应用国产与进口耗材行宫颈液基细胞学检查的对比研究

Comparative Study of Homemade and Imported Materials in Cervical Cytological Test

目的:观察应用国产与进口耗材行宫颈液基细胞学检查结果的一致性。方法:选取600例符合条件的对象同时采用国产与进口两种耗材行液基细胞学制片,进行宫颈液基细胞学检查。细胞学诊断采用TBS分级系统。阳性诊断包括意义不明的不典型鳞状细胞(ASC-US)以上病变。细胞学诊断阳性者,全部在阴道镜下取活组织检查,所有检查均在双盲下进行。结果:利用国产与进口耗材行液基细胞学制片,阳性检出率分别为14.7%(88/600)、15.5%(93/600),与组织病理学对照结果显示,鳞状上皮内高度以上病变(>HSIL)均为83.3%(5/6);鳞状上皮低度病变(LSIL)分别为73.1%(19/26)、74.1%(20/27),结果差异无统计学意义(P>0.05)。结论:利用国产与进口耗材行宫颈液基细胞学检查,结果有较好的一致性,应用国产耗材行宫颈液基细胞学检查,成本较低,能够满足临床诊断的要求。

Objective： To compare the concordance of two liquid - based cytology materials （ homemade and imported） used in cervical cytological tests. Methods： 600 patients were selected to have cervical liquid -based cytological test by ：using two materials（ homemade and imported） at the same time. The cytological diagnosis criterion was TBS taxonomy. All LCT（ liquid -based cytologic test） ≥atypical squamous cells of undetermined sign（ ASC - US） was considered as positive results, which will have biopsy in colposcopy, All tests were conducted double blind. Results： The detected rate of LCT≥ ASCUS examined by homemade and imported materials were 14.7% （88/600） and 15.5% （93/600） respectively. The histopathological results were showed that the concordance rate of LCT 〉 HSIL were both 83.3% （5/6）, and LCT = LSIL were 73.1% （19/26） and 74. 1% （20/27）, respectively, which showed no significant difference （P 〉 0.05 ）. Conclusion： It appears good concordance between homemade materials and imported ones in cervical cytological tests. Homemade material is more suitable to be developed in grass - root hospitals because of its cheapness.