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
2012-2014년사천내강지구무상헌혈자중매독라선체정약반응성양본적학인시험검측결과분석
Analysis of diagnosis assay to weak reactive treponemiapallidum samples among blood donors in Neijiang area of Sichuan Province from 2012 to 2014
  • 万方数据
    国际输血及血液学杂志 국제수혈급혈액학잡지
    International Journal of Blood Transfusion and Hematology
    2015年 5期 388-392 ,共5页

    邓文英%钟方财%李运鸾%吴垚林%邓芳

    산문영%종방재%리운란%오요림%산방

    梅毒%供血者%酶联免疫吸附测定%凝集试验 梅毒%供血者%酶聯免疫吸附測定%凝集試驗
    매독%공혈자%매련면역흡부측정%응집시험
    Syphilis%Blood donors%Enzyme-linked immunosorbent assay%Agglutination tests
    目的 探讨对志愿无偿献血者采用酶联免疫吸附试验(ELISA)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-ELISA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45 144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(72/45 144,0.16％),B试剂盒检出1 56份(156/45 144,0.35％),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＞0.05).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＞0.05).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％(15/19),特异度为98.1％(52/53),B试剂盒初检灵敏度为90.3％(28/31),特异度为(96.8％,121/125).2种试剂盒双孔复检结果灵敏度与初检相比均有提高,特异度变化不大.与TPPA确认检测结果之间的一致性分析结果显示,试剂盒初检结果为0.5≤S/CO＜0.7区间符合率最高(95.5％),0.7≤S/CO＜1.0区间最低(91.2％);B试剂盒随着S/CO值的递增,其符合率从100％递减至87.5％.2种试剂盒初检、双孔复检的Kappa系数均大于0.75,2种试剂盒双孔复检的Kappa系数均高于初检.结论 TP-ELISA初检结果为0.5≤S/CO＜2.0的呈弱反应性样本中,0.5≤S/CO＜0.7区间假阴性率最低,其他区间假阴性率均占一定比例;双孔复检可提高TP ELISA检测灵敏度与特异度,双孔复检与TPPA确认检测结果符合率高于初检.
    목적 탐토대지원무상헌혈자채용매련면역흡부시험(ELISA)진행매독라선체(TP)초검,대우초검정약반응성양본적초검흡광도/림계(S/CO)치여쌍공복검결과급매독라선체명효응집시험(TPPA)학인검측결과지간적관계,위혈참설치합리적TP-ELISA회구범위제공삼고.방법 2012년7월지2014년6월우내강시중심혈참채집적지원무상헌혈자전혈양본45 144빈,전부전혈양본균채용2충불동엄가적TP-ELISA시제합진행TP초검,공발현S/CO위0.5～2.0적전혈양본위193빈,기중158례무상헌혈자양본위단시제합검측결과정약반응성,35빈양본위쌍시제합검측결과정약반응성.193빈전혈양본전부납입본연구,작위연구대상.대양본진행동시제합쌍공복검급TPPA학인검측,대비분석불동S/CO치양본쌍공복검급TPPA학인결과적관계,평개쌍시제합초검여동시제합쌍공복검대우매독적사사개치.결과 ①2충시제합초검결과현시,A시제합검출결과위0.5≤S/CO＜2.0양본유72빈(72/45 144,0.16％),B시제합검출1 56빈(156/45 144,0.35％),B시제합약양성검출솔고우A시제합,단차이무통계학의의(P＞0.05).2충시제합검출양본S/CO구간분포정황비교,차이균무통계학의의(P＞0.05).②초검결과위0.5≤S/CO＜0.7적양본,량충시제쌍공복검균검출양성(+/+)양본,경TPPA학인검측,검출1례양본정양성.초검결과위0.7≤S/CO＜1.0적양본,량시제상동시제합쌍공복검,균검출양성(+/+),경TPPA시제합학인검측,검출5례양본정양성;초검결과위1.0≤S/CO＜2.0적양본,경상동시제합쌍공복검유음성결과,경TPPA시제학인검측미발현양성,단경상동시제합쌍공복검결과정양성적양본,경TPPA시제합학인검측,학인1례정음성.③A시제합초검령민도위78.9％(15/19),특이도위98.1％(52/53),B시제합초검령민도위90.3％(28/31),특이도위(96.8％,121/125).2충시제합쌍공복검결과령민도여초검상비균유제고,특이도변화불대.여TPPA학인검측결과지간적일치성분석결과현시,시제합초검결과위0.5≤S/CO＜0.7구간부합솔최고(95.5％),0.7≤S/CO＜1.0구간최저(91.2％);B시제합수착S/CO치적체증,기부합솔종100％체감지87.5％.2충시제합초검、쌍공복검적Kappa계수균대우0.75,2충시제합쌍공복검적Kappa계수균고우초검.결론 TP-ELISA초검결과위0.5≤S/CO＜2.0적정약반응성양본중,0.5≤S/CO＜0.7구간가음성솔최저,기타구간가음성솔균점일정비례;쌍공복검가제고TP ELISA검측령민도여특이도,쌍공복검여TPPA학인검측결과부합솔고우초검.
    Objective 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 ①Initial 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).②1 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 confirmed positive by TPPA test.But 1 case out of blood samples with initial screening results of 1.0 ≤ S/CO＜ 2.0 and positive double check result were confirmed negative by TPPA test.③The sensitivity of TP-ELISA kit A was 78.9％ (15/19) with specificity of 98.1％ (52/53),and the sensitivity of TP-ELISA kit B was 90.3％ (28/31) with specificity of 96.8％ (121/125).The sensitivity of two kits of double check was improved compared with the initial screening.However,the specificity showed little change.Consistency analysis of initial screening and double check with the TPPA test results showed that coincidence rate of kit A in initial screening within 0.5≤S/CO＜ 0.7 interval was the highest (95.5％),0.7 ≤ S/CO＜ 1.0 interval was the minimum (91.2％).The coincidence rate of kit B declined from 100％ to 87.5％ with the increasing of S/CO value.The kappa coefficient of both TP-ELISA kits in initial screening and double check were greater than 0.75,and the kappa coefficient of double check were higher than that of initial inspection.Conclusions Among TP-ELISA weak reactive samples with 0.5≤S/CO＜2.0 in the initial screening,the false negative rate of 0.5≤S/CO＜0.7 interval is the lowest,the false negative rate of other intervals have a certain proportion.Double check can improve the detection sensitivity and specificity of TP-ELISA,and the coincidence rate of double check results with TPPA test is higher than that of the initial screening.
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