Comparison of care HPV and Hybrid Capture 2 Assays for Detection of High-Risk Human Papillomavirus DNA in Cervical Samples from HIV-1-Infected African Women

Abstract

The careHPV and HC2 assays were compared for high-risk human papillomavirus (HR-HPV) DNA detection in cervical samples from 149 HIV-1-infected African women. The HR-HPV DNA detection rates were 37.6% and 34.9% for careHPV and HC2, respectively. Agreement between the two tests was 94.6% (95% confidence interval [CI], 89.7% to 97.7%) with a kappa value of 0.88 (95% CI, 0.81 to 0.96), indicating an excellent agreement. careHPV may be considered as suitable as HC2 for cervical cancer screening among HIV-infected African women. Cervical cancer is the third-most-common cancer in women worldwide, with more than 500,000 annual cases, and the fourth-most-common cause of cancer death in women, with about 275,000 annual deaths. However, more than 85% of cases and deaths occur in developing countries, cervical cancer being the commonest cancer and the leading cause of cancer death in African women (Globocan 2008 [http://globocan.iarc.fr]). The high mortality rate observed in Africa is due mainly to the absence of cervical cancer screening, resulting in diagnosis of advanced and often untreatable disease (1).Virtually all cases of cervical cancer result from persistent infection with carcinogenic genotypes of human papillomavirus (HPV) (2). It is now well established that detection of these highrisk HPV (HR-HPV) genotypes in cervical samples allows identification of women at risk of precancerous or cancerous cervical lesions, and HR-HPV DNA testing has been proposed as a primary screening test for cervical cancer prevention (3, 4).The incidence of HR-HPV infection and of high-grade cervical lesions is significantly increased in women infected with HIV-1 (5-7). Therefore, a screening strategy based on HR-HPV testing in African women infected with HIV-1 may play an important role in cervical cancer prevention.The Hybrid Capture 2 (HC2) assay (Qiagen Corporation, Gaithersburg, MD) is a Food and Drug Administration (FDA)-approved test for cervical cancer screening. This assay is based on HR-HPV detection using a cocktail of RNA probes targeting 13 HR-HPV types, namely, HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, and HPV68. The careHPV assay (Qiagen) is a new signal amplification assay adapted from HC2. This assay, which is designed to be simpler and more rapid to use and more affordable than HC2 in resource-poor settings, targets 14 HR-HPV types, HPV66 being included in the probe cocktail in addition to the 13 HR-HPV types targeted by the HC2 assay (8, 9). There has been no published evaluation of the direct comparison between the two assays.We compared the careHPV assay with the HC2 assay for a subset of women enrolled in the HARP (HPV in Africa Research Partnership) study, which is conducted in two sub-Saharan African countries, South Africa and Burkina Faso, with the aim to evaluate cervical cancer screening and treatment approaches for the prevention of cervical neoplasia in HIV-1-infected African women. More than 1,200 consenting HIV-1-seropositive women ages 25 to 50, of whom two-th...

A population-based observational study comparing Cervista and Hybrid Capture 2 methods: improved relative specificity of the Cervista assay by increasing its cut-off

“…In order to resolve discordant results genotyping by INNO-LiPA Extra was performed. LiPA genotyping has previously been used as an adjudicating assay in test comparison studies [26],[27] because of its excellent analytical sensitivity of 20 to 70 copies per assay [28]. In line with previous studies (summarized by [29]) our discrepancy analysis demonstrated substantial cross-reactivity of HC2 with non-target HPV types (n = 16 versus n = 3 for HC2 and Cervista, respectively).…”

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

“…In the first round of screening, we have shown that, compared with the INNO-LiPA HPV genotyping Extra assay, HC2 performed well in this population, with a similar sensitivity and a higher specificity for the diagnosis of high-grade cervical intraepithelial neoplasia (CIN) grade 2 or more severe (CIN2+). We have already reported an excellent agreement between HC2 and care HPV in a subgroup of HARP participants ( Ngou et al , 2013 ), comparable to what was found in HIV-seronegative women in China ( Chen et al , 2014 ; Lin et al , 2014 ). However, it remained to be demonstrated that care HPV had a good performance among African WLHA.…”

Prevention of cervical cancer in HIV-seropositive women from developing countries through cervical cancer screening: a systematic review

“…The sensitivity of high-risk human papillomavirus (HR-HPV) DNA detection tests/tools such as careHPV®, HC2® test, INNO-LiPA®, Xpert HPV® and P16INK4a® is better when compared to cytology-based tests and visual tests as indicated by a sensitivity of 80.0–97%. However, the specificity of these HPV tests is similar in some cases but mostly lower to cytology or visual tests, 51.0–78.0% [ 21 , 23 – 25 , 27 – 30 , 40 , 42 , 43 ]. Although the OncoE6® had a specificity of 99.0% (95% CI 97.0–100), it had a low sensitivity of between 16.0 and 50.0% [ 43 ].…”