Dataset Information

Performance and Diagnostic Accuracy of Human Papillomavirus Testing on Self-Collected Urine and Vaginal Samples in a Referral Population.

ABSTRACT:

Purpose

The study aimed to evaluate the diagnostic accuracy of polymerase chain reaction ‒based high-risk human papillomavirus (HPV) assays on self-collected vaginal and urine samples for detection of precancerous cervical lesions in referral population.

Materials and methods

Women referred for colposcopy following abnormal cytology, were included this study. A total of 314 matched urine, vaginal, and cervical samples were collected. All samples were tested for HPV DNA using the RealTime HR-S HPV and Anyplex II HPV 28 assays. Primary endpoints were sensitivity for cervical intraepithelial neoplasia (CIN) 2+/CIN3+ and specificity for ResultsThe sensitivity of Realtime HR-S and Anyplex HPV assay was 93.13% (95% confidence interval [CI], 87.36 to 96.81) and 90.08% (95% CI, 83.63 to 94.61) for CIN2+ (n=130); specificity for ConclusionThe detection performance for hrHPV and CIN2+ on self-collected vaginal samples was comparable to that of clinician-collected cervical samples. On the other hand, HPV tests using urine were inferior to those using clinician-collected cervical samples in terms of detecting hrHPV and CIN2+.

SUBMITTER: Cho HW

PROVIDER: S-EPMC8291188 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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Publications

Performance and Diagnostic Accuracy of Human Papillomavirus Testing on Self-Collected Urine and Vaginal Samples in a Referral Population.

Cho Hyun-Woong HW Hong Jin Hwa JH Min Kyung Jin KJ Ouh Yung-Taek YT Seong Seok Ju SJ Moon Jun Hye JH Cho Seong Hwan SH Lee Jae Kwan JK

Cancer research and treatment 20201224 3

<h4>Purpose</h4>The study aimed to evaluate the diagnostic accuracy of polymerase chain reaction ‒based high-risk human papillomavirus (HPV) assays on self-collected vaginal and urine samples for detection of precancerous cervical lesions in referral population.<h4>Materials and methods</h4>Women referred for colposcopy following abnormal cytology, were included this study. A total of 314 matched urine, vaginal, and cervical samples were collected. All samples were tested for HPV DNA using the R ...[more]

PMID: 33421987

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Project description:ObjectivesTo increase effectiveness of the cervical cancer screening program, self-sampling can be an option. Both self-collected vaginal samples (SCV) and urine samples may be useful alternatives to clinician-taken cervical samples (CS).DesignCross-sectional study.SettingColposcopy clinic.ParticipantsWomen (n=305) referred to colposcopy after abnormal cervical screening result or conditions like postcoital bleeding.InterventionAll women self-collected a urine and a vaginal sample prior to colposcopy, where a CS and biopsies were taken. All samples were tested for high-risk human papillomavirus (HPV) using the Cobas HPV assay. The gold standard was histology diagnoses (CIN2+/CIN3+) from biopsies obtained at the same examination.Primary outcomeAbsolute and relative sensitivity and specificity of HPV testing on SCV and urine to detect CIN2+/CIN3+ compared with the CS.Secondary outcomeThe acceptability by women of self-sampling.ResultsBoth the vaginal and urine sample were comparable to the CS in identifying severe intraepithelial neoplasia (CIN2+/CIN3+). Absolute sensitivity ranged from 93% for urine samples to 96% for SCV for detecting CIN2+, which is comparable to the sensitivity of CS (overlapping 95% CI).The relative sensitivity for detecting CIN2+ was 1.00 (95% CI 0.96 to 1.04) for SCV and 0.96 (95% CI 0.91 to 1.03) for urine samples. At CIN3+, the relative sensitivity was 1.00 (95% CI 0.96 to 1.08) and 0.97 (95% CI 0.89 to 1.07) for SCV and urine samples, respectively. There were no statistical differences between the self-collected samples and the CS (McNemar's test >0.05). The relative specificity was also similar (1.03 (95% CI 0.95 to 1.12) for SCV and 0.98 (95% CI 0.89 to 1.09) for urine samples) (McNemar's test >0.05).The acceptability of self-sampling was evaluated by questionnaire. The women found the instructions on sample collection easy to understand and were positive about self-sampling with a preference for the urine sample.ConclusionSelf-sampling by SCV and urine is a clinically safe alternative to CS with a high degree of acceptability.

