目的评价我国酶联免疫斑点法(ELISPOT)用于诊断肺结核患者的应用价值。方法结核特异性ELISPOT法检测76例诊断明确的肺结核患者外周血单核细胞。同时选择30例无结核接触史、胸部X线片无异常且PPD皮试阴性的成年人作为对照。数据采用卡方检验和非参数Mann—Whitney检验。结果76例患者总体阳性率为71.0%,健康对照组阳性率为6.7%。按照患者抗结核疗程分为治疗1个月内、治疗6个月内、治疗6个月以上3组,阳性率分别为87.5%、74.1%和52.0%(x^2=35.63,P=0.000)。该技术在初冶结核患者中的灵敏度为87.5%,特异度为93.3%,阳性预测值为91.3%,阴性预测值为90.3%。结论结核特异性ELISPOT技术在我国初治(抗结核化疗疗程1个月内)的结核病患者中具有较高诊断价值。
Objective To evaluate the application of a new enzyme linked immunospot assay (ELSIPOT) based on Mycobacterium tuberculosis-sepcific T cells detection in the diagnosis of active pulmonary tuberculosis in China. Methods Using the ELISPOT assay, T cells specific for early secreted antigenic target 6-kDa protein (ESAT 6) and culture filtrate protein 10 (CFP-10) in the peripheral blood from 76 active pulmonary tuberculosis patients were measured. Thirty healthy people were recruited as healthy controls, which had no tuberculosis contacting history and were normal for chest X ray examination as well as negative for tuberculosis skin test (TST). The data were analyzed using Chi-square test and Mann-Whitney test. Results The positive rate of ELISPOT was71. 0% (54/76) and 6. 7% (2/30) in the patients with active pulmonary tuberculosis and healthy controls respectively. Furthermore, the positive rate was as high as 87.5 % in patients with antituberculosis treatment course less than 1 month, and decreased to 74.1 % and 52.0% in the patients with the treatment course varying from 1 to 6 months and more than 6 months respectively(x^2= 35. 63, P= 0. 000). In the patients with treatment course less than 1 month, the sensitivity, specificity, positive predictive value and negative predictive value of ELISPOT were 87.5 %, 93.3%, 91.3% and 90.3%, respectively. Conclusion ELISPOT assay is a sensitive assay for detecting tuberculosis infection, especially in the patients with anti-tuberculosis treatment course less than 1 month.