Self-sampling with HPV mRNA analyses from vagina and urine compared with cervical samples

Asciutto, Katrin Christine; Ernstson, Avalon; Forslund, Ola; Borgfeldt, Christer

doi:10.1016/j.jcv.2018.02.002

Cited by 44 publications

(42 citation statements)

References 39 publications

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“…Histological results are generally used as the gold standard for assessing cervical screening tests performance with most studies using either CIN2(+) or CIN3(+) as their marker for cervical disease, a precursor to cervical cancer. In the three studies examined by Arbyn and colleagues for the detection of CIN2+ by self-collected specimens tested for HPV on the Aptima, the results indicated that 4/30 [27], 10/69 [28], and 6/16 [29] of histologically-confirmed CIN2+ cases were missed. All 20 of these cases were detected by the paired clinician-collected specimens.…”

Section: Hologic Aptimamentioning

confidence: 98%

“…The Hologic Aptima assay targets the mRNA of the HPVE6/E7 region of the same 14 types as many of the other clinically validated and automated HPV assays, with a reflex test for partial genotyping of HPV16 and a combined HPV18/45. In a recent meta-analysis, Arbyn et al [10] examined three studies [27][28][29] which utilised the Aptima HPV assay and determined that, whilst results from self-collected specimens indicated good specificity for cervical intraepithelial neoplasia grade 2 or above (CIN2+), they were significantly less sensitive than clinician-collected samples. Histological results are generally used as the gold standard for assessing cervical screening tests performance with most studies using either CIN2(+) or CIN3(+) as their marker for cervical disease, a precursor to cervical cancer.…”

Section: Hologic Aptimamentioning

confidence: 99%

See 1 more Smart Citation

Self-Collection for Cervical Screening Programs: From Research to Reality

Hawkes

Keung

Huang

et al. 2020

Cancers

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In 2018, there were an estimated 570,000 new cases of cervical cancer globally, with most of them occurring in women who either had no access to cervical screening, or had not participated in screening in regions where programs are available. Where programs are in place, a major barrier for women across many cultures has been the requirement to undergo a speculum examination. With the emergence of HPV-based primary screening, the option of self-collection (where the woman takes the sample from the vagina herself) may overcome this barrier, given that such samples when tested using a PCR-based HPV assay have similar sensitivity for the detection of cervical pre-cancers as practitioner-collected cervical specimens. Other advantages of HPV-based screening using self-collection, beyond the increase in acceptability to women, include scalability, efficiency, and high negative predictive value, allowing for long intervals between negative tests. Self-collection will be a key strategy for the successful scale up of cervical screening programs globally in response to the WHO call for all countries to work towards the elimination of cervical cancer as a public health problem. This review will examine self-collection for HPV-based cervical screening including the collection devices, assays and possible routine laboratory processes considering how they can be utilized in cervical screening programs.

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Section: Hologic Aptimamentioning

confidence: 98%

Section: Hologic Aptimamentioning

confidence: 99%

Self-Collection for Cervical Screening Programs: From Research to Reality

Hawkes

Keung

Huang

et al. 2020

Cancers

View full text Add to dashboard Cite

show abstract

“…The self-samples were analyzed by Aptima HPV mRNA assay (Hologic Inc) on a Panther instrument, according to the manufacturer's instructions. The assay detects HPV mRNA from 14 h-HPV types [16,18,31,33,35,39,45,51,52, 56, 58, 59, 66 and 68].…”

Section: Study Proceduresmentioning

confidence: 99%

“…Asciutto et al found a similar clinical sensitivity of self-collected samples analyzed by Aptima mRNA assay as compared to routine cytology. Recently an improvement of this self-collection approach showed a sensitivity of 95.3% for severe dysplasia [16,17].…”

Section: Introductionmentioning

confidence: 99%

Cervical cancer prevention among long-term screening non-attendees by vaginal self-collected samples for hr-HPV mRNA detection

