中文摘要：Illumigene支原体蛋白直接扩增试剂盒（iMD）是利用LAMP技术体外直接检测呼吸道样本中肺炎支原体DNA。以往的iM 试剂盒通常需要对样本的核苷酸进行预纯化，而iMD试剂盒省去了这一步骤。本研究的目的是进行iMD试剂盒与iM 试剂盒的性能比较。结果表明：在456个样本中，iM 试剂盒检测出的阳性样本比例为5.5%，iMD试剂盒为7.5%；iMD试剂盒检测结果中出现了10个假阳性和1个假阴性样本。2种方法阳性率和阴性率的一致度分别为96%和97.7%。与iM试剂盒相比，iMD试剂盒免去了DNA提取步骤，在检测咽拭子肺炎支原体方面具有简单、省时、经济等优点。
 
外文摘要：Mycoplasma pneumoniae (MP) is a common cause of community-acquired pneumonia. The illumigene Mycoplasma Direct (iMD) DNA amplification assay is a qualitative in vitro test utilizing LAMP technology for the direct detection of MP DNA in respiratory specimens. The iMD assay does not require the pre-extraction of nucleic acid from specimens, which is a prerequisite step for the previously approved illumigene Mycoplasma (iM) assay. The aim of this prospective multicenter study was to evaluate the performance characteristics of the newly developed iMD assay with those of the iM assay. Subjects with symptoms of upper respiratory illness suggestive of MP were enrolled across three sites in the United States. Respiratory specimens were obtained using a dual throat swab. One swab was tested at each enrollment site by the iMD assay. Reference testing with iM assay was performed by the manufacturer. Among 456 specimens tested, the iM reference method detected MP in 25 (5.5%) specimens, while the iMD assay detected 34 (7.5%) specimens as MP positive. There were 10 false positive and one false negative detections with the iMD assay. The overall positive and negative percent agreement was 96.0% (95% CI 80.5-99.3%) and 97.7% (95% CI 95.8-98.7%), respectively. The overall percent agreement was determined to be 97.6% (95% CI 95.7-98.6%). We conclude that the iMD test results were comparable with the iM assay. The removal of DNA extraction step in the iMD assay simplifies testing, saves time, and reduces the expense of detecting MP from throat swabs when compared to the iM assay.
外文关键词：Mycoplasma pneumoniae； illumigene assay； LAMP technology
作者：Kanwar, N； Pence, MA； Mayne, D； Michael, J； Selvarangan, R
作者单位：美国儿童关爱医院和临床研究中心
期刊名称：JOURNAL OF CLINICAL MICROBIOLOGY
期刊影响因子：3.712
出版年份：2018
出版刊次：7
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