Comparison of GP and Path Vysion FISH assays in measuring HER2 gene status in breast cancer / 中华检验医学杂志

ABSTRACT

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.