Article Figures & Data
Figures
- 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
- 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
Diagnosis n hrHPV positivitya detected by SPF10 in: κ (95% CI) P value Dry Brush and physician-obtained samples Physician-obtained samples only Dry Brush samples only Neither of the two systems Negativeb 70 21 7 3 39 0.695 (0.522–0.868) 0.344 BMDc 28 15 0 5 8 0.632 (0.360–0.904) 0.063 CIN 1 9 4 1 1 3 0.550 (0.001–1.000) 1.500 CIN 2 13 11 0 0 2 1.000 (1.000–1.000) 2.000 CIN 3 14 11 2 0 1 0.440 (0–1.000) 0.500 Total 134 62 10 9 53 0.715 (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
Genotype hrHPV positivitya detected by SPF10-LiPA25 in: κ value (95% CI) P value Dry Brush and physician-obtained samples Physician-obtained samples only Dry Brush samples only Neither of the two systems HPV16 13 1 3 117 0.850 (0.706–0.994) 0.625 HPV18 8 2 0 124 0.881 (0.719–1.000) 0.500 HPV31 8 3 6 117 0.604 (0.369–0.839) 0.508 HPV33 5 1 0 128 0.905 (0.721–1.000) 1.000 HPV35 2 1 0 131 0.796 (0.407–1.000) 1.000 HPV39 2 4 2 126 0.378 (0–0.770) 0.687 HPV45 2 0 0 132 1.000 (1.000–1.000) 2.000 HPV51 7 0 4 123 0.763 (0.540–0.985) 0.125 HPV52 5 5 5 119 0.460 (0.177–0.743) 1.000 HPV56 4 3 3 124 0.548 (0.226–0.870) 1.000 HPV58 1 1 0 132 0.663 (0.044–1.000) 1.000 HPV59 4 4 0 126 0.653 (0.339–0.967) 0.125 HPV66 9 1 4 120 0.763 (0.563–0.962) 0.375 HPV68/73 1 2 2 129 0.318 (0–0.812) 1.000 HPV39/68/73 0 2 0 132 NCb 0.500 Any type 71 30 29 1,880 0.691 (0.617–0.766) 1.000 - 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
Diagnosis n hrHPV positivitya detected by GP5+/6+ in: κ value (95% CI) P value Dry Brush and physician-obtained samples Physician-obtained samples only Dry Brush samples only Neither of the two systems Negativeb 70 13 4 4 49 0.689 (0.490–0.889) 1.273 BMDc 28 12 1 3 12 0.716 (0.460–0.971) 0.625 CIN 1 9 4 2 0 3 0.571 (0.098–1.000) 0.500 CIN 2 13 9 1 1 2 0.567 (0.032–1.000) 1.500 CIN 3 14 10 2 0 2 0.588 (0.107–1.000) 0.500 Total 134 48 10 8 68 0.725 (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
Genotype hrHPV positivitya detected by GP5+/6+-LQ in: κ value (95% CI) P value Dry Brush and physician-obtained samples Physician-obtained samples only Dry Brush samples only Neither of the two systems HPV16 11 4 3 116 0.729 (0.539–0.920) 1.000 HPV18 7 1 1 125 0.867 (0.686–1.000) 1.000 HPV31 6 3 2 123 0.686 (0.427–0.945) 1.000 HPV33 5 1 0 128 0.905 (0.721–1.000) 1.000 HPV35 2 0 0 132 1.000 (1.000–1.000) 2.000 HPV39 2 0 1 131 0.796 (0.407–1.000) 1.000 HPV45 2 0 0 132 1.000 (1.000–1.000) 1.000 HPV51 4 3 1 126 0.651 (0.334–0.969) 0.625 HPV52 1 1 1 131 0.492 (0–1.000) 1.000 HPV56 4 4 0 126 0.653 (0.339–0.967) 0.125 HPV58 2 1 0 131 0.796 (0.407–1.000) 1.000 HPV59 3 0 1 130 0.853 (0.570–1.000) 1.000 HPV66 8 2 1 123 0.830 (0.642–1.000) 1.000 HPV68 0 1 0 133 NCb 1.000 Any type 56 21 11 1,658 0.768 (0.691–0.846) 0.110 - TABLE 5
Sensitivity and specificity for the two collection devices with the SPF10 and the GP5+/6+-system for the detection of CIN2+
Characteristic Physician-obtained samplesa Dry Brush samplesa SPF10 GP5+/6+ SPF10 GP5+/6+ Sensitivity 88.9% (24/27) 81.5% (22/27) 81.5% (22/27) 74.1% (20/27) Specificity 55.1% (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 topic Excellent Very good Good Moderate Poor n % n % n % n % n % Experience 43 34 39 31 42 33 3 2 0 0 Instructions 46 36 35 28 43 34 3 2 0 0 Convenience 45 35 45 35 35 28 1 1 1 1 Convenience compared to physician-taken smear 56 44 30 24 34 27 5 4 2 1
