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  1. Article: The Use of CA-125 KELIM to Identify Which Patients Can Achieve Complete Cytoreduction after Neoadjuvant Chemotherapy in High-Grade Serous Advanced Ovarian Cancer.

    Zouzoulas, Dimitrios / Tsolakidis, Dimitrios / Tzitzis, Panagiotis / Sofianou, Iliana / Chatzistamatiou, Kimon / Theodoulidis, Vasilis / Topalidou, Maria / Timotheadou, Eleni / Grimbizis, Grigoris

    Cancers

    2024  Volume 16, Issue 7

    Abstract: 1) Background: Neoadjuvant chemotherapy followed by interval debulking surgery is used in the treatment of advanced ovarian cancer. However, no tool can safely predict if complete cytoreduction after 3-4 cycles can be achieved. This study aims to ... ...

    Abstract (1) Background: Neoadjuvant chemotherapy followed by interval debulking surgery is used in the treatment of advanced ovarian cancer. However, no tool can safely predict if complete cytoreduction after 3-4 cycles can be achieved. This study aims to investigate if the KELIM score can be a triage tool in the identification of patients that will be ideal candidates for interval debulking surgery (IDS). (2) Methods: We retrospectively analyzed the records of patients with high-grade serous advanced ovarian cancer that were treated in the 1st Department of Obstetrics-Gynecology, 2012-2022, with neoadjuvant chemotherapy followed by IDS. Patient characteristics, oncological outcome and follow-up information were collected. The primary outcome was the association of the KELIM score with residual disease. (3) Results: 83 patients were categorized into two groups: Group A (51 patients) with favorable (≥1) and Group B (32 patients) with unfavorable (<1) KELIM scores. A statistically significant correlation between KELIM and residual disease (
    Language English
    Publishing date 2024-03-24
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2527080-1
    ISSN 2072-6694
    ISSN 2072-6694
    DOI 10.3390/cancers16071266
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: High risk HPV-positive women cervicovaginal microbial profiles in a Greek cohort: a retrospective analysis of the GRECOSELF study.

    Sofou, Electra / Gkoliou, Glykeria / Pechlivanis, Nikolaos / Pasentsis, Konstantinos / Chatzistamatiou, Kimon / Psomopoulos, Fotis / Agorastos, Theodoros / Stamatopoulos, Kostas

    Frontiers in microbiology

    2023  Volume 14, Page(s) 1292230

    Abstract: Increasing evidence supports a role for the vaginal microbiome (VM) in the severity of HPV infection and its potential link to cervical intraepithelial neoplasia. However, a lot remains unclear regarding the precise role of certain bacteria in the ... ...

    Abstract Increasing evidence supports a role for the vaginal microbiome (VM) in the severity of HPV infection and its potential link to cervical intraepithelial neoplasia. However, a lot remains unclear regarding the precise role of certain bacteria in the context of HPV positivity and persistence of infection. Here, using next generation sequencing (NGS), we comprehensively profiled the VM in a series of 877 women who tested positive for at least one high risk HPV (hrHPV) type with the COBAS
    Language English
    Publishing date 2023-11-30
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2587354-4
    ISSN 1664-302X
    ISSN 1664-302X
    DOI 10.3389/fmicb.2023.1292230
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Economic evaluation of HPV DNA test as primary screening method for cervical cancer: A health policy discussion in Greece.

    Skroumpelos, Anastasios / Agorastos, Theodoros / Constantinidis, Theodoros / Chatzistamatiou, Kimon / Kyriopoulos, John

    PloS one

    2019  Volume 14, Issue 12, Page(s) e0226335

    Abstract: Background: HPV test appears to be more effective in cervical cancer (CC) screening. However, the decision of its adoption as a primary screening method by substituting the established cytology lies in the evaluation of multiple criteria. Aim of this ... ...

