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HIV组合检测工具获得临床实验室改进修正案豁免

By LabMedica International staff writers
Posted on 14 Apr 2015
一种能检测出人类免疫缺陷病毒(HIV-1/2)抗体和无HIV-1 p24抗原的快速即时检测工具已获得临床实验室改进修正案(CLIA)豁免。
该检测工具已获准在美国销售,供授权开展复杂度中等检验的卫生机构和实验室使用,现在获得此项批准后将可在医生办公室、临床和其他公共卫生环境中使用。
美国食品药品管理局(FDA;Silver Springs,MD,USA)已授权第四代Alere Determine HIV-1/2 Ag/Ab组合检测(Alere;San Diego,CA,USA)豁免CLIA。该检测工具可检测出仅在感染HIV抗体后能出现的p24抗原,此抗原出现在能检测出HIV抗体之前,可能在疾病早期过程检测出HIV感染。早期检测允许医疗服务提供者通过早期诊断和治疗HIV检测阳性的患者改善临床结果。
Rutgers University(Piscataway Township,NJ,USA)的病理学和实验室医学教授,Eugene Martin博士说明,“我很高兴得知Alere Determine HIV-1/2 Ag/Ab组合获得CLIA豁免,并将更广泛的用于HIV筛查。我们都期待第四代快速HIV检验工具,因为这样将允许筛选机构潜在识别早期HIV感染,并尽快引导最可能令其他人面临感染HIV风险的人及早接受治疗。”
Alere感染病全球总监Avi Pelossof说明,“Alere Determine HIV-1/2 Ag/Ab组合的CLIA豁免将有助于促进准确和早期检测HIV,在对于遏制美国艾滋病的蔓延很关键,并通过更接近患者的重要医疗保健服务产生积极的经济影响。扩展检验工具在实验室、医生办公室、临床和其他公共卫生环境的可用性,通过快速诊断推进Alere致力于提供可靠和可操作的信息的承诺。”

Related Links:
US食品药品管理局 
Alere 
Rutgers University 


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