广州地区献血者梅毒血清学检测结果分析

SEROLOGICAL TEST FOR SYPHILIS AMONG BLOOD DONORS IN GUANGZHOU

目的了解广州地区献血人群梅毒感染情况,评价酶联免疫吸附试验(ELISA)检测梅毒螺旋体抗体的准确性。方法先用两种不同的ELISA试剂对献血人群进行梅毒筛查,筛查出阳性及灰区者再用梅毒螺旋体明胶凝集试验(TPPA)进行确证。结果 2012年共检测标本286 096份,ELISA检测阳性1 399份,阳性率0.49%,经TPPA试验确证阳性者有913份;单种ELISA试剂阳性371例,TPPA确认阳性9例;试剂A、试剂B阳性标本与TPPA检测结果符合率分别为69.25%、81.61%,差异有统计学意义(p<0.01);ELISA检测结果为强阳性者,其与TPPA确证结果阳性者符合率最高;ELISA检测结果为灰区者,其与TPPA确证结果阳性者符合率为0。结论近年来广州地区梅毒感染率有所增长。不同的梅毒ELISA试剂的检出效能存在较大差异,血站在选择筛查试剂时应做试剂评估。应采用灵敏度高,特异性好,具有一定互补性的两种试剂,确保所有阳性样本的检出,保障临床安全输血。

Objective To assess the validity of enzyme - linked immunosorbent assay （ELISA） for the de- tection of Treponema pallidum by investigating the prevalence of syphilis among blood donors in Guangzhou. Methods Two different ELISA reagents were used to screen blood donors for syphilis, and T. pallidum particle agglutination test （TPPA） was used to confirm positive results and gray zone. Results In 2012, 286,096 samples were detected. 1,399 sampleswere detected positive by ELISA, with 0.49% positive rate, and 913 samples were confirmed positive by TPPA test. 371 samples were detected positive by only one ELISA reagent, and 9 samples among them were con- firmed by TPPA test. The coincidence rates of the positive samples detected by reagent A and B in ELISA and the re- suits of TPPA were 69.25% and 81.61% , respectively, and the difference between two reagents was statistically sig- nificant （p 〈0. 01 ）. The coincidence rate between ELISA and TPPA test was highest for the strong positive samples- detected by ELISA, and none of the ＂gray zone＂ samplesdetected by ELISA were confirmed by TPPA test. Conclu- sion The prevalence of syphilis in Guangzhou has increased in recent years. The efficiency of different ELISA rea- gents is very different, so the reagents are needed to be evaluated by blood center before they are used in screening. Two kinds of reagents with high sensitivity, specificity and complementarity to each other should be used to ensure all the samples with syphilis are detected and ensure the safety of clinical blood transfusion.