    Abstract Background: HPV test appears to be more effective in cervical cancer (CC) screening. However, the decision of its adoption as a primary screening method by substituting the established cytology lies in the evaluation of multiple criteria. Aim of this study is to evaluate the economic and clinical impact of HPV test as primary screening method for CC.
    Methods: A decision tree and a Markov model were developed to simulate the screening algorithm and the natural history of CC. Fourteen different screening strategies were evaluated, for women 25-65 years old. Clinical inputs were drawn from the HERMES study and cost inputs from the official price lists. In the absence of CC treatment cost data, the respective Spanish costs were used after being converted to 2017 Greek values. One-way and probabilistic sensitivity analyses were conducted.
    Results: All screening strategies, that offer as primary screening method triennial HPV genotyping (simultaneous or reflex) alone or as co-testing with cytology appear to be more effective than all other strategies, with regards to both annual CC mortality, due to missed disease (-10.1), and CC incidence(-7.5) versus annual cytology (current practice). Of those, the strategy with HPV test with simultaneous 16/18 genotyping is the strategy that provides savings of 1.050 million euros annually. However, when the above strategy is offered quinquennially despite the fact that outcomes are decreased it remains more effective than current practice (-7.7 deaths and -1.3 incidence) and more savings per death averted (1.323 million) or incidence reduced (7.837 million) are realized.
    Conclusions: HPV 16/18 genotyping as a primary screening method for CC appears to be one of the most effective strategies and dominates current practice in respect to both cost and outcomes. Even when compared with all other strategies, the outcomes that it generates justify the cost that it requires, representing a good value for money alternative.
    MeSH term(s) Adult ; Aged ; Cervical Intraepithelial Neoplasia/diagnosis ; Cervical Intraepithelial Neoplasia/economics ; Cervical Intraepithelial Neoplasia/epidemiology ; Cervical Intraepithelial Neoplasia/virology ; Cost-Benefit Analysis ; Early Detection of Cancer/economics ; Female ; Greece/epidemiology ; Health Care Costs ; Health Policy ; Human Papillomavirus DNA Tests/economics ; Human Papillomavirus DNA Tests/methods ; Humans ; Incidence ; Middle Aged ; Papillomaviridae/classification ; Papillomaviridae/genetics ; Papillomavirus Infections/complications ; Papillomavirus Infections/virology ; Uterine Cervical Neoplasms/diagnosis ; Uterine Cervical Neoplasms/economics ; Uterine Cervical Neoplasms/epidemiology ; Uterine Cervical Neoplasms/virology
    Language English
    Publishing date 2019-12-12
    Publishing country United States
    Document type Journal Article
    ISSN 1932-6203
    ISSN (online) 1932-6203
    DOI 10.1371/journal.pone.0226335
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Is there a role for single-port laparoscopy in the treatment of endometriosis?

    Daniilidis, Angelos / Chatzistamatiou, Kimon / Assimakopoulos, Efstratios

    Minerva ginecologica

    2017  Volume 69, Issue 5, Page(s) 488–503

    Abstract: Endometriosis is among the most common benign gynecological conditions, and it affects 6-15% of women of reproductive. During recent decades, minimally invasive surgical techniques, and especially laparoscopy, have gained significant ground concerning ... ...

    Abstract Endometriosis is among the most common benign gynecological conditions, and it affects 6-15% of women of reproductive. During recent decades, minimally invasive surgical techniques, and especially laparoscopy, have gained significant ground concerning the treatment of gynecological disorders. To date, laparoscopy is considered the gold standard for the diagnosis and treatment of endometriosis. Available English-language papers in PubMed and Scopus databases have been used for the current narrative review. Data from all relevant literature regarding single-port laparoscopy and treatment of endometriosis have been extracted. The main key words used by the authors for the search were: single-port laparoscopy, endometriosis and laparoscopy. Two authors (A.D. and K.C.) performed the data base search and extraction of relevant studies, and a third author (E.A.) consented to the study selection of the 23 relevant papers, consulted and approved the final presentation of the results and conclusions. To date, the laparo-endoscopic single-site surgery (LESS) technique has been used for a variety of procedures in gynecology as well as for a variety of diagnoses. Thus, adhesiolysis, ovarian endometrioma enucleation and salpingo-oophorectomy can be easily performed using the LESS approach. Novel single-site trocars as well as appropriate curved instruments are being designed and produced to facilitate the surgeon utilizing such a demanding technique. However, single-site surgery does not seem to have a place to date in the treatment of deep infiltrating endometriosis due to the complicated surgical maneuvers required for the treatment of this condition combined with technical difficulties posed by the loss of triangulation, and the instrument crowding when LESS is implemented. Apart from being feasible, LESS has also proven to be non-inferior in terms of surgical safety and efficacy, and according to most, but not all, reports, better in terms of cosmetics and postoperative body image perception. Currently, it has been shown that most of the gynecologic operations are feasible using the LESS approach. So, this approach has a role to play in the treatment of endometriosis too, especially concerning the most common manifestations of the disease. However, more extensive research is required to properly evaluate single-port access techniques to conventional minimally invasive ones in the treatment of the different manifestations of endometriosis, concerning short term as well as long term outcomes of the treatment, including the ones associated to fertility.
    Language English
    Publishing date 2017-10
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 80159-8
    ISSN 1827-1650 ; 0026-4784 ; 0325-8793
    ISSN (online) 1827-1650
    ISSN 0026-4784 ; 0325-8793
    DOI 10.23736/S0026-4784.17.04036-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Comparison of different strategies for the triage to colposcopy of women tested high-risk HPV positive on self-collected cervicovaginal samples.

