Feasibility and Sensitivity of Saliva GeneXpert MTB/RIF Ultra for Tuberculosis Diagnosis in Adults in Uganda.
Feasibility and Sensitivity of Saliva GeneXpert MTB/RIF Ultra for Tuberculosis Diagnosis in Adults in Uganda.
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DOI：
10.1128/spectrum.00860-22
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发表时间：
2022-10-26
影响因子：
3.7
通讯作者：
Davis, J. Lucian
中科院分区：
文献类型：
--
作者：
Byanyima, Patrick;Kaswabuli, Sylvia;Musisi, Emmanuel;Nabakiibi, Catherine;Zawedde, Josephine;Sanyu, Ingvar;Sessolo, Abdul;Andama, Alfred;Worodria, William;Huang, Laurence;Davis, J. Lucian
关键词：
本前瞻性观察性研究在乌干达坎帕拉的中乌友谊医院-纳古鲁进行，旨在确定GeneXpert MTB/RIF Ultra（Xpert Ultra）分子检测唾液对接受TB诊断评价且痰液检测结果为Xpert Ultra阳性的连续成人中活动性结核（TB）疾病的性能。我们计算了敏感性，以确定结核病诊断性能相比，结核分枝杆菌液体和固体培养物的两个现场痰标本的复合参考标准。相对于基于痰培养的复合参考标准，Xpert Ultra对单个唾液样本的灵敏度为90%（95%置信区间[CI]，81 - 95%），与荧光显微镜（FM）对两份痰涂片抗酸杆菌的复合灵敏度87%（95% CI，77 - 94%）相似。唾液Xpert Ultra的灵敏度低24%（差异的95% CI，2 - 48%; P = 0.003）（71%; 95% CI，44 - 90%）FM阳性患者（96%; 95% CI，87 - 99%）比FM阴性患者（50%; 95% CI，19 - 81%）高46%（95% CI，14 - 77%; P < 0.0001）。同一患者的痰液样本的半定量Xpert Ultra等级系统性高于配对唾液样本。总之，唾液分子检测用于活动性结核病诊断是可行的，并且在高结核病负担环境中几乎与痰液分子检测一样敏感。结核病是全球发病率和死亡率的主要原因之一，这在很大程度上是因为每年有超过300万人未经诊断和治疗。世纪以来，痰液一直是结核病诊断的主要依据，但患者很难产生痰液。此外，采集痰液时需要剧烈咳嗽，可能导致附近的个人和卫生工作者感染。在这项仅病例研究中，将超灵敏的GeneXpert MTB/RIF Ultra分子诊断检测试剂应用于唾液，在乌干达一家综合医院门诊部接受结核病评估的81名成人中检出了90%的培养确诊结核病病例，并检测出痰液GeneXpert MTB/RIF Ultra阳性。这些结果表明，唾液可能是一个可行的和敏感的替代痰结核病诊断，从而满足世界卫生组织提出的两个关键指标，在其目标性能概况的非痰结核病测试。
The objective of this prospective observational study carried out at China-Uganda Friendship Hospital-Naguru in Kampala, Uganda, was to determine the performance of GeneXpert MTB/RIF Ultra (Xpert Ultra) molecular testing on saliva for active tuberculosis (TB) disease among consecutive adults undergoing TB diagnostic evaluation who were Xpert Ultra positive on sputum. We calculated sensitivity to determine TB diagnostic performance in comparison to a composite reference standard of Mycobacterium tuberculosis liquid and solid cultures on two spot sputum specimens. Xpert Ultra on a single saliva sample had a sensitivity of 90% (95% confidence interval [CI], 81 to 95%) relative to the composite sputum culture-based reference standard, similar to the composite sensitivity of 87% (95% CI, 77 to 94%) for fluorescence microscopy (FM) for acid-fast bacilli on two sputum smears. The sensitivity of salivary Xpert Ultra was 24% lower (95% CI for difference, 2 to 48%; P = 0.003) among persons living with HIV (71%; 95% CI, 44 to 90%) than among persons living without HIV (95%; 95% CI, 86 to 99%) and 46% higher (95% CI, 14 to 77%; P < 0.0001) among FM-positive (96%; 95% CI, 87 to 99%) than among FM-negative (50%; 95% CI, 19 to 81%) patients. The semiquantitative Xpert Ultra grade was systematically higher in sputum than in a paired saliva sample from the same patient. In conclusion, molecular testing of saliva for active TB diagnosis was feasible and almost as sensitive as molecular testing of sputum in a high TB burden setting. IMPORTANCE Tuberculosis is among the leading causes of morbidity and mortality worldwide, in large part because >3 million people go undiagnosed and untreated each year. Sputum has been the mainstay for TB diagnosis for over a century but can be difficult for patients to produce. In addition, the vigorous coughing required during sputum collection can lead to infection of nearby individuals and health workers. In this case-only study, applying the ultra-sensitive GeneXpert MTB/RIF Ultra molecular diagnostic assay to saliva detected 90% of culture-confirmed TB cases among 81 adults who were undergoing TB evaluation at the outpatient department of a general hospital in Uganda and tested sputum GeneXpert MTB/RIF Ultra positive. These results suggest that saliva may be a feasible and sensitive alternative to sputum for TB diagnosis, thereby meeting two key metrics proposed by the World Health Organization in its target performance profile for a nonsputum test for TB.
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