Ernstson

Urdell

Forslund

et al. 2020

Infect Agents Cancer

Self Cite

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Background: The efficacy of cervical cancer screening programs is dependent on the participation rate. To increase participation among women not attending cervical cancer screening, self-collected samples for detection of highrisk human papillomavirus (hr-HPV) may be an option. The aims of this study were: to investigate the response rate to sending a self-collected vaginal sample for hr-HPV mRNA detection to long-term non-attendees; the compliance with follow-up among women positive for HPV in the self-sample; the prevalence of cervical dysplasia (high grade squamous intraepithelial lesion (HSIL), atypical squamous cells that cannot exclude HSIL (ASC-H) or adenocarcinoma in situ (AIS)) or cancer among the responders; as well as to explore reasons for not returning a self-sample. Methods: A vaginal self-sampling kit was sent to 6023 women aged 30-70 years who had not provided a cervical screening sample for ≥7 years in the Region of Skåne, Sweden in November and December 2017. The self-sample was analyzed by Aptima HPV mRNA assay (Hologic). All vaginal self-samples returned no later than May 31, 2018 were included in the study. Follow-up of the results was registered until January 31, 2019 with a follow-up time varying between eight to 14 months. Women positive for hr-HPV mRNA were invited for a follow-up examination. This examination consisted of a cervical sample for cytological analysis and renewed Aptima HPV mRNA testing. Two hundred thirty-five women who had not returned the self-sample were randomly selected for telephone interviews, in order to explore their reasons. Results: The response rate for the self-collected vaginal hr-HPV sample was 13.2% [(797/6023), 95% CI 12.4-14.1%] and 9.9% [(79/796), 95% CI 7.9-12.2%] were positive for hr-HPV mRNA. The prevalence of severe dysplasia or cancer in the whole group of responders was 1.3% [(10/796), 95% CI 0.6-2.3%], with a cervical cancer prevalence of 0.4% [(3/796), 95% CI 0.1-1.1%]. Only 27 women participated in the telephone interviews, no particular reason for not returning self-samples was observed. Conclusions: Self-collected vaginal hr-HPV samples increased participation in the cervical cancer screening among long-term non-attendees. The prevalence of cervical cancer was almost seven times higher for long-term nonattendees than in the organized screening population.

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“…Several studies have reported the usefulness of HPV DNA testing with urine specimens for cervical cancer prevention [13,16,17]. However, its validity as compared with that assessed with cervical sample and urine sample from the same person not been well studied.…”

Section: Discussionmentioning

confidence: 99%

Usefulness Analysis of Urine Samples for Early Screening of Human Papilloma Virus Infection

2019

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Human papilloma virus (HPV) is known to be a major cause of cervical cancer. In Korea, although the mortality of cervical cancer has decreased, HPV infection rates are increasing rapidly in young women. One of the reasons for a high rate of human immunodeficiency virus (HIV) infection appears to be associated with a low frequency to visit gynecology clinics because of the uncomfortable sampling process for HPV testing. Therefore, it is necessary to develop a non-invasive method, such as urine testing to diagnose cervical cancer rather than use of the existing invasive method. This study aimed to test validity of HPV DNA detection in urine specimens that can be easily collected from women. Paired vaginal discharge and urine samples were collected prospectively from 203 women who visited the local hospital between January and August 2018 in Busan, Korea. By using the Virocheck ® assay kit (Optipharm), we found that 17.2% (35/203) of vaginal discharge samples were HPV positive and 82.8% (168/203) were HPV negative. In urine samples, 15.8% (32/203) were HPV positive and 84.2% (171/203) were HPV negative. The co-incident rate for HPV DNA detection was 84.8% in both vaginal discharge and urine samples. These results suggest that the HPV DNA detection using urine samples might be an alternative way to diagnose HPV infection in a non-invasive way. This analytical approach can be utilized as a screening test to identify HIV-infected patients who need a follow-up process by using urine samples.

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Self-sampling with HPV mRNA analyses from vagina and urine compared with cervical samples

Cited by 44 publications

References 39 publications

Self-Collection for Cervical Screening Programs: From Research to Reality

Self-Collection for Cervical Screening Programs: From Research to Reality

Cervical cancer prevention among long-term screening non-attendees by vaginal self-collected samples for hr-HPV mRNA detection

Usefulness Analysis of Urine Samples for Early Screening of Human Papilloma Virus Infection

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