Li L F, Lin M C, Chen N H, Hsieh M J, Lee C H, Tsao T C
Department of First Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan, R.O.C.
Changgeng Yi Xue Za Zhi. 1998 Sep;21(3):258-64.
For early diagnosis of tuberculosis (TB), especially in the patients without adequate sputum specimens for examination, we found a simple, rapid and inexpensive method among many current available diagnostic tools, the enzyme-linked immunosorbent assay (ELISA). To investigate the diagnostic effectiveness of this method, we applied ELISA for detection of antigen 60 IgG and IgM as well as antigen 38 IgG antibodies at Chang Gung Memorial Hospital from April 1995 through June 1996.
Sixty-seven patients were enrolled and divided into 3 groups, Group A (n = 24), patients with positive sputum acid-fast stain; Group B (n = 18), patients with lung cancer and negative sputum acid-fast stain; and Group C (n = 25), patients with chest roentgenogram (CXR) which were suggestive of TB but with negative acid-fast stain results or no sputum for examination.
For the A60 IgG antibody, we found a sensitivity rate of 91.7% for Group A and Group B, and 85.7% for Group C as well as an overall sensitivity of 89.5% but with lower specificity. For the A60 IgM antibody, a lower sensitivity (37.5%, 14.3%, 28.9%, respectively) was found but with higher specificity. For the A38 IgG antibody, we found a lower sensitivity (40%, 11.1%, 31%, respectively) but with higher specificity (100%, 71.4%, 90%, respectively).
With a high sensitivity but low specificity for diagnosis of TB, A60 IgG ELISA could be used as a rapid, simple screening test for patients with results suggestive of TB, especially in those who had no sputum or had negative sputum acid-fast stain results. Otherwise, A60 IgM or A38 IgG ELISA, with a high specificity, could be used as a reliable test in the diagnosis of pulmonary TB when the result is positive. In summary, although ELISA is a simple, rapid, inexpensive method, it is helpful but limited in the diagnosis of pulmonary TB.
为了实现结核病(TB)的早期诊断,尤其是对于那些没有足够痰液样本用于检查的患者,我们在当前众多可用的诊断工具中发现了一种简单、快速且廉价的方法——酶联免疫吸附测定(ELISA)。为了研究该方法的诊断效果,我们于1995年4月至1996年6月在长庚纪念医院应用ELISA检测抗原60 IgG和IgM以及抗原38 IgG抗体。
招募了67名患者并将其分为3组,A组(n = 24),痰涂片抗酸染色阳性的患者;B组(n = 18),患有肺癌且痰涂片抗酸染色阴性的患者;C组(n = 25),胸部X线片(CXR)提示结核病但抗酸染色结果为阴性或无痰液可供检查的患者。
对于A60 IgG抗体,我们发现A组和B组的灵敏度为91.7%,C组为85.7%,总体灵敏度为89.5%,但特异性较低。对于A60 IgM抗体,灵敏度较低(分别为37.5%、14.3%、28.9%),但特异性较高。对于A38 IgG抗体,我们发现灵敏度较低(分别为40%、11.1%、31%),但特异性较高(分别为100%、71.4%、90%)。
A60 IgG ELISA对结核病诊断具有高灵敏度但低特异性,可作为对提示结核病结果的患者,特别是那些没有痰液或痰涂片抗酸染色结果为阴性的患者进行快速、简单的筛查试验。否则,A60 IgM或A38 IgG ELISA具有高特异性,当结果为阳性时可作为诊断肺结核的可靠试验。总之,尽管ELISA是一种简单、快速、廉价的方法,但它在肺结核诊断中虽有帮助但也存在局限性。