Dayal R, Sirohi G, Singh M K, Mathur P P, Agarwal B M, Katoch V M, Joshi B, Singh P, Singh H B
Department of Pediatrics, S.N. Medical College, Agra.
J Trop Pediatr. 2006 Dec;52(6):433-7. doi: 10.1093/tropej/fml047. Epub 2006 Sep 27.
Two separate studies (study I and study II) were conducted to evaluate the efficacy of ELISA serological test for the detection of IgG antibodies against specific glycolipid antigen (PGLTb1) and ESAT 6 antigen of Mycobacterium tuberculosis, respectively. These results were compared with bacteriological tests [Ziehl Neelson (ZN) staining for acid-fast bacilli and culture on Lowenstein Jensen (LJ) medium] and polymerase chain reaction (PCR) targeting IS6110 sequence. Both studies were carried out on children with pulmonary, central nervous system, lymph node, and gastrointestinal tuberculosis along with matching controls (65 cases and 27 controls for study I and 83 cases and 22 controls for study II). Informed consents of their parents or guardians were taken. They were subjected to clinical examination, relevant laboratory investigations, tuberculin test and chest radiograph. Relevant body fluids were subjected to bacteriological tests and PCR. Sera samples were analyzed for antibodies against PGLTbl and ESAT 6 antigen in study I and study II, respectively. ELISA tests showed a significantly higher sensitivity (49% study I; 53%, study II) as compared with LJ medium culture method (15.4%, study I; 28.9% study II) and ZN staining (27.7%, study I; 20.5%, study II) in all patients (p < 0.05). The results were comparable with PCR (40%, study I; 42.2% study II). Specificity of ELISA test was 100% in all the patients except in those with pulmonary disease (92.8%, study I; 84.8%, study II). In view of the convenience, low cost and comparable sensitivity with PCR, these ELISA tests have a promising future in the diagnosis of childhood tuberculosis.
分别进行了两项独立研究(研究I和研究II),以评估酶联免疫吸附测定(ELISA)血清学检测分别针对结核分枝杆菌特异性糖脂抗原(PGLTb1)和早期分泌性抗原靶6(ESAT 6)抗原的IgG抗体的功效。将这些结果与细菌学检测[萋-尼(ZN)抗酸杆菌染色及罗氏(LJ)培养基培养]以及靶向IS6110序列的聚合酶链反应(PCR)进行比较。两项研究均在患有肺结核、中枢神经系统结核、淋巴结结核和胃肠道结核的儿童以及匹配的对照组中开展(研究I为65例病例和27例对照,研究II为83例病例和22例对照)。获取了其父母或监护人的知情同意书。对他们进行了临床检查、相关实验室检查、结核菌素试验和胸部X线检查。对相关体液进行了细菌学检测和PCR。在研究I和研究II中,分别对血清样本分析了针对PGLTbl和ESAT 6抗原的抗体。ELISA检测显示,与LJ培养基培养法(研究I为15.4%;研究II为28.9%)和ZN染色法(研究I为27.7%;研究II为20.5%)相比,在所有患者中其敏感性显著更高(研究I为49%;研究II为53%)(p<0.05)。结果与PCR相当(研究I为40%;研究II为42.2%)。除患有肺部疾病的患者外(研究I为92.8%;研究II为84.8%),ELISA检测在所有患者中的特异性均为100%。鉴于其便利性、低成本以及与PCR相当的敏感性,这些ELISA检测在儿童结核病诊断方面具有广阔的前景。