Performance of Xpert HPV on Self-collected Vaginal Samples for Cervical Cancer Screening Among Women in South Africa

Abstract

Objectives Self-sampling may increase access to cervical cancer screening in low-resource settings. Using Xpert HPV, we compared test performance of self- and clinician-collected samples in HIV-positive and HIV-negative women in South Africa. Materials and Methods Three hundred thirty HIV-positive and 375 HIV-negative women in the screening group and 202 HIV-negative and 200 HIV-positive women in the referral group, aged 30–65 years, participated in the study. All women self-collected a vaginal sample, and then, a cervical sample was collected by a clinician (both tested using Xpert HPV), followed by colposcopic examination and collection of histologic specimens. Results There was good agreement between self- and clinician-collected samples for detection of any high-risk human papillomavirus (HPV, κ = 0.72 [95% CI = 0.669–0.771]). Prevalence of HPV and sensitivity of the test to detect cervical intraepithelial neoplasia 2+ was similar in self- and clinician-collected samples. Specificity was lower in self-collected than in clinician-collected samples in both HIV-negative (self: 77.5% [95% CI = 72.8–81.8] vs clinician: 86.9% [95% CI = 82.9–90.2]) and HIV-positive (self: 44.0% [95% CI = 38.0–50.1] vs clinician: 59.7% [95% CI = 53.6–65.6]) women. Restricting the definition of screen-positive to 3 of 5 channels on HPV Xpert improved specificity in both HIV-negative (self: 83.2% [95% CI = 78.8–87.0] vs clinician: 89.7% [95% CI = 86.1–92.7]) and HIV-positive (self: 54.2% [95% CI = 48.1–60.2] vs clinician: 67.4% [95% CI = 61.5–72.9]) women. Conclusions The self-collected sample had good agreement with the clinician-collected sample for the detection of HPV, and restricting the HPV types may improve the specificity in HIV-positive women.

HPV Self-Sampling for Cervical Cancer Screening among Women Living with HIV in Low- and Middle-Income Countries: What Do We Know and What Can Be Done?

“…Overall, 3178 women were enrolled in those studies and 2105 (66%) of the women were with HIV. Seven studies included women with HIV only, but five studies included both women with HIV and HIV-negative women, with the latter group used as a comparison group [ 36 , 45 , 46 , 47 , 48 ]. Study participants were women between the ages of 25 and 65 years and the sample size for the studies markedly varied.…”

“…Understanding the extent to which self-sampling has been applied in women with HIV in LMICs is important for two reasons. First, due to poor health care infrastructure and inadequate qualified personnel, clinician-provided screenings such as HPV tests, Pap tests, and visual inspection with acetic acid (VIA) are few and far between in LMICs, making self-sampling a viable option to increase CC screening among women in LMICs [ 35 , 36 , 37 ]. Second, and most importantly, women with HIV bear a significant burden of CC and require regular screening [ 38 , 39 ], yet those women are underrepresented in standard CC screening [ 34 , 40 ].…”

Utilisation of cervical cancer screening among women living with HIV at Kenya’s national referral hospital

“…The WHO recommends molecular testing for HPV as primary screening for cervical cancer in low- and middle-income countries using platforms such as Xpert HPV ® which has better sensitivity than cytology and VIA, even with self-sampling. 24 , 25 To date, Xpert HPV ® has not been evaluated as a strategy to improve cervical cancer screening utilisation in Kenya and could be one approach to addressing implementation barriers identified in our study. However, the governments’s support is required in the implementation and sustainability of this novel approach.…”

Prevalence and distribution of selected cervical human papillomavirus types in HIV infected and HIV uninfected women in South Africa, 1989–2021: A narrative review

“… 61 , 62 Lastly with South Africa having high levels of disparities in terms of access to health and health outcomes from rural and urban settings, it would have been great to determine the HPV type distribution and prevalence in those two settings. However, out of 69 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 , 99 , 100 , 101 , 102 , 103 , 104 , 105 , 106 , 107 , 108 , 109 , 110 , 111 , 112 , 113 , 114 , 115 , 116 , 117 , 118 , 119 , 120 , 121 , 122 , 123 , …”