Increased and Expedited Case Detection by Xpert MTB/RIF Assay in Childhood Tuberculosis: A Prospective Cohort Study
Increased and Expedited Case Detection by Xpert MTB/RIF Assay in Childhood Tuberculosis: A Prospective Cohort Study
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DOI：
10.1093/cid/cis190
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发表时间：
2012-05-15
影响因子：
11.8
通讯作者：
Hoelscher, Michael
中科院分区：
文献类型：
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作者：
Rachow, Andrea;Clowes, Petra;Hoelscher, Michael
背景儿童结核病的诊断和及时治疗因缺乏快速和可靠的检测而受到阻碍，特别是在人类免疫缺陷病毒（艾滋病毒）时代。本研究的目的是评价Xpert MTB/RIF检测试剂盒（Xpert）在结核病/HIV高负担环境中对疑似结核病儿童的诊断性能。在一项至少随访12个月的前瞻性研究中，根据微生物学和临床结果，将164名疑似结核病儿童分配到预定义的诊断亚组。将涂片镜检和培养的结果与Xper. Results的诊断性能进行比较。164名儿童中有28名（17.1%）确诊为结核病。Xpert检测到100%（95%置信区间[CI]，59.0%-100%）的涂片阳性病例和66.6%（95% CI，43.0%-85.4%）的培养阳性但涂片阴性病例。在每样本分析中，Xpert显示出与培养方法相似的灵敏度（54.7% [95% CI，42.7%-66.2%]）。Xpert检测到的确诊结核病例是涂片镜检的3倍，但速度相同。Xpert诊断出另外4例（8.5%）临床结核但培养阴性的病例。检测第二个和第三个样本，灵敏度分别提高了20%和16%。当结核病被可靠地排除时，Xpert的特异性为100%。HIV感染不影响Xpert的诊断准确性。Xpert易于操作，在疑似结核病的儿童中显示出与培养方法相似的诊断准确性。快速的周转时间应减少治疗延迟并改善患者的预后，尽管敏感性仍不理想，并且访问依赖于当地实验室基础设施。
Background. Diagnosis and timely treatment of tuberculosis in children is hampered by the absence of fast and reliable tests, especially in the era of human immunodeficiency virus (HIV). The aim of this study was to evaluate the diagnostic performance of the Xpert MTB/RIF assay (Xpert) in children with suspected tuberculosis in a high tuberculosis/HIV-burden setting.Methods. In a prospective study with a minimum follow-up of 12 months, 164 children with suspected tuberculosis were assigned to predefined diagnostic subgroups, based on microbiological and clinical findings. Results of smear microscopy and culture were compared against diagnostic performance of Xpert.Results. Twenty-eight of 164 children (17.1%) had confirmed tuberculosis. Xpert detected 100% (95% confidence interval [CI], 59.0%-100%) of smear-positive cases and 66.6% (95% CI, 43.0%-85.4%) of culture-positive but smear-negative cases. In the per-sample analysis, Xpert displayed a similar sensitivity (54.7% [95% CI, 42.7%-66.2%]) compared with culture methods. Xpert detected 3-fold more confirmed tuberculosis cases than smear microscopy but with equal rapidity. Four additional cases (8.5%) with clinical tuberculosis but negative culture were diagnosed by Xpert. Testing second and third samples increased sensitivity by 20% and an additional 16%, respectively. When tuberculosis was reliably excluded, Xpert's specificity was 100%. HIV infection did not affect diagnostic accuracy of Xpert.Conclusions. Xpert was easy to perform and displayed similar diagnostic accuracy as culture methods in children with suspected tuberculosis. Rapid turnaround times should reduce treatment delay and improve patient outcome, although sensitivity remains suboptimal and access is dependent on local laboratory infrastructure.