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Field Evaluation of Xpert HPV Point-Of-Care Test for Detection of Human Papillomavirus Infection by Use of Self-Collected Vagina

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Field Evaluation of Xpert HPV Point-Of-Care Test for Detection of Human Papillomavirus Infection by Use of Self-Collected Vagina crossmark Field Evaluation of Xpert HPV Point-of-Care Test for Detection of Human Papillomavirus Infection by Use of Self-Collected Vaginal and Clinician-Collected Cervical Specimens P. Toliman,a S. G. Badman,b J. Gabuzzi,a S. Silim,a L. Forereme,c A. Kumbia,c B. Kombuk,d Z. Kombati,d J. Allan,a G. Munnull,a C. Ryan,e L. M. Vallely,a,b A. Kelly-Hanku,a,f H. Wand,b G. D. L. Mola,g R. Guy,b P. Siba,a J. M. Kaldor,b S. N. Tabrizi,h,i A. J. Vallelya,b Papua New Guinea Institute of Medical Research, Goroka, Papua New Guineaa; The Kirby Institute, UNSW Australia, Sydney, Australiab; Eastern Highlands Provincial Hospital, Goroka, Papua New Guineac; Mt. Hagen General Hospital, Western Highlands Province, Mt. Hagen, Papua New Guinead; The Burnet Institute, Melbourne, e f Australia ; School of Public Health and Community Medicine, UNSW Australia, Sydney, Australia ; Department of Obstetrics and Gynaecology, School of Medicine and Downloaded from Health Sciences, University of Papua New Guinea, National Capital District, Papua New Guineag; Department of Microbiology, The Royal Women’s Hospital, Parkville, Victoria, Australiah; Department of Obstetrics and Gynaecology, University of Melbourne, Victoria, Australiai The World Health Organization has recommended that testing for high-risk human papillomavirus (HPV) (hrHPV) infection be incorporated into cervical screening programs in all settings worldwide. In many high-burden, low-income countries, it will not be feasible to achieve high cervical screening coverage using hrHPV assays that require clinician-collected samples. We con- ducted the first evaluation of self-collected vaginal specimens compared with clinician-collected cervical specimens for the detec- tion of hrHPV infection using the Xpert HPV test. Women aged 30 to 54 years attending two well-woman clinics in Papua New Guinea were invited to participate and provided self-collected vaginal and clinician-collected cervical cytobrush specimens. Both http://jcm.asm.org/ specimen types were tested at the point of care by using the Xpert HPV test. Women were given their cervical test result the same day. Those with a positive hrHPV test and positive examination upon visual inspection of the cervix with acetic acid were offered same-day cervical cryotherapy. A total of 1,005 women were enrolled, with 124 (12.3%; 95% confidence interval [CI], 10.3%, 14.4%) being positive for any hrHPV infection. There was a 99.4% overall percent agreement (OPA) between vaginal and cervical tests for HPV-16 (95% CI, 98.9%, 99.9%), a 98.5% OPA for HPV-18/45 (95% CI, 97.7%, 99.3%), a 94.4% OPA for other hrHPV infections (95% CI, 92.9%, 95.9%), and a 93.4% OPA for all hrHPV types combined (95% CI, 91.8%, 95.0%). Self-collected vagi- nal specimens had excellent agreement with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert HPV test. This approach provides for the first time an opportunity to incorporate point-of-care hrHPV testing into clini- cal cervical screening algorithms in high-burden, low-income settings. on September 23, 2018 by guest he recognition that infection with certain high-risk types of compared favorably to the FDA-approved Cobas 4800 (Roche Thuman papillomavirus (HPV) (hrHPV) is the primary cause Molecular Systems, Pleasanton, CA) and Hybrid Capture 2 of both cervical precancer and cancer led to the development of (hc2; Qiagen, Germantown, MD) assays for the detection of new technologies that would allow hrHPV DNA to be detected as hrHPV using clinician-collected cervical specimens (2, 9) and had part of population-based screening. These tests are more sensitive sensitivity, specificity, and positive predictive values comparable than cytology for the detection of high-grade cervical intraepithe- to those of the above-mentioned assays for high-grade CIN (2). lial neoplasia (CIN) and invasive disease and have comparable Disposable cartridges hold the reagents, primers, and probes for specificities (1, 2), and their potential efficacy for population- the simultaneous detection of 14 hrHPV types responsible for based cervical screening has been conclusively demonstrated in over 95% of cervical cancers (HPV-16, -18, -31, -33, -35, -39, -45, large-scale randomized trials and prospective studies (3–5). These -51, -52, -56, -58, -59, -66, and -68); a human reference gene; and findings led to recommendations in Europe, the United States, an internal probe check control (PCC) (2). The system monitors Australia, and other high-income settings for cervical screening the presence of inhibitors in a real-time PCR assay to signal a programs to incorporate hrHPV DNA testing (2, 5–7). In this rapidly developing environment, and based on trials directly com- paring HPV screening with cytology (3–5), the World Health Or- Received 9 