Accuracy of self-collected vaginal dry swabs using the Xpert human papillomavirus assay

Abstract

BackgroundPolymerase chain reaction-based Xpert human papillomavirus (HPV) assay is a rapid test that detects high-risk HPV (hrHPV) infection. This point-of-care test is usually performed by collecting a cervical specimen in a vial of PreservCyt® transport medium. We compared HPV test positivity and accuracy between self-collected sample with a dry swab (s-DRY) versus physician-collected cervical sampling using a broom like brush and immediate immersion in PreservCyt (dr-WET).MethodsIn this cross-sectional study, we recruited 150 women ≥ 18 years old attending the colposcopy clinic in the University Hospital of Geneva. Each participant first self-collected a vaginal sample using a dry swab and then the physician collected a cervical specimen in PreservCyt. HPV analysis was performed with Xpert. Part of the PreservCyt-collected sample was used for hrHPV detection with the cobas® HPV test. HPV test positivity and performance of the two collection methods was compared.ResultsHPV positivity was 49.1% for s-DRY, 41.8% for dr-WET and 46.2% for cobas. Good agreement was found between s-DRY and dr-WET samples (kappa±Standard error (SE) = 0.64±0.09,), particularly for low-grade squamous intraepithelial lesions (LSIL+) (kappa±SE = 0.80±0.17). Excellent agreement was found between the two samples for HPV16 detection in general (kappa±SE = 0.91±0.09) and among LSIL+ lesions (kappa±SE = 1.00±0.17). Sensitivities and specificities were, respectively, 84.2% and 47.1%(s-DRY), 73.1% and 58.7%. (dr-WET) and 77.8% and 45.7% (cobas) for CIN2+ detection. The median delay between sampling and HPV analysis was 7 days for the Xpert HPV assay and 19 days for cobas. There were 36 (24.0%) invalid results among s-DRY samples and 4 (2.7%) among dr-WET (p = 0.001). Invalid results happened due to the long interval between collection and analysis.ConclusionSelf-collected vaginal dry swabs are a valid alternative to collecting cervical samples in PreservCyt solution for HPV testing with the Xpert HPV assay.ImpactHPV self-collection with dry cotton swabs might assist in the implementation of an effective screening strategy in developing countries.Trial registrationInternational Standard Randomized Controlled Trial Number Registry ISRCTN83050913

Evaluation of self-collected vaginal specimens for the detection of high-risk human papillomavirus infection and the prediction of high-grade cervical intraepithelial lesions in a high-burden, low-resource setting

“…Across all assays, the V specimen had high sensitivity, specificity and predictive value for this clinical end point, and performed similarly to the technical reference standard that was built from a clinician-collected cervical specimen. Our findings are comparable to those of a recent pilot study in Geneva among 150 women known to have previous abnormal cytology where they investigated Xpert HPV using selfcollected specimens for the detection of stage 2 cervical intraepithelial neoplasia or worse and found moderately high sensitivity and PPV for this outcome (>84%), but lower specificity and NPV (<50%) compared with the current study, for reasons that are unclear [15]. Furthermore, in the Geneva pilot study, cliniciancollected specimens were only used for cytology and did not undergo HPV testing.…”

“…The use of point-of-care HPV testing is one such approach. This study adds to a growing body of evidence demonstrating that hrHPV testing can be offered at point-of-care with minimal need for speculum examinations for women, to guide same-day clinical management for cervical cancer prevention [6,7,15].…”

Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses

“…This update contains 19 new reports containing 22 diagnostic studies and nine new randomized participation trials, 26 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 which were added to the 34 accuracy studies and to the 16 participation trials already included in the previous meta-analyses. 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 The updated meta-analyses finally comprised 56 diagnostic test accuracy studies a...…”

Cervico-vaginal self-collection in HIV-infected and uninfected women from Tapajós region, Amazon, Brazil: High acceptability, hrHPV diversity and risk factors

“…New technologies in cervical cancer screening have been proposed to directly benefit high-risk populations [18]. Several studies showed the safety of self-collection compared to the clinician-collected cervical samples [14–16,19–21] and the improved performance of a primary HPV test in early detection of HSIL compared with negative cytology [22–26]. HPV-DNA molecular testing coupled with samples obtained by CVSC is a valid alternative to be considered in the practice of cervical cancer screening in the Tapajós region, because of the ease and feasibility both for women who routinely attend clinics, such as HIV-infected women, and those who undergo it for the first time or less regularly, such as those from our study.…”