高危人乳头瘤病毒（HPV）的检测对于早期筛查和预防宫颈癌至关重要。然而，高级医院工作量大或基层医院资源有限阻碍了广泛的检测。为了解决这个问题，我们探索了一种从样本到答案的基因分型系统，并通过将其与手动进行的传统实时聚合酶链反应 (PCR) 方法进行比较来评估其性能。使用全自动 GenPlex® 系统重新分析从进行常规实时 PCR 检测的样本中随机选取的样本。该系统通过普通 PCR 和基于微阵列的反向杂交相结合，识别 24 种 HPV。通过两种方法的重复测试证实结果不一致，并采用κ一致性检验来评估两种方法之间的差异。从 7259 名女性中随机抽取了 365 个样本。根据实时PCR结果，76例高危型HPV阴性，289例高危型HPV阳性。 GenPlex® 系统对除 HPV 51 之外的 14 种高危 HPV 实现了大于 0.9 的 κ 值（范围从 0.920 至 1.000，p< 0.0001）（κ = 0.697，p< 0.0001）。然而，其他方法在实时PCR中发现高危型HPV 51结果不一致，结果为假阳性。在不区分高危型HPV的情况下对样本进行计数时，两种方法的结果完全一致（κ = 1.000，p < 0.0001）。值得注意的是，GenPlex® 系统发现了更多的阳性病例，其中 73 例具有实时 PCR 未涵盖的 HPV 类型，20 例可能是由于后者无法检测到 DNA 浓度低所致。与常规使用的实时PCR检测相比，GenPlex®系统表现出较高的一致性。重要的是，该系统在自动操作和密封芯片实验室格式方面的优势分别减少了手工工作并防止了气溶胶污染。为了广泛使用 GenPlex® 系统，应保证遵循国际标准的正式临床验证。© 2024 Wiley periodicals LLC。

The detection of high-risk human papillomaviruses (HPVs) is crucial for early screening and preventing cervical cancer. However, the substantial workload in high-level hospitals or the limited resources in primary-level hospitals hinder widespread testing. To address this issue, we explored a sample-to-answer genotyping system and assessed its performance by comparing it with the traditional real-time polymerase chain reaction (PCR) method conducted manually. Samples randomly selected from those undergoing routine real-time PCR detection were re-analyzed using the fully automatic GenPlex® system. This system identifies 24 types of HPV through a combination of ordinary PCR and microarray-based reverse hybridization. Inconsistent results were confirmed by repeated testing with both methods, and the κ concordance test was employed to evaluate differences between the two methods. A total of 365 samples were randomly selected from 7259 women. According to real-time PCR results, 76 were high-risk HPV negative, and 289 were positive. The GenPlex® system achieved a κ value greater than 0.9 (ranging from 0.920 to 1.000, p < 0.0001) for 14 types of high-risk HPV, except HPV 51 (κ = 0.697, p < 0.0001). However, the inconsistent results in high-risk HPV 51 were revealed to be false positive in real-time PCR by other method. When counting by samples without discriminating the high-risk HPV type, the results of both methods were entirely consistent (κ = 1.000, p < 0.0001). Notably, the GenPlex® system identified more positive cases, with 73 having an HPV type not covered by real-time PCR, and 20 potentially due to low DNA concentration undetectable by the latter. Compared with the routinely used real-time PCR assay, the GenPlex® system demonstrated high consistency. Importantly, the system's advantages in automatic operation and a sealed lab-on-chip format respectively reduce manual work and prevent aerosol pollution. For widespread use of GenPlex® system, formal clinical validation following international criteria should be warranted.© 2024 Wiley Periodicals LLC.