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。 作者: wwwkkk83 时间: 2015-9-24 14:05
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.