摘要
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 (HLA)-B27 is closely connected to the occurrence of some rheumatic diseases such as ankylosing spondylitis and can be used as an important factor for evaluating the diagnosis of ankylosing spondylitis. Immunomagnetic separation and enzyme-linked immunosorbent assay (IMS-ELISA) has been applied to the detection of HLA-B27. OBJECTIVE: To explore the accuracy, sensitivity and specificity of IMS-ELISA for detecting HLA-B27 and its value in the auxiliary diagnosis of ankylosing spondylitis. DESIGN: A clinical trial in comparison with the gold standard. SETTING: Departments of Rheumatology and Clinical Laboratory, Third Affiliated Hospital of Sun Yat-sen University. PARTICIPANTS: Eighty-six patients suffering from low back pain and/or arthritis who were treated for the first time in Department of Rheumatology from December 2002 to April 2003. Inclusion criteria: ① Presence of manifestations of low back pain and/or arthritis; ② Thorough documentation of clinical and other examinations; ③ Informed consent to HLA-B27 examination; ④ Treatment for the first time in the Third Affiliated Hospital of Sun Yet-sen University. Those with other serious diseases or with incomplete record of clinical and/or accessory examinations were excluded. The 86 patients included 56 male and 30 female patients aged from 12 to 65 years. METHODS: Blood sample was detected for HLA-B27 by both IMS-ELISA and microlymphocytotoxicity test, and the latter was selected as the gold standard. The coincidence rate of the results detected by the two methods as well as the sensitivity, specificity, positive and negative predictive values of IMS-ELISA were calculated. MAIN OUTCOME MEASURES: ① The coincidence rate of the results of the two methods. ② The sensitivity and specificity of IMS-ELISA for detecting HLA-B27. RESULTS: None of the patients was lost. For the 33 patients with ankylosing spondylitis, the positivity rate of IMS-ELISA (90.9%) was higher than that of microlymphocytotoxicity test (87.9%), but the difference was not statistically significant (P>0.05). The total coincidence rate of the two methods was 93.0% in all the 86 patients. The sensitivity, specificity, positive and negative predictive values of IMS-ELISA were 90.0%, 95.7%, 94.7% and 91.7% respectively. CONCLUSION: Both IMS-ELISA and microlymphocytotoxicity test are capable of reliable examination of HLA-B27 with high sensitivity and specificity.
出处
《中国临床康复》
CSCD
北大核心
2005年第23期222-223,共2页
Chinese Journal of Clinical Rehabilitation
