Performance of careHPV for detecting high-grade cervical intraepithelial neoplasia among women living with HIV-1 in Burkina Faso and South Africa: HARP study

Abstract

Background:The careHPV assay is a test for high-risk (HR) human papillomaviruses (HPV) detection designed to be affordable in resource-poor settings. We evaluated the performance of careHPV screening among 1052 women living with HIV/AIDS included in the HARP (HPV in Africa Research Partnership) study in Burkina Faso (BF) and South Africa (SA).Methods:Cervical samples were tested for HR-HPV by the careHPV and the INNO-LiPA HPV genotyping Extra assays. All women had Pap smear testing, visual inspection with acetic acid/Lugol's iodine (VIA/VILI) and colposcopy. Cervical biopsies were obtained for participants who were HR-HPV DNA positive by careHPV or who had abnormalities detected on cytology, VIA/VILI or colposcopy.Results:Overall, 45.1% of women had a positive careHPV test (46.5% in BF, 43.8% in SA). The careHPV positivity rate increased with the grade of cytological lesions. Sensitivity and specificity of careHPV for the diagnosis of CIN2+ (n=60, both countries combined) were 93.3% (95% confidence interval (CI): 83.8–98.2) and 57.9% (95% CI: 54.5–61.2), respectively. Specificity increased with CD4 count. careHPV had a similar clinical sensitivity but higher specificity than the INNO-LiPA assay for detection of CIN2+.Conclusions:Our results suggest that careHPV testing is a reliable tool for cervical cancer screening in HIV-1-infected women in sub-Saharan Africa.

A systematic review and meta-analysis of studies evaluating the performance of point-of-care tests for human papillomavirus screening

“…The characteristics of the included publications are summarised in Table 1. One publication24 provided performance estimates for two countries and was considered as two separate populations in the analysis; one publication23 provided performance estimates for four countries and was considered as four separate populations in the analysis, and one publication27 provided performance estimates separately for women living with HIV (WLHIV) and HIV-negative women and was considered as two populations. This resulted in 12 separate populations included in the final analysis, among 29 657 women.…”

“…This resulted in 12 separate populations included in the final analysis, among 29 657 women. Two studies measured the performance of care HPV for CIN2+ detection among 1215 WLHIV in Burkina Faso and South Africa,24 and Uganda 27…”

Detection of hypermethylated genes as markers for cervical screening in women living with HIV

“…Primary hrHPV testing is currently the preferred method for cervical screening, irrespective of resource settings or HIV‐prevalence . However as most infections are self‐limiting and do not cause cervical lesions, hrHPV testing has limited specificity , particularly in WLHIV . Therefore, subsequent triage testing of hrHPV positive women is needed to distinguish women with underlying high‐grade cervical disease from women with transient infections .…”

Associations of human gene EPB41L3 DNA methylation and cervical intraepithelial neoplasia in women living with HIV-1 in Africa

“…HPV DNA based screening has high sensitivity for CIN2+, but as it detects many transient infections it has low specificity [10]. This has important implications for screening WLHIV among whom the prevalence of HR-HPV is high [11]. Novel methods are required that are sensitive enough to detect clinically relevant HR-HPV needing colposcopy referral and treatment but with high specificity to rule out HPV-positive women without evidence of disease, thereby avoiding the need for repeat testing which can result in substantial losses to follow-up [12,13], and unnecessary referrals for colposcopy which increase costs and burden to the service.…”