摘要
目的：评价四川省新成生物科技有限责任公司（A厂家）研制的赛盟自免棆抗dsDNA抗体检测试剂盒（酶联免疫吸附试验）与已上市销售的同类产品的优劣。方法收集2013年6～8月临床确诊为系统性红斑狼疮（SLE）的患者血清50例设为试验组，收集同期体检健康者血清50例设为对照组，分别采用A厂家和德国某知名B厂家生产的抗dsDNA抗体检测试剂盒进行定量检测，对检测结果进行统计分析。结果A厂家的抗dsDNA抗体检测试剂盒（酶联免疫吸附试验）阳性符合率高于B厂家同类试剂，结果差异具有统计学意义（P＜0．05），两个厂家的阴性符合率差异无统计学意义（P＞0．05）；线性相关性分析r＝0．9848，转换为定性结果后采用Kappa分析，Kappa系数为0．91。结论A厂家生产的抗dsDNA抗体检测试剂盒（酶联免疫吸附试验）和德国某知名B厂家已上市销售的同类产品具有等效性，符合临床应用要求。
Objective To compare the pros and cons of anti-dsDNA antibody assay kits of two different manu-factures .Methods From June to August 2013 ,anti-dsDNA in serum samples ,collected from 50 patients with sys-temic lupus erythematosus（SLE） and 50 healthy subjects ,were detected by reagent A ,manufactured by Xincheng Bi-otechnology Company ,and reagent B ,manufactured by a German company .Results ,detected by the two kits ,were statistically analyzed .Results The positive coincidence rate of reagent A was higher than reagent B （P〈0 .05） ,but the negative coincidence rates of the two reagents were without statistical difference （P〉0 .05） .The correlation coef-ficient of results ,detected by the two kits ,was 0 .984 8 ,and the Kappa coefficient was 0 .91 .Conclusion The per-formance of the two kinds of anti-dsDNA antibody assay kit might be equivalent ,both of which could meet the re-quirements of clinical application .
出处
《检验医学与临床》
CAS
2014年第9期1204-1205,共2页
Laboratory Medicine and Clinic
关键词
抗DSDNA抗体
系统性红斑狼疮
酶联免疫吸附法
anti-dsDNA antibody
systemic lupus erythematosus
enzyme-linked immunosorbent assay
