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

The Hybrid Capture 2 (HC2) High-Risk HPV DNA assay serves as a triage test in the Slovenian national cervical cancer screening programme ZORA. To improve the limited analytical accuracy of HC2 test results near the cut-off value (1.0 relative light units/cut-off (RLU/CO)), we follow an internal prot...

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Main Authors: Varl Jerneja, Ivanus Urska, Marinsek Ziva Pohar, Jerman Tine, Valencak Anja Ostrbenk, Poljak Mario, Prevodnik Veronika Kloboves
Format: Article
Language:English
Published: Sciendo 2019-09-01
Series:Radiology and Oncology
Subjects:
Online Access:https://doi.org/10.2478/raon-2019-0044
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spelling doaj-d43bb42382974580a06f5a2d7209c35a2021-09-05T14:01:19ZengSciendoRadiology and Oncology1581-32072019-09-0153331632210.2478/raon-2019-0044raon-2019-0044Clinical relevance of the borderline results of the Hybrid Capture 2 High-Risk HPV DNA assay with cervical samples collected in Specimen Transport MediumVarl Jerneja0Ivanus Urska1Marinsek Ziva Pohar2Jerman Tine3Valencak Anja Ostrbenk4Poljak Mario5Prevodnik Veronika Kloboves6Department of Experimental Oncology, Institute of Oncology Ljubljana, Ljubljana, SloveniaZORA National Cervical Cancer Screening Programme, Epidemiology and Cancer Registry, Institute of Oncology Ljubljana, Ljubljana, SloveniaDepartment of Cytopathology, Institute of Oncology Ljubljana, Ljubljana, SloveniaZORA National Cervical Cancer Screening Programme, Epidemiology and Cancer Registry, Institute of Oncology Ljubljana, Ljubljana, SloveniaInstitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, SloveniaInstitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, SloveniaDepartment of Cytopathology, Institute of Oncology Ljubljana, Ljubljana, SloveniaThe Hybrid Capture 2 (HC2) High-Risk HPV DNA assay serves as a triage test in the Slovenian national cervical cancer screening programme ZORA. To improve the limited analytical accuracy of HC2 test results near the cut-off value (1.0 relative light units/cut-off (RLU/CO)), we follow an internal protocol of repeating the test on all samples with borderline results within the 0.7-2.0 RLU/CO interval. The aim of the study was (i) to determine the clinical relevance of HC2 test results within three different “grey zones” for samples stored in Specimen Transport Medium (STM) and (ii) to determine whether the current algorithm of retesting “grey zone” STM specimens with the HC2 assay is clinically relevant.https://doi.org/10.2478/raon-2019-0044hybrid capture 2hpv testborderline resultsgrey zonespecimen transport medium
collection DOAJ
language English
format Article
sources DOAJ
author Varl Jerneja
Ivanus Urska
Marinsek Ziva Pohar
Jerman Tine
Valencak Anja Ostrbenk
Poljak Mario
Prevodnik Veronika Kloboves
spellingShingle Varl Jerneja
Ivanus Urska
Marinsek Ziva Pohar
Jerman Tine
Valencak Anja Ostrbenk
Poljak Mario
Prevodnik Veronika Kloboves
Clinical relevance of the borderline results of the Hybrid Capture 2 High-Risk HPV DNA assay with cervical samples collected in Specimen Transport Medium
Radiology and Oncology
hybrid capture 2
hpv test
borderline results
grey zone
specimen transport medium
author_facet Varl Jerneja
Ivanus Urska
Marinsek Ziva Pohar
Jerman Tine
Valencak Anja Ostrbenk
Poljak Mario
Prevodnik Veronika Kloboves
author_sort Varl Jerneja
title Clinical relevance of the borderline results of the Hybrid Capture 2 High-Risk HPV DNA assay with cervical samples collected in Specimen Transport Medium
title_short Clinical relevance of the borderline results of the Hybrid Capture 2 High-Risk HPV DNA assay with cervical samples collected in Specimen Transport Medium
title_full Clinical relevance of the borderline results of the Hybrid Capture 2 High-Risk HPV DNA assay with cervical samples collected in Specimen Transport Medium
title_fullStr Clinical relevance of the borderline results of the Hybrid Capture 2 High-Risk HPV DNA assay with cervical samples collected in Specimen Transport Medium
title_full_unstemmed Clinical relevance of the borderline results of the Hybrid Capture 2 High-Risk HPV DNA assay with cervical samples collected in Specimen Transport Medium
title_sort clinical relevance of the borderline results of the hybrid capture 2 high-risk hpv dna assay with cervical samples collected in specimen transport medium
publisher Sciendo
series Radiology and Oncology
issn 1581-3207
publishDate 2019-09-01
description The Hybrid Capture 2 (HC2) High-Risk HPV DNA assay serves as a triage test in the Slovenian national cervical cancer screening programme ZORA. To improve the limited analytical accuracy of HC2 test results near the cut-off value (1.0 relative light units/cut-off (RLU/CO)), we follow an internal protocol of repeating the test on all samples with borderline results within the 0.7-2.0 RLU/CO interval. The aim of the study was (i) to determine the clinical relevance of HC2 test results within three different “grey zones” for samples stored in Specimen Transport Medium (STM) and (ii) to determine whether the current algorithm of retesting “grey zone” STM specimens with the HC2 assay is clinically relevant.
topic hybrid capture 2
hpv test
borderline results
grey zone
specimen transport medium
url https://doi.org/10.2478/raon-2019-0044
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