Orduña A, Almaraz A, Prado A, Gutierrez M P, Garcia-Pascual A, Dueñas A, Cuervo M, Abad R, Hernández B, Lorenzo B, Bratos M A, Torres A R
Departamento de Microbiología, Facultad de Medicina, Valladolid, Spain.
J Clin Microbiol. 2000 Nov;38(11):4000-5. doi: 10.1128/JCM.38.11.4000-4005.2000.
We evaluated the validity and the usefulness of a new test for the diagnosis of human brucellosis based on an immunocapture-agglutination technique. A total of 315 sera from 82 patients with a diagnosis of brucellosis, 157 sera from patients in whom brucellosis was suspected but not confirmed, and 412 sera from people living in rural areas with endemic brucellosis were studied. The seroagglutination test (SAT), Coombs anti-Brucella test, and Brucellacapt test were evaluated. All the initial sera from the 82 patients proved to be positive in Brucellacapt and Coombs tests, while only 75 (91.4%) were positive in the SAT. If a >/=1/160 diagnostic threshold titer was defined for the Brucellacapt test, Coombs test, and SAT, the sensitivities were 95.1, 91.5, and 65.8%, respectively. Taking the same diagnostic threshold titer for the 157 sera from the unconfirmed but suspected patients, the specificities of the Brucellacapt, Coombs, and SAT were 81.5, 96.2, and 100%, respectively; for the 412 control sera, the specificities were 99.0, 99.8, and 100%. The diagnostic efficiency (area below the receiver operating characteristic curve) of Brucellacapt was 0.987852 (95% confidence interval [CI], 0.95109 to 0.99286), very similar to the diagnostic efficiency of the Coombs test (0.97611; 95% CI, 0.94781 to 0.99146) and higher than that of SAT (0.91013; 95% CI, 0.86649 to 0.94317). The results of the Brucellacapt test were compared with those of the Coombs test (correlation coefficient, 0.956; P = 0.000) and SAT (correlation coefficient, 0.866; P = 0.000). The study shows very good correlation between the Brucellacapt and Coombs tests, with a high concordance between titers obtained in the two tests. Nevertheless, lower correlation and concordance were found between the Brucellacapt and Coombs tests when the results for titers of >/=1/160 were compared (0.692; P = 0.000). In acute brucellosis, the Brucellacapt and Coombs tests render positive titers of >/=1/160. When the titers are lower, they increase significantly in the following 30 days, despite the evolution of SAT titers. In contrast, Brucellacapt and Coombs titers are always high (>/=1/640) in brucellosis with long evolution, whether SAT titers are higher or lower than 1/160.
我们评估了一种基于免疫捕获凝集技术的新型人类布鲁氏菌病诊断检测方法的有效性和实用性。研究了来自82例确诊布鲁氏菌病患者的315份血清、157份疑似但未确诊布鲁氏菌病患者的血清以及412份来自布鲁氏菌病流行农村地区人群的血清。对血清凝集试验（SAT）、抗布鲁氏菌库姆斯试验和布鲁氏菌捕获试验进行了评估。82例患者的所有初始血清在布鲁氏菌捕获试验和库姆斯试验中均呈阳性，而在SAT中只有75例（91.4%）呈阳性。如果将布鲁氏菌捕获试验、库姆斯试验和SAT的诊断阈值滴度定义为≥1/160，则敏感性分别为95.1%、91.5%和65.8%。对于157份未确诊但疑似患者的血清采用相同的诊断阈值滴度，布鲁氏菌捕获试验、库姆斯试验和SAT的特异性分别为81.5%、96.2%和100%；对于412份对照血清，特异性分别为99.0%、99.8%和100%。布鲁氏菌捕获试验的诊断效率（受试者工作特征曲线下面积）为0.987852（95%置信区间[CI]，0.95109至0.99286），与库姆斯试验的诊断效率（0.97611；95%CI，0.94781至0.99146）非常相似，且高于SAT（0.91013；95%CI，0.86649至0.94317）。将布鲁氏菌捕获试验的结果与库姆斯试验（相关系数，0.956；P = 0.000）和SAT（相关系数，0.866；P = 0.000）的结果进行了比较。研究表明，布鲁氏菌捕获试验和库姆斯试验之间具有很好的相关性，两种试验获得的滴度之间具有高度一致性。然而，当比较≥1/160滴度的结果时，布鲁氏菌捕获试验和库姆斯试验之间的相关性和一致性较低（0.692；P = 0.000）。在急性布鲁氏菌病中，布鲁氏菌捕获试验和库姆斯试验的滴度≥1/160呈阳性。当滴度较低时，尽管SAT滴度有所变化，但在接下来的30天内它们会显著升高。相比之下，在病程较长的布鲁氏菌病中，无论SAT滴度高于还是低于1/160，布鲁氏菌捕获试验和库姆斯试验的滴度始终较高（≥1/640）。
