CIN2+ detection of the HPV DNA Array genotyping assay in comparison with the Cobas 4800 HPV test and cytology
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RESEARCH
Open Access
CIN2+ detection of the HPV DNA Array genotyping assay in comparison with the Cobas 4800 HPV test and cytology Aleksandra Pesic1, Amrei Krings1, Matthias Hempel2, Rosemarie Preyer2, Kimon Chatzistamatiou3, Theodoros Agorastos4 and Andreas M. Kaufmann1*
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: Cervical Cancer, HPV assay, HPV detection, Human papillomavirus, Validation
Background Cervical cancer, caused by persistent HPV infection [1], is an easily preventable disease. With the introduction of mass cervical cancer screening, a significant 75% decline in cancer incidence has been observed in developed countries, achieved through regular cytological screening [2, 3]. However, cytology is a method hard to implement in developing countries and has a variable sensitivity for disease detection (44–78%) [4]. The recent advancement of detection methods, and the causal link between HPV and cervical cancer, has led to a change in paradigm. HPV testing advanced from usage as a triaging method to a method for primary cervical cancer screening, * Correspondence: [email protected] 1 Gynaecology Clinic, Charité Universitätsmedizin, Corporate member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Hindenburgdamm 30, 12200 Berlin, Germany Full list of author information is available at the end of the article
approved by WHO [5] and FDA. In 2014, the Cobas 4800 HPV test (Roche Diagnostics) was approved by FDA for primary cervical cancer screening in the USA [6]. The following year, the American Society for Colposcopy and Cervical Pathology included the HPV genotyping tests as primary tests (without cytology) for cervical cancer screening in its guidelines [7]. There is evidence that HPV-based screening is more sensitive in detec
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