Fuller V J, Kolb R W
Appl Microbiol. 1968 Mar;16(3):458-62. doi: 10.1128/am.16.3.458-462.1968.
The potency of the U.S. Reference Smallpox Vaccine, Lot 2, the International Reference Preparation of Smallpox Vaccine, and commercial smallpox vaccines was determined by the chorioallantoic membrane (CAM) and rabbit scarification (RS) potency assay methods. The mean titer of the U.S. Reference (based on 107 ampoules) was 10(8.1) pock-forming units (PFU) per ml and that of the International Reference (based on 3 ampoules) was 10(7.8) PFU/ml. A statistical analysis of the CAM data for the U.S. Reference resulted in the establishment of a table of limits of acceptance for smallpox vaccines. Of the commercial smallpox vaccines tested by the CAM and RS methods, 89% demonstrated potencies comparable to the U.S. Reference. Our results show that the CAM test method has application in the control testing of smallpox vaccines produced by U.S. licensed manufacturers provided it is used within the limits discussed.
通过绒毛尿囊膜（CAM）和兔划痕（RS）效价测定方法，测定了美国参考天花疫苗第2批、国际天花疫苗参考制剂以及商用天花疫苗的效价。美国参考疫苗（基于107支安瓿）的平均效价为每毫升10(8.1)个痘疱形成单位（PFU），国际参考疫苗（基于3支安瓿）的平均效价为每毫升10(7.8) PFU。对美国参考疫苗的CAM数据进行统计分析后，制定了天花疫苗的验收限度表。通过CAM和RS方法检测的商用天花疫苗中，89%的效价与美国参考疫苗相当。我们的结果表明，只要在讨论的限度内使用，CAM检测方法可应用于美国持牌制造商生产的天花疫苗的对照检测。
