Cubie Heather A, Moore Catherine, Waller Michael, Moss Sue
Specialist Virology Centre, Royal Infirmary of Edinburgh, 51 Little France Cres, Edinburgh EH16 4SA, UK.
J Clin Virol. 2005 Aug;33(4):287-92. doi: 10.1016/j.jcv.2004.12.011.
Cervical screening by cytology is effective but lacks sensitivity. The addition of human papillomavirus (HPV) testing can improve the effectiveness of screening for early identification of cervical disease. As HPV testing represents a new technology, a quality assurance (QA) programme is necessary to confirm the accuracy of results.
Our main objective was to design a QA programme for use in the English NHS liquid-based cytology (LBC) and HPV Cervical Screening Pilot Study. Our second objective was to use the knowledge gained to design a QA scheme for future general use within cervical screening and HPV testing programmes.
Four elements were included in the programme: provision of clinical samples of known HPV status for internal quality control (IQC), distribution of panels of unknown samples for external quality assessment (EQA), resubmission of aliquots of samples to the reference laboratory for repeat testing and resubmission to reference laboratory to check for transport problems. Three sites took part in the QA programme using PreservCyt medium and ThinPrep for LBC preparation. The assay used at test sites was HPV hybrid capture (hc2) while the quality assurance laboratory used a combination of hc2, in-house HPV polymerase chain reaction (PCR) tests and HPV linear array (LA).
Four negative, three low positive and 11 positive pools were used in 22 distributions of IQC samples. Seven distributions each of five 'unknown' EQA samples were sent out. Over 400 samples underwent repeat testing. Discrepant samples were further assessed to provide an explanation. Inter- and intra-laboratory consistency was high as measured by Kappa statistics and 96% agreement for EQA samples was obtained.
The validity of the QA programme was established and reproducibility in different lab settings was reassuring. These results support the use of hc2 as a potential screening test in diagnostic laboratories. The need for robust quality assurance of HPV testing in cervical screening programmes was confirmed and lessons learnt from this pilot study will be incorporated in future schemes.
通过细胞学进行宫颈筛查是有效的，但缺乏敏感性。增加人乳头瘤病毒（HPV）检测可提高筛查效果，以便早期发现宫颈疾病。由于HPV检测是一项新技术，需要一个质量保证（QA）计划来确认结果的准确性。
我们的主要目标是设计一个用于英国国家医疗服务体系（NHS）液基细胞学（LBC）和HPV宫颈筛查试点研究的QA计划。我们的第二个目标是利用所获得的知识，设计一个供未来在宫颈筛查和HPV检测计划中普遍使用的QA方案。
该计划包括四个要素：提供已知HPV状态的临床样本用于内部质量控制（IQC），分发未知样本组用于外部质量评估（EQA），将样本等分重新提交给参考实验室进行重复检测，以及重新提交给参考实验室以检查运输问题。三个地点使用PreservCyt培养基和ThinPrep进行LBC制备，参与了QA计划。检测地点使用的检测方法是HPV杂交捕获（hc2），而质量保证实验室使用hc2、内部HPV聚合酶链反应（PCR）检测和HPV线性阵列（LA）的组合。
在IQC样本的22次分发中，使用了4个阴性、3个低阳性和11个阳性样本池。发送了7次，每次7份的5个“未知”EQA样本。超过400个样本进行了重复检测。对有差异的样本进行了进一步评估以提供解释。通过Kappa统计量测量，实验室间和实验室内的一致性很高，EQA样本的一致性达到96%。
QA计划的有效性得到确立，在不同实验室环境中的可重复性令人放心。这些结果支持将hc2用作诊断实验室的潜在筛查检测方法。证实了宫颈筛查计划中对HPV检测进行强有力质量保证的必要性，并且从该试点研究中吸取的经验教训将纳入未来的方案中。
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