Lytle C D, Truscott W, Budacz A P, Venegas L, Routson L B, Cyr W H
Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Maryland 20857.
Appl Environ Microbiol. 1991 Sep;57(9):2549-54. doi: 10.1128/aem.57.9.2549-2554.1991.
This study evaluated bacteriophages phi X174, T7, PRD1, and phi 6 as possible surrogates for pathogenic human viruses to challenge barrier materials and demonstrated some important factors for their use. Chemical incompatibility with test material was demonstrated when lipid-enveloped phi 6 was inactivated by an aqueous eluate of vinyl gloves, but 0.5% calf serum protected phi 6 from the eluate. Low concentrations (2%) of calf serum also prevented the exaggerated binding of the bacteriophages to filters. Recovery of viruses from surfaces decreased with increasing time before recovery. Penetration through punctures displayed different types of kinetics. The combined data indicate that (i) some bacteriophages may serve as surrogate viruses, (ii) experimental conditions determine whether a particular virus is appropriate as a challenge, and (iii) phi X174 is an excellent choice as a surrogate virus to test barrier materials. The data further indicate that before barrier materials are challenged with viruses, adequate tests should be performed to ensure that the virus is compatible with the test material and test conditions, so that meaningful data will result.
本研究评估了噬菌体φX174、T7、PRD1和φ6作为致病性人类病毒的可能替代物来挑战屏障材料,并证明了使用它们的一些重要因素。当包膜噬菌体φ6被乙烯基手套的水性洗脱液灭活时,证明了其与测试材料的化学不相容性,但0.5%的小牛血清可保护φ6免受洗脱液的影响。低浓度(2%)的小牛血清也可防止噬菌体与过滤器的过度结合。从表面回收病毒的效率随着回收前时间的增加而降低。通过穿刺的渗透表现出不同类型的动力学。综合数据表明:(i)一些噬菌体可作为替代病毒;(ii)实验条件决定了特定病毒是否适合作为挑战物;(iii)φX174是测试屏障材料的替代病毒的极佳选择。数据进一步表明,在用病毒挑战屏障材料之前,应进行充分的测试,以确保病毒与测试材料和测试条件相容,从而得出有意义的数据。