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Diagnostic test accuracy of droplet digital PCR for the detection of EGFR mutation (T790M) in plasma: Systematic review and meta-analysis.
Clinica Chimica Acta ( IF 5 ) Pub Date : 2019-12-02 , DOI: 10.1016/j.cca.2019.11.023
Yingyin Liao 1 , Yuan Chen 2 , Xiaoxia Kou 1 , Yi Xiao 3 , Junkai Ye 2 , Aiwu Wu 1
Affiliation  

BACKGROUND T790M mutation was a primary lead cause in the acquired resistance to EGFR-TKIs confirmed in earlier studies. Since the shortcomings of tumor tissue detection are well known, the liquid biopsy is more appropriate to track T790M status. We assessed the accuracy and clinical significance of the droplet digital PCR (ddPCR) detection of T790M mutation in plasma. METHODS We retrieved PubMed, Embase, Cochrane, and Web of science with no limitation of language and publication year. Summary sensitivity and specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR) and diagnostic odds ratio of detection of EGFR T790M status were calculated from extracted data from included articles. The summary receiver operating curve (SROC), diagnostic odds ratio (DOR), and the area under the summary receiver operating curve (AUC) was used to assess the overall diagnostic accuracy. I2 and meta-regression were used to evaluate heterogeneity and the source of heterogeneity, respectively. RESULT We identified 15 studies in the total search of 1364 reports, including 427 paired tissue and plasma samples. The pooled sensitivity and the pooled specificity were 0.68 (95% CI 0.61-0.75) and 0.85 (95% CI 0.75-0.91) by the bivariate model, respectively. The AUC and the pooled DOR were 0.78 (95% CI 0.74-0.81) and 12 (95% CI 7-22), respectively. None of the cofactors could account for the heterogeneity. CONCLUSION The plasma analysis is of a promising performance to screen EGFR-T790M mutation status by ddPCR.

中文翻译:

液滴数字PCR诊断血浆中EGFR突变(T790M)的诊断测试准确性:系统评价和荟萃分析。

背景技术T790M突变是早期研究中证实的对EGFR-TKIs获得性耐药的主要原因。由于肿瘤组织检测的缺点是众所周知的,因此液体活检更适合跟踪T790M的状态。我们评估了血浆中T790M突变的液滴数字PCR(ddPCR)检测的准确性和临床意义。方法我们检索了PubMed,Embase,Cochrane和Web of Science,不受语言和出版年份的限制。汇总的敏感性和特异性,阳性似然比(PLR),阴性似然比(NLR)和EGFR T790M状况检测的诊断比值比是从包括的文章中提取的数据计算得出的。摘要接收器工作曲线(SROC),诊断比值比(DOR),摘要接收器工作曲线(AUC)下的面积用于评估总体诊断准确性。I2和元回归分别用于评估异质性和异质性的来源。结果我们在1364份报告的总检索中确定了15项研究,包括427对配对的组织和血浆样品。通过双变量模型,合并的敏感性和合并的特异性分别为0.68(95%CI 0.61-0.75)和0.85(95%CI 0.75-0.91)。AUC和合并的DOR分别为0.78(95%CI 0.74-0.81)和12(95%CI 7-22)。没有一个辅因子可以解释异质性。结论血浆分析在通过ddPCR筛选EGFR-T790M突变状态方面具有广阔的前景。I2和元回归分别用于评估异质性和异质性的来源。结果我们在1364份报告的总检索中确定了15项研究,包括427对配对的组织和血浆样品。通过双变量模型,合并的敏感性和合并的特异性分别为0.68(95%CI 0.61-0.75)和0.85(95%CI 0.75-0.91)。AUC和合并的DOR分别为0.78(95%CI 0.74-0.81)和12(95%CI 7-22)。没有一个辅因子可以解释异质性。结论血浆分析在通过ddPCR筛选EGFR-T790M突变状态方面具有广阔的前景。I2和元回归分别用于评估异质性和异质性的来源。结果我们在1364份报告的总检索中确定了15项研究,包括427对配对的组织和血浆样品。通过双变量模型,合并的敏感性和合并的特异性分别为0.68(95%CI 0.61-0.75)和0.85(95%CI 0.75-0.91)。AUC和合并的DOR分别为0.78(95%CI 0.74-0.81)和12(95%CI 7-22)。没有一个辅因子可以解释异质性。结论血浆分析在通过ddPCR筛选EGFR-T790M突变状态方面具有广阔的前景。75)和0.85(95%CI 0.75-0.91)的二元模型。AUC和合并的DOR分别为0.78(95%CI 0.74-0.81)和12(95%CI 7-22)。没有一个辅因子可以解释异质性。结论血浆分析在通过ddPCR筛选EGFR-T790M突变状态方面具有广阔的前景。75)和0.85(95%CI 0.75-0.91)的二元模型。AUC和合并的DOR分别为0.78(95%CI 0.74-0.81)和12(95%CI 7-22)。没有一个辅因子可以解释异质性。结论血浆分析在通过ddPCR筛选EGFR-T790M突变状态方面具有广阔的前景。
更新日期:2019-12-02
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