High-Risk Human Papillomavirus Messenger RNA Testing in Physician- and Self-Collected Specimens for Cervical Lesion Detection in High-Risk Women, Kenya

Ting, Jie PhD, MSPH*; Mugo, Nelly MBChB, MPH; Kwatampora, Jessie MBChB; Hill, Craig PhD§; Chitwa, Michael BSc; Patel, Suha MD; Gakure, Hannah; Kimani, Joshua MBChB, MPH; Schoenbach, Victor J. PhD, MSPH*; Poole, Charles PhD, MPH*; Smith, Jennifer S. PhD, MPH*∥

Sexually Transmitted Diseases: July 2013 - Volume 40 - Issue 7 - p 584–589
doi: 10.1097/OLQ.0b013e31828e5a91
Original Study

Background: Little is known about the performance of physician-versus self-collected specimens for high-risk human papillomavirus (hrHPV) messenger RNA (mRNA) testing or risk factors for hrHPV mRNA positivity in physician- versus self-collected specimens. We compared the performance of hrHPV mRNA testing of physician- and self-collected specimens for detecting cytological high-grade squamous intraepithelial lesions or more severe (≥HSIL) and examined risk factors for hrHPV mRNA positivity in female sex workers in Nairobi.

Methods: From 2009 to 2011, 344 female sex workers participated in this cross-sectional study. Women self-collected a cervicovaginal specimen. A physician conducted a pelvic examination to obtain a cervical specimen. Physician- and self-collected specimens were tested for hrHPV mRNA and sexually transmitted infections using APTIMA nucleic acid amplification assays (Hologic/Gen-Probe Incorporated, San Diego, CA). Cervical cytology was conducted using physician-collected specimens and classified according to the Bethesda criteria.

Results: Overall hrHPV mRNA prevalence was similar in physician- and self-collected specimens (30% vs. 29%). Prevalence of ≥HSIL was 4% (n = 15). Overall sensitivity of hrHPV testing for detecting ≥HSIL was similar in physician-collected (86%; 95% CI, 62%–98%; 13 cases detected) and self-collected specimens (79%; 95% CI, 55%–95%; 12 cases detected). Overall specificity of hrHPV mRNA for ≥HSIL was similar in both physician-collected (73%; 95% CI, 68%–79%) and self-collected (75%; 95% CI, 70%–79%) specimens. High-risk HPV mRNA positivity in both physician- and self-collected specimens seemed higher in women who were younger (<30 years), had Trichomonas vaginalis or Mycoplasma genitalium infections, or had more than 8 years of educational attainment.

Conclusions: Self-collected specimens for hrHPV mRNA testing seemed to have similar sensitivity and specificity as physician-collected specimens for the detection of ≥HSIL among high-risk women.

Among female sex workers in Kenya, sensitivity and specificity of high-risk human papillomavirus messenger RNA testing of self-collected specimens for cervical high-grade lesions were similar to those of physician-collected specimens.

From the *Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC; †Kenya Medical Research Institute (KEMRI), Nairobi, Kenya; ‡Kenyatta National Hospital/University of Nairobi, Nairobi, Kenya; §Hologic/Gen-Probe Incorporated, San Diego, CA; ¶Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA; and ∥Lineberger Comprehensive Cancer Center, Chapel Hill, NC

Supported by Hologic/Gen-Probe Incorporated and a UNC Center for AIDS Research grant (Grant No. 5-51060). Dr Suha Patel was a Howard Hughes Medical Research Fellow from 2009 to 2010.

Potential conflict of interest: Dr Jennifer S. Smith has received unrestricted educational grants, consultancy, and research grants from Hologic/Gen-Probe, Hologic, and QIAGEN over the past 5 years. Dr Craig Hill is an employee of Hologic/Gen-Probe. The remaining authors have no conflict of interest to declare.

Correspondence: Jie Ting, MSPH, Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, McGavran-Greenberg CB #7435, Chapel Hill, NC 27599. E-mail: jieting@email.unc.edu.

Received for publication October 22, 2012, and accepted February 20, 2013.

© Copyright 2013 American Sexually Transmitted Diseases Association