March 2016 Returned for modification 28 March 2016 ganization recently recommended that hrHPV testing be incorpo- Accepted 31 March 2016 rated into cervical screening programs in low- and middle-income Accepted manuscript posted online 13 April 2016 countries (LIMCs), particularly where cytological testing is not Citation Toliman P, Badman SG, Gabuzzi J, Silim S, Forereme L, Kumbia A, Kombuk available and where visual inspection of the cervix after the appli- B, Kombati Z, Allan J, Munnull G, Ryan C, Vallely LM, Kelly-Hanku A, Wand H, Mola cation of acetic acid (VIA) or visual inspection after the applica- GDL, Guy R, Siba P, Kaldor JM, Tabrizi SN, Vallely AJ. 2016. Field evaluation of Xpert HPV point-of-care test for detection of human papillomavirus infection by use of tion of Lugol’s iodine (VILI) is the principal cervical screening self-collected vaginal and clinician-collected cervical specimens. J Clin Microbiol strategy (8). 54:1734–1737. doi:10.1128/JCM.00529-16. The Xpert HPV test (GeneXpert; Cepheid, Sunnyvale, CA) is a Editor: D. J. Diekema, University of Iowa College of Medicine newly available, rapid, fully automated, and easy-to-use nonbatch Address correspondence to A. J. Vallely, [email protected]. test for hrHPV infection that is as accurate as laboratory-based Copyright © 2016, American Society for Microbiology. All Rights Reserved. nucleic acid amplification tests (NAATs) (2, 9). Xpert HPV 1734 jcm.asm.org Journal of Clinical Microbiology July 2016 Volume 54 Number 7 Field Evaluation of Xpert HPV Test at Point of Care potentially false-negative result. Test results are available in 60 PreservCyt (Hologic, Marlborough, MA) immediately after collection. min and are displayed on the accompanying laptop, typically as Xpert HPV testing of cervical and vaginal specimens was conducted side- three outputs: “HPV-16,” “HPV-18/45,” and “other hrHPV” (a by-side on a clinic-based GeneXpert machine operated by a trained mem- summary of test results for HPV-31, -33, -35, -39, -51, -52, -56, ber of the clinical research team in accordance with the manufacturer’s -58, -59, -66, and -68). The Xpert HPV test uses the same Cepheid instructions. Women were given their cervical Xpert HPV test result the GeneXpert platform that has now been widely introduced for the same day. Those with a positive cervical hrHPV test and a positive VIA diagnosis of tuberculosis in LMIC settings worldwide. The avail- examination were offered same-day ablative cervical cryotherapy. ability of a test for hrHPV DNA that uses this same platform Ethical considerations. Approval was provided by the Medical Re- search Advisory Committee (MRAC) of the Papua New Guinea National represents an opportunity for the first time to integrate clinic- Department of Health (approval number 14.28), the Institutional Review based hrHPV testing into same-day “test-and-treat” cervical Board (IRB) of the Papua New Guinea Institute of Medical Research (ap- screening programs in LMICs (8), particularly if self-collected proval number 1306), and the Human Research Ethics Committee specimens were proven to be as accurate as clinician-collected (HREC) of UNSW Australia (approval number HC13268). Written in- specimens for the detection of hrHPV infection. formed consent (signature or witnessed thumbprint) was obtained from Downloaded from We previously evaluated the GeneXpert platform for point-of- all participants prior to enrollment. care testing and treatment of Chlamydia trachomatis, Neisseria Statistical analysis. Test result data were automatically stored by a gonorrhoeae, and Trichomonas vaginalis in routine-clinic settings GeneXpert-associated laptop computer. Results were also written into a in Australia (10) and are currently evaluating this approach daily test result log and entered into a study-specific MS Excel database at among antenatal women in Papua New Guinea (A. Vallely, pre- each clinic site by a trained member of the clinical research team. At the sented at the World STI & HIV Congress 2015, Brisbane, Austra- end of the study, the MS Excel database was checked for completeness, lia, 13 to 16 September 2015). In this paper, we report findings and all entries were verified against the GeneXpert laptop and written test from the first evaluation of self-collected vaginal specimens com- result logs. pared with clinician-collected cervical specimens for the detection Positive percent agreement (PPA), negative percent agreement (NPA) http://jcm.asm.org/ of hrHPV infection using the Xpert HPV test conducted at the and overall percent agreement (OPA) between cervical and vaginal spec- imens were calculated by using standard methods (16) for (i) HPV-16, (ii) point of care in the high-burden, low-income setting of Papua HPV-18/45, (iii) other hrHPV infections (HPV-31, -33, -35, -39, -51, -52, New Guinea (12–14). -56, -58, -59, -66, and -68), and (iv) any hrHPV infection (i.e., any one or more of the 14 hrHPV types detected by the Xpert HPV test). The kappa MATERIALS AND METHODS statistic was calculated with 95% confidence intervals (CIs) for the test Setting.
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