流式微载体技术检测类风湿因子方法的研究

Flow Cytometric Microcarrier Assay in Determination .of Rheumatoid Factor （RF） in Rheumatoid Arthritis

目的建立基于流式微载体技术（flowcytometricmicrocarrierassay，FCMA）的血清类风湿因子（RF）的检测方法.方法分别用FCMA和酶联免疫吸附试验（ELISA）检测89例类风湿性关节炎（RA）患者、52例非RA的自身免疫性疾病患者和60例健康对照血清标本中IgM—RF和IgA—RF.结果FCMA所测IgM—RF的组内和组间CV分别为3．1%±1．7%和5．6%±2．2%，显著（P〈0．05）低于ELISA组（6．7%±3．6%和11%±3．9%）.IgA—RF亦是如此.以健康体检者为对照，FCMAIgM—RF和IgA—RF敏感度为80．9%和77．5%，特异度均为98．3%.以非RA的自身免疫性疾病患者为对照，FCMAIgM—RF和IgA—RF的敏感度为80．9%和77．5%，特异度为80．7%和82．7%.FCMA结果显著（P〈0．05）高于ELISA结果.结论结果提示测定血清RF，FCMA比ELISA有更好的灵敏度、特异度和稳定性，建议临床推广和应用.

Objective To develop a flow cytometric microcarrier assay （FCMA） for detection of rheumatoid factor （RF） in rheumatoid arthritis（RA）. Methods Sera IgM-RF and IgA-RF were detected in RA patients （89 cases）,non-RA patients （52 cases）,and healthy control subjects （60 cases） by FCMA and ELISA,respectively. Results In FCMA,Intra-and inter-group coefficient of variation （CV） of IgM-RF were to 3.1% ± 1.7 % and 5.6 % ±2.2 % ,respectively,significantly lower （P〈0. 05） when compared to that by ELISA（6. 7%±3. 6% and 11%±3.9%）. Similar results were observed for IgARF. Comparing with the normal control subjects, the sensitivities and specificities of IgM-RF and IgA-RF in RA patients were 80.9% and 77. 5%, 98. 3%, respectively. Comparing with non-RA patients, the sensitivities and specificities were 80. 9% and 77.5% ,80. 7% and 82.7% ,respectively. All of which were significantly higher （P（0. 05） than that examined by ELISA. Conclusion Results suggest that FCMA has higher sensibility, specificity,and stability compared to ELISA, and has higher clinical application value.