Evaluation of the Seeplex® Meningitis ACE Detection Kit for the Detection of 12 Common Bacterial and Viral Pathogens of Acute Meningitis
Evaluation of the Seeplex® Meningitis ACE Detection Kit for the Detection of 12 Common Bacterial and Viral Pathogens of Acute Meningitis
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DOI：
10.3343/alm.2012.32.1.44
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发表时间：
2012-01-01
影响因子：
4.9
通讯作者：
Koo, Sun Hoe
中科院分区：
文献类型：
--
作者：
Shin, So Youn;Kwon, Kye Chul;Koo, Sun Hoe
背景：细菌性脑膜炎是一种死亡率高、严重后遗症发生率高的传染病。早期识别致病细菌和病毒病原体对于及时和适当地治疗脑膜炎和预防危及生命的临床结果非常重要。在本研究中，我们评估了Seeplex脑膜炎ACE检测试剂盒(Seegene Inc.，Korea)的诊断价值。Seeplex ACE检测试剂盒是一种新开发的采用双重启动寡核苷酸方法的多重PCR试剂盒，用于诊断急性脑膜炎。方法：使用试剂盒所针对的每种病原体的参考菌株来研究该试剂盒的分析敏感性，同时使用人类基因组DNA和58株临床上鉴定良好的参考菌株来研究其分析特异性。临床验证实验采用27份对照脑脊液和78份临床脑脊液标本。结果：对12种病毒和细菌的检测下限为101份/亩L到5×10(1)份/亩L。未观察到交叉反应。在验证研究中，获得了56.4%的高检测率。结论：Seeplex脑膜炎血管紧张素转换酶检测试剂盒对临床脑脊液标本中病原体的鉴定具有较高的敏感性、特异性和检出率。该试剂盒可用于快速鉴定重要的急性脑膜炎病原体。
Background: Bacterial meningitis is an infectious disease with high rates of mortality and high frequency of severe sequelae. Early identification of causative bacterial and viral pathogens is important for prompt and proper treatment of meningitis and for prevention of life-threatening clinical outcomes. In the present study, we evaluated the value of the Seeplex Meningitis ACE Detection kit (Seegene Inc., Korea), a newly developed multiplex PCR kit employing dual priming oligonucleotide methods, for diagnosing acute meningitis.Methods: Analytical sensitivity of the kit was studied using reference strains for each pathogen targeted by the kit, while it's analytical specificity was studied using the human genome DNA and 58 clinically well-identified reference strains. For clinical validation experiment, we used 27 control cerebrospinal fluid (CSF) samples and 78 clinical CSF samples collected from patients at the time of diagnosis of acute meningitis.Results: The lower detection limits ranged from 101 copies/mu L to 5x10(1) copies/mu L for the 12 viral and bacterial pathogens targeted. No cross-reaction was observed. In the validation study, high detection rate of 56.4% was obtained. None of the control samples tested positive, i.e., false-positive results were absent.Conclusions: The Seeplex Meningitis ACE Detection kit showed high sensitivity, specificity, and detection rate for the identification of pathogens in clinical CSF samples. This kit may be useful for rapid identification of important acute meningitis-causing pathogens.