化学发光免疫分析法检测梅毒抗体在临床筛查试验中的应用价值分析

Analysis of the value of chemiluminescence immunoassay detection of syphilis antibody in clinical screening test

目的分析化学发光免疫分析法(CLIA)检测梅毒抗体在临床筛查试验中的应用价值。方法采集8500例血清样本,利用CLIA测定梅毒特异性抗体情况,对样品的吸光度/标准的吸光度(S/CO)值为1~10患者进行梅毒螺旋体明胶凝集实验(TPPA)复检,利用甲苯胺红不加热血清试验(TRUST)测定梅毒非特异性抗体。分析TP-CLIA及TRUST的梅毒检出情况;对比不同年龄段TP-CLIA假阳性率,不同TP-CLIA检测血清梅毒抗体S/CO值患者的TPPA复检率。结果8500例受试者中确诊梅毒100例,梅毒检出率为1.18%。其中TRUST阳性结果共计110例(1.29%);TP-CLIA阳性结果共计262例(3.08%);TRUST单阳性共计10例(0.12%);TP-CLIA单阳性共计162例(1.91%)。8500例受试者排除现症及既往梅毒感染共135例(1.59%)TP-CLIA假阳性患者,其中,≤40岁13例(0.76%),41~64岁46例(1.18%),≥65岁76例(2.62%)。患者的TP-CLIA假阳性率随着年龄增长呈现上升趋势,≥65岁患者的TP-CLIA假阳性率最高,不同年龄段TP-CLIA假阳性率对比差异有统计学意义(χ^(2)=31.289,P=0.000<0.05)。TP-CLIA检测血清梅毒抗体S/CO值1~10的122例患者进行TPPA复检,复检率为1.44%(122/8500);S/CO值1~5患者的TPPA复检阳性符合率100.00%(41/41)高于S/CO值5~10患者的43.21%(35/81),差异有统计学意义(χ^(2)=36.740,P=0.000<0.05)。结论应用CLIA展梅毒螺旋体(TP)筛查可靠性强,针对梅毒抗体S/CO值比较低的样本,特别是S/CO是1~5的样本需要复检处理,目的在于排除假阳性结果,从根本上提升检测结果的精准度,以免出现非必要纠纷。

Objective To analyze the application value of chemiluminescence immunoassay(CLIA)detection of syphilis antibody in clinical screening test.Methods Serum samples from 8500 outpatients/physical examination cases were selected as the research objects.CLIA was used to determine the syphilis specific antibody.Samples with signal-to-cut off(S/CO)value of 1-10 were retested by treponema pallidum gelatin agglutination test(TPPA),and non-specific antibodies to syphilis were determined by tolulized red unheated serum test(TRUST).The detection of syphilis by TP-CLIA and TRUST was analyzed.The false-positive rate of TP-CLIA in different age groups was compared,as well as the retest rate of TPPA in patients with different serum syphilis antibody S/CO value by TP-CLIA was compared.Results Out of 8500 subjects,100 cases were diagnosed with syphilis,with a syphilis detection rate of 1.18%.Among them,110 cases(1.29%)were positive for TRUST,262 cases(3.08%)were positive for TP-CLIA,10 cases(0.12%)were single positive for TRUST,and 162 cases(1.91%)were single positive for TP-CLIA.A total of 135(1.59%)of 8500 subjects were TP-CLIA false positive,excluding existing syphilis and previous syphilis infection,including 13 cases(0.76%)aged≤40 years old,46 cases(1.18%)aged 41-64 years old,and 76 cases(2.62%)aged≥65 years old.The false positive rate of TP-CLIA increased with age,and the false positive rate of TP-CLIA in patients≥65 years old was the highest,and the difference in false positive rate of TP-CLIA in different age groups was statistically significant(χ^(2)=31.289,P=0.000<0.05).TPPA retesting was performed in 122 patients with serum syphilis antibody S/CO value of 1-10 by TP-CLIA,with a retesting rate of 1.44%(122/8500).The positive coincidence rate of patients with S/CO value of 1-5 was 100.00%(41/41),which was higher than that of 43.21%(35/81)of patients with S/CO of 5-10,and the difference was statistically significant(P<0.05).Conclusion The CLIA is highly reliable in screening treponema pallidum(TP).The samples with low S/CO,especially those with S/CO of 1-5,need to be retested.The purpose is to eliminate false-positive results and fundamentally improve the accuracy of test results,so as to avoid unnecessary disputes.