of HR HPV were detected in 34.5%, three – in 9.5%, four – in 6%, five – in 1.2 % patients. Self-sampling using the Qvintip device was a well-accepted method. Compared to physician-sampling, women reported a preference for self-sampling (64%), as it was more comfortable (75% vs 22.2%, р<0.001) and caused less pain (70.3% vs 22.2%, р<0.001) and less embarrassment (25.8% vs 1.4%, р<0.001). Most preferred to take the self-sample at home in the future (96%) because it was simple and did not require a doctor’s appointment. Conclusion. Reproductive age women show a high rate of HR HPV infection (42%). Vaginal self-sampling using the Qvintip device was more easy and comfortable, and shown higher diagnostic efficiency than the clinician-taken samples. Offering self-sampling for HPV testing may improve screening participation rates and overcome women’s embarrassment regarding clinician examination.
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7. Lorincz A, Castanon A, Wey Wey Lim A, Sasieni P. New Strategies for HPV-based Cervical Screening. Womens Health (Lond Engl) 2013; 9 (5). DOI: 10.2217/whe.13.48 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3880859/
8. Wright TC, Stoler MH, Behrens CM et al. Primary cervical cancer screening with human papillomavirus: end of study results from the
ATHENA study using HPV as the first-line screening test. Gynecol Oncol 2015; 136 (2): 189–97.
9. Martins TR, de Oliveira CM, Rosa LR et al. HPV genotype distribution in Brazilian women with and without cervical lesions: correlation to cytological data. Virol J 2016; 13: 138.
10. Katki HA, Kinney WK, Fetterman B et al. Cervical Cancer Risk for 330,000 Women Undergoing Concurrent HPV Testing and Cervical Cytology in Routine Clinical Practice at a Large Managed Care Organization. Lancet Oncol 2011; 12 (7): 663–72.
11. Agorastos T, Chatzistamatiou K, Katsamagkas T et al and the HERMES study group. Primary Screening for Cervical Cancer Based on High-Risk Human Papillomavirus (HPV) Detection and HPV 16 and HPV 18 Genotyping, in Comparison to Cytology. PLoS One 2015; 10 (3): e0119755. DOI: 10.1371/journal.pone.0119755. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4368762/
12. Deleré Y, Schuster M, Vartazarowa E et al. Cervicovaginal Self-Sampling Is a Reliable Method for Determination of Prevalence of Human Papillomavirus Genotypes in Women Aged 20 to 30 Years. J Clin Microbiol 2011; 49 (10): 3519–22.
13. Arbyn M, Verdoodt F, Snijders PJ et al. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol 2014; 15 (2): 172–83. DOI: 10.1016/S1470-2045(13)70570-9.
14. Chen K, Ouyang Y, Hillemanns P, Jentschke M. Excellent analytical and clinical performance of a dry self-sampling device for human papillomavirus detection in an urban Chinese referral population. J Obstet Gynaecol Res 2016; 42 (12): 1839–45. DOI: 10.1111/jog.13132.
15. Del Mistro A, Frayle H, Ferro A et al. Efficacy of self-sampling in promoting participation to cervical cancer screening also in subsequent round. Prev Med Rep 2016; 5: 166-68. DOI: 10.1016/j.pmedr.2016.12.017. eCollection 2017.
16. Wong ELY, Chan Paul KS, Chor JSY et al. Evaluation of the Impact of Human Papillomavirus DNA Self-sampling on the Uptake of Cervical Cancer Screening. Cancer Nurs 2016; 39 (1): E1–E11.
17. Jentschke M, Chen K, Arbyn M et al. Direct comparison of two vaginal self-sampling devices for the detection of human papillomavirus infections. J Clin Virol 2016; 82: 46–50. DOI: 10.1016/j.jcv.2016.06.016.
18. Ma'som M, Bhoo-Pathy N, Nasir NH et al. Attitudes and factors affecting acceptability of self-administered cervicovaginal sampling for human papillomavirus (HPV) genotyping as an alternative to Pap testing among multiethnic Malaysian women. BMJ Open 2016; 6 (8): e011022. DOI: 10.1136/bmjopen-2015-011022.
