2012—2014年四川内江地区无偿献血者中梅毒螺旋体呈弱反应性样本的确认试验检测结果分析  

Analysis of diagnosis assay to weak reactive treponemiapallidum samples among blood donors in Neijiang area of Sichuan Province from 2012 to 2014

作　　者：邓文英[1] 钟方财[2] 李运鸾 吴垚林 邓芳[1] 

机构地区：[1]四川省内江市中心血站,641000 [2]四川省内江市第一人民医院

出　　处：《国际输血及血液学杂志》2015年第5期388-392,共5页International Journal of Blood Transfusion and Hematology

摘　　要：目的探讨对志愿无偿献血者采用酶联免疫吸附试验（EusA）进行梅毒螺旋体（TP）初检，对于初检呈弱反应性样本的初检吸光度／临界（S／CO）值与双孔复检结果及梅毒螺旋体明胶凝集试验（TPPA）确认检测结果之间的关系，为血站设置合理的TP—EuSA灰区范围提供参考。方法2012年7月至2014年6月于内江市中心血站采集的志愿无偿献血者全血样本45144份，全部全血样本均采用2种不同厂家的TP—ELISA试剂盒进行TP初检，共发现S／CO为0．5--2．0的全血样本为193份，其中158例无偿献血者样本为单试剂盒检测结果呈弱反应性，35份样本为双试剂盒检测结果呈弱反应性。193份全血样本全部纳入本研究，作为研究对象。对样本进行同试剂盒双孔复检及TPPA确认检测，对比分析不同S／CO值样本双孔复检及TPPA确认结果的关系，评价双试剂盒初检与同试剂盒双孔复检对于梅毒的筛查价值。结果①2种试剂盒初检结果显示，A试剂盒检出结果为0．5≤S／CO〈2．0样本有72份（72／45144，0．16％），B试剂盒检出156份（156／45144，0．35％），B试剂盒弱阳性检出率高于A试剂盒，但差异无统计学意义（P〉O．05）。2种试剂盒检出样本S／CO区间分布情况比较，差异均无统计学意义（P〉O．05）。②初检结果为0．5≤S／CO〈0．7的样本，两种试剂双孔复检均检出阳性（＋／＋）样本，经TPPA确认检测，检出1例样本呈阳性。初检结果为0．7≤S／CO〈1．0的样本，两试剂相同试剂盒双孔复检，均检出阳性（＋／＋），经TPPA试剂盒确认检测，检出5例样本呈阳性；初检结果为1．0≤S／CO〈2．0的样本，经相同试剂盒双孔复检有阴性结果，经TPPA试剂确认检测未发现阳性，但经相同试剂盒双孔复检结果呈阳性的样本，经TPPA试剂盒确认检测，确认1例呈阴性。③A试剂盒初检灵敏度为78．9％（15／19Objective To investigate the relationship between sample/cut-off （S/CO） value of treponemiapallidum （TP）- enzyme-linked immuosorbent assay （ELISA） weak reactive samples in the initial screening, double check and treponemapallidum particle agglutination （TPPA） test results of voluntary blood donors, and to provide a reference for the blood center in setting reasonable grey area. Methods From July 2012 to June 2014, a total of 45 144 blood samples from voluntary blood donors in Neijiang blood center were carried out test with 2 different TP-ELISA kits. It showed that S/CO value of 193 samples were between 0.5-2.0, and in which, 158 samples were weakly reactive with single kit, and 35 samples were weakly reactive with both kits. These 193 cases of blood samples were included into this study, as the research subject. The samples were rechecked using the same TP-ELISA kit and confirmed by TPPA test. The results of double check and TPPA test for samples with different S/CO values were compared and screening value of initial screening by two TP-ELISA kits and double recheck by same kit for syphilis was evaluated. Results （1）Initial screening results showed that 72 （72/45 144, 0. 16%） cases of blood samples with 0.5≤S/CO〈2.0 were detected by TP-ELISA kit A, and 156 （0, 35%, 156/45 144） cases by TP-ELISA kit B. The weak positive detection rate of kit B was higher than that of kit A, though without statistical difference （P〉0. 05）. Compared the distribution of S/CO between two kits, though without statistical difference neither（P〉0.05）. （2）1 cases out of blood samples with initial screening results of 0.5≤S/CO〈0.7 and double check result of （＋/＋）by kit A were confirmed positive by TPPA test. 5 case out of blood samples with initial screening results of 0. 7≤S/CO〈1.0 and double check result of （＋/＋） were confirmed positive by TPPA test. None of blood samples with initial screening results of 1.0≤S/CO〈2.0 and negative double check result were confirm

关 键 词：梅毒 供血者 酶联免疫吸附测定 凝集试验 

分 类 号：R446.6[医药卫生—诊断学]