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Clinical evaluation of modifications to a human papillomavirus assay to optimise its utility for cervical cancer screening in low-resource settings: A diagnostic accuracy study

The Lancet Global Health Jan 31, 2020

Kuhn L, Saidu R, Boa R, et al. - This study was undertaken to assess whether HPV type restriction and more stringent cutoffs on Xpert HPV optimize performance characteristics of this assay for screen and treat. They included HIV-negative and HIV-positive women aged 30–65 years from a primary care facility and a referral colposcopy clinic in Cape Town, South Africa. They enrolled a sum of 1,121 women aged 30–65 years, 586 of whom were HIV-negative and 535 HIV-positive. They applied logistic regression and receiver operating characteristic curves to assess improvements in specificity attained by modifying cycle threshold cutoffs to define screen-positive results. More powerful cycle threshold cutoffs on selected channels in Xpert HPV increase specificity with only modest losses in sensitivity, performing this assay an optimal choice for HPV-based screen and treat in settings with a high prevalence of HIV. These corrections can be earned from standard output with no requirement for new engineering. Results of this study indicated that decision making about performance characteristics of HPV testing can be moved to programme implementers and cutoffs selected according to resource availability and community preferences.
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