表观健康儿童人类白细胞分化抗原B27参考区间的建立

Establishment of reference interval of human leukocyte antigen-B27 in apparent healthy children

目的建立健康儿童人白细胞抗原B27(HLA-B27)的参考区间,为幼年特发型关节炎(JIA)附着点炎症相关型(ERA)的诊断和鉴别诊断提供实验室依据。方法选取460例无自觉脊柱、外周关节、关节周围组织炎症或其他病变的儿童作为参考区间建立人群,另选取200名表观健康儿童和50例ERA患儿作为参考区间验证人群。检测所有对象的外周血HLA-B27,建立参考区间,并进行验证。结果 460例儿童HLA-B27平均荧光强度检测结果呈偏态分布(Z=1.615,P=0.011),采用中位数(M)[百分位数(P2.5-P97.5)]表示,结果为100(78-121)。不同年龄和性别儿童HLA-B27平均荧光强度差异均无统计学意义(P>0.05)。采用百分位数法建立单侧97.5%的参考区间,HLA-B27参考区间为<121。一致性比较结果显示,建立的新参考区间与厂商提供的HLA-B27参考区间(0-147)之间一致性较差(kappa=0.013,P<0.001)。根据新参考区间,200名表观健康儿童HLA-B27的异常率为5%,50例ERA患儿的HLA-B27阳性率为78%;根据厂商提供的参考区间,200名表观健康儿童HLA-B27的异常率为3%,50例ERA患儿的HLA-B27阳性率为26%;二者异常率差异无统计学意义(χ^2=1.41,P>0.05),阳性率差异有统计学意义(χ^2=49.18,P<0.001)。结论建立了南京地区儿童外周血HLA-B27的参考区间,依据该参考区间诊断ERA的特异性与厂商提供的参考区间无差异,但提高了诊断敏感性,降低了漏诊率。

Objective To establish the reference interval of human leukocyte antigen-B27(HLA-B27) in apparent healthy children,and to provide a reference for the diagnosis and differential diagnosis of juvenile idiopathic arthritis(JIA)enthesitis related arthritis(ERA) in children. Methods A total of 460 children without conscious spine,peripheral joints,inflammation around the joints or other lesions were enrolled to establish the reference interval. Another 200 apparent healthy children and 50 ERA children were enrolled to verify the reference interval. Peripheral blood HLA-B27 was determined,and the reference interval was established and verified. Results The HLA-B27 mean fluorescence intensity of 460 children showed a skewed distribution(Z=1.615,P=0.011),which was 100(78-121) expressed as median(M) [percentiles(P2.5-P97.5)]. There was no statistical significance for the mean fluorescence intensity of HLA-B27 with different ages and sex(P>0.05). The percentile method was used to establish a 97.5% reference interval on one side,and the HLA-B27 reference interval was <121. Consistency comparison results showed that the new reference interval and the HLA-B27 reference interval provided by manufacturer(0-147) showed a poor consistency(kappa=0.013,P<0.001). According to the new reference interval,the abnormal rate of HLA-B27 in 200 apparent healthy children was 5%,and the positive rate of HLA-B27 in 50 children with ERA was 78%. According to the reference interval provided by manufacturer,the abnormal rate of HLA-B27 in 200 apparent healthy children was 3%,and the positive rate of HLA-B27 in 50 children with ERA was 26%. There was no statistical significance for the abnormal rate of HLA-B27(χ^2=1.41,P>0.05),and the difference of positive rate fo HLA-B27 had statistical significance(χ^2=49.18,P<0.001). Conclusions The reference interval of HLA-B27 in peripheral blood of children in Nanjing has been established. The specificity of reference interval for the diagnosis of ERA is not different from the reference interval provided by manufacturer,but it improves the diagnostic sensitivity and decreases the rate of missed diagnosis.