Clinical evaluation of a new single-tube multiplex reverse transcription PCR assay for simultaneous detection of 11 respiratory viruses, Mycoplasma pneumoniae and Chlamydia in hospitalized children with acute respiratory infections.
Clinical evaluation of a new single-tube multiplex reverse transcription PCR assay for simultaneous detection of 11 respiratory viruses, Mycoplasma pneumoniae and Chlamydia in hospitalized children with acute respiratory infections.
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DOI：
10.1016/j.diagmicrobio.2017.03.010
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发表时间：
2017-06
影响因子：
2.9
通讯作者：
Ma XJ
中科院分区：
文献类型：
--
作者：
Zhao MC;Li GX;Zhang D;Zhou HY;Wang H;Yang S;Wang L;Feng ZS;Ma XJ
呼吸道病原体13检测试剂盒（13×试剂盒）能够在单一反应中同时检测11种呼吸道病毒、肺炎支原体（MP）和衣原体。使用572例住院儿童鼻咽吸出物，评价13×试剂盒检测11种呼吸道病毒的临床性能，并与中国省级疾病预防控制中心常规使用的双管多重逆转录PCR检测（双管检测）进行比较。通过商业实时定量PCR（qPCR）试剂盒或测序评价13×试剂盒检测MP和衣原体的临床性能。对于供试病毒，试验一致性为95.98%，kappa系数为0.89。13×试剂盒检测MP和衣原体阳性标本均为真阳性。在临床环境中使用13×试剂盒将有助于医生根据病毒类型或多重感染评估临床结局，并限制抗生素的使用。13×试剂盒可同时检测MP和Ch等11种呼吸道病毒，检出率与双管法相当（kappa >0.75）。13×试剂盒的敏感性和特异性分别为97.41%和91.89%。 通过qPCR/测序验证13×试剂盒检测到的MP和衣原体为真阳性。
Respiratory Pathogen 13 Detection Kit (13× kit) is able to simultaneously detect 11 respiratory viruses, Mycoplasma pneumoniae (MP) and Chlamydia in a single reaction. Using 572 Nasopharyngeal aspirates collected from hospitalized children, the clinical performance of 13× kit for detecting 11 respiratory viruses was evaluated in comparison with a routinely used 2-tube multiplex reverse transcription PCR assay (2-tube assay) at provincial Centers for Disease Control and Prevention in China. The clinical performance of 13× kit for detecting MP and Chlamydia was evaluated by commercial real-time quantitative PCR (qPCR) kits or sequencing. For tested viruses, the assay concordance was 95.98% and the kappa coefficient was 0.89. All the MP and Chlamydia positive samples detected by 13× kit were confirmed as true positives. The utilization of the 13× kit in clinical settings will be helpful for doctors to assess clinical outcome according to virus type or multiple infections, and to limit the use of antibiotics. A 13× kit allowed for simultaneous detection of 11 respiratory viruses, MP and Ch. The detection rate of 13× kit was comparable to that of 2-tube assay (kappa >0.75). A 13× kit has high sensitivity (97.41%) and specificity (91.89%). MP and Chlamydia detected by 13× kit were verified by qPCR/sequencing as true positives.
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