    Chatzistamatiou, Kimon / Tsertanidou, Athena / Moysiadis, Theodoros / Mouchtaropoulou, Evangelia / Pasentsis, Konstantinos / Skenderi, Alkmini / Stamatopoulos, Kostas / Agorastos, Theodoros

    Gynecologic oncology

    2021  Volume 162, Issue 3, Page(s) 560–568

    Abstract: Objective: To identify the optimal strategy for the triage of women who test high-risk (hr) HPV positive on self-collected cervicovaginal samples.: Methods: This is a diagnostic accuracy sub-analysis of the GRECOSELF study, which reported on HPV-DNA ... ...

    Abstract Objective: To identify the optimal strategy for the triage of women who test high-risk (hr) HPV positive on self-collected cervicovaginal samples.
    Methods: This is a diagnostic accuracy sub-analysis of the GRECOSELF study, which reported on HPV-DNA testing with self-sampling in Greece. More than 13,000 women, 25-60 years old, who resided in rural areas of Greece, provided a self-collected cervicovaginal sample. Samples were tested for HPV-DNA and HPV16/18 genotyping with the cobas® HPV test (Roche® Molecular Systems, Pleasanton, CA, USA). HrHPV positive women were referred for colposcopy. Prior to colposcopy a physician-collected sample was obtained for cytology. After colposcopy/biopsy, women were classified as having cervical disease or not, and treated accordingly.
    Results: Out of 1070 hrHPV positive women, 773 were subjected to colposcopy. Seventeen triage strategies, combining HPV16/18 genotyping and cytology, were investigated. The strategy referring to colposcopy women positive for HPV16 regardless of the cytology report, and women positive for other hrHPVs, in case of a subsequent atypical squamous cells of undetermined significance or worse (ASCUS+) cytology report, presented optimal trade-off; sensitivity 96.36% [(95%CI: (91.41-100.0)], positive predictive value (PPV) 27.46% [95%CI: (21.16-33.76)], and number of colposcopies required to detect one case of Cervical Intraepithelial Neoplasia grade-2 or worse (CIN2+) 3.64.
    Conclusions: The optimal strategy for the triage to colposcopy of hrHPV positive women, detected with the cobas® HPV test on self-collected cervicovaginal samples, is referring all HPV16 positive women directly to colposcopy, and women positive for HPV18 or other hrHPVs only after an ASCUS or worse cytology report.
    MeSH term(s) Adult ; Alphapapillomavirus/genetics ; Alphapapillomavirus/isolation & purification ; Atypical Squamous Cells of the Cervix/pathology ; Atypical Squamous Cells of the Cervix/virology ; Cervical Intraepithelial Neoplasia/diagnosis ; Cervical Intraepithelial Neoplasia/pathology ; Cervical Intraepithelial Neoplasia/virology ; Cervix Uteri/pathology ; Cervix Uteri/virology ; Colposcopy/methods ; Female ; Greece/epidemiology ; Human papillomavirus 16/genetics ; Human papillomavirus 16/isolation & purification ; Human papillomavirus 18/genetics ; Human papillomavirus 18/isolation & purification ; Humans ; Middle Aged ; Papillomavirus Infections/diagnosis ; Papillomavirus Infections/epidemiology ; Papillomavirus Infections/virology ; ROC Curve ; Self Care/methods ; Specimen Handling/methods ; Triage/methods ; Uterine Cervical Neoplasms/diagnosis ; Uterine Cervical Neoplasms/pathology ; Uterine Cervical Neoplasms/virology ; Vaginal Smears/methods
    Language English
    Publishing date 2021-06-29
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 801461-9
    ISSN 1095-6859 ; 0090-8258
    ISSN (online) 1095-6859
    ISSN 0090-8258
    DOI 10.1016/j.ygyno.2021.06.020
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: CIN2+ detection of the HPV DNA Array genotyping assay in comparison with the Cobas 4800 HPV test and cytology

