Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, EH16 4SA, Edinburgh, Scotland, United Kingdom.
Dept of Pathology, Monklands Hospital, Lanarkshire, Monkscourt Avenue, Airdrie, MLS 0JS, United Kingdom.
J Clin Virol. 2021 Apr;137:104756. doi: 10.1016/j.jcv.2021.104756. Epub 2021 Feb 11.
The implementation of Human Papillomavirus based cervical screening continues apace on a global scale. Understanding the basis and burden of inadequate or invalid samples is important to ensure confidence in high quality laboratory results and inform the development of new technologies. Here we present population based data from Scotland and Denmark which detail the extent of invalid samples for HPV detection in both clinician-taken and self-taken samples. As a comparator we report on the rate of inadequate cytology preparations in both countries.
The proportion of samples with an invalid HPV test result was calculated by retrospective analysis of routine laboratory data associated with cervical screening programmes in the two countries. Two assays were in use for the programmes at the time (the Abbott RealTime High Risk HPV assay and the BD Onclarity); both have internal endogenous controls for human genes. In addition, acellular cytology samples were reported through a prospective audit (Scotland) and National quality reporting (Denmark).
In total, 89,418 clinician samples and 14,677 self-taken samples were assessed. We observed low rates of invalid HPV tests in clinician taken samples (0.05-0.10 %), irrespective of sample collection media (ThinPrep or SurePath), HPV test system/endogenous control type or clinical indication for testing (primary screening, triage or test of cure). For self-taken samples, the number of invalid samples was 0.18 %. Complete absence of sample material (acellular) in clinician taken samples were observed at a level of 1 in approximately 16.5 thousand.
Clinician and self-taken samples appear robust specimens for HPV testing and acellular samples are very rare. Efforts to develop endogenous controls for HPV assays that provide greater insight into true sample adequacy for cervical disease detection, beyond measuring the presence of human cells, will be welcome.
人乳头瘤病毒（HPV）为基础的子宫颈筛查在全球范围内迅速实施。了解不充分或无效样本的基础和负担对于确保高质量实验室结果的可信度以及为新技术的开发提供信息非常重要。在这里，我们提供了来自苏格兰和丹麦的基于人群的数据，详细说明了在临床医生采集和自我采集样本中 HPV 检测无效样本的程度。作为比较，我们报告了这两个国家细胞学检查准备不充分的比率。
通过对这两个国家的宫颈筛查计划相关的常规实验室数据进行回顾性分析，计算出无效 HPV 检测结果的样本比例。当时有两种检测方法（雅培实时高风险 HPV 检测和 BD Onclarity）用于这些项目；两者都有内部人基因的内源性对照。此外，还通过前瞻性审计（苏格兰）和国家质量报告（丹麦）报告了无细胞细胞学样本。
总共评估了 89418 例临床医生采集样本和 14677 例自我采集样本。我们观察到临床医生采集样本中 HPV 检测无效的比例很低（0.05-0.10%），无论样本采集介质（ThinPrep 或 SurePath）、HPV 检测系统/内源性对照类型或检测的临床指征（初筛、分流或治疗后检测）如何。对于自我采集的样本，无效样本的数量为 0.18%。在大约 16500 例临床医生采集样本中观察到完全没有样本材料（无细胞）的情况，比例为 1 例。
临床医生和自我采集的样本似乎是 HPV 检测的可靠样本，无细胞样本非常罕见。努力开发 HPV 检测的内源性对照，除了测量人细胞的存在外，还能更深入地了解真正的样本充足性，用于检测宫颈疾病，将受到欢迎。
