Rastogi S C, Seligmann E B, Hochstein H D, Dawson J H, Farag L G, Marquina R E
Appl Environ Microbiol. 1979 Nov;38(5):911-5. doi: 10.1128/aem.38.5.911-915.1979.
A study was designed to estimate variability of the Limulus amoebocyte lysate test by comparing a reference lysate against itself. Three technicians performed parallel tests, i.e., titrated side by side, the contents of two vials of reference lysate on 4 different days using 24 vials of the United States reference lysate and 12 vials of the United States reference endotoxin. Each parallel test was replicated three times. From the sensitivity endpoints, ratios were calculated for each parallel test. These ratios were converted to the logarithm for estimating variability among technicians and among vials of endotoxin. By using the overall variability of log ratios, a statistical procedure was developed to evaluate the sensitivity of each lot of licensed lysate submitted to the Bureau of Biologics for release.
设计了一项研究，通过将一种参比裂解物与其自身进行比较来估计鲎试剂检测的变异性。三名技术人员进行了平行试验，即在4个不同日期，使用24瓶美国参比裂解物和12瓶美国参比内毒素，并排滴定两小瓶参比裂解物的内容物。每次平行试验重复三次。从灵敏度终点，计算每次平行试验的比值。这些比值被转换为对数，以估计技术人员之间以及内毒素瓶之间的变异性。通过使用对数比值的总体变异性，开发了一种统计程序来评估提交给生物制品局进行放行的每批许可裂解物的灵敏度。
