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作 者:樊璐[1] 李玉 庄养林[1] 王芳[1] FAN Lu;LI Yu;ZHUANG Yanglin;WANG Fang(Jiangxi Blood Center,Nanchang 330052.)
机构地区:[1]江西省血液中心,南昌330052
出 处:《江西医药》2022年第3期223-227,231,共6页Jiangxi Medical Journal
基 金:江西省卫生健康委科技计划,编号202110116。
摘 要:目的探究南昌地区献血者梅毒螺旋体(TP)感染状况,评估酶联免疫吸附试验(ELISA)试剂、金标试剂检测性能。方法采用ELISA方法对南昌地区97554人份无偿献血标本进行抗-TP双试剂检测,收集其中184例抗-TP筛查阳性血浆标本开展梅毒螺旋体明胶颗粒凝集试验(TPPA)确证,并进行乙肝表面抗原(HBsAg)/TP抗体金标联检。结果南昌地区献血人群抗-TP ELISA筛查阳性率0.19%,TPPA确证阳性率0.13%,TPPA确证阳性符合率70.65%;抗-TP ELISA筛查阳性标本中,双试剂阳性72.83%,试剂A单阳9.24%,试剂B单阳17.93%;ELISA双阳标本中TPPA阳性93.28%,单阳标本中TPPA阴性82%、TPPA阳性10%;ELISA双阳标本中抗-TP金标阳性90.30%;抗-TP金标阳性标本中TPPA阳性97.58%;试剂A、试剂B真阳性率为83.44%、77.25%(P>0.05)。结论南昌地区献血者梅毒感染率处于较低水平;抗-TP ELISA双试剂阳性标本的TPPA确证阳性符合率较高;不同厂家ELISA双试剂筛查形成互补,防止漏检;ELISA筛查存在一定比例假阳性;献血前检测项目可增加抗-TP胶体金法初筛;南昌地区梅毒感染献血人群以36~55岁年龄段、农民、工人、自由职业者、低学历人员为主。Objective To investigate the infection status of treponema pallidum(TP)in blood donors in Nanchang and evaluate the detection performance of enzyme-linked immunosorbent assay(ELISA)reagents and gold standard test strip.Methods The anti-TP dual-reagent ELISA was used to detect 97554 voluntary blood donation samples in Nanchang.184 plasma samples with positive anti-TP screening were collected and confirmed by treponema pallidum gelatin particle agglutination test(TPPA),and hepatitis B surface antigen(HBsAg)/TP antibody gold standard combined detection.Results The positive rate of anti-TP ELISA screening in blood donors in Nanchang was 0.19%,the confirmatory positive rate of TPPA was 0.13%,and the confirmatory positive coincidence rate was 70.65%.Among the positive samples screened by anti-TP ELISA,72.83%were dual-reagent positive,9.24%were single positive with reagent A and 17.93%were single positive with reagent B.93.28%of ELISA dual-reagent positive samples were TPPA positive,82%of single-reagent positive samples were TPPA negative and 10%were TPPA positive.90.30%of the dual-reagent positive samples of ELISA were positive for anti-TP gold standard test strip.97.58%of the anti-TP gold labeled positive samples were TPPA positive.The true positive rates of reagent A and reagent B were 83.44%and 77.25%(P>0.05).Conclusion The syphilis infection rate of blood donors in Nanchang is at a low level.The confirmatory positive coincidence rate of anti-TP ELISA dual-reagent positive samples is high.ELISA dual-reagent screening from different manufacturers complement each other to prevent missed detection.There is a certain proportion of false positives in ELISA screening.Anti-TP colloidal gold method can be added to the test items before blood donation.Blood donors infected with syphilis in Nanchang are mainly 36~55 years old,farmers/workers/freelancers and low educated people.
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