    Pesic, Aleksandra / Krings, Amrei / Hempel, Matthias / Preyer, Rosemarie / Chatzistamatiou, Kimon / Agorastos, Theodoros / Kaufmann, Andreas M

    Virology journal. 2019 Dec., v. 16, no. 1

    2019  

    Abstract: BACKGROUND: HPV DNA Array is an E1-targeting PCR genotyping test, with capability of distinguishing 18 high-risk (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82) and 11 low-risk HPV types (6, 11, 40, 42, 44, 54, 67, 69, 70, 85, 97) ...

    Abstract BACKGROUND: HPV DNA Array is an E1-targeting PCR genotyping test, with capability of distinguishing 18 high-risk (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82) and 11 low-risk HPV types (6, 11, 40, 42, 44, 54, 67, 69, 70, 85, 97). HPV DNA Array uses multiplex PCR for E1-gene sequence amplification. The amplicons are detected and genotyped by reverse hybridization to immobilized DNA probes spotted as triplets in single 96 well-plate wells and read by AID ELISPOT reader. METHODS: Aim of the study was to evaluate the clinical performance of the assay against internationally accepted and FDA approved Cobas 4800 HPV test (Roche Diagnostics). Study population comprised of 500 cervical samples. RESULTS: HPV DNA Array demonstrated a very high sensitivity of 100% for CIN2+ and 100% for CIN3+ detection, same as Cobas 4800. HPV DNA Array showed greater sensitivity for CIN2+ detection than cytology (100% vs. 13.6%). The agreement to Cobas 4800 for HPV detection, irrespective of type, was 81.4% with κ = 0.613. The agreement for HPV 16 was 92.8% (κ = 0.929), and for HPV 18 54.2% (κ = 0.681). CONCLUSION: HPV DNA Array demonstrated good clinical performance for detection of high-grade lesions, and may be considered for usage in a screening setting.
    Keywords DNA ; DNA probes ; cell biology ; diagnostic techniques ; genotyping ; nucleic acid hybridization ; polymerase chain reaction ; screening
    Language English
    Dates of publication 2019-12
    Size p. 92.
    Publishing place BioMed Central
    Document type Article
    ISSN 1743-422X
    DOI 10.1186/s12985-019-1197-6
    Database NAL-Catalogue (AGRICOLA)

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  7. Article ; Online: Low recurrence rate of high-grade cervical intraepithelial neoplasia after successful excision and routine colposcopy during follow-up.

    Lili, Eleftheria / Chatzistamatiou, Kimon / Kalpaktsidou-Vakiani, Andromachi / Moysiadis, Theodoros / Agorastos, Theodoros

    Medicine

    2018  Volume 97, Issue 4, Page(s) e9719

    Abstract: The aim of the present cohort study was to assess the long-term (follow-up period up to 22 years) recurrence rate of preinvasive disease and the newly detected invasive disease rate in a cohort of women treated with excisional methods for high-grade ... ...

    Abstract The aim of the present cohort study was to assess the long-term (follow-up period up to 22 years) recurrence rate of preinvasive disease and the newly detected invasive disease rate in a cohort of women treated with excisional methods for high-grade cervical intraepithelial neoplasia (CIN).Women treated with large loop excision of the transformation zone (LLETZ) and cold knife conization (CKC) for histologically proven high-grade CIN were followed up for up to 22 years. Surgical specimens underwent histological examination and the status of endocervical as well as ectocervical margins was recorded. Follow-up protocol included conventional Pap test, colposcopy and pelvic examination at 3, 6, and 12 months after the initial treatment, and every 12 months thereafter, provided that the results were normal. In case of high-grade cytological findings and/or atypical colposcopic impression, multiple punch biopsies were taken in order to verify or exclude recurrent disease.In total, 804 women were followed for a mean time of 77.1 months (range: 6-266). LLETZ was used in 569 (70.7%) and CKC in 235 cases (29.2%). No woman developed invasive cervical cancer. Recurrent high-grade disease, developed in 9 women (1.1%, 95% confidence interval 0.5-2.2). Median treatment-to-recurrence time was 46.5 months (range: 6-235.3). One woman treated for squamous CIN2 on clear margins developed adenocarcinoma in situ 59.2 months post-treatment.Women having undergone excisional treatment for high-grade CIN indicate a very low risk for recurrent disease and potentially negligible risk for invasive cancer, provided that a strict and vigorous follow-up is offered after treatment.
    MeSH term(s) Adult ; Cervix Uteri/pathology ; Cervix Uteri/surgery ; Colposcopy/methods ; Female ; Follow-Up Studies ; Humans ; Middle Aged ; Neoplasm Grading ; Neoplasm Recurrence, Local/epidemiology ; Neoplasm Recurrence, Local/pathology ; Retrospective Studies ; Treatment Outcome ; Uterine Cervical Neoplasms/pathology ; Uterine Cervical Neoplasms/surgery ; Young Adult ; Uterine Cervical Dysplasia/pathology ; Uterine Cervical Dysplasia/surgery
    Language English
    Publishing date 2018-01-24
    Publishing country United States
    Document type Journal Article
    ZDB-ID 80184-7
    ISSN 1536-5964 ; 0025-7974
    ISSN (online) 1536-5964
    ISSN 0025-7974
    DOI 10.1097/MD.0000000000009719
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Comparison of cytology, HPV DNA testing and HPV 16/18 genotyping alone or combined targeting to the more balanced methodology for cervical cancer screening.

