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  • Self- and physician-collected high-risk human papillomavirus (HPV) testing to detect high-grade cervical lesions among Thai women

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Original research
Self- and physician-collected high-risk human papillomavirus (HPV) testing to detect high-grade cervical lesions among Thai women
  1. Natacha Phoolcharoen1,
  2. Wilasinee Areeruk1,
  3. Nuttavut Kantathavorn2,
  4. Jitima Tiyayon3,
  5. Suwicha Chittithaworn4,
  6. Thanita Wetcho2,
  7. Sikarn Satitniramai4,
  8. Uraiwan Khomphaiboonkij5,
  9. Supakorn Pitakkarnkul5,
  10. Wichai Termrungruanglert1,
  11. Jatupol Srisomboon6,
  12. Siriwan Tangjitgamol7 and
  13. Thai Gynecologic Cancer Society Research Group8
  1. 1 Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Bangkok, Thailand
  2. 2 Princess Srisavangavadhana College of Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, Thailand
  3. 3 Obstetrics and Gynecology, Rajavithi Hospital, Bangkok, Thailand
  4. 4 Obstetrics and Gynecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
  5. 5 Gynecologic Oncology, National Cancer Institute of Thailand, Bangkok, Thailand
  6. 6 Obstetrics and Gynecology, Chiang Mai University, Chiang Mai, Thailand
  7. 7 Obstetrics and Gynecology, Faculty of Medicine, Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand
  8. 8 Thai Gynecologic Cancer Society, Bangkok, Thailand
  1. Correspondence to Dr Jitima Tiyayon, Obstetrics and Gynecology, Rajavithi Hospital, Bangkok, Thailand; tjitima{at}gmail.com

Abstract

Objective We compared the performance of high-risk human papillomavirus (HPV) messenger RNA testing of physician- and self-collected specimens for detecting histological grade 2 or higher cervical intraepithelial neoplasia (CIN) among women who visited a colposcopy clinic in Thailand.

Methods From January 2022 to April 2022, 500 women participated in this cross-sectional multicenter study; 494 had complete data and valid specimen results. The participants were women who attended any one of the 10 participating institutes’ colposcopy clinics due to abnormal cytology, positive high-risk HPV testing, or for follow-up. Participants used a self-sampling Aptima Multitest Swab specimen collection kit to self-collect vaginal samples before physicians biopsied the cervix during the colposcopic examination. The self- and physician-collected specimens were tested for high-risk HPV messenger RNA using Aptima nucleic acid amplification assays. Cervical tissues were collected during colposcopic-directed biopsy from the most severe lesion or a random biopsy and endocervical curettage specimen if no lesion was detected.

Results We detected high-risk HPV messenger RNA in 75.4% of self-collected specimens and 70.6% of physician-collected specimens. The prevalence of histological grade 2 or higher CIN from cervical histology was 25.1% (n=124). For self-collected specimens, the sensitivity and specificity of high-risk HPV messenger RNA for grade 2 or higher CIN were 87.0% (95% CI 79.7% to 92.4%; n=108) and 28.5% (95% CI 24.0% to 33.4%). For physician-collected specimens, the sensitivity and specificity of high-risk HPV messenger RNA for grade 2 or higher CIN were 90.2% (95% CI 83.6% to 94.9%; n=112) and 36.1% (95% CI 31.2% to 41.3%).

Conclusions Self-collected specimens for high-risk HPV messenger RNA testing demonstrated good sensitivity and negative predictive value for detecting grade 2 or higher CIN in Thai women attending the participating institutes’ colposcopy clinics. Self-collected samples performed similarly to physician-collected ones.

  • Cervical Cancer
  • Cervix Uteri

Data availability statement

Data are available upon reasonable request. In accordance with the Journal’s guidelines, we will provide our data for independent analysis by a team selected by the Editorial Team for the purposes of additional data analysis or for the reproducibility of this study in other centers if such is requested.

https://doi.org/10.1136/ijgc-2023-004424

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    Data availability statement

    Data are available upon reasonable request. In accordance with the Journal’s guidelines, we will provide our data for independent analysis by a team selected by the Editorial Team for the purposes of additional data analysis or for the reproducibility of this study in other centers if such is requested.

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    Footnotes

    • Twitter @nphoolcharoen

    • Collaborators Thai Gynecologic Cancer Society Research Group: Natacha Phoolcharoen, Wilasinee Areeruk, Nuttavut Kantathavorn, Jitima Tiyayon, Suwicha Chittithaworn, Thanita Wetcho, Sikarn Satitniramai, Uraiwan Khomphaiboonkij, Supakorn Pitakkarnkul, Wichai Termrungruanglert, Jatupol Srisomboon, Siriwan Tangjitgamol, Awassada Punyashthira, Nattapong Sreamsukcharoenchai, Piyawan Pariyawateekul, Saranya Chanpanitkitchot, Sunamchok Srijaipracharoen, Nida Jareemit, Sumonmal Manusirivithaya, Nopwaree Chantawong, Kristsanamon Rittiluechai, Worrawan Sirichai, Sathon Boonlikit, Thannaporn Kittisiam, Perapong Inthasorn.

    • Contributors NP, JT: guarantor including study design, data collection, manuscript preparation and revision. WA, NK, SC, TW, SS, UK, SP: study design, data collection, and manuscript revision. WT, JS: study design, manuscript revision. ST: study design, statistical analysis, manuscript preparation, and revision. TGCS Research Group: study design and data collection.

    • Funding This work is in the umbrella project of ‘Self-sampling HPV’ supported by the Thai Gynecologic Oncology Society. The Winnergy Medical Public Company Limited provided all the self-sampling Aptima Multitest Swab specimen collection kits.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.