化学发光微粒法检测抗TP抗体复检流程探讨  

Investigation on the retesting procedure of anti-TP antibody determined by chemiluminescence microparticle immunoassay

作　　者：杨华[1] 杨晓东[1] 饶丽华[1] 

机构地区：[1]三峡大学仁和医院检验科,湖北宜昌443001

出　　处：《检验医学》2015年第12期1181-1184,共4页Laboratory Medicine

摘　　要：目的探讨化学发光微粒法（CMIA）检测抗梅毒螺旋体（TP）抗体的复检范围并进行流程改进分析。方法 21 894份血清样本用CMIA筛查抗TP抗体,呈阳性反应的样本用CMIA相同厂家、相同批号的试剂复检,以免疫印迹法（WB）为确证试验。以信号/临界值（S/CO）比值进行分段统计。结果 21 894份血清样本中CMIA初检阳性630例,按照CMIA初检抗TP抗体S/CO比值将样本分为7组：1.0~2.0、2.1~4.0、4.1~6.0、6.1~8.0、8.1~9.0、9.1~10.0、〉10.1。各组CMIA复检结果符合率分别为62.5%（40/64）、80.0%（60/75）、93.9%（77/82）、100.0%（94/94）、100.0%（85/85）、100.0%（50/50）和100.0%（180/180）。各组CMIA复检结果与WB符合率分别为35.0%（14/40）、46.7%（28/60）、75.3%（58/77）、81.9%（77/94）、88.2%（75/85）、96.0%（48/50）和98.8%（178/180）。结论在规范操作的前提下,以阳性预测值≥95%为目标,CMIA筛查抗TP抗体的复检范围S/CO比值设定为1.0~8.0,若S/CO比值≥8.1,可直接发出报告;1.0≤S/CO比值≤8.0,须采用WB确证,这样既能保证检验结果的准确性,又可减少须进行确证试验的样本量。Objective To investigate the retesting range of ani-treponema pallidum（ TP） antibody determined by chemiluminescence microparticle immunoassay（ CMIA） and improve the retesting procedure. Methods A total of 21 894 serum samples were screened by CMIA,the positive samples were retested duplicately by the same reagent kit of the same lot number and confirmed by western blotting（ WB）. The detection results were classifed into several groups for further analysis according to signal-to-cut off（ S / CO） ratios. Results In 21 894 serum samples,630 cases were positive by CMIA. The samples were classified into 7 groups according to S / CO ratios： 1. 0-2. 0,2. 1-4. 0,4. 1-6. 0,6. 1-8. 0,8. 1-9. 0,9. 1-10. 0 and 〉 10. 1. The retesting coincidence rates by CMIA were 62. 5%（ 40 /64）,80. 0%（ 60 /75）,93. 9%（ 77 /82）,100. 0%（ 94 /94）,100. 0%（ 85 /85）,100. 0%（ 50 /50） and 100. 0%（ 180 /180）. The coincidence rates for retesting by WB and CMIA were 35. 0%（ 14 /40）,46. 7%（ 28 /60）,75. 3%（ 58 /77）,81. 9%（ 77 /94）,88. 2%（ 75 /85）,96. 0%（ 48 /50） and 98. 8%（ 178 /180）. Conclusions The S/CO ratio for retesting range by CMIA for the determination of anti-TP antibody is considered appropriate from 1. 0-8. 0 under a standardized laboratory condition and positive predictive value ≥95%. Reports can be sent directly with S / CO ratio ≥8. 1. WB should be employed to confirmation assay with 1. 0 ≤S / CO ratio ≤8. 0. The appropriate retesting range not only can assure the accuracy of testing results,but also can reduce the sample numbers of confirmation assay.

关 键 词：抗梅毒螺旋体抗体 复检 范围 化学发光微粒法 免疫印迹法 

分 类 号：R446.12[医药卫生—诊断学]