19. Silva J, Cerqueira F, Medeiros R. Acceptability of self-sampling in Portuguese women: the good, the bad or the ugly? Sex Health 2017. DOI: 10.1071/SH16077.
20. Sultana F, Mullins R, English DR et al. Women’s experience with home-based self-sampling for human papillomavirus testing. BMC Cancer 2015; 15: 849.
21. Boggan JC, Walmer DK, Henderson G et al. Vaginal self-sampling for human papillomavirus infection as a primary cervical cancer screening tool in a naitian population. Sex Transm Dis 2015; 42 (11): 655–9.
22. Zhao FH, Lewkowitz AK, Chen F et al. Pooled analysis of a self-sampling HPV DNA test as a cervical cancer primary screening method. J Natl Cancer Inst 2012; 104 (3): 178–88.
23. Balasubramanian A, Kulasingam SL, Baer A et al. Accuracy and cost-effectiveness of cervical cancer screening by high-risk human papillomavirus DNA testing of self-collected vaginal samples. J Lower Genit Tract Dis 2010; 14 (3): 185–95.
24. Bhatla N, Dar L, Patro AR et al. Can human papillomavirus DNA testing of self-collected vaginal samples compare with physician-collected cervical samples and cytology for cervical cancer screening in developing countries? Cancer Epidemiol 2009; 33 (6): 446–50.
25. Szarewski A, Cadman L, Mallett S et al. Human papillomavirus testing by self-sampling: assessment of accuracy in an unsupervised clinical setting. J Med Screen 2007; 14 (1): 34–42.
26. Артымук Н.В., Марочко К.В. Эффективность выявления вируса папилломы человека при помощи устройства для самостоятельного забора вагинального отделяемого. Акушерство и гинекология. 2016; 3: 85–91. / Artymuk N.V., Marochko K.V. Effektivnost' vyiavleniia virusa papillomy cheloveka pri pomoshchi ustroistva dlia samostoiatel'nogo zabora vaginal'nogo otdeliaemogo. Akusherstvo i ginekologiia. 2016; 3: 85–91. [in Russian]
27. Wright TCJr, Denny L, Kuhn L et al. HPV DNA testing of self-collected vaginal samples compared with cytologic screening to detect cervical cancer. JAMA 2000; 283 (1): 81–6.
28. Haguenoer K, Sengchanh S, Gaudy-Graffin C et al. Vaginal self-sampling is a cost-effective way to increase participation in a cervical cancer screening programme: a randomised trial. Br J Cancer 2014; 111 (11): 2187–96. DOI: 10.1038/bjc.2014.510.
29. Bansil P, Wittet S, Lim JL et al. Acceptability of self-collection sampling for HPV-DNA testing in low-resource settings: a mixed methods approach. BMC Public Health 2014; 14: 596.
30. Doorbar J, Egawa N, Griffin H et al. Human papillomavirus molecular biology and disease association. Rev Med Virol 2015; 25 (Suppl. 1): 2–23. DOI: 10.1002/rmv.1822.
31. Rogovskaya SI, Shabalova IP, Mikheeva IV et al. Human papillomavirus prevalence and type-distribution, cervical cancer screening practices and current status of vaccination implementation in Russian Federation, the Western countries of the former Soviet Union, Caucasus region and Central Asia. Vaccine 2013; 31 (Suppl. 7): H46-58. DOI: 10.1016/j.vaccine.2013.06.043.
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36. Ortiz AP, Alejandro N, Pérez CM et al. Acceptability of Cervical and Anal HPV Self-sampling in a Sample of Hispanic Women in Puerto Rico. PR Health Sci J 2012; 31 (4): 205–12.
37. Darlin L, Borgfeldt C, Forslund O et al. Comparison of use of vaginal HPV self-sampling and offering flexible appointments as strategies to reach long-term non-attending women in organized cervical screening. J Clin Virol 2013; 58 (1): 155–60.
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1. Bruni L, Barrionuevo-Rosas L, Albero G et al. ICO Information Centre on HPV and Cancer (HPV Information Centre). Human Papillomavirus and Related Diseases in the World. Summary Report 15 December 2016.
