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Two Years of Cytology and HPV Co-Testing in Germany: Initial Experience
Introduction On 1 January 2020 the screening programme for the prevention of cervical cancer in women from the age of 35 years of the Statutory Health Insurance (GKV) in Germany changed from an annual cytology examination to cytological and HPV co-testing carried out every three years. A large stand...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Georg Thieme Verlag KG
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9713299/ https://www.ncbi.nlm.nih.gov/pubmed/36467972 http://dx.doi.org/10.1055/a-1886-3311 |
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author | Xhaja, Arjola Ahr, André Zeiser, Ilona Ikenberg, Hans |
author_facet | Xhaja, Arjola Ahr, André Zeiser, Ilona Ikenberg, Hans |
author_sort | Xhaja, Arjola |
collection | PubMed |
description | Introduction On 1 January 2020 the screening programme for the prevention of cervical cancer in women from the age of 35 years of the Statutory Health Insurance (GKV) in Germany changed from an annual cytology examination to cytological and HPV co-testing carried out every three years. A large standard diagnostics laboratory has been using liquid-based cytology (LBC) with computer-assisted screening (CAS) since 1 January 2020 to assess the samples. Patients and Methods The cytological and HPV results for all cases examined with co-testing from 01.01.2020 to 31.12.2021 (n = 395759) are reported and the cytology results obtained using co-testing are compared with the results obtained using only conventional primary cytology screening from the two previous years (n = 588192). Cytology tests were carried out using LBC and computer-assisted screening. A DNA PCR test which can identify 14 types of HPV was used for HPV testing. The cytology results are reported using the Munich Nomenclature III, which is mandatory in Germany, and converted to The Bethesda System (TBS). Problems occurring during the implementation phase are described here. Results A total of 983951 cases who had primary screening between 01.01.2018 and 31.12.2021 were analysed. The HR HPV-positive rate with co-testing for all age groups was 6.41%. Of this group, 16.31% were positive for HPV-16, 4.43% for HPV-18, and 71.40% had one or more of the other 12 HR HPV types. Several different HPV types were identified in 7.86% of cases. The HPV-positive rate for cases with unremarkable cytological findings was 4.03%. 0.46% of tests were technically invalid. The results of primary cytology screening for 2020/21 (LBC) were: Pap 0 (TBS: unsatisfactory) 0.09%, Pap I and Pap II-a (NILM) 96.82%, Pap II-p/g (~ASC-US/AGC) 1.23%, Pap III-p/g (~ASC-H/AGC) 0.19%, Pap III D1 (LSIL) 1.08%, Pap III D2 (HSIL) 0.31%, Pap IVa/b-p/g (HSIL/AIS) 0.18%, and Pap V-p/g (carcinoma) 0.01%. The rates for 2018/19 (conventional cytology without routine testing for HPV) were significantly higher for Pap II-p/g (1.64%) and significantly lower for Pap III-p/g (0.13%), Pap III D1 (0.45%), Pap III D2 (0.10%) and Pap IVa/b-p/g (0.05%). Conclusion Evaluation of the data for the two first years of cytology and HPV co-testing from a standard diagnostics laboratory found low HR HPV-positive rates. As regards the cytology tests, the Pap II-p/g rate was significantly lower and the ≥ Pap III rate was significantly higher compared to the two previous years. This points to a probable higher sensitivity and specificity of the new method. |
format | Online Article Text |
id | pubmed-9713299 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Georg Thieme Verlag KG |
record_format | MEDLINE/PubMed |
spelling | pubmed-97132992022-12-02 Two Years of Cytology and HPV Co-Testing in Germany: Initial Experience Xhaja, Arjola Ahr, André Zeiser, Ilona Ikenberg, Hans Geburtshilfe Frauenheilkd Introduction On 1 January 2020 the screening programme for the prevention of cervical cancer in women from the age of 35 years of the Statutory Health Insurance (GKV) in Germany changed from an annual cytology examination to cytological and HPV co-testing carried out every three years. A large standard diagnostics laboratory has been using liquid-based cytology (LBC) with computer-assisted screening (CAS) since 1 January 2020 to assess the samples. Patients and Methods The cytological and HPV results for all cases examined with co-testing from 01.01.2020 to 31.12.2021 (n = 395759) are reported and the cytology results obtained using co-testing are compared with the results obtained using only conventional primary cytology screening from the two previous years (n = 588192). Cytology tests were carried out using LBC and computer-assisted screening. A DNA PCR test which can identify 14 types of HPV was used for HPV testing. The cytology results are reported using the Munich Nomenclature III, which is mandatory in Germany, and converted to The Bethesda System (TBS). Problems occurring during the implementation phase are described here. Results A total of 983951 cases who had primary screening between 01.01.2018 and 31.12.2021 were analysed. The HR HPV-positive rate with co-testing for all age groups was 6.41%. Of this group, 16.31% were positive for HPV-16, 4.43% for HPV-18, and 71.40% had one or more of the other 12 HR HPV types. Several different HPV types were identified in 7.86% of cases. The HPV-positive rate for cases with unremarkable cytological findings was 4.03%. 0.46% of tests were technically invalid. The results of primary cytology screening for 2020/21 (LBC) were: Pap 0 (TBS: unsatisfactory) 0.09%, Pap I and Pap II-a (NILM) 96.82%, Pap II-p/g (~ASC-US/AGC) 1.23%, Pap III-p/g (~ASC-H/AGC) 0.19%, Pap III D1 (LSIL) 1.08%, Pap III D2 (HSIL) 0.31%, Pap IVa/b-p/g (HSIL/AIS) 0.18%, and Pap V-p/g (carcinoma) 0.01%. The rates for 2018/19 (conventional cytology without routine testing for HPV) were significantly higher for Pap II-p/g (1.64%) and significantly lower for Pap III-p/g (0.13%), Pap III D1 (0.45%), Pap III D2 (0.10%) and Pap IVa/b-p/g (0.05%). Conclusion Evaluation of the data for the two first years of cytology and HPV co-testing from a standard diagnostics laboratory found low HR HPV-positive rates. As regards the cytology tests, the Pap II-p/g rate was significantly lower and the ≥ Pap III rate was significantly higher compared to the two previous years. This points to a probable higher sensitivity and specificity of the new method. Georg Thieme Verlag KG 2022-08-16 /pmc/articles/PMC9713299/ /pubmed/36467972 http://dx.doi.org/10.1055/a-1886-3311 Text en The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/). https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited. |
spellingShingle | Xhaja, Arjola Ahr, André Zeiser, Ilona Ikenberg, Hans Two Years of Cytology and HPV Co-Testing in Germany: Initial Experience |
title | Two Years of Cytology and HPV Co-Testing in Germany: Initial Experience |
title_full | Two Years of Cytology and HPV Co-Testing in Germany: Initial Experience |
title_fullStr | Two Years of Cytology and HPV Co-Testing in Germany: Initial Experience |
title_full_unstemmed | Two Years of Cytology and HPV Co-Testing in Germany: Initial Experience |
title_short | Two Years of Cytology and HPV Co-Testing in Germany: Initial Experience |
title_sort | two years of cytology and hpv co-testing in germany: initial experience |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9713299/ https://www.ncbi.nlm.nih.gov/pubmed/36467972 http://dx.doi.org/10.1055/a-1886-3311 |
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