HIV-1、HIV-2快速诊断试验已获FDA批准

8月8日，首个可同时检测HIV-1 p24抗原以及HIV-1和HIV-2抗体的快速诊断试验通过了美国食品药品管理局(FDA)的核准。

与其他HIV检测方法相同，Alere Determine HIV-1/2 Ag/Ab联合检测可检出人体静脉和指尖血样品的血清、血浆中的HIV-1（最常见的HIV类型）和HIV-2抗体。不同的是，新的检测方法可区分急性HIV-1感染和既有的HIV-1感染。如血液样品为HIV-1 p24抗原阳性，而HIV-1和 HIV-2抗体阴性，则为急性HIV-1感染。


Karen Midthun博士

对于识别在传统医疗机构中可能无法检出的HIV感染个体，这种新的检测方法可作为一种重要工具，FDA生物学评估与研究中心主管Karen Midthun博士在声明中指出：“这种检测方法有助于在更大范围内更早诊断HIV感染，使感染患者可更快寻求医疗服务。”

Orgenics公司是Alere Determine HIV-1/2 Ag/Ab联合检测方法的制造商。

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By: MIKE BOCK, Ob.Gyn. News Digital Network

The first rapid diagnostic test to simultaneously detect the HIV-1 p24 antigen and antibodies to both HIV-1 and HIV-2 earned Food and Drug Administration approval August 8.

Like other HIV tests, the Alere Determine HIV-1/2 Ag/Ab Combo test can detect antibodies to HIV-1, the most common type of HIV, and HIV-2 in human serum, plasma, or venous and fingerstick blood specimens.
 
But the new test also can distinguish acute HIV-1 infection from established HIV-1 infection, if the blood specimen is positive for HIV-1 p24 antigen but negative for HIV-1 and HIV-2 antibodies.

The new test could be a crucial tool for identifying HIV-infected individuals who might not be able to be tested in traditional health care settings, said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

"This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner," Dr. Midthun explained.

Orgenics makes the Alere Determine HIV-1/2 Ag/Ab Combo test.