HPV self-sampling with isothermal amplification detection may become part of cervical cancer screening

A prospective study in women attending a colposcopy clinic in Hong Kong supports the use of self-sampling with an isothermal amplification (AmpFire)–based assay for human papillomavirus (HPV) detection in cervical cancer screening, showing substantial agreement with clinician sampling using either the AmpFire-based or polymerase chain reaction (PCR)–based reference assay.

The study also showed that self-sampling was generally well accepted. As the procedure was simple and quick, a substantial proportion of women with self-sampling experience were willing to undergo repeat HPV testing with this sampling method. [Diagnostics 2023;13:3297]

The WHO proposes that ≥70 percent of women should be screened twice for cervical cancer using a high-performance HPV test by the ages of 35 years and 45 years. Introducing HPV self-sampling may increase the screening rate by overcoming social-cultural barriers, such as embarrassment, inconvenience, and discomfort associated with gynaecological examination. Additionally, the use of AmpFire assays, a cost-effective technology with accuracy and sensitivity comparable to PCR-based assays, may facilitate HPV detection in the screening process. [https://www.who.int/publications/i/item/9789240014107; J Adv Nurs 2004;46:42-52; J Natl Cancer Inst 2012;104:166-167; Int J Cancer 2022;151:1142-1149; Infect Agent Cancer 2020;15:65]

“Before incorporating a new HPV detection assay into cervical cancer screening programmes, it is important to validate the assay with different sample collection methods,” the researchers wrote.

The researchers recruited women aged 30–65 years with a history of sexual activity who attended the colposcopy clinic at Queen Mary Hospital between April 2022 and July 2022 due to abnormal smears. Exclusion criteria included a history of hysterectomy and pregnancy or menstruation at the time of recruitment. [Diagnostics 2023;13:3297]

In the study, participants used self-collection kits to collect vaginal specimens in a private room after watching an instruction video. Subsequently, a gynaecologist obtained cervical specimens, and the participants completed a questionnaire about their self-sampling experience. AmpFire-based HPV detection was applied to both self-collected vaginal samples and clinician-collected cervical samples, while the PCR-based assay was used as the reference standard in clinician-collected samples. Concordance rates were calculated by absolute agreement and Cohen’s kappa statistics.

Among a total of 104 eligible women (median age, 45 years; Chinese, 81 percent), 101 self-collected and 99 clinician-collected samples were tested with the AmpFire-based assay, and 100 clinician-collected samples were tested with PCR-based standard assay. 

Results demonstrated substantial agreement in AmpFire-based HPV detection between self-collected and clinician-collected samples, with an 89.8 percent concordance rate and a kappa value of 0.769 (positive agreement, 93.1 percent; negative agreement, 88.4 percent). Self-sampling with AmpFire-based assay also showed substantial agreement in HPV detection compared with clinician-sampling using PCR-based assay, with an 84.4 percent concordance rate and a kappa value of 0.643 (positive agreement, 88.5 percent; negative agreement, 82.9 percent).

Higher agreement was observed between AmpFire-based and PCR-based HPV detection in clinician-collected samples, with a 95.8 percent concordance rate and a kappa value of 0.897 (positive agreement, 96.1 percent; negative agreement, 95.6 percent).

In the questionnaire survey (n=100), 68 percent of respondents reported little or no embarrassment during self-sampling, 58 percent found it convenient, and 46 percent considered it easy to perform. Notably, 65 percent of respondents expressed willingness for future self-sampling, mostly due to its simplicity (75 percent) and quick sampling process (48 percent). However, 67 percent of respondents were not confident in taking self-sampling accurately.