细胞学标本行基因检测的可靠性分析及质控方法的初步探索

Reliability of gene detection using cytologic specimens and its quality control

目的对细胞学标本行基因检测的可靠性进行分析并初步建立细胞学标本在基因检测过程中质量控制的方法。方法对625例行基因检测的细胞学标本进行抽查及重复实验,并分析两次结果的一致性。结果 625例细胞学标本DNA浓度为11.191±21.387 ng/μL,内参Ct值为14.509±2.555,阳性率为20.8%。抽查31例样品与原始样品实验结果的一致率为96.8%(30/31),两次实验的内参Ct值、阳性位点的Ct值均无差异(P>0.05),实验结果的稳定性较好。结论细胞学标本行基因检测是一种稳定可靠、重复性较好的方法,但由于细胞学标本的特殊性,故在检测过程中对标本进行严格质控非常必要。

Objective To analyze the reliability of gene detection by using cytologic specimens and to establish primarily a quality control method in the detection. Methods A total of 625 cases of gene detection with cytologic specimens were collected during the period of Sept. 2015 - Jan. 2016. 31 cases from the 625 specimens were selected and performed for genetic test experiments with double repeats. Consistency between two results was analyzed. Results Of the 625 cases, DNA concentration was 11. 191± 21. 387 ng/μL, Ct value of reference gene was 14. 509 ± 2. 555, and positive rate was 20. 800%. Consistency between both tests was 96. 774% （30/31）. Both Ct value of reference and target gene had no difference （P 〉 0. 05 ）. Conclusions Gene detection with cytologic specimens has good repeatability and reliability. Besides, quality control in the process of detection is very necessary, because of the specificity of cytologic specimens.