Comparison of DRY and WET vaginal swabs with cervical specimens in Roche Cobas 4800 HPV and Abbott RealTime High Risk HPV tests

Jun, Jae Kwan; Lim, Myong Cheol; Hwang, Sang‐Hyun; Shin, Hang-Sik; Hwang, Na Rae; Kim, Yeon-Jin; Yoo, Chong Woo; Lee, Dong Ock; Joo, Jungnam; Park, Sang-Yoon; Lee, Do‐Hoon

doi:10.1016/j.jcv.2016.04.012

Cited by 21 publications

(22 citation statements)

References 26 publications

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“…In the current study, commonly used LBC samples were selected as a reference to evaluate the stability of swab samples. A series of studies compared the performance of dry and wet cervicovaginal samples in HPV assays, but the stability of the two sample types was not evaluated ( 9 – 15 ). Our study is the first, to the best of our knowledge, to demonstrate the stability of dry and wet cervical samples for HPV DNA testing, but we did not evaluate the performance of vaginal or self-collected samples in cobas HPV testing by means of the current dry-collected and dry-stored approach.…”

Section: Discussionmentioning

confidence: 99%

Stability Study of Cervical Specimens Collected by Swab and Stored Dry Followed by Human Papillomavirus DNA Detection Using the cobas 4800 Test

et al. 2017

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Safer, more convenient methods for cervical sample collection and storage are necessary to facilitate human papillomavirus (HPV) DNA testing in low-resource settings. Our study aimed to evaluate the stability of cervical specimens collected with dry swabs and stored dry, compared to liquid-based cytology (LBC) samples, as detected by HPV DNA testing. Women with abnormal cytological findings or HPV-positive results at colposcopy were recruited from the West China Second University Hospital, Sichuan University, between October 2013 and March 2014. From each woman, physicians collected cervical specimens with a swab placed into a Sarstedt tube and a CytoBrush placed into LBC medium. Samples were randomly assigned to be stored at uncontrolled ambient temperature for 2, 7, 14, or 28 days and then were tested for 14 high-risk HPV (HR-HPV) types using the cobas HPV test. The rates of agreement between dry swab and LBC samples for any HR-HPV type, HPV16, HPV18, and the 12 pooled HR-HPV types were 93.8%, 97.8%, 99.4%, and 93.2%, respectively, with kappa values of 0.87 (95% confidence interval [CI], 0.83 to 0.91), 0.94 (95% CI, 0.91 to 0.97), 0.94 (95% CI, 0.87 to 1.00), and 0.86 (95% CI, 0.82 to 0.90). The performance of swab samples for detection of cervical precancerous lesions by means of cobas HPV testing was equal to that of LBC samples, even with stratification by storage time. Dry storage of swab-collected cervical samples can last for 1 month without loss of test performance by cobas HPV testing, compared to LBC samples, which may offer a simple inexpensive approach for cervical cancer screening in low-resource settings.

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Section: Discussionmentioning

confidence: 99%

Stability Study of Cervical Specimens Collected by Swab and Stored Dry Followed by Human Papillomavirus DNA Detection Using the cobas 4800 Test

et al. 2017

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“…Previous studies have shown that the open-fiber structure of nylon flocked swabs allows both for a greater cellular retrieval and a more efficient sample release, leading to a higher HPV DNA detection rate. 12 , 13 Although the Anyplex II assay detects copies of the β-globin gene rather than human genomes, our results show that the higher the cellular retrieval and subsequent release, the more likely it is to obtain a valid HPV test result. Moreover, when looking at samples with discordant HPV test results, we found that HPV-positive results were more likely to be encountered in the sample taken first, perhaps suggesting that a greater cellular retrieval may influence the self-sample test result, although small numbers may hamper the reliability of such conclusions.…”

Section: Discussionmentioning

confidence: 74%

“… 11 Nevertheless, flocked swabs yield a higher detection of HPV than fiber-wrapped or dacron swabs. 12 , 13 …”

