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Comparative performance of cobas 4800 HPV Test and Anyplex II HPV HR for high-risk human papillomavirus detection

Title: Comparative performance of cobas 4800 HPV Test and Anyplex II HPV HR for high-risk human papillomavirus detection
Authors: Godoy, Luani R.; El-Zein, Mariam; Padalko, Elizaveta; Verberckmoes, Bo; Vermandere, Heleen; Van Eenooghe, Bodine; Dias, Sónia; Gama, Ana; Crespo, Bernardo Vega; Neira, Vivian Alejandra; Franco, Eduardo L.; Longatto-Filho, Adhemar; ELEVATE Study Group
Contributors: Escola Nacional de Saúde Pública (ENSP); Laboratório Associado de Translacção e Inovação para a Saúde Global - LA Real (Pólo ENSP); Comprehensive Health Research Centre (CHRC) - Pólo ENSP; Centro de Investigação em Saúde Pública (CISP/PHRC)
Publication Year: 2025
Collection: Repositório da Universidade Nova de Lisboa (UNL)
Subject Terms: Anyplex II HPV HR assay; cobas 4800 HPV test; human papillomavirus; performance; Microbiology (medical); SDG 3 - Good Health and Well-being
Description: Publisher Copyright: Copyright © 2025 Godoy et al. ; Numerous molecular tests are available to detect human papillomavirus (HPV). We compared the analytical performance of cobas and Anyplex for detection of high-risk (HR) carcinogenic HPV genotypes, assessed the composition of HPV types (other than 16 and 18) that influenced cobas performance, and considered the impact of viral load on test performance. We used data from the Early Detection of Cervical Cancer in Hard-to-Reach Populations of Women Through Portable and Point-of-Care HPV Testing project, which involved collection (2019–2022) of cervicovaginal samples from 1,042 women aged 21–74 years in Belgium (n = 244), Portugal (n = 309), Brazil (n = 244), and Ecuador (n = 245). Samples were tested by cobas (provides individual results for HPV16 and HPV18 and a pooled result for 12 other HR-HPV types) and Anyplex (provides separate results for 14 HR-HPVs). We calculated HPV positivity by each test and compared performance between tests by calculating Cohen’s kappa statistics. Based on 938 samples with complete data from both tests, positivity rates by cobas were 13.4%, 3.6%, 34.3%, and 45.3% for HPV16, HPV18, 12 pooled HR-HPVs, and any HR-HPV, respectively. Corresponding HPV positivity rates by Anyplex were 14.9%, 3.7%, 37.9%, and 50.0% for the same categories, respectively, with high concordance; kappa statistics were 0.90, 0.87, 0.82, and 0.85, respectively. Based on 355 samples that tested positive for at least 1 of the 12 pooled HR-HPVs, most types showed high agreement (80.9%–100.0%) between individual-Anyplex and pooled-cobas HPV results, except for HPV68 (61.3% agreement). Our findings suggest that the two commercial tests may have different performances, depending on the specific HPV types detected, emphasizing the need for continued research on conditions that may affect these tests, especially for less common or less studied HPV types. ; publishersversion ; published
Document Type: article in journal/newspaper
Language: English
Relation: PURE: 128141744; Scopus: 105013319170; PubMed: 40631887; WOS: 001524623400001; PubMedCentral: PMC12345211; https://hdl.handle.net/10362/187138
DOI: 10.1128/jcm.00200-25
Availability: https://hdl.handle.net/10362/187138; https://doi.org/10.1128/jcm.00200-25
Rights: openAccess
Accession Number: edsbas.DD41908E
Database: BASE