CAJ | 학술논문

目的通过与进口PathVysion HER2试剂盒比较,评价国产金菩嘉GP HER2试剂盒检测乳腺癌患者HER2基因状态的临床应用价值.方法收集108例乳腺浸润性导管癌(简称"乳腺癌")肿瘤组织标本,分别采用FISH技术与GP HER2试剂盒和PathVysion HER2试剂盒检测乳腺癌患者HER2基因表达水平,比较2种试剂盒检测乳腺癌患者HER2基因表达差异,并评价GP HER2试剂盒检测乳腺癌患者组织标本中HER2基因扩增的敏感度、特异度和准确性.结果 GP HER2试剂盒和PathVysion HER2试剂盒检测乳腺癌患者组织标本中HER2基因扩增率分别为25.0%(27/108)和26.9%(29/108).与PathVysion HER2试剂盒相比,GP HER2试剂盒检测乳腺癌患者组织标本中HER2基因扩增的敏感度、特异度和准确性分别为89.7%(26/29)、98.7%(78/79)和96.3%(104/108),PPV和NPV均为96.3%(26/27,78/81).GP HER2试剂盒检出第17号染色体多倍体的敏感度、特异度和准确性分别为93.3%(14/15)、100%(93/93)和99.1%(107/108).结论 GPHER2试剂盒在检测乳腺癌患者组织标本中HER2基因状态的敏感度和特异度及准确性高,在临床评价乳腺癌HER2基因状态中具有广泛应用价值.
목적 통과여진구PathVysion HER2시제합비교,평개국산금보가GP HER2시제합검측유선암환자HER2기인상태적림상응용개치.방법 수집108례유선침윤성도관암(간칭"유선암")종류조직표본,분별채용FISH기술여GP HER2시제합화PathVysion HER2시제합검측유선암환자HER2기인표체수평,비교2충시제합검측유선암환자HER2기인표체차이,병평개GP HER2시제합검측유선암환자조직표본중HER2기인확증적민감도、특이도화준학성.결과 GP HER2시제합화PathVysion HER2시제합검측유선암환자조직표본중HER2기인확증솔분별위25.0%(27/108)화26.9%(29/108).여PathVysion HER2시제합상비,GP HER2시제합검측유선암환자조직표본중HER2기인확증적민감도、특이도화준학성분별위89.7%(26/29)、98.7%(78/79)화96.3%(104/108),PPV화NPV균위96.3%(26/27,78/81).GP HER2시제합검출제17호염색체다배체적민감도、특이도화준학성분별위93.3%(14/15)、100%(93/93)화99.1%(107/108).결론 GPHER2시제합재검측유선암환자조직표본중HER2기인상태적민감도화특이도급준학성고,재림상평개유선암HER2기인상태중구유엄범응용개치.
Objective To evaluate clinical application of Jin Pujia GP HER2 probe kit in testing HER2 gene status of breast cancer through comparing it with PathVysion HER2 probe kit. Methods HER2 gene status were detected from 108 cases with invasive ductal breast cancer using GP and PathVysion HER2 probe kits by FISH. HER2 gene expression levels were measured by GP and PathVysion HER2 probe kits, and the sensitivity, the specificity and the accuracy of GP HER2 probe kit were evaluated. Results HER2 gene amplification positive rates detected by GP HER2 probe kit and PathVysion HER2 probe kit were 25.0%(27/108) and 26.9% (29/108), respectively. As compared with PathVysion HER2 probe kit, the sensitivity, the specificity and the accuracy of the GP HER2 kit were 89. 7% (26/29), 98.7% (78/79)and 96. 3% ( 104/108), respectively, whereas the PPV and NPV were 96. 3% (26/27) and 96. 3% (78/81), respectively. The GP HER2 probe kit had a sensitivity of 93.3% ( 14/15), a specificity of 100%(93/93) and an accuracy of 99. 1% (107/108) for detecting polysomy 17. Conclusion GP HER2 probe kit has high sensitivity and specificity for detecting HER2 gene status in breast cancer patients, and it has clinical application value.