Project description:BackgroundSelf-collected human papillomavirus (HPV) testing could reduce barriers to cervical cancer screening, with performance comparable to clinician-collected specimens. The ability of self-collected specimens to cross-sectionally and prospectively detect precursor lesions was investigated in an HPV vaccine randomized trial in Costa Rica.MethodsIn the trial, 7466 women age 18 to 25 years received an HPV16/18 or control vaccine and were followed at least annually for four years. In this secondary analysis, we included all women who provided a self-collected cervicovaginal specimen six months after enrollment (5109 women = full analytical cohort). A subset (615 women = restricted cohort) also had clinician-collected specimens at the six-month postenrollment visit. High-grade squamous intraepithelial lesion or repeat low-grade squamous intraepithelial lesion prompted colposcopic referral throughout the study. HPV testing was performed with SPF10PCR/DEIA/LiPA25. Cross-sectional and prospective sensitivity, specificity, and predictive values were estimated.ResultsIn the full cohort, one-time HPV testing on self-collected samples detected prevalent CIN2+ with a sensitivity of 88.7% (95% confidence interval [CI] =77.0% to 95.7%) and a specificity of 68.9% (95% CI = 67.6% to 70.1%). For predicting incident CIN2+ in the subsequent four years, sensitivity was 73.9% (95% CI = 65.8% to 81.0%) and specificity 69.4% (95% CI = 68.1% to 70.7%). In the restricted cohort, for incident CIN2+, self-collected HPV was much more sensitive than cytology (80.0% vs 10.0%); relative sensitivity was 0.1 (95% CI = 0.03% to 0.5%). Furthermore, three times more women with normal baseline cytology developed incident CIN2+ than those with negative self-collected HPV. Self-collected and clinician-collected HPV testing had comparable performance. Agreement between self- and clinician-collected samples was 89.7% (kappa = 0.78, McNemar χ2 = 0.62) for carcinogenic HPV types.ConclusionsSelf-collected specimens can be used for HPV-based screening, providing sensitivity and specificity comparable with clinician-collected specimens and detecting disease earlier than cytology.

Project description: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.

Project description:The Fujifilm SILVAMP TB LAM (FujiLAM) assay offers improved sensitivity compared to Determine TB LAM Ag (AlereLAM) for detecting tuberculosis (TB) among people with HIV. Here, we examined the diagnostic value of FujiLAM testing on early morning urine versus spot urine and the added value of a two-sample strategy. We assessed the diagnostic accuracy of FujiLAM on cryopreserved urine samples collected and stored as part of a prospective cohort of adults with HIV presenting for antiretroviral treatment in Ghana. We compared FujiLAM sensitivity and specificity in spontaneously voided urine samples collected at inclusion (spot urine) versus in the first voided early morning urine (morning urine) and for a one (spot urine) versus two samples (spot and morning urine) strategy. Diagnostic accuracy was determined against both microbiological (using sputum culture and Xpert MTB/RIF testing of sputum and urine to confirm TB) and composite reference standards (including microbiologically confirmed and probable TB cases). Paired urine samples of spot and morning urine were available for 389 patients. Patients had a median CD4 cell count of 176 cells/μL (interquartile range [IQR], 52 to 361). Forty-three (11.0%) had confirmed TB, and 19 (4.9%) had probable TB. Overall agreement for spot versus morning urine test results was 94.6% (kappa, 0.81). Compared to a microbiological reference standard, the FujiLAM sensitivity (95% confidence interval [CI]) was 67.4% (51.5 to 80.9) for spot and 69.8% (53.9 to 82.8) for morning urine, an absolute difference (95% CI) of 2.4% (-10.2 to 14.8). Specificity was 90.2% (86.5 to 93.1) versus 89.0% (85.2 to 92.1) for spot and morning urine, respectively, a difference of 1.2% (-3.7 to 1.4). A two-sample strategy increased FujiLAM sensitivity from 67.4% (51.5 to 80.9) to 74.4% (58.8 to 86.5), a difference of 7.0% (-3.0 to 16.9), while specificity decreased from 90.2% (86.5 to 93.1) to 87.3% (83.3 to 90.6), a difference of -2.9% (-4.9 to -0.8). This study indicates that FujiLAM testing performs equivalently on spot and early morning urine samples. Sensitivity could be increased with a two-sample strategy but at the risk of lower specificity. These data can inform future guidelines and clinical practice. IMPORTANCE This study indicates that FujiLAM testing performs equivalently on spot and early morning urine samples for detecting tuberculosis among people with HIV. Sensitivity could be increased with a two-sample strategy but at the risk of lower specificity. These data can inform future guidelines and clinical practice around FujiLAM.

Dataset Information

Performance and Diagnostic Accuracy of Human Papillomavirus Testing on Self-Collected Urine and Vaginal Samples in a Referral Population.

Purpose

Materials and methods

Publications

Performance and Diagnostic Accuracy of Human Papillomavirus Testing on Self-Collected Urine and Vaginal Samples in a Referral Population.

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