Abstract
To make the clinical evaluation of a solid-state human papillomavirus (HPV) sampling medium in combination with an economical HPV testing method (careHPV™) for cervical cancer screening. 396 women aged 25-65 years were enrolled for cervical cancer screening, and four samples were collected. Two samples were collected by woman themselves, among which one was stored in DCM preservative solution (called "liquid sample") and the other was applied on the Whatman Indicating FTA Elute® card (FTA card). Another two samples were collected by physician and stored in DCM preservative solution and FTA card, respectively. All the samples were detected by careHPV™ test. All the women were administered a colposcopy examination, and biopsies were taken for pathological confirmation if necessary. FTA card demonstrated a comparable sensitivity of detecting high grade Cervical Intraepithelial Neoplasia (CIN) with the liquid sample carrier for self and physician-sampling, but showed a higher specificity than that of liquid sample carrier for self-sampling (FTA vs Liquid: 79.0% vs 71.6%, p=0.02). Generally, the FTA card had a comparable accuracy with that of Liquid-based medium by different sampling operators, with an area under the curve of 0.807 for physician and FTA, 0.781 for physician and Liquid, 0.728 for self and FTA, and 0.733 for self and Liquid (p>0.05). FTA card is a promising sample carrier for cervical cancer screening. With appropriate education programmes and further optimization of the experimental workflow, FTA card based self-collection in combination with centralized careHPV™ testing can help expand the coverage of cervical cancer screening in low-resource areas.
Highlights
Cervical cancer, the most widely screened cancer, has a long natural history with slow progressing precancerous lesions such as cervical intraepithelial neoplasia grade 2 and 3 (CIN 2 and Cervical Intraepithelial Neoplasia (CIN) 3) and adenocarcinoma in-situ caused by persistent infection with the oncogenic types of human papillomaviruses (HPV)
Two samples were collected by woman themselves, among which one was stored in DCM preservative solution and the other was applied on the Whatman Indicating FTA Elute® card (FTA card)
The results showed that careHPVTM test failed to identify more CIN2+ cases by self-sampling than that of physician-sampling whether using FTA card (Self vs Physician: 5 vs 3) or DCM preservative solution (Self vs Physician: 3 vs 2) as the sample carrier
Summary
The most widely screened cancer, has a long natural history with slow progressing precancerous lesions such as cervical intraepithelial neoplasia grade 2 and 3 (CIN 2 and CIN 3) and adenocarcinoma in-situ caused by persistent infection with the oncogenic types of human papillomaviruses (HPV). The precursor lesions may progress to invasive cervical cancer over a period of 5-15 years. Screening tests can identify women with cervical intraepithelial neoplasia as well as early invasive cancer, if provided with quality assurance and by welltrained providers. It has been shown that Pap smear screening at the population level every three to five years can reduce cervical cancer incidence up to 80% in several developed countries (IARC, 2005). The challenges and resources required in introducing cytology screening and its sub-optimal performance in low- and middle-income countries have prompted evaluation of alternative screening methods such as visual inspection with acetic acid (VIA) and HPV testing which have been found to be effective in preventing cervical cancer (Sankaranarayanan et al, 2007; Arbyn et al, 2012; Ronco et al, 2014). In December of 2013, WHO released the latest guidelines for screening and treatment of precancerous lesions for cervical cancer, and recommended using HPV testing as the primary screening method for cervical cancer in areas with enough resources
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