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B族链球菌诊断测定通过FDA认证

By LabMedica International staff writers
Posted on 27 Aug 2018
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图片:在288分子系统上运行NeuMoDx GBS测定(图片蒙NeuMoDx Molecular公司惠赐)。
图片:在288分子系统上运行NeuMoDx GBS测定(图片蒙NeuMoDx Molecular公司惠赐)。

B族链球菌(GBS)是一种革兰氏阳性菌,存在于10%35%的健康成人体内,是人体内的一种常见细菌。携带GBS且不表现GBS疾病症状的人被称为GBS定植

 

然而,一般不认为GBS定植是传染性的,某些情况下,GBS可能侵入人体,引起严重感染;这被称为B族链球菌病。它是新生儿致命细菌感染的首要原因,这些新生儿通过生产过程中(母亲到婴儿)的垂直传播染病。每年发生约2,000例新生儿感染,估计死亡率为每1,000名存活新生儿0.27

 

美国密歇根州安娜堡市NeuMoDx Molecular公司(www.neumodx.com)的高通量分子诊断平台与B族链球菌测定已通过美国食品药品管理局(FDA, Silver Springs, MD, USA; www.fda.gov)510(k)认证。288分子系统是一套从样本到结果的自动化诊断平台,能以连续随机取放模式运行多达288份病人样本。该公司称,得到第一批结果约需一小时,无人值守的时间窗超过六小时,NeuMoDx公司给该系统设计的使用场合是医院的中央实验室和临床参考实验室。

 

GBS定植的化验通常在妊娠的第三个三月期进行,以预防分娩和生产过程中传染给新生儿。NeuMoDx GBS测定是一种定性的基于聚合酶链反应(PCR)的诊断检验,可检测pcsB基因的88碱基对区域,并集成了样本裂解、自动提取DNA与实时PCR。该公司说该测定相对于一项多中心临床性能研究的灵敏度是97%,特异性是96%

 

革命性的干型试剂无需冷藏,机载稳定期超过60天,极其稳定,常温储藏的保存期超过一年。此外,干试剂的单元化形式极大提升了操作效率,同时最大程度减少了要求手工重组和/或使用大批量冻干试剂的系统造成的浪费。

Related Links:

 

美国食品药品管理局>>> www.fda.gov

NeuMoDx Molecular >>> www.neumodx.com


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