FDA批准首个实时PCR检测用于流感病毒A/B检测

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　罗氏公司近日宣布，其cobas 流感A / B病毒检测已被FDA批准可用于cobas LIAT系统。

　　该公司在9月22日发布了相关消息，据悉这是首个获得临床实验室改进法案(Clinical Laboratory Improvement Amendments）免除的检测，实时PCR检测可在约20分钟及以内通过鼻咽拭子标本的RNA检测就可以检测并区分A型流感病毒和B型流感病毒的。

　　据罗氏诊断首席运营官 Roland Diggelmann 在新闻稿中说道“今天针对 cobas 流感病毒A/B检测的CLIA免除让实时PCR技术（实时PCR技术是分子诊断的金标准）可以在即时检测（POCT）中获得应用并可以快速的检测并区分流感病毒A型和B型。”

　　他还说道，“感染流感病毒后的有效治疗需要依赖在发病内48小时的精确检测，而这对基于现有实验室的周转时间获得检测结果来说是一个挑战。而cobas 流感病毒A/B检测可以在20分钟内提供符合实验室质量的PCR检测结果，从而确保医生可以快速的对患者病情作出自信的诊断并尽可能快的做出治疗。”

　　另据该公司介绍，该项检测“提供了超过30种常见的流感A型和B型菌株的检测覆盖。”

　　cobas 流感病毒A/B检测是第二种获得 CLIA 免除可用在cobas LIAT系统的方法。罗氏的 cobas Strep A 检测获得CLIA 免除是在2015年的5月份。cobas LIAT分析仪、Ccobas流感A/ B检测和cobas链球菌A检测均获得(Community European欧洲共同体、CE) 认证标志，并获得FDA批准和 CLIA 免除。

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FDA Clears First Real-time PCR Test for Influenza A/B

The US Food and Drug Administration (FDA) has cleared thecobas Influenza A/B test for use on the cobas Liat System, according to manufacturer Roche.

It is the first Clinical Laboratory Improvement Amendments (CLIA)-waived, real-time polymerase chain reaction (PCR) test to detect and differentiate influenza A virus and influenza B virus in RNA in nasopharyngeal swab specimens in about 20 minutes or less, the company notes in a September 22 news release.

"Today's CLIA waiver for the cobas Influenza A/B test allows real-time PCR technology, the gold standard in molecular testing, to be utilized at the point of care to accurately and quickly detect and differentiate influenza A and B," Roland Diggelmann, chief operating officer of Roche Diagnostics, said in the release.

"Effective management of influenza relies on accurate detection within 48 hours of onset, which can be challenging with current turnaround times for lab-based test results. The cobas Influenza A/B test provides lab-quality PCR results in ~20 minutes, enabling health care providers in all settings to give prompt and confident diagnosis and treatment to patients," he added.

According to the company, the test "provides broad strain coverage of over 30 commonly found strains of influenza A and B."

The cobas Influenza A/B test is the second assay on the cobas Liat System to receive CLIA waiver. Roche's cobas Strep A test received CLIA waiver in May 2015. The cobas Liat Analyzer, cobas Influenza A/B test, and cobas Strep A test are CE Marked, cleared by the FDA and CLIA waived, the company notes.