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目的:探讨直接检测痰液标本MPB64蛋白作为结核病快速诊断方法的可能性。方法:对65例肺结核病患者和72例非结核病患者的痰液标本同时进行痰涂片染色抗酸菌检查、实时荧光定量PCR检测结核杆菌DNA和免疫胶体金法检测MPB64蛋白,比较分析3种方法的检测结果,并依据临床诊断对MPB64蛋白检测结果进行诊断方法学评价。结果:MPB64蛋白检测法与涂片染色、荧光定量PCR检测结果的符合率均为60.58%;MPB64蛋白检测的敏感度、特异度、准确度分别为58.46%、69.44%和64.23%,其敏感度显著高于涂片染色法的27.69%与荧光定量PCR法的35.38%,但其特异度和准确度则低于涂片染色法(100%、65.69%)与荧光定量PCR法(98.61%、68.61%)。结论:采用免疫胶体金法直接检测痰液标本中MPB64蛋白对结核病的诊断具有较高的敏感度,可以作为筛查检测手段;但特异度相对较低,可否作为一种结核病快速诊断方法值得进一步研究。
Objective: To explore the possibility of directly detecting sputum specimen MPB64 protein as a rapid diagnostic method for tuberculosis. Methods: Sputum samples of sputum from 65 patients with pulmonary tuberculosis and 72 patients with non-tuberculosis were tested for anti-acid bacterium by sputum smear, MPB64 protein was detected by real-time fluorescence quantitative PCR and immunogold assay, Method of test results, and based on clinical diagnosis of MPB64 protein test results diagnostic methodological evaluation. Results: The coincidence rates of MPB64 protein assay and smear staining and fluorescence quantitative PCR assay were 60.58%. The sensitivity, specificity and accuracy of MPB64 protein assay were 58.46%, 69.44% and 64.23%, respectively. The sensitivity Which was significantly higher than that of smear staining and 35.38% of fluorescence quantitative PCR, but its specificity and accuracy were lower than that of smear staining (100%, 65.69%) and fluorescence quantitative PCR (98.61%, 68.61 %). CONCLUSION: The direct detection of MPB64 protein in sputum samples by immuno-colloidal gold method is highly sensitive to the diagnosis of tuberculosis and can be used as a screening test. However, the specificity of MPB64 protein is relatively low and may be worth further testing as a rapid diagnostic method for tuberculosis the study.