    Chatzistamatiou, Kimon / Moysiadis, Theodoros / Moschaki, Viktoria / Panteleris, Nikolaos / Agorastos, Theodoros

    Gynecologic oncology

    2016  Volume 142, Issue 1, Page(s) 120–127

    Abstract: Objectives: The objective of the present study was to identify the most effective cervical cancer screening algorithm incorporating different combinations of cytology, HPV testing and genotyping.: Methods: Women 25-55years old recruited for the " ... ...

    Abstract Objectives: The objective of the present study was to identify the most effective cervical cancer screening algorithm incorporating different combinations of cytology, HPV testing and genotyping.
    Methods: Women 25-55years old recruited for the "HERMES" (HEllenic Real life Multicentric cErvical Screening) study were screened in terms of cytology and high-risk (hr) HPV testing with HPV 16/18 genotyping. Women positive for cytology or/and hrHPV were referred for colposcopy, biopsy and treatment. Ten screening algorithms based on different combinations of cytology, HPV testing and HPV 16/18 genotyping were investigated in terms of diagnostic accuracy.
    Results: Three clusters of algorithms were formed according to the balance between effectiveness and harm caused by screening. The cluster showing the best balance included two algorithms based on co-testing and two based on HPV primary screening with HPV 16/18 genotyping. Among these, hrHPV testing with HPV 16/18 genotyping and reflex cytology (atypical squamous cells of undetermined significance - ASCUS threshold) presented the optimal combination of sensitivity (82.9%) and specificity relative to cytology alone (0.99) with 1.26 false positive rate relative to cytology alone.
    Conclusion: HPV testing with HPV 16/18 genotyping, referring HPV 16/18 positive women directly to colposcopy, and hrHPV (non 16/18) positive women to reflex cytology (ASCUS threshold), as a triage method to colposcopy, reflects the best equilibrium between screening effectiveness and harm. Algorithms, based on cytology as initial screening method, on co-testing or HPV primary without genotyping, and on HPV primary with genotyping but without cytology triage, are not supported according to the present analysis.
    MeSH term(s) Algorithms ; Cervical Intraepithelial Neoplasia/diagnosis ; Cervical Intraepithelial Neoplasia/pathology ; Cervical Intraepithelial Neoplasia/virology ; DNA, Viral/analysis ; DNA, Viral/genetics ; Datasets as Topic ; Female ; Genotype ; Human papillomavirus 16/genetics ; Human papillomavirus 16/isolation & purification ; Human papillomavirus 18/genetics ; Human papillomavirus 18/isolation & purification ; Humans ; Middle Aged ; Papillomavirus Infections/diagnosis ; Papillomavirus Infections/pathology ; Papillomavirus Infections/virology ; Uterine Cervical Neoplasms/diagnosis ; Uterine Cervical Neoplasms/pathology ; Uterine Cervical Neoplasms/virology
    Chemical Substances DNA, Viral
    Language English
    Publishing date 2016
    Publishing country United States
    Document type Journal Article
    ZDB-ID 801461-9
    ISSN 1095-6859 ; 0090-8258
    ISSN (online) 1095-6859
    ISSN 0090-8258
    DOI 10.1016/j.ygyno.2016.04.027
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Letter to the editor referring to the manuscript entitled: "Increasing fear of adverse effects drops intention to vaccinate after the introduction of prophylactic HPV vaccine" reported by Sotiriadis et al. (Arch Gynecol Obstet. 2012 Jun;285(6):1719-24).

