Cutaneous warts are infectious disorders caused by human papillomavirus (HPV). A recent study revealed that the HPV genotype influences the natural course and response to treatment for plantar warts, suggesting that HPV genotyping could potentially be used to optimize wart treatment schemes. For this purpose, a wart‐associated HPV genotyping assay was developed. The assay was subjected to an intensive validation process including, i.a., empiric determination of the annealing temperature, primer‐probe optimization, evaluation of the analytical specificity and sensitivity, viral load quantification, and qualitative as well as quantitative analysis of intra‐run repeatability and inter‐run reproducibility. The newly developed assay was employed in a small‐scale HPV genotyping study of wart biopsies (n = 50). The assay exhibited an analytical type‐specific sensitivity and specificity of 100% (95% confidence interval [CI]: 83.9%–100%). The limit of quantification of the tested sequences corresponded to less than 17 viral copies/µl, while the limit of detection was less than 5 copies/µl. Very good to excellent agreements were gained between intra‐ and inter‐run measurements (κ = 0.85–1.00) and coefficients of variation of the quantitative agreements were less then 3%. 22.5% (95% CI: 11%–39%) of the analyzed biopsies were negative for the tested HPV types, while 35% (95% CI: 21%–52%) contained multiple infections. The wart‐associated HPV quantitative polymerase chain reaction assay was proven to be highly sensitive and specific. Multiple HPV infections were detected in 35% of lesions, contradicting the current literature claiming that in immunocompetent patients only 4%–16% of warts exhibit multiple HPV infections. This assay is qualified to be implemented in development of future genotype specific wart treatment strategies.

中文翻译：

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用于检测皮肤疣中 HPV 的疣相关人乳头状瘤病毒基因分型测定的开发和验证

皮肤疣是由人乳头瘤病毒 (HPV) 引起的传染性疾病。最近的一项研究表明，HPV 基因型影响足底疣的自然病程和治疗反应，这表明 HPV 基因分型有可能用于优化疣治疗方案。为此，开发了一种与疣相关的 HPV 基因分型测定法。该测定经过严格的验证过程，包括退火温度的经验确定、引物探针优化、分析特异性和灵敏度的评估、病毒载量定量以及运行内重复性和稳定性的定性和定量分析。运行间的再现性。新开发的检测方法被用于疣活检的小规模 HPV 基因分型研究（n  = 50）。该检测显示出 100% 的分析类型特异性灵敏度和特异性（95% 置信区间 [CI]：83.9%–100%）。测试序列的定量限相当于低于 17 个病毒拷贝/μl，而检测限低于 5 个拷贝/μl。批内和批间测量之间获得了非常好的到极好的一致性（κ  = 0.85-1.00），并且定量一致性的变异系数小于 3%。22.5% (95% CI: 11%–39%) 分析的活检组织检测 HPV 类型呈阴性，而 35% (95% CI: 21%–52%) 包含多重感染。疣相关 HPV 定量聚合酶链反应检测被证明具有高度敏感性和特异性。在 35% 的病变中检测到多重 HPV 感染，这与当前文献声称的免疫功能正常患者中只有 4%–16% 的疣表现出多重 HPV 感染相矛盾。该测定有资格在未来基因型特异性疣治疗策略的开发中实施。