Rowe D S, Anderson S G, Grab B
Bull World Health Organ. 1970;42(4):535-52.
A pooled human serum, partly diluted, has been distributed into ampoules and freeze-dried in several batches. The freeze-dried material has been examined in an international collaborative assay and certain properties have also been estimated in individual laboratories.On the basis of these tests this material was considered to be suitable for use as a standard for the estimation of IgG, IgA and IgM for clinical purposes using the single-radial-diffusion or similar techniques. Greater uniformity of results than is obtained at present should be achieved if this material were in general use.Estimates of immunoglobulins from different laboratories using this material as a standard showed small but significant variability. This variability was probably related to the heterogeneity of immunoglobulins and of antisera, and it limits the precision of immunoglobulin estimations by techniques at present in use.Batches of this material have been distributed to various centres. 67/68 has been established as the British research standard for human serum immunoglobulins IgG, IgA and IgM for which the unit of potency is defined as the activity present in 0.8147 mg of dry powder. The average activity per ampoule of 67/86 is 100 units of IgG, IgA and IgM. The average activities of other related preparations have been estimated.
一份经过部分稀释的混合人血清已分装入安瓿并分几批进行冻干。冻干材料在一项国际协作测定中进行了检验，某些特性也在个别实验室进行了评估。基于这些测试，该材料被认为适用于作为使用单向辐射扩散或类似技术进行临床目的IgG、IgA和IgM测定的标准品。如果该材料得到普遍使用，应能实现比目前更高的结果一致性。使用该材料作为标准品，不同实验室对免疫球蛋白的测定显示出虽小但显著的变异性。这种变异性可能与免疫球蛋白和抗血清的异质性有关，并且它限制了目前使用的技术对免疫球蛋白测定的精密度。该材料的批次已分发到各个中心。67/68已被确立为英国人类血清免疫球蛋白IgG、IgA和IgM的研究标准品，其效价单位定义为0.8147毫克干粉中所含的活性。67/86每安瓿的平均活性为100单位的IgG、IgA和IgM。其他相关制剂的平均活性也已进行了评估。
