Ritchie R F, Palomaki G E, Neveux L M, Navolotskaia O
Foundation for Blood Research, Scarborough, Maine 04074, USA.
J Clin Lab Anal. 1998;12(6):371-7. doi: 10.1002/(SICI)1098-2825(1998)12:6<371::AID-JCLA7>3.0.CO;2-T.
Clinical interpretation of immunoglobulin measurements requires accurate and precise assays and widely accepted reference preparations, as well as reliable age- and gender-specific reference ranges. This last requirement, the topic of numerous publications, has not been addressed adequately. By a combination of computerized and hand searching of the literature from 1961 to 1997, we identified 109 publications presenting IgA, IgG, and/or IgM reference data in healthy individuals. After eliminating studies that lacked appropriate clinical, statistical, or reference material information, data from the 17 acceptable studies were converted to a common reference material, CRM 470/RPPHS. When median levels from our recently published large cohort study are superimposed on these published medians, they fall within the ranges of reported medians. The widths of published 95 percentile reference ranges (where each individual's health was verified) were also found to agree closely with the reference range widths found in our data (where inclusion was based on the reported diagnosis). The current combined study of narrowly applied reference ranges validates our recently published age- and gender-specific reference data for immunoglobulinsA, G, and M. Those new data can now be considered as a source of reliable reference ranges to be used by laboratories when interpreting immunoglobulin measurements.
免疫球蛋白测量的临床解读需要准确且精密的检测方法、广泛认可的参考制剂，以及可靠的针对特定年龄和性别的参考范围。最后一个要求，即众多出版物的主题，尚未得到充分解决。通过对1961年至1997年的文献进行计算机检索和手工检索相结合的方式，我们确定了109篇呈现健康个体中IgA、IgG和/或IgM参考数据的出版物。在剔除缺乏适当临床、统计或参考材料信息的研究后，将17项可接受研究的数据转换为一种通用参考材料CRM 470/RPPHS。当我们最近发表的大型队列研究中的中位数水平叠加在这些已发表的中位数上时，它们落在报告中位数的范围内。已发表的95%百分位数参考范围（其中每个个体的健康状况都经过核实）的宽度也被发现与我们数据中发现的参考范围宽度密切一致（其中纳入是基于报告的诊断）。当前对狭义应用参考范围的综合研究验证了我们最近发表的针对免疫球蛋白A、G和M的特定年龄和性别的参考数据。这些新数据现在可以被视为实验室在解读免疫球蛋白测量结果时使用的可靠参考范围的来源。
