Role of Culture Free Rapid ImmunoAssay (ELISA) and Genexpert (MTB/RIF) Technology in the Diagnosis of Tuberculosis

Shahida Hussain, Sikander Sultan, Saba Riaz, Hajra Hussain, Chetan Lal
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Abstract

Introduction: Prolonged laboratory processes are major hurdles in the early diagnosis of tuberculosis. Prompt management of this disease is utmost necessary to control its spread. For this purpose, use of rapid and reliable laboratory testing methods for the diagnosis of Mycobacterium tuberculosis are crucial alongwith timely infection management and preventing its transmission to the close contact population. Aims and Objective: The aim of this study was to establish a diagnostic-connection between culture free cost effective rapid immuno-assay (IgG and IgM) and GeneXpert (MTB/RIF) technology for the detection of Mycobacterium tuberculosis within the shortest possible turnaround time. Place and Duration of Study: This cross-sectional study was carried out at Institute of Microbiology and Molecular Genetic, University of the Punjab, Pakistan in collaboration with the Department of Pulmonology and TB Outpatient Department (OPD) at Jinnah Hospital, Lahore over the time of one year (2019-2020). Material and Methods: To achieve the aim, a total of 180 (pulmonary and extra-pulmonary) samples along with blood samples were collected from clinical suspects of Tuberculosis. All collected samples were subjected to AFB microscopy, GeneXpert (MTB/RIF) assay and Enzyme-linked Immunosorbent Assay (ELISA) for IgG and IgM. The diagnostic sensitivity and specificity of both methods were determined by using the solid culture as the gold standard.Study data collected through questionnaire was entered and analyzed using Statistical Package for Social Sciences (SPSS version 20).p value of ? 0.05 was considered significant. Results: The overall sensitivity and specificity of GeneXpert (MTB/RIF) assay were 98.2 % and 82.4% respectively, whereas, for IgG (ELISA) antibodies, it was 50.0% and 76.4% and for IgM (ELISA) antibodies 50.4% and 97.1% respectively. Conclusion: It was concluded that with fully automated GeneXpert (MTB/RIF) technology, maximum sensitivity and specificity can be achieved for diagnosis of tuberculosis within 2 hours.
无培养基快速免疫分析(ELISA)和基因检测(MTB/RIF)技术在结核病诊断中的作用
导言:漫长的实验室过程是结核病早期诊断的主要障碍。要控制结核病的传播,就必须对这种疾病进行及时治疗。为此,使用快速可靠的实验室检测方法诊断结核分枝杆菌至关重要,同时还要及时进行感染管理,防止其传播给密切接触人群:本研究的目的是在尽可能短的周转时间内,建立免培养、经济有效的快速免疫测定(IgG 和 IgM)与 GeneXpert(MTB/RIF)技术之间的诊断联系,以检测结核分枝杆菌:这项横断面研究是在巴基斯坦旁遮普大学微生物学和分子遗传学研究所与肺病科和拉合尔真纳医院结核病门诊部(OPD)合作开展的,为期一年(2019-2020年):为实现上述目标,从肺结核临床疑似患者处收集了 180 份(肺部和肺外)样本和血液样本。对所有采集的样本进行 AFB 显微镜检查、GeneXpert(MTB/RIF)检测和酶联免疫吸附试验(ELISA)检测 IgG 和 IgM。通过问卷收集的研究数据使用社会科学统计软件包(SPSS 20 版)进行输入和分析:结果:GeneXpert(MTB/RIF)检测的总体灵敏度和特异性分别为 98.2 % 和 82.4%,而 IgG(ELISA)抗体的灵敏度和特异性分别为 50.0 % 和 76.4%,IgM(ELISA)抗体的灵敏度和特异性分别为 50.4 % 和 97.1%:结论:采用全自动基因Xpert(MTB/RIF)技术,可在 2 小时内达到诊断结核病的最高灵敏度和特异性。
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