2. Comprehensive Cervical Cancer Control. A guide to essential practice Second edition. World Health Organization, 2014.
3. WHO guidance note: comprehensive cervical cancer prevention and control: a healthier future for girls and women. World Health Organization, 2013.
4. Profilaktika raka sheiki matki. Pod red. G.T.Sukhikh, V.N.Prilepskoi. Rukovodstvo dlia vrachei. M.: MEDpress-inform, 2012. [in Russian]
5. WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention. World Health Organization, 2013.
6. Bosch FX, Broker TR, Forman D et al. Comprehensive control of human papillomavirus infections and related diseases. Vaccine 2013; 31 (Suppl. 7): H1-31.
7. Lorincz A, Castanon A, Wey Wey Lim A, Sasieni P. New Strategies for HPV-based Cervical Screening. Womens Health (Lond Engl) 2013; 9 (5). DOI: 10.2217/whe.13.48 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3880859/
8. Wright TC, Stoler MH, Behrens CM et al. Primary cervical cancer screening with human papillomavirus: end of study results from the ATHENA study using HPV as the first-line screening test. Gynecol Oncol 2015; 136 (2): 189–97.
9. Martins TR, de Oliveira CM, Rosa LR et al. HPV genotype distribution in Brazilian women with and without cervical lesions: correlation to cytological data. Virol J 2016; 13: 138.
10. Katki HA, Kinney WK, Fetterman B et al. Cervical Cancer Risk for 330,000 Women Undergoing Concurrent HPV Testing and Cervical Cytology in Routine Clinical Practice at a Large Managed Care Organization. Lancet Oncol 2011; 12 (7): 663–72.
11. Agorastos T, Chatzistamatiou K, Katsamagkas T et al and the HERMES study group. Primary Screening for Cervical Cancer Based on High-Risk Human Papillomavirus (HPV) Detection and HPV 16 and HPV 18 Genotyping, in Comparison to Cytology. PLoS One 2015; 10 (3): e0119755. DOI: 10.1371/journal.pone.0119755. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4368762/
12. Deleré Y, Schuster M, Vartazarowa E et al. Cervicovaginal Self-Sampling Is a Reliable Method for Determination of Prevalence of Human Papillomavirus Genotypes in Women Aged 20 to 30 Years. J Clin Microbiol 2011; 49 (10): 3519–22.
13. Arbyn M, Verdoodt F, Snijders PJ et al. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol 2014; 15 (2): 172–83. DOI: 10.1016/S1470-2045(13)70570-9.
14. Chen K, Ouyang Y, Hillemanns P, Jentschke M. Excellent analytical and clinical performance of a dry self-sampling device for human papillomavirus detection in an urban Chinese referral population. J Obstet Gynaecol Res 2016; 42 (12): 1839–45. DOI: 10.1111/jog.13132.
15. Del Mistro A, Frayle H, Ferro A et al. Efficacy of self-sampling in promoting participation to cervical cancer screening also in subsequent round. Prev Med Rep 2016; 5: 166-68. DOI: 10.1016/j.pmedr.2016.12.017. eCollection 2017.
16. Wong ELY, Chan Paul KS, Chor JSY et al. Evaluation of the Impact of Human Papillomavirus DNA Self-sampling on the Uptake of Cervical Cancer Screening. Cancer Nurs 2016; 39 (1): E1–E11.
17. Jentschke M, Chen K, Arbyn M et al. Direct comparison of two vaginal self-sampling devices for the detection of human papillomavirus infections. J Clin Virol 2016; 82: 46–50. DOI: 10.1016/j.jcv.2016.06.016.
18. Ma'som M, Bhoo-Pathy N, Nasir NH et al. Attitudes and factors affecting acceptability of self-administered cervicovaginal sampling for human papillomavirus (HPV) genotyping as an alternative to Pap testing among multiethnic Malaysian women. BMJ Open 2016; 6 (8): e011022. DOI: 10.1136/bmjopen-2015-011022.
19. Silva J, Cerqueira F, Medeiros R. Acceptability of self-sampling in Portuguese women: the good, the bad or the ugly? Sex Health 2017. DOI: 10.1071/SH16077.
