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布鲁氏菌酶免疫测定法与2-巯基乙醇标准凝集试验在墨西哥患者布鲁氏菌病诊断和监测中的比较

Comparison of a Brucella Enzyme Immunoassay and the Standard Agglutination with 2-Mercaptoethanol Test in the Diagnosis and Monitoring of Brucellosis in Mexican Patients.

作者信息

Camacho-Martínez Juan Carlos, Rios-Lugo María Judith, Gaytán-Hernández Darío, Hernández-Mendoza Héctor

出版信息

Clin Lab. 2020 Sep 1;66(9). doi: 10.7754/Clin.Lab.2020.190932.

DOI:10.7754/Clin.Lab.2020.190932
PMID:32902225
Abstract

BACKGROUND

The diagnosis of human brucellosis is difficult based on clinical grounds alone. Thus, the diagnosis is based on microbiological and serological tests. Therefore, the diagnosis relies predominantly on laboratory testing. The objective of this study was to determine the most efficient test for the diagnosis and monitoring of patients treated for brucellosis by comparing the standard agglutination test in a tube with 2-mercaptoethanol (SAT-2Me) to an enzyme-linked immunosorbent assay for the detection of antibodies against Brucella IgM (IgM ELISA).

METHODS

A retrospective chart review was performed. A total of 108 patients with brucellosis were analyzed at diagnosis and at the first and second follow-ups after treatment. The data were captured and analyzed using the SPSS 18.0 program. Frequencies, percentages, the Pearson's chi-square test, the kappa coefficient, sensitivity, specificity, predictive values, odds ratio, and conditional odds ratio (OR and COR) were calculated.

RESULTS

Diagnostic test: the IgM ELISA showed 96.3% sensitivity vs. 73.1% sensitivity for the SAT-2Me (p < 0.001). First follow-up: the IgM ELISA presented significant differences vs. the SAT-2Me in sensitivity (97.2% vs. 72.2%) and specificity (89.7% vs. 44.1%). Additionally, the second follow-up data showed significant differences in the sensitivity (85.7% vs. 71.4%) and specificity (82.8% vs. 41.4%) for the IgM ELISA vs. the SAT-2Me, re-spectively. In addition, the IgM ELISA showed significant concordance (0.836, p < 0.001 and 0.563, p < 0.001) at the first and second follow-ups, respectively, vs. the SAT-2Me.

CONCLUSIONS

The IgM ELISA is a more reliable and useful assay for the diagnosis and monitoring of brucellosis patients than the SAT-2 Me, avoiding up to 45.6% of unnecessary treatments. The SAT-2Me showed lower efficiency for diagnosis than the IgM ELISA and limited relevance for monitoring.

摘要

背景

仅基于临床症状很难诊断人类布鲁氏菌病。因此,诊断需依据微生物学和血清学检测。所以,诊断主要依赖实验室检测。本研究的目的是通过比较试管凝集试验加2-巯基乙醇(SAT-2Me)与检测抗布鲁氏菌IgM抗体的酶联免疫吸附试验(IgM ELISA),确定诊断和监测布鲁氏菌病治疗患者的最有效检测方法。

方法

进行回顾性病历审查。共对108例布鲁氏菌病患者在诊断时以及治疗后的首次和第二次随访时进行分析。使用SPSS 18.0程序收集和分析数据。计算频率、百分比、Pearson卡方检验、kappa系数、敏感性、特异性、预测值、比值比和条件比值比(OR和COR)。

结果

诊断检测:IgM ELISA的敏感性为96.3%,而SAT-2Me的敏感性为73.1%(p < 0.001)。首次随访:IgM ELISA与SAT-2Me在敏感性(97.2%对72.2%)和特异性(89.7%对44.1%)方面存在显著差异。此外,第二次随访数据显示,IgM ELISA与SAT-2Me相比,敏感性(85.7%对71.4%)和特异性(82.8%对41.4%)也分别存在显著差异。此外,IgM ELISA在首次和第二次随访时与SAT-2Me相比,分别显示出显著的一致性(0.836,p < 0.001和0.563,p < 0.001)。

结论

与SAT-2Me相比,IgM ELISA是诊断和监测布鲁氏菌病患者更可靠、更有用的检测方法,可避免高达45.6%的不必要治疗。SAT-2Me在诊断方面的效率低于IgM ELISA,且在监测方面的相关性有限。

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