Hôpital Ambroise Paré, Marseille, France.
J Clin Virol. 2010 Aug;48(4):246-50. doi: 10.1016/j.jcv.2010.05.008. Epub 2010 Jun 11.
BACKGROUND: Abbott RealTime (RT) High-Risk (HR) HPV assay is a new qualitative real-time polymerase chain reaction (PCR) based assay for the detection of 14 HR HPV DNA. The assay can differentiate between the infection by HPV 16, HPV 18 and non-HPV 16/18 types through the distinct fluorescent labels on the type specific probes. OBJECTIVES: To evaluate the clinical performance of the Abbott RT HR HPV test, in comparison with biopsy, Hybrid Capture II (HCII), and Linear Array (LA), for detection of high-grade disease (CIN2+). STUDY DESIGN: The study population consisted of 143 women who were included in three referral gynecology clinics in Marseilles (France) between March 2007 and June 2008. The clinical performance of the RT HR HPV assay, performed on the fully automated m2000 system, was compared with HCII and LA. RESULTS: HR HPV positivity rate was similar for all tests (Abbott RT HR HPV and HCII, 62%, and LA 63%). All tests had high sensitivities and negative predictive values for CIN2+ detection (>90%). The agreement between HCII and Abbott RT HR HPV, and between HCII and LA were 93% (k=0.85) and 96% (k=0.91) respectively. As expected, HPV16 or HPV18 positivity was greater in advanced grades of disease, especially in CIN2+ patients: 85% in CIN2+ vs. 33% in <CIN2 patients (p<.0001); 60% in CIN3+ vs. 47% in <CIN3 patients (p not significant). CONCLUSIONS: The clinical performance of the Abbott RT HR HPV assay is good and closely correlated with the two other assays. The automation and ability to identify type 16 and 18 make this a very attractive option for HPV testing in laboratories and potentially provides improved patient management.
背景：雅培实时（RT）高风险（HR）HPV 检测是一种新的基于实时聚合酶链反应（PCR）的定性检测方法，用于检测 14 种 HR HPV DNA。该检测方法通过特定探针上的独特荧光标记，区分 HPV 16、HPV 18 和非 HPV 16/18 型感染。
目的：评估雅培 RT HR HPV 检测与活检、杂交捕获 II（HCII）和线性阵列（LA）检测用于诊断高级别疾病（CIN2+）的临床性能。
研究设计：研究人群包括 2007 年 3 月至 2008 年 6 月马赛（法国）的三个转诊妇科诊所的 143 名女性。在全自动 m2000 系统上进行的 RT HR HPV 检测与 HCII 和 LA 进行比较。
结果：所有检测方法的 HR HPV 阳性率相似（雅培 RT HR HPV 和 HCII 为 62%，LA 为 63%）。所有检测方法对 CIN2+检测的灵敏度和阴性预测值均较高（>90%）。HCII 与 Abbott RT HR HPV 之间，以及 HCII 与 LA 之间的一致性分别为 93%（k=0.85）和 96%（k=0.91）。正如预期的那样，HPV16 或 HPV18 阳性率在疾病的高级别中更高，尤其是在 CIN2+患者中：CIN2+患者中为 85%，<CIN2 患者中为 33%（p<.0001）；CIN3+患者中为 60%，<CIN3 患者中为 47%（p 无统计学意义）。
结论：雅培 RT HR HPV 检测的临床性能良好，与另外两种检测方法密切相关。该检测方法的自动化和识别 16 型和 18 型的能力使其成为 HPV 检测实验室的一个非常有吸引力的选择，并且可能为患者管理提供了改进。
J Clin Virol. 2009-7
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