肝细胞癌双目标血液检测试剂盒的分析和诊断性能

IF 1.5 Q4 ONCOLOGY Cancer reports Pub Date : 2024-09-26 DOI:10.1002/cnr2.70017

Qiankun Yang, Lanlan Dong, Lianglu Zhang, Wei Zhang, Yan Zhang, Yue Huang, Huifang Jin, Hao Yang, Xing Liu, Yanteng Zhao

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引用次数: 0

摘要

背景目前仍迫切需要对肝细胞癌（HCC）具有高灵敏度和特异性的监测方法。以往的研究表明，GNB4 和 Riplet 的甲基化可有效诊断 HCC。目的本研究计划分析利用 GNB4 和 Riplet 甲基化检测 HCC 的血液检验的性能。方法和结果本研究主要考察了双靶标 HCC 血液检验（DT-HBT）的分析性能，包括临界值、检出限（LOD）、精密度、分析特异性和吻合率。此外，还在 1030 份临床血浆样本（214 份 HCC 和 816 份非 HCC）中验证了对 HCC 的检测性能。为了评估该试剂盒用于术后复发监测的可行性，还收集了 25 名 HCC 患者肝切除术后的血浆样本。DT-HBT 的所有分析性能均符合预设要求。GNB4、Riplet和β-肌动蛋白的LOD为1%甲基化/100拷贝/μL，临界值分别为43、43和35。DT-HBT 的精确度非常高，CV 值在 5%以内。它检测其他癌症的特异性为 91.5%，检测乳腺癌、肺癌和膀胱癌的特异性为 100%。与 9 种潜在干扰物质未发生交叉反应。DT-HBT 检测参照样本和临床样本的吻合率达到 100%。临床性能研究发现，该试剂盒对 I 期 HCC 的灵敏度为 81.7%，总体灵敏度和特异性分别为 87.4% 和 92.3%。术后复发患者的检测灵敏度为 95.8%，特异性为 100%。结论 DT-HBT 的分析性能符合预设标准。它为 HCC 患者提供了一种可靠、高效的新血液检测方法，用于诊断和监测 HCC。试验注册 ClinicalTrials.gov identifier：NCT05685524

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Analytical and Diagnostic Performance of a Dual-Target Blood Detection Test for Hepatocellular Carcinoma

Background

Surveillance approaches with high sensitivity and specificity for hepatocellular carcinoma (HCC) are still urgently needed. Previous studies have shown that methylation of GNB4 and Riplet can effectively diagnose HCC.

Aims

This study plan to analyze the performance of a blood test for detecting HCC using GNB4 and Riplet methylation.

Methods and Results

This study mainly investigated the analytical performance of the dual-target HCC blood test (DT-HBT), including cut-off value, limit of detection (LOD), precision, analytical specificity, and coincidence rate. In addition, the detection performance for HCC was validated in 1030 clinical plasma samples (214 HCC and 816 non-HCC). Plasma samples from 25 HCC patients after hepatectomy were collected to assess the feasibility of the kit for postoperative recurrence monitoring. All analytical performance of the DT-HBT met prespecified requirements. The LOD for GNB4, Riplet, and β-actin was 1% methylation/100 copies/μL with cut-offs of 43, 43, and 35, respectively. The DT-HBT showed excellent precision, within 5% CV. It had a specificity of 91.5% for detecting other cancers, and 100% for breast, lung, and bladder cancer. No cross-reactions were observed with 9 potential interfering substances. The DT-HBT achieved a 100% coincidence rate in detecting reference and clinical samples. The clinical performance study found that the kit showed a sensitivity of 81.7% for stage I HCC, and an overall sensitivity and specificity of 87.4% and 92.3%, respectively. The detection sensitivity for postoperative recurrent patients was 95.8%, with a specificity of 100%.

Conclusion

The analytical performance of the DT-HBT met prespecified criteria. It provided HCC patients with a reliable and high-performing new blood test for the HCC diagnosis and surveillance.