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地点:美国加洲大学圣迭戈医学中心。目标:建立一种包括抗体检测的结核病(TB)简单筛查策略,以提高痰抗酸杆菌镜检(AFB涂片)的准确性。方法:血清标本来自190名可疑活动性结核患者。结核病的诊断通过结核杆菌培养确定。HIV感染状况由商业化的血清学试验确定。IgG抗体水平使用纯化的结核杆菌抗原用ELISA法测定。从130名随机选择的病人资料用于制定筛查策略,另60名病人资料用于验证。结果:抗酸菌涂片敏感性为70％,特异性为88％。单个或多个抗原的ELISA同AFB涂片及HIV状况相结合诊断模式的敏感性比每个单项试验都高。包括4种抗原ELISA(38KD抗原,脂阿拉伯甘露聚糖,MPT-64和谷氨酰胺合成酶)诊断敏感性为93％,特异性为76％。和AFB涂片相比其敏感性较高,而特异性无统计学差异。结论:本研究建议建立将多种抗原ELISA同AFB涂片和HIV检查整合在一起的筛查策略。
Location: University of California, San Diego Medical Center. Objectives: To establish a simple screening test for tuberculosis (TB) that includes antibody testing to improve the accuracy of sputum acid-fast bacilli microscopy (AFB smears). Methods: Serum samples from 190 suspicious active tuberculosis patients. The diagnosis of tuberculosis is confirmed by Mycobacterium tuberculosis culture. HIV status was determined by commercial serological tests. IgG antibody levels were determined by ELISA using purified Mycobacterium tuberculosis antigen. Data from 130 randomly selected patients was used to develop screening strategies and another 60 patient data were used for validation. Results: The antacid smear showed a sensitivity of 70% and a specificity of 88%. The combination of single or multiple antigen ELISA with AFB smear and HIV status is more sensitive than diagnostic modalities in each individual test. Including four antigen ELISA (38KD antigen, lipid arabinan, MPT-64 and glutamine synthetase) diagnostic sensitivity of 93%, specificity of 76%. Compared with AFB smear, its sensitivity is higher, while the specificity is not statistically different. Conclusion: This study suggests a screening strategy that integrates multiple antigen ELISA with AFB smear and HIV testing.