BACKGROUND The indicating FTA card is a dry medium used for collection of cervical samples. HPVIR is a multiplex real-time PCR test that detects 12 high-risk human papillomavirus types (hrHPV) and provides single genotype information for HPV16, - 31, - 35, - 39, - 51, - 56, and - 59 and pooled type information for HPV18/45 and HPV33/52/58. The aim of this study was to evaluate whether a strategy with cervical samples collected on the FTA card and subsequently analysed with the HPVIR test complies with the criteria of the international guidelines for a clinically validated method for cervical screening. METHODS We performed a non-inferiority test comparing the clinical sensitivity and specificity of the candidate test (FTA card and HPVIR) with a clinically validated reference test (Cobas® HPV test) based on liquid-based cytology (LBC) samples. Two clinical samples (LBC and FTA) were collected from 896 participants in population-based screening. For evaluation of the specificity we used 799 women without ≥ CIN2, and for clinical sensitivity we used 67 women with histologically confirmed ≥ CIN2. The reproducibility was studied by performing inter- and intra-laboratory tests of 558 additional clinical samples. RESULTS The clinical sensitivity and specificity for samples collected on the FTA card and analysed using the HPVIR test were non-inferior to samples analysed with the Cobas® HPV test based on LBC samples (non-inferiority test score, p = 1.0 × 10- 2 and p = 1.89 × 10- 9, respectively). Adequate agreement of > 87% was seen in both the intra- and inter-laboratory comparisons. CONCLUSIONS Samples collected on the indicating FTA card and analysed with HPVIR test fulfil the requirements of the international guidelines and can therefore be used in primary cervical cancer screening.

中文翻译：

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根据国际宫颈癌筛查人类乳头瘤病毒DNA测试要求的准则，对宫颈样品进行HPVIR高风险HPV检测的临床验证。

背景技术指示性FTA卡是用于收集宫颈样品的干燥介质。HPVIR是一项多重实时PCR测试，可检测12种高危型人乳头瘤病毒（hrHPV）并提供HPV16，-31，-35，-39，-51，-56和-59以及合并型HPV的单一基因型信息有关HPV18 / 45和HPV33 / 52/58的信息。这项研究的目的是评估采用FTA卡收集的宫颈样本并随后用HPVIR测试进行分析的策略是否符合临床验证的宫颈筛查方法的国际准则的标准。方法我们进行了一项非劣效性测试，将候选测试（FTA卡和HPVIR）的临床敏感性和特异性与基于液体细胞学（LBC）样品的临床验证参考测试（Cobas®HPV测试）进行了比较。在基于人群的筛查中，从896名参与者中收集了两个临床样本（LBC和FTA）。为了评估特异性，我们使用了799例CIN2≥的女性，为了临床敏感性，我们使用了67例组织学上≥CIN2的女性。通过对558个其他临床样品进行实验室间和实验室内部测试，研究了可重复性。结果FTA卡上收集的样品和使用HPVIR测试分析的样品的临床敏感性和特异性均不逊于基于LBC样品的Cobas®HPV测试分析的样品（非劣性测试评分，p = 1.0×10- 2和p分别为1.89×10-9）。在实验室内部和实验室之间的比较中，均发现> 87％的一致性。