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Virology

Dry Storage and Transport of a Cervicovaginal Self-Sample by Use of the Evalyn Brush, Providing Reliable Human Papillomavirus Detection Combined with Comfort for Women

Romy van Baars, Remko P. Bosgraaf, Bram W. A. ter Harmsel, Willem J. G. Melchers, Wim G. V. Quint, Ruud L. M. Bekkers
Romy van Baars
aDDL Diagnostic Laboratory, Rijswijk, Netherlands
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Remko P. Bosgraaf
bDepartment of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands
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Bram W. A. ter Harmsel
cDepartment of Obstetrics and Gynaecology, Reinier de Graaf Groep, Voorburg, Netherlands
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Willem J. G. Melchers
dDepartment of Medical Microbiology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands
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Wim G. V. Quint
aDDL Diagnostic Laboratory, Rijswijk, Netherlands
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Ruud L. M. Bekkers
bDepartment of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands
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DOI: 10.1128/JCM.01506-12
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    Fig 1

    The Evalyn Brush. The Evalyn Brush is about 20 cm in length and consists of a transparent case with wings. Within the casing is a pink stick with a pink plunger at one end and a white brush at the other. You can push the white brush out of the case by pushing the pink plunger toward the transparent casing. After self-sampling, you can pull the brush back in, and a cap can be clicked onto the case before transport.

Tables

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  • TABLE 1

    Agreement in hrHPV positivity (14 hrHPV genotypes) in self-sampled dry Evalyn Brush samples compared to physician-obtained samples with SPF10-DEIA-LiPA25 in relation to the diagnoses

    DiagnosisnhrHPV positivitya detected by SPF10 in:κ (95% CI)P value
    Dry Brush and physician-obtained samplesPhysician-obtained samples onlyDry Brush samples onlyNeither of the two systems
    Negativeb702173390.695 (0.522–0.868)0.344
    BMDc28150580.632 (0.360–0.904)0.063
    CIN 1941130.550 (0.001–1.000)1.500
    CIN 213110021.000 (1.000–1.000)2.000
    CIN 314112010.440 (0–1.000)0.500
    Total13462109530.715 (0.597–0.834)1.000
    • ↵a Values indicate the number of samples.

    • ↵b Two of these results were not obtained at the same time as the sample for HPV analysis was obtained.

    • ↵c Three of these results were not obtained at the same time as the sample for HPV analysis was obtained; one of these samples was a vagina top smear. BMD, borderline or mild dyskaryosis.

  • TABLE 2

    Comparison of hrHPV genotyping by SPF10-DEIA-LiPA25 in physician-obtained and dry Evalyn Brush samples

    GenotypehrHPV positivitya detected by SPF10-LiPA25 in:κ value (95% CI)P value
    Dry Brush and physician-obtained samplesPhysician-obtained samples onlyDry Brush samples onlyNeither of the two systems
    HPV1613131170.850 (0.706–0.994)0.625
    HPV188201240.881 (0.719–1.000)0.500
    HPV318361170.604 (0.369–0.839)0.508
    HPV335101280.905 (0.721–1.000)1.000
    HPV352101310.796 (0.407–1.000)1.000
    HPV392421260.378 (0–0.770)0.687
    HPV452001321.000 (1.000–1.000)2.000
    HPV517041230.763 (0.540–0.985)0.125
    HPV525551190.460 (0.177–0.743)1.000
    HPV564331240.548 (0.226–0.870)1.000
    HPV581101320.663 (0.044–1.000)1.000
    HPV594401260.653 (0.339–0.967)0.125
    HPV669141200.763 (0.563–0.962)0.375
    HPV68/731221290.318 (0–0.812)1.000
    HPV39/68/73020132NCb0.500
    Any type7130291,8800.691 (0.617–0.766)1.000
    • ↵a Values indicate the number of samples.

    • ↵b NC, this quantity cannot be calculated.

