Translational Research Division, International Vaccine Institute, Seoul, Korea.
BMC Infect Dis. 2011 May 24;11:147. doi: 10.1186/1471-2334-11-147.
Typhoid fever remains a significant health problem in many developing countries. A rapid test with a performance comparable to that of blood culture would be highly useful. A rapid diagnostic test for typhoid fever, Tubex®, is commercially available that uses particle separation to detect immunoglobulin M directed towards Salmonella Typhi O9 lipopolysaccharide in sera.
We assessed the sensitivity and specificity of the Tubex test among Tanzanian children hospitalized with febrile illness using blood culture as gold standard. Evaluation was done considering blood culture confirmed S. Typhi with non-typhi salmonella (NTS) and non - salmonella isolates as controls as well as with non-salmonella isolates only.
Of 139 samples tested with Tubex, 33 were positive for S. Typhi in blood culture, 49 were culture-confirmed NTS infections, and 57 were other non-salmonella infections. Thirteen hemolyzed samples were excluded. Using all non - S. Typhi isolates as controls, we showed a sensitivity of 79% and a specificity of 89%. When the analysis was repeated excluding NTS from the pool of controls we showed a sensitivity of 79% and a specificity of 97%. There was no significant difference in the test performance using the two different control groups (p > 0.05).
This first evaluation of the Tubex test in an African setting showed a similar performance to those seen in some Asian settings. Comparison with the earlier results of a Widal test using the same samples showed no significant difference (p > 0.05) for any of the performance indicators, irrespective of the applied control group.
伤寒在许多发展中国家仍是一个重大的健康问题。一种性能可与血培养相媲美的快速检测方法将非常有用。一种名为 Tubex®的伤寒快速诊断检测试剂已经上市,它使用颗粒分离技术来检测血清中针对伤寒沙门氏菌 O9 脂多糖的免疫球蛋白 M。
我们使用血培养作为金标准,评估了 Tubex 试验在坦桑尼亚因发热而住院的儿童中的敏感性和特异性。评估时考虑了血培养确认的伤寒沙门氏菌(S. Typhi)与非伤寒沙门氏菌(NTS)和非沙门氏菌分离株作为对照,以及仅与非沙门氏菌分离株作为对照。
在 139 份用 Tubex 检测的样本中,33 份血培养阳性为 S. Typhi,49 份为培养确认的 NTS 感染,57 份为其他非沙门氏菌感染。13 份溶血样本被排除在外。使用所有非 S. Typhi 分离株作为对照,我们的敏感性为 79%,特异性为 89%。当分析排除 NTS 从对照组中时,我们的敏感性为 79%,特异性为 97%。使用这两种不同的对照组,测试性能没有显著差异(p > 0.05)。
这是在非洲环境中对 Tubex 试验的首次评估,其性能与一些亚洲环境中的结果相似。与使用相同样本的早期魏达试验结果进行比较,无论应用哪种对照组,在任何性能指标上都没有显著差异(p > 0.05)。