CAJ | 학술논문

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。
목적：평개사천성신성생물과기유한책임공사（A엄가）연제적새맹자면륜항dsDNA항체검측시제합（매련면역흡부시험）여이상시소수적동류산품적우렬。방법수집2013년6～8월림상학진위계통성홍반랑창（SLE）적환자혈청50례설위시험조，수집동기체검건강자혈청50례설위대조조，분별채용A엄가화덕국모지명B엄가생산적항dsDNA항체검측시제합진행정량검측，대검측결과진행통계분석。결과 A엄가적항dsDNA항체검측시제합（매련면역흡부시험）양성부합솔고우B엄가동류시제，결과차이구유통계학의의（P＜0．05），량개엄가적음성부합솔차이무통계학의의（P＞0．05）；선성상관성분석 r＝0．9848，전환위정성결과후채용Kappa분석， Kappa계수위0．91。결론 A엄가생산적항dsDNA항체검측시제합（매련면역흡부시험）화덕국모지명B엄가이상시소수적동류산품구유등효성，부합림상응용요구。
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 .