    Chatzistamatiou, Kimon / Sotiriadis, Alexandros / Agorastos, Theodoros

    Archives of gynecology and obstetrics

    2014  Volume 289, Issue 3, Page(s) 471–472

    MeSH term(s) Fear/psychology ; Female ; Humans ; Male ; Papillomavirus Infections/prevention & control ; Papillomavirus Vaccines/adverse effects ; Uterine Cervical Neoplasms/prevention & control ; Uterine Cervical Neoplasms/virology ; Vaccination/psychology
    Chemical Substances Papillomavirus Vaccines
    Language English
    Publishing date 2014-03
    Publishing country Germany
    Document type Comment ; Letter
    ZDB-ID 896455-5
    ISSN 1432-0711 ; 0932-0067
    ISSN (online) 1432-0711
    ISSN 0932-0067
    DOI 10.1007/s00404-013-3010-x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: CIN2+ detection of the HPV DNA Array genotyping assay in comparison with the Cobas 4800 HPV test and cytology.

    Pesic, Aleksandra / Krings, Amrei / Hempel, Matthias / Preyer, Rosemarie / Chatzistamatiou, Kimon / Agorastos, Theodoros / Kaufmann, Andreas M

    Virology journal

    2019  Volume 16, Issue 1, Page(s) 92

    Abstract: Background: HPV DNA Array is an E1-targeting PCR genotyping test, with capability of distinguishing 18 high-risk (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82) and 11 low-risk HPV types (6, 11, 40, 42, 44, 54, 67, 69, 70, 85, ... ...

    Abstract Background: HPV DNA Array is an E1-targeting PCR genotyping test, with capability of distinguishing 18 high-risk (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82) and 11 low-risk HPV types (6, 11, 40, 42, 44, 54, 67, 69, 70, 85, 97). HPV DNA Array uses multiplex PCR for E1-gene sequence amplification. The amplicons are detected and genotyped by reverse hybridization to immobilized DNA probes spotted as triplets in single 96 well-plate wells and read by AID ELISPOT reader.
    Methods: Aim of the study was to evaluate the clinical performance of the assay against internationally accepted and FDA approved Cobas 4800 HPV test (Roche Diagnostics). Study population comprised of 500 cervical samples.
    Results: HPV DNA Array demonstrated a very high sensitivity of 100% for CIN2+ and 100% for CIN3+ detection, same as Cobas 4800. HPV DNA Array showed greater sensitivity for CIN2+ detection than cytology (100% vs. 13.6%). The agreement to Cobas 4800 for HPV detection, irrespective of type, was 81.4% with κ = 0.613. The agreement for HPV 16 was 92.8% (κ = 0.929), and for HPV 18 54.2% (κ = 0.681).
    Conclusion: HPV DNA Array demonstrated good clinical performance for detection of high-grade lesions, and may be considered for usage in a screening setting.
    MeSH term(s) Adult ; Aged ; Cervical Intraepithelial Neoplasia/diagnosis ; Cervical Intraepithelial Neoplasia/virology ; Cervix Uteri/pathology ; Cervix Uteri/virology ; Cytological Techniques ; DNA, Viral/genetics ; Early Detection of Cancer ; Female ; Genotype ; Genotyping Techniques/methods ; Human papillomavirus 16/genetics ; Human papillomavirus 18/genetics ; Humans ; Middle Aged ; Oligonucleotide Array Sequence Analysis ; Papillomaviridae/genetics ; Papillomavirus Infections/diagnosis ; Papillomavirus Infections/virology ; Reagent Kits, Diagnostic ; Sensitivity and Specificity ; Uterine Cervical Neoplasms/diagnosis ; Uterine Cervical Neoplasms/virology ; Vaginal Smears ; Young Adult
    Chemical Substances DNA, Viral ; Reagent Kits, Diagnostic
    Language English
    Publishing date 2019-07-23
    Publishing country England
    Document type Evaluation Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 1743-422X
    ISSN (online) 1743-422X
    DOI 10.1186/s12985-019-1197-6
    Database MEDical Literature Analysis and Retrieval System OnLINE

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