Hilfenhaus J W, Gregersen J P, Mehdi S, Volk R
Cancer Detect Prev. 1990;14(3):369-75.
Human retroviruses causing AIDS (HIV-1, HIV-2) can occur in human plasma donations. Since HIV-contaminated plasma cannot be completely excluded by testing for anti-HIV-1 (routine plasma screening for anti-HIV-2 has not yet been established), a safeguard against AIDS in therapeutics derived from human plasma can only be achieved by introducing HIV inactivating/eliminating methods into the manufacturing process of plasma derivatives. To investigate the HIV inactivating efficiency of such methods, aliquots of infectious HIV-1 or HIV-2 concentrates were added to a protein preparation, the resulting HIV spiked preparation was then treated according to the method to be studied, and the amount of infectious HIV in this preparation was determined before and after treatment. Methods by which HIV-1 or HIV-2, respectively, were completely inactivated were ethanol fractionation according to the Cohn procedure, pepsin treatment, affinity chromatography, protein precipitation by various methods, and pasteurization (heat treatment at 60 degrees C in aqueous solution). The use of these methods for manufacturing human plasma derivatives resulted in products that were free of any infectious HIV-1 or HIV-2 and thus unable to transmit AIDS.
导致艾滋病的人类逆转录病毒（HIV-1、HIV-2）可存在于人类血浆捐献物中。由于通过检测抗HIV-1无法完全排除受HIV污染的血浆（针对抗HIV-2的常规血浆筛查尚未确立），要保障源自人类血浆的治疗产品不传播艾滋病，只能通过在血浆衍生物的制造过程中引入HIV灭活/去除方法来实现。为研究此类方法的HIV灭活效率，将等分的具有感染性的HIV-1或HIV-2浓缩物添加到一种蛋白质制剂中，然后将所得的加样HIV制剂按照待研究的方法进行处理，并在处理前后测定该制剂中具有感染性的HIV量。分别可使HIV-1或HIV-2完全灭活的方法有按照科恩程序进行乙醇分级分离、胃蛋白酶处理、亲和层析、用各种方法进行蛋白质沉淀以及巴氏消毒法（在水溶液中60摄氏度热处理）。使用这些方法制造人类血浆衍生物所得到的产品不含任何具有感染性的HIV-1或HIV-2，因而不会传播艾滋病。
