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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

Jerneja Varl
Jerneja Varl
, 
Urska Ivanus
Urska Ivanus
, 
Ziva Pohar Marinsek
Ziva Pohar Marinsek
, 
Tine Jerman
Tine Jerman
, 
Anja Ostrbenk Valencak
Anja Ostrbenk Valencak
, 
Mario Poljak
Mario Poljak
 et 
Veronika Kloboves Prevodnik
Veronika Kloboves Prevodnik
   | 24 sept. 2019
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Article Category: Research Article
Publié en ligne: 24 sept. 2019
Pages: 316 - 322
Reçu: 10 juil. 2019
Accepté: 06 août 2019
DOI: https://doi.org/10.2478/raon-2019-0044
© 2019 Jerneja Varl, Urska Ivanus, Ziva Pohar Marinsek, Tine Jerman, Anja Ostrbenk Valencak, Mario Poljak, Veronika Kloboves Prevodnik, published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

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 value N and % women (Ntot = 594) N and % CIN2+ (Ntot = 162) Risk for CIN2+ (%) N and % CIN3+ (Ntot = 114) Risk for CIN3+ (%)
RLU/CO < 0.4 253 (42.6) 8 (4.9) 3.2 2 (1.8) 0.8
0.4 ≤ RLU/CO < 0.7 18 (3.0) 1 (0.6) 5.6 1 (0.9) 5.6
0.7 ≤ RLU/CO < 1.0 12 (2.0) 1 (0.6) 8.3 1 (0.9) 8.3
1.0 ≤ RLU/CO ≤ 2.0 15 (2.5) 1 (0.6) 6.7 1 (0.9) 6.7
2.0 < RLU/CO ≤ 2.5 8 (1.3) 3 (1.9) 37.5 2 (1.8) 25.0
2.5 < RLU/CO ≤ 4.0 11 (1.9) 3 (1.9) 27.3 2 (1.8) 18.2
4.0 < RLU/CO ≤ 10.0 26 (4.4) 7 (4.3) 26.9 6 (5.3) 23.1
10.0 < RLU/CO ≤ 100 112 (18.9) 48 (29.6) 42.9 33 (28.9) 29.5
100 < RLU/CO ≤ 1000 105 (17.7) 68 (42.0) 64.8 53 (46.5) 50.5
1000 < RLU/CO 34 (5.7) 22 (13.6) 64.7 13 (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 I N and % women (Ntot = 594)
< 1.0 283 (47.6)
1.0–2.5 23 (3.9)
> 2.5 288 (48.5)
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Medicine, Clinical Medicine, Internal Medicine, Haematology, Oncology, Radiology
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