20. Sultana F, Mullins R, English DR et al. Women’s experience with home-based self-sampling for human papillomavirus testing. BMC Cancer 2015; 15: 849.
21. Boggan JC, Walmer DK, Henderson G et al. Vaginal self-sampling for human papillomavirus infection as a primary cervical cancer screening tool in a naitian population. Sex Transm Dis 2015; 42 (11): 655–9.
22. Zhao FH, Lewkowitz AK, Chen F et al. Pooled analysis of a self-sampling HPV DNA test as a cervical cancer primary screening method. J Natl Cancer Inst 2012; 104 (3): 178–88.
23. Balasubramanian A, Kulasingam SL, Baer A et al. Accuracy and cost-effectiveness of cervical cancer screening by high-risk human papillomavirus DNA testing of self-collected vaginal samples. J Lower Genit Tract Dis 2010; 14 (3): 185–95.
24. Bhatla N, Dar L, Patro AR et al. Can human papillomavirus DNA testing of self-collected vaginal samples compare with physician-collected cervical samples and cytology for cervical cancer screening in developing countries? Cancer Epidemiol 2009; 33 (6): 446–50.
25. Szarewski A, Cadman L, Mallett S et al. Human papillomavirus testing by self-sampling: assessment of accuracy in an unsupervised clinical setting. J Med Screen 2007; 14 (1): 34–42.
26. Artymuk N.V., Marochko K.V. Effektivnost' vyiavleniia virusa papillomy cheloveka pri pomoshchi ustroistva dlia samostoiatel'nogo zabora vaginal'nogo otdeliaemogo. Akusherstvo i ginekologiia. 2016; 3: 85–91. [in Russian]
27. Wright TCJr, Denny L, Kuhn L et al. HPV DNA testing of self-collected vaginal samples compared with cytologic screening to detect cervical cancer. JAMA 2000; 283 (1): 81–6.
28. Haguenoer K, Sengchanh S, Gaudy-Graffin C et al. Vaginal self-sampling is a cost-effective way to increase participation in a cervical cancer screening programme: a randomised trial. Br J Cancer 2014; 111 (11): 2187–96. DOI: 10.1038/bjc.2014.510.
29. Bansil P, Wittet S, Lim JL et al. Acceptability of self-collection sampling for HPV-DNA testing in low-resource settings: a mixed methods approach. BMC Public Health 2014; 14: 596.
30. Doorbar J, Egawa N, Griffin H et al. Human papillomavirus molecular biology and disease association. Rev Med Virol 2015; 25 (Suppl. 1): 2–23. DOI: 10.1002/rmv.1822.
31. Rogovskaya SI, Shabalova IP, Mikheeva IV et al. Human papillomavirus prevalence and type-distribution, cervical cancer screening practices and current status of vaccination implementation in Russian Federation, the Western countries of the former Soviet Union, Caucasus region and Central Asia. Vaccine 2013; 31 (Suppl. 7): H46-58. DOI: 10.1016/j.vaccine.2013.06.043.
32. Belokrinitskaia T.E., Frolova I.I., Tarbaeva D.A. i dr. Konfaunding-faktory papillomavirusnoi infektsii i tservikal'noi displazii u molodykh zhenshchin. Doktor.Ru. 2015; 14 (115): 7–12. [in Russian].
33. Merzliakova M.K., Nikitina E.G., Bychkov V.A. i dr. Sravnitel'nye aspekty rasprostranennosti genotipov virusa papillomy cheloveka u zhenskogo naseleniia Tomskoi oblasti i Respubliki Tyva. Sib. onkol. zhurn. 2012; Pril. 1: 108–9. [in Russian]
34. Osnovnye pokazateli deiatel'nosti akushersko-ginekologicheskoi sluzhby v Rossiiskoi Federatsii v 2015 godu. Pod red. E.N.Baibarinoi. M., 2016. [in Russian]
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36. Ortiz AP, Alejandro N, Pérez CM et al. Acceptability of Cervical and Anal HPV Self-sampling in a Sample of Hispanic Women in Puerto Rico. PR Health Sci J 2012; 31 (4): 205–12.
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