Field Evaluation of Xpert HPV Point-of-Care Test for Detection of Human Papillomavirus Infection by Use of Self-Collected Vaginal and Clinician-Collected Cervical Specimens

Abstract

iThe World Health Organization has recommended that testing for high-risk human papillomavirus (HPV) (hrHPV) infection be incorporated into cervical screening programs in all settings worldwide. In many high-burden, low-income countries, it will not be feasible to achieve high cervical screening coverage using hrHPV assays that require clinician-collected samples. We conducted the first evaluation of self-collected vaginal specimens compared with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert HPV test. Women aged 30 to 54 years attending two well-woman clinics in Papua New Guinea were invited to participate and provided self-collected vaginal and clinician-collected cervical cytobrush specimens. Both specimen types were tested at the point of care by using the Xpert HPV test. T he recognition that infection with certain high-risk types of human papillomavirus (HPV) (hrHPV) is the primary cause of both cervical precancer and cancer led to the development of new technologies that would allow hrHPV DNA to be detected as part of population-based screening. These tests are more sensitive than cytology for the detection of high-grade cervical intraepithelial neoplasia (CIN) and invasive disease and have comparable specificities (1, 2), and their potential efficacy for populationbased cervical screening has been conclusively demonstrated in large-scale randomized trials and prospective studies (3-5). These findings led to recommendations in Europe, the United States, Australia, and other high-income settings for cervical screening programs to incorporate hrHPV DNA testing (2, 5-7). In this rapidly developing environment, and based on trials directly comparing HPV screening with cytology (3-5), the World Health Organization recently recommended that hrHPV testing be incorporated into cervical screening programs in low-and middle-income countries (LIMCs), particularly where cytological testing is not available and where visual inspection of the cervix after the application of acetic acid (VIA) or visual inspection after the application of Lugol's iodine (VILI) is the principal cervical screening strategy (8).The Xpert HPV test (GeneXpert; Cepheid, Sunnyvale, CA) is a newly available, rapid, fully automated, and easy-to-use nonbatch test for hrHPV infection that is as accurate as laboratory-based nucleic acid amplification tests (NAATs) (2, 9). Xpert HPV compared favorably to the FDA-approved Cobas 4800 (Roche Molecular Systems, Pleasanton, CA) and Hybrid Capture 2 (hc2; Qiagen, Germantown, MD) assays for the detection of hrHPV using clinician-collected cervical specimens (2, 9) and had sensitivity, specificity, and positive predictive values comparable to those of the above-mentioned assays for high-grade CIN (2). Disposable cartridges hold the reagents, primers, and probes for the simultaneous detection of 14 hrHPV types responsible for over 95% of cervical cancers ; a human reference gene; and an internal probe check control (PCC) (2). The system monitors the presence of inh...

Global Cancer in Women: Burden and Trends

“…Other more feasible methods include HPV DNA testing and visual inspection with acetic acid (VIA). HPV DNA testing has been shown to be an effective test for primary cervical screening (61), and a few studies have even shown promising results from using self-collection methods in LMICs (62)(63)(64). VIA can be successfully performed by trained mid-level providers (65).…”

Predictive Value of HPV Testing in Self-collected and Clinician-Collected Samples Compared with Cytology in Detecting High-grade Cervical Lesions

“…Given that one of the fundamental advantages of HPV testing is that it can be done with self-collected vaginal specimens, two central questions of HPV self-sampling relate to its diagnostic accuracy and the performance and acceptability of the sampling device. Several studies that compared vaginal self-sampling with cervical physician-sampling found high concordance for HPV detection (1,(11)(12)(13)(14)(15)(16)(17)(18) and comparable clinical accuracy to detect high-grade cervical intraepithelial neoplasia (CIN) and cancers, provided that validated assays are used (17,(19)(20)(21)(22). In a recent meta-analysis of 56 accuracy studies, the pooled relative sensitivity of high-risk HPV (hrHPV) assays (based on PCR) on self-collected versus physician-collected samples was 99% for CIN2 þ or CIN3 þ , and the positive predictive values (PPV) for either histologic endpoint were not significantly lower for self-collected samples (22).…”

Integrated cervical cancer screening in Mayuge District Uganda (ASPIRE Mayuge): a pragmatic sequential cluster randomized trial protocol

“…A CHW goes door-todoor asking women to participate in a baseline survey, offers participants sexually transmitted infection (STI) and cervical cancer health education, and provides them with instructions on how to self-collect for CCS. The specimen is then dropped at a HCII or HCIII by the CHW and transported to a central laboratory at a local health centre for testing using GeneXpert point of care [22]. Samples are not banked and swabs are destroyed after testing.…”