  • TABLE 3

    Agreement in hrHPV positivity (14 hrHPV genotypes) in self-sampled dry Evalyn Brush samples compared to physician-obtained samples with GP5+/6+-LQ in relation to the diagnoses

    DiagnosisnhrHPV positivitya detected by GP5+/6+ in:κ value (95% CI)P value
    Dry Brush and physician-obtained samplesPhysician-obtained samples onlyDry Brush samples onlyNeither of the two systems
    Negativeb701344490.689 (0.490–0.889)1.273
    BMDc281213120.716 (0.460–0.971)0.625
    CIN 1942030.571 (0.098–1.000)0.500
    CIN 21391120.567 (0.032–1.000)1.500
    CIN 314102020.588 (0.107–1.000)0.500
    Total13448108680.725 (0.607–0.843)0.815
    • ↵a Values indicate the number of samples.

    • ↵b Two of these results were not obtained at the same time as the sample for HPV analysis was obtained.

    • ↵c Three of these results were not obtained at the same moment as the sample for HPV analysis was obtained; one of these samples was a vagina top smear. BMD, borderline or mild dyskaryosis.

  • TABLE 4

    Comparison of hrHPV genotyping by GP5+/6+-LQ in physician-obtained and dry Evalyn Brush samples

    GenotypehrHPV positivitya detected by GP5+/6+-LQ in:κ value (95% CI)P value
    Dry Brush and physician-obtained samplesPhysician-obtained samples onlyDry Brush samples onlyNeither of the two systems
    HPV1611431160.729 (0.539–0.920)1.000
    HPV187111250.867 (0.686–1.000)1.000
    HPV316321230.686 (0.427–0.945)1.000
    HPV335101280.905 (0.721–1.000)1.000
    HPV352001321.000 (1.000–1.000)2.000
    HPV392011310.796 (0.407–1.000)1.000
    HPV452001321.000 (1.000–1.000)1.000
    HPV514311260.651 (0.334–0.969)0.625
    HPV521111310.492 (0–1.000)1.000
    HPV564401260.653 (0.339–0.967)0.125
    HPV582101310.796 (0.407–1.000)1.000
    HPV593011300.853 (0.570–1.000)1.000
    HPV668211230.830 (0.642–1.000)1.000
    HPV68010133NCb1.000
    Any type5621111,6580.768 (0.691–0.846)0.110
    • ↵a Values indicate the number of samples.

    • ↵b NC, this quantity cannot be calculated.

  • TABLE 5

    Sensitivity and specificity for the two collection devices with the SPF10 and the GP5+/6+-system for the detection of CIN2+

    CharacteristicPhysician-obtained samplesaDry Brush samplesa
    SPF10GP5+/6+SPF10GP5+/6+
    Sensitivity88.9% (24/27)81.5% (22/27)81.5% (22/27)74.1% (20/27)
    Specificity55.1% (59/107)66.4% (71/107)54.2% (58/107)66.4% (71/107)
    • ↵a Values in parentheses are number of samples in which CIN2+ was detected/total number.

  • TABLE 6

    Questionnaire results

    Question topicExcellentVery goodGoodModeratePoor
    n%n%n%n%n%
    Experience4334393142333200
    Instructions4636352843343200
    Convenience4535453535281111
    Convenience compared to physician-taken smear5644302434275421
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Dry Storage and Transport of a Cervicovaginal Self-Sample by Use of the Evalyn Brush, Providing Reliable Human Papillomavirus Detection Combined with Comfort for Women
Romy van Baars, Remko P. Bosgraaf, Bram W. A. ter Harmsel, Willem J. G. Melchers, Wim G. V. Quint, Ruud L. M. Bekkers
Journal of Clinical Microbiology Nov 2012, 50 (12) 3937-3943; DOI: 10.1128/JCM.01506-12

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Dry Storage and Transport of a Cervicovaginal Self-Sample by Use of the Evalyn Brush, Providing Reliable Human Papillomavirus Detection Combined with Comfort for Women
Romy van Baars, Remko P. Bosgraaf, Bram W. A. ter Harmsel, Willem J. G. Melchers, Wim G. V. Quint, Ruud L. M. Bekkers
Journal of Clinical Microbiology Nov 2012, 50 (12) 3937-3943; DOI: 10.1128/JCM.01506-12
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