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在儿童结核病中进行Xpert Ultra测试的便处理方法:一个前性的,多国准确性研究.
Devan Jaganath1,2, Pamela Nabeta3, Mark P Nicol4
1Division of Pediatric Infectious Diseases, University of California, San Francisco, San Francisco, USA.
使用Xpert Ultra进行儿童结核病 (TB) 检测的无离心机便处理方法被发现是可以接受和可用的. 各种方法的表现相似,培养阳性结核病例的灵敏度更高.
科学领域:
- 微生物学 微生物学
- 传染性疾病 传染性疾病
- 儿科 儿科 儿科
背景情况:
- 在儿童结核病 (TB) 中进行便Xpert Ultra测试的无离心机方法正在出现.
- 关于这些新型结核病诊断方法的准确性,可接受性和可用性的数据有限.
研究的目的:
- 未来评估三种无离心机便处理方法的准确性,可接受性和可用性,用于Xpert Ultra测试可能患有结核病的儿童.
- 为了比较便处理套件 (SPK),简单的一步 (SOS) 和优化糖漂浮 (OSF) 与参考标准的性能.
主要方法:
- 一项前性研究涉及607名儿童 (<15岁) 在印度,南非和乌干达被认为患有结核病.
- 便样本使用SPK,SOS和OSF进行处理,随后进行Xpert Ultra测试.
- 与微生物学参考标准 (MRS) 和复合参考标准 (CRS) 相比,评估了准确性;调查了实验室工作人员的可用性和可接受性.
主要成果:
- 对SPK,SOS和OSF对MRS的敏感性分别为36.9%,38.6%和31.3%;特异性很高 (97.1-98.2%).
- 实验室工作人员发现这些方法是可以接受和可用的,SOS被认为是外围环境中最可行的.
- 在培养阳性儿童中,敏感性显著改善 (55-77.3%),但与CRS (13-16.7%) 相比仍然很低.
结论:
- 对于Xpert Ultra,无离心机便处理方法 (SPK,SOS,OSF) 是可接受的,可用于儿童结核病诊断.
- 这两种方法表现相似,对培养阳性结核病例的敏感性有显著改善.
- 可能需要进一步的研究来优化灵敏度,特别是对复合参考标准.
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