Merryman P, Louie P
Department of Medicine, Hospital for Joint Diseases Orthopaedic Institute, New York University Medical Center, NY 10003.
J Clin Pathol. 1991 Aug;44(8):685-9. doi: 10.1136/jcp.44.8.685.
The specificity and sensitivity of two commercial enzyme linked immunosorbent assays (ELISAs), Diamedix (Miami, Florida) and Lipogen (Noxville, Tennessee), were assessed and compared with haemagglutination and immunodiffusion assays. Sera from 53 patients with various connective tissue disorders were examined for the presence of antibodies to nuclear antigens (ANA), double stranded DNA (dsDNA), Sm, RNP, SSA/Ro, and SSB/La. Of the 53 patients, 42 were ANA positive, 11 were ANA negative, and 22 had antibodies to dsDNA. Seven patients had antibodies to Sm by haemagglutination assay; these were also positive in both ELISA systems (only five of the seven patients were assayed by the Lipogen ELISA system). Two additional Sm positive values were obtained in each of the ELISA systems but only one of these was positive in both. Ten positive RNP results were obtained by haemagglutination and nine of these were also positive by the Diamedix ELISA. Only eight samples were tested by the Lipogen assay and seven of these were positive. Three additional RNP positive values were obtained by the Diamedix and six by the Lipogen ELISA assays. Of these, only two were positive in both. Antibodies to SSA/Ro were obtained in 11 patients by immunodiffusion and lines of partial identity were observed in nine. SSB/La antibodies were positive in six patients and two had lines of partial identity. All the SSA/Ro and SSB/La positive sera were also positive in both ELISA systems. Moreover, eight additional SSA/Ro positive values were obtained in each of the ELISAs, four of which had partial identity lines in the immunodiffusion assay. Furthermore, three additional SSB/La positive values were obtained by the Diamedix and four by the Lipogen assays. Of these, only two were positive in both ELISAs. This study shows that the above ELISAs are comparable in specificity and sensitivity with haemagglutination assay for detection of antibodies to Sm and RNP antigens and are more sensitive than immunodiffusion for the detection of SSA/Ro and SSB/La antigens.
对两种商业酶联免疫吸附测定法（ELISA），即Diamedix（佛罗里达州迈阿密）和Lipogen（田纳西州诺克斯维尔）的特异性和敏感性进行了评估，并与血凝试验和免疫扩散试验进行了比较。检测了53例患有各种结缔组织疾病患者的血清中核抗原（ANA）、双链DNA（dsDNA）、Sm、RNP、SSA/Ro和SSB/La抗体的存在情况。53例患者中，42例ANA阳性，11例ANA阴性，22例有dsDNA抗体。血凝试验检测出7例患者有Sm抗体；这7例在两种ELISA系统中也均为阳性（7例患者中仅5例通过Lipogen ELISA系统检测）。每种ELISA系统还另外获得了2个Sm阳性结果，但其中只有1个在两种系统中均为阳性。血凝试验获得10个RNP阳性结果，其中9个通过Diamedix ELISA也为阳性。Lipogen测定法仅检测了8个样本，其中7个为阳性。Diamedix ELISA另外获得3个RNP阳性结果，Lipogen ELISA获得6个。其中，只有2个在两种方法中均为阳性。免疫扩散法检测出11例患者有SSA/Ro抗体，其中9例观察到部分同源条带。6例患者的SSB/La抗体为阳性，2例有部分同源条带。所有SSA/Ro和SSB/La阳性血清在两种ELISA系统中也均为阳性。此外，每种ELISA还另外获得8个SSA/Ro阳性结果，其中4个在免疫扩散试验中有部分同源条带。此外，Diamedix另外获得了3个SSB/La阳性结果，Lipogen测定法获得4个。其中，只有2个在两种ELISA中均为阳性。本研究表明，上述ELISA在检测Sm和RNP抗原抗体方面的特异性和敏感性与血凝试验相当，在检测SSA/Ro和SSB/La抗原方面比免疫扩散更敏感。