Section: Introductionmentioning

confidence: 99%

A comparison of cotton and flocked swabs for vaginal self-sample collection

Viviano¹,

Willame²,

Cohen³

et al. 2018

IJWH

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ObjectiveVaginal self-sampling for human papillomavirus (HPV) testing has recently been proposed to optimize cervical cancer screening coverage. The objective of this study was to compare the performance of self-taken samples using flocked and cotton swabs for HPV detection and cellular retrieval.MethodsWe recruited women aged 21–65 years, referred to colposcopy at the Division of Gynecology of the Geneva University Hospitals between May and September 2016. Each participant collected 2 vaginal samples: 1 with a cotton swab and 1 with a flocked swab. A 1:1 randomization determined the order in which the 2 samples were taken. The swabs were introduced into a 20 mL PreservCyt® vial. Real-time polymerase chain reaction analysis using the Anyplex™ II HPV HR assay, cytofluorometric analysis and cytological cell counting were performed on each sample.ResultsA total of 119 participants were recruited in the study. Their mean ± standard deviation age was 35.1±8.9 years. The HPV prevalence was 29.7% and 38.1% according to the cotton and flocked swab, respectively (p=0.006). The mean number of cells collected per milliliter according to cytofluorometry was 96,726.6 with the cotton swab and 425,544.3 with the flocked swab (p<0.001). The mean number of cells detected at cytological cell count was 13,130.42 using the cotton swab and 17,503.6 using the flocked swab (p<0.001).ConclusionThe flocked swab achieved a greater cellular retrieval and showed an improved performance in HPV detection. Further studies are needed to assess the usability and cost-effectiveness of the 2 self-sampling devices.

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“…Self-sampling has been found to show high concordance with physician-acquired samples for HPV detection and to be readily acceptable to women 12 , 13 . As a noninvasive, self-sampling method, urine-based HPV DNA testing has been suggested to be of use in women who do not attend cervical cancer screening clinics 14 .…”

Section: Introductionmentioning

confidence: 97%

“…A few studies have compared HPV tests based on real-time qualitative PCR (RQ-PCR) of urine samples and cervical samples 15 – 17 . Previously, we showed that using vaginal swabs could be an alternative to collecting cervical samples for RQ-PCR-based HPV DNA testing 12 . We also demonstrated that fully-automated RQ-PCR systems could reduce the variability in HPV detection with non-invasive urine samples 18 .…”

Section: Introductionmentioning

confidence: 99%

A prospective pilot evaluation of vaginal and urine self-sampling for the Roche cobas 4800 HPV test for cervical cancer screening

Hwang

Shin

Lee

et al. 2018

Sci Rep

Self Cite

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This pilot study sought to evaluate the feasibility of utilizing vaginal self-swabs and urine samples for HPV-based cervical cancer screening in 700 women who had undergone conventional Pap smear screening via the national cervical cancer program in Korea. The cobas 4800 HPV test was utilized to detect HPV in the self-samples. Pap smear results revealed three cases of atypical squamous cells of undetermined significance, 649 cases of negative for an intraepithelial lesion or malignancy, and 48 non-specific inflammatory findings. High-risk HPV was detected in 6.7% of urine samples and 9.6% of vaginal self-swab samples. The overall agreement for HPV 16/18 between urine and vaginal self-swab samples was 99.1% (95%CI 98.1% to 99.6%). Colposcopic biopsy revealed one cervical intraepithelial neoplasia (CIN) 3 lesion, 12 CIN1 lesions, and 23 normal or chronic cervicitis lesions. In conclusion, urine and vaginal self-swab sampling was feasible and deemed a potential alternative for HPV detection in women who hesitate to participate in cervical cancer screening programs. Meanwhile, due to overall lower rates of abnormal cytology and sexual risk behaviors in Korea, a larger sample size than expected is needed to assess the sensitivity of CIN2+ detection via self-samples.

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Comparison of DRY and WET vaginal swabs with cervical specimens in Roche Cobas 4800 HPV and Abbott RealTime High Risk HPV tests

Cited by 21 publications

References 26 publications

Stability Study of Cervical Specimens Collected by Swab and Stored Dry Followed by Human Papillomavirus DNA Detection Using the cobas 4800 Test

Stability Study of Cervical Specimens Collected by Swab and Stored Dry Followed by Human Papillomavirus DNA Detection Using the cobas 4800 Test

A comparison of cotton and flocked swabs for vaginal self-sample collection

A prospective pilot evaluation of vaginal and urine self-sampling for the Roche cobas 4800 HPV test for cervical cancer screening

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