Background: Rapid diagnostic tests (RPTs) for high-risk HPV genotypes can help triage people living with HIV (PLHIV), who are at greater risk for oral cancers especially in low-and-middle-income-countries (LMICs), that have a high burden of both HIV and oral cancers. We evaluated the utility of Xpert® HPV, a RPT for oral HPV among PLHIV. Methods: We used data from 429 PLHIV receiving care at a tertiary care hospital affiliated antiretroviral therapy center in Pune, India. Oral HPV was evaluated using oral rinse samples. Samples were classified as usable (if they were successfully processed on Xpert® HPV) or not usable (if they were not successfully processed on Xpert® HPV). Factors associated with non-usability were evaluated using logistic regression. We compared the sensitivity and specificity of the Xpert® HPV for oral samples with conventional polymerase chain reaction (PCR). Results: The Xpert® HPV deemed almost a third (29.8%) of the oral samples not usable for oral HPV detection. We were unable to identify factors associated with non-usability. Compared to conventional polymerase chain reaction (PCR), the sensitivity of Xpert® HPV was 6.2% and specificity 100%, for detection of oral HPV. Conclusions: Xpert® HPV cannot be used for the detection of oral HPV among PLHIV presently. More research to optimize Xpert® HPV for oral samples is required.

Background People living with HIV (PLHIV) are at higher risk for human papillomavirus (HPV)-related oropharyngeal cancers compared to the general population. Xpert HPV test is a polymerase chain reaction (PCR) assay capable of rapid HPV detection. Performing the assay requires minimal intervention by laboratory personnel. Its use could improve oropharyngeal cancer screening among PLHIV living in low-and middle-income countries (LMICs) with limited diagnostic capacities. However, Xpert HPV performance for oral samples has not been evaluated. Here, we describe our experience with Xpert HPV and compare its results with traditional PCR, for oral samples. Methods Oral samples from 429 PLHIV receiving care at a tertiary care hospital affiliated antiretroviral therapy center in Pune, India were used. Samples were collected either after a 30s oral rinse and gargle (n = 335) or in combination with cytobrush scraping of the oral mucosa (n = 91). Unsuccessful tests were those that generated an invalid or error result on Xpert HPV. Successful tests were those that generated a positive or negative result. Kappa statistic was used to compare concordance between Xpert HPV and traditional real-time PCR results. Results There were 29.8% (n = 127) unsuccessful tests, of which 78.7% (n = 100) were invalid and 21.3% (n = 27) were error results. Adding cytobrush scraping to oral rinse as a collection procedure did not significantly reduce the proportion of unsuccessful tests (p = 0.9). For successful tests, HPV positivity on Xpert was 0.3% (n = 1/299). Kappa statistic was 0.11, indicating poor agreement between Xpert HPV and traditional PCR results. Conclusions Presently, Xpert HPV appears to have limited use for oral HPV detection among PLHIV using oral samples. More research to improve the diagnostic capabilities of Xpert HPV for oral samples among PLHIV is needed.