FDA核准定性抗HCV免疫檢驗法
作者：Yael Waknine
出處：WebMD醫學新聞
June 2, 2010 — 美國食品藥管理局（FDA）核准上市前電化學螢光染色法（Elecsys Anti-HCV；羅氏診斷集團）用於定性偵測人類血清或血漿C型肝炎（HCV）病毒。
HCV感染主要是經由血液或血液製品的汙染而得，且通常會導致慢性肝炎或肝硬化；這也證實與發生肝細胞惡性腫瘤有關。
這個只要18分鐘的免疫檢驗結果適用於與其他檢驗結果、臨床資訊結合，作為高風險以及那些有相關病徵與症狀病患之HCV預先診斷的一個輔助工具。
根據該公司新聞稿，抗HCV檢驗已經被核准在3種由羅氏製造的平台上：獨立的Cobas e 411分析儀，用於少量檢驗，以及Cobas e 601與Modular Analytics e 170分析儀，這些分別用於中量與大量檢驗的穩固檢驗/臨床化學系統的模組。
這項檢驗將於2010年7月開始發送。
4月時，FDA通過510 k清除率作為另一個電化學螢光免疫檢驗（Elecsys Rubella IgM；羅氏），用於人類血清與血漿中麻疹病毒免疫球蛋白M抗體的定性檢驗。這項檢驗適用於急性或最近麻疹感染，特別是懷孕年齡女性的預先診斷輔助工具。
FDA Approves Qualitative Anti-HCV Immunoassay
By Yael Waknine
Medscape Medical News
June 2, 2010 — The US Food and Drug Administration (FDA) has granted premarket approval for an electrochemiluminescence immunoassay (Elecsys Anti-HCV; Roche Diagnostics Corp) for the qualitative detection of total antibodies to the hepatitis C virus (HCV) in human serum or plasma.
HCV infection is primarily contracted through contaminated blood and blood products and frequently leads to chronic hepatitis and cirrhosis; it has also been linked to the development of hepatocellular carcinoma.
Results of the 18-minute immunoassay are indicated in conjunction with other laboratory results and clinical information as an aid for the presumptive diagnosis of HCV infection in at-risk patients and those with related signs and symptoms. The test does not determine the state of infection or associated disease.
According to a company news release, the anti-HCV test has been approved for use on 3 platforms made by Roche: the stand-alone Cobas e 411 analyzer for low-volume testing and the Cobas e 601 and Modular Analytics e 170 analyzers, which are modules of consolidated immunoassay/clinical chemistry systems for midvolume and high-volume testing, respectively.
The test is expected to ship in July 2010.
In April, the FDA granted 510k clearance for another electrochemiluminescence immunoassay (Elecsys Rubella IgM; Roche) for the qualitative determination of immunoglobulin M antibodies to rubella virus in human serum and plasma. The test is indicated as an aid in the presumptive diagnosis of acute or recent rubella infection, particularly in women of childbearing age.
