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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Bibliographic Details
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
Description
Summary: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.
ISSN:1581-3207