Cato Vercaeren, Davy Kieffer, Annelies Louwagie, An Nijs, Sigrun Delvaux, David Strybol, Tina Pirens, Stéphanie Petermans, Wim Maurissen, Sophie Steels
Department of Laboratory Medicine, Sint-Trudo Hospital, Sint-Truiden, Belgium.
Department of Pathology, Sint-Trudo Hospital, Sint-Truiden, Belgium.
Acta Clin Belg. 2025 Aug;80(4):91-99. doi: 10.1080/17843286.2025.2546421. Epub 2025 Aug 13.
OBJECTIVE: Cervical cancer, primarily caused by persistent infections with high-risk human papillomaviruses (hrHPV), remains a significant global health issue. Effective screening methods are essential for early detection and prevention. This study evaluates a novel 'heat protocol' (HP) for pre-treatment of cervical samples in SurePath medium in the detection of hrHPV using the Seegene Allplex HPV HR Assay on the fully automated Seegene STARlet platform. METHODS: 50 cervical samples from women aged 21-69 were collected between March 2024 and June 2025 during routine screening at Sint-Trudo Hospital. Samples were pre-treated using either the HP (95 °C for 55 minutes on the Seegene STARlet) or the validated LB method. All were tested using the Allplex HPV HR Assay. The Alinity m assay served as reference. Precision, accuracy, and method comparison were assessed using clinical and external quality control samples. Statistical analyses included kappa agreement, non-inferiority testing, and Bland-Altman analysis of Ct values. . RESULTS: Our findings demonstrate that the HP shows higher sensitivity (96%) than both the LB pre-treatment (93%) and the external reference method (Alinity m). The HP also identified additional HPV genotypes not detected by the other methods, suggesting improved detection of low viral loads. Ct values were on average lower with HP, which supports this increased sensitivity. A non-inferiority analysis confirmed that HP is not inferior to LB. CONCLUSION: The study confirms that the new HP offers excellent precision, accuracy, and sensitivity. While the LB pre-treatment remains a viable alternative, the HP's efficiency, reduced hands-on time and improved sensitivity make it the preferred method for our routine clinical practice.
目的:宫颈癌主要由高危型人乳头瘤病毒(hrHPV)持续感染引起,仍然是一个重大的全球健康问题。有效的筛查方法对于早期检测和预防至关重要。本研究评估了一种新型“加热方案”(HP),用于在SurePath培养基中对宫颈样本进行预处理,以便在全自动Seegene STARlet平台上使用Seegene Allplex HPV HR检测法检测hrHPV。 方法:2024年3月至2025年6月期间,在Sint-Trudo医院的常规筛查中收集了50份年龄在21 - 69岁之间女性的宫颈样本。样本分别使用HP(在Seegene STARlet上95°C处理55分钟)或经过验证的LB方法进行预处理。所有样本均使用Allplex HPV HR检测法进行检测。以Alinity m检测法作为参考。使用临床和外部质量控制样本评估精密度、准确性和方法比较。统计分析包括kappa一致性分析、非劣效性检验以及Ct值的Bland-Altman分析。 结果:我们的研究结果表明,HP的灵敏度(96%)高于LB预处理方法(93%)和外部参考方法(Alinity m)。HP还检测出了其他方法未检测到的额外HPV基因型,表明对低病毒载量的检测有所改善。HP处理后的Ct值平均较低,这支持了其灵敏度的提高。非劣效性分析证实HP不劣于LB。 结论:该研究证实新的HP具有出色的精密度、准确性和灵敏度。虽然LB预处理仍然是一种可行的替代方法,但HP的效率、减少的操作时间和提高的灵敏度使其成为我们常规临床实践中的首选方法。
Cochrane Database Syst Rev. 2013-3-28
J Low Genit Tract Dis. 2025-7-1