8分钟检测A群链球菌感染 Alere分子诊断试剂获FDA批准

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美艾利尔（Alere）公司开发的诊断试剂Alere i Strep A test日前获得了FDA批准，用于A群链球菌的检测，最多8分钟就能从咽拭子标本中检测出患者是否发生感染。

“Alere i Strep A test能让临床诊断变得快速、高效、准确，及时给出恰当的治疗方案。避免盲目滥用抗生素，提高患者治愈率。”美艾利尔传染病业务部全球总监Avi Pelossof在新闻发布会上这样说道。

美艾利尔也提交了《临床实验室改进修正案》（CLIA）豁免申请，希望能在除一般实验室外的场所应用该试剂盒，比如医生办公室、医院急诊科以及健康诊所。

这个试剂盒应用了美艾利尔的专利技术—核酸等温快速扩增技术，与普通的聚合酶链式反应（PCR）不同，这项新技术不需要反复的热循环以及复杂的DNA纯化，在较宽的条件范围内，能快速扩增核酸分子，给出结果。

同样使用该技术的产品还有流感病毒检测试剂盒。2014年6月，美艾利尔对于A型和B型流感病毒的检测和分型试剂盒获得了FDA批准。2015年1月，美艾利尔流感病毒检测试剂盒被授予CLIA豁免权。

“Alere i Strep A test增加了Alere i平台的检测项目，扩大了适用人群。”美艾利尔公司负责人说，“A群链球菌缺少季节特征，全年范围内都可能发生感染，人们应该及时用Alere i Strep A test进行检测。”  

英文原文：Rapid Group A Strep Test Clears FDA
The US Food and Drug Administration (FDA) has approved marketing clearance for the Alere i Strep A test (Alere Inc), the first molecular test that detects group A streptococcus bacteria in throat swab specimens in 8 minutes or less, the company said today.

"The speed and accuracy of the Alere i Strep A test empower healthcare professionals to initiate the right treatment in an actionable timeframe, which is a critical step in reducing unnecessary prescription of antibiotics and enhancing operational efficiency," Avi Pelossof, Alere's global president of infectious disease, said in a news release.

Alere has submitted an application for a Clinical Laboratory Improvement Amendments waiver for the test, which would allow it to be used in nontraditional laboratory sites such as physician offices, hospital emergency departments, and health department clinics.
The new test uses Alere's proprietary Molecular in Minutes isothermal nucleic acid amplification technology. Unlike polymerase chain reaction tests, isothermal nucleic acid amplification technology does not require lengthy and complex thermocycling or DNA purification, and can therefore deliver polymerase chain reaction–caliber results more quickly and in a broad range of settings, the company notes.

The Alere i molecular platform was initially cleared for marketing by the FDA for the detection and differentiation of influenza A and B virus in June 2014.

In January 2015, the Alere i Influenza A & B Test became the first molecular test to receive a CLIA waiver.

"Expanding the menu on the Alere i platform to include Strep A and potentially other assays increases the utility of the platform for a wider range of users," the company said. "Furthermore, given the less seasonal nature of Strep A, its addition enhances the value of the platform for users on a year-round basis."