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Clinical relevance of the borderline results of the Hybrid Capture 2 High-Risk HPV DNA assay with cervical samples collected in Specimen Transport Medium Cover

Clinical relevance of the borderline results of the Hybrid Capture 2 High-Risk HPV DNA assay with cervical samples collected in Specimen Transport Medium

Open Access
|Sep 2019

Figures & Tables

Figure 1

Changes in the RLU/CO values after retesting samples within the 0.4–4.0 RLU/CO range. The red arrow represents the samples with changes in the results from negative to positive, the blue arrows represent samples with changes in the results from positive to negative, and the black arrows represent samples that retained the original result.
Changes in the RLU/CO values after retesting samples within the 0.4–4.0 RLU/CO range. The red arrow represents the samples with changes in the results from negative to positive, the blue arrows represent samples with changes in the results from positive to negative, and the black arrows represent samples that retained the original result.

Figure 2

ROC curve demonstrating the sensitivity and specificity of the HC2 test for CIN2+ with marked RLU/CO cutoff values that represent the lower and upper borders of the “grey zone” ranges.
ROC curve demonstrating the sensitivity and specificity of the HC2 test for CIN2+ with marked RLU/CO cutoff values that represent the lower and upper borders of the “grey zone” ranges.

The distribution of women with a CIN2+/3+ diagnosis and the risk for CIN2+/3+ based on the RLU/CO values of their HPV test results

RLU/CO valueN and % women (Ntot = 594)N and % CIN2+ (Ntot = 162)Risk for CIN2+ (%)N and % CIN3+ (Ntot = 114)Risk for CIN3+ (%)
RLU/CO < 0.4253 (42.6)8 (4.9)3.22 (1.8)0.8
0.4 ≤ RLU/CO < 0.718 (3.0)1 (0.6)5.61 (0.9)5.6
0.7 ≤ RLU/CO < 1.012 (2.0)1 (0.6)8.31 (0.9)8.3
1.0 ≤ RLU/CO ≤ 2.015 (2.5)1 (0.6)6.71 (0.9)6.7
2.0 < RLU/CO ≤ 2.58 (1.3)3 (1.9)37.52 (1.8)25.0
2.5 < RLU/CO ≤ 4.011 (1.9)3 (1.9)27.32 (1.8)18.2
4.0 < RLU/CO ≤ 10.026 (4.4)7 (4.3)26.96 (5.3)23.1
10.0 < RLU/CO ≤ 100112 (18.9)48 (29.6)42.933 (28.9)29.5
100 < RLU/CO ≤ 1000105 (17.7)68 (42.0)64.853 (46.5)50.5
1000 < RLU/CO34 (5.7)22 (13.6)64.713 (11.4)38.2

Number of HPV test results according to “grey zones” proposed by the manufacturer (PreservCyt)I, Seme et al_ (STM)II, and the Department of Cytopathology at Institute of Oncology Ljubljana (STM)Ill

RLU/CO value IN and % women (Ntot = 594)
< 1.0283 (47.6)
1.0–2.523 (3.9)
> 2.5288 (48.5)
DOI: https://doi.org/10.2478/raon-2019-0044 | Journal eISSN: 1581-3207 | Journal ISSN: 1318-2099
Language: English
Page range: 316 - 322
Submitted on: Jul 10, 2019
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Accepted on: Aug 6, 2019
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Published on: Sep 24, 2019
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year

© 2019 Jerneja Varl, Urska Ivanus, Ziva Pohar Marinsek, Tine Jerman, Anja Ostrbenk Valencak, Mario Poljak, Veronika Kloboves Prevodnik, published by Association of Radiology and Oncology
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.