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背景:人类白细胞抗原-B27与强直性脊柱炎等风湿病发病密切关联,对强直性脊柱炎有重要的辅助诊断价值。磁珠酶联免疫分析近来已应用于检测人类白细胞抗原-B27。目的:了解磁珠酶联免疫分析法检测人类白细胞抗原-B27的准确性、敏感性和特异性,探讨其在强直性脊柱炎辅助诊断中的价值。设计:金标准对照。单位:中山大学附属第三医院风湿科及检验科。对象:选择2002-12/2003-04首次于本院风湿科门诊或住院有腰痛和/或关节炎表现的86例患者。纳入标准:①有下腰痛和/或关节炎表现;②相关临床及辅助检查资料完整;③同意接受人类白细胞抗原-B27检测;④为首次在本院就诊或住院患者。排除临床或辅助检查资料不完整及患其他重大疾病者。86例患者中男56例,女30例,年龄12～65岁。方法:同时以磁珠酶联免疫分析和微量淋巴细胞毒试验法对入选患者血标本进行检测。以微量淋巴细胞毒试验法测定结果为金标准,统计两法结果的符合率,并计算磁珠酶联免疫分析检测人类白细胞抗原-B27的敏感度、特异度及阳性、阴性预测值。主要观察指标:①两种方法对人类白细胞抗原-B27检测结果的符合率。②磁珠酶联免疫分析检测人类白细胞抗原-B27的敏感度及特异度。结果:所有患者均进入结果分析。①对于33例强直性脊柱炎患者,磁珠酶联免疫分析检测人类白细胞抗原-B27的阳性率(90.9%)高于微量淋巴细胞毒试验法(87.9%),但差异无显著性意义(P>0.05)。②应用两法对33例强直性脊柱炎和53例有下腰痛和/或关节炎症状的其他患者测定人类白细胞抗原-B27,结果的总体符合率达93.0%。磁珠酶联免疫分析检测的敏感度为90.0%,特异度为95.7%,阳性预测值为94.7%,阴性预测值为91.7%。结论:对于强直性脊柱炎和其他风湿病患者,磁珠酶联免疫分析与微量淋巴细胞毒试验法均能可靠地检测人类白细胞抗原-B27,磁珠酶联免疫分析的敏感度和特异度均已达较高水平。
BACKGROUND: Human leukocyte antigen-B27 is closely associated with the onset of rheumatism such as ankylosing spondylitis. It is an important auxiliary diagnostic value for ankylosing spondylitis. Magnetic bead enzyme immunoassay has recently been applied to detect human leukocyte antigen-B27. OBJECTIVE: To understand the accuracy, sensitivity and specificity of magnetic beads ELISA in the detection of human leukocyte antigen-B27 and to explore its value in the auxiliary diagnosis of ankylosing spondylitis. Design: gold standard control. Unit: Third Affiliated Hospital of Sun Yat-sen Rheumatology and Laboratory. PARTICIPANTS: A total of 86 patients with low back pain and / or arthritis who were admitted to our rheumatology clinic or hospitalized for the first time from December 2002 to April 2003 were enrolled. Inclusion criteria: ① have low back pain and / or arthritis performance; ② relevant clinical and auxiliary examination complete information; ③ agreed to accept human leukocyte antigen-B27 test; ④ for the first time in our hospital or hospitalized patients. Exclude clinical or auxiliary examination of incomplete information and other major diseases. Among the 86 patients, 56 were male and 30 were female, ranging in age from 12 to 65 years. Methods: The blood samples of patients were tested by magnetic beads ELISA and trace lymphocyte cytotoxicity assay. The results of micro-cytotoxicity assay were the gold standard, and the coincidence rates of the two methods were calculated. The sensitivity, specificity, positive and negative predictive value of magnetic beads ELISA for detecting human leukocyte antigen-B27 were calculated. MAIN OUTCOME MEASURES: ① The coincidence rates of the two methods on human leukocyte antigen-B27 test results. ② magnetic beads enzyme-linked immunosorbent assay to detect human leukocyte antigen B27 sensitivity and specificity. Results: All patients entered the result analysis. ① In 33 patients with ankylosing spondylitis, the positive rate of human leukocyte antigen-B27 by magnetic bead ELISA (90.9%) was higher than that of the trace lymphocyte cytotoxicity test (87.9%), but there was no significant difference (P > 0.05). ② The two methods were applied to determine the human leukocyte antigen-B27 in 33 patients with ankylosing spondylitis and 53 patients with low back pain and / or arthritis symptoms. The overall coincidence rate was 93.0%. The sensitivity of magnetic beads ELISA was 90.0%, the specificity was 95.7%, the positive predictive value was 94.7% and the negative predictive value was 91.7%. CONCLUSION: Magnetic resonance spectroscopy and micro-lymphocyte cytotoxicity assays are able to reliably detect human leukocyte antigen-B27 in patients with ankylosing spondylitis and other rheumatic diseases. The sensitivity and specificity of magnetic bead ELISA Has reached a high level.