摘要
目的用相同标本比较国内外结核菌聚合酶链反应诊断试剂盒的临床检测效果,并初步探讨结核菌聚合酶链反应荧光诊断试剂盒在临床应用中定量检测结核菌数量的可行性。方法用聚合酶链反应技术,荧光探针杂交技术、酶联免疫反应技术以及常规细菌学方法检测并经双盲编号的84份临床痰标本和8份含痰结核菌标准品。结果在59例结核病患者痰标本中,国产PCR-酶联免疫检测试剂盒与PCR荧光试剂盒分别检出26例阳性和24例阳性,国外试剂盒检出24例阳性;在25例非结核病患者痰标本中,国产PCR-酶联免疫检测试剂盒与PCR荧光试剂盒分别检出21例真阴性和24例真阴性,国外试剂盒检出23例真阴性;细菌学各级别检查结果与PCR荧光检测CT值不呈递减关系。结论国内外结核菌聚合酶链反应诊断试剂盒对临床标本的检测结果无显著性差异;结核菌聚合酶链反应荧光诊断试剂盒尚不能定量检测痰标本中的结核菌数量,有待更多的临床数据加以证实。
Objective To compare homemade and import mycobacterium tuberculosis PCR diag- nostic kits by the same sputum specimens, and primarily to discuss the feasibility of quantitative detection by the fluorescence PCR diagnostic kit in the clinical application. Method 84 clinical sputum specimens and 8 standard sputum samples with of mycobacterium tuberculosis were tested by the PCR and fluorescence probe hybridization and ELISA and antiacid staining methods. Results In 59 TB samples, 26 and 24 samples were positive respectively by the homemade PCR- ELISA and PCR- fluorescence kits, and 24 samples were positive by the import kit. In 25 non-TB samples, 21 and 24 samples were negtive respectively by the homemade PCR-ELISA and PCR- fluorescence kits, and 23 samples were negtive by the import kit. The result of the antiacid stain- ing method and CT of the PCR- fluorescence were not the descending relation. Conclusion There are no significant difference between the homemade and import diagnostic kits in the clini- cal application; The numbers of mycobacterium tuberculosis in the sputum can not be measured.
出处
《药品评价》
CAS
2005年第5期374-376,共3页
Drug Evaluation
关键词
结核菌
聚合酶链反应
试剂盒
诊断
痰标本
荧光定量
mycobacterium tuberculosis
Polymerase chain reaction
reagent kits
diagnosticsputum specimens
fluorescence quantitative
