梅毒检测结果判读对结果准确性的影响
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摘要
目的探讨不同判读模式对梅毒螺旋体抗体检测-乳胶法(TP-AD)和梅毒螺旋体明胶颗粒凝集试验(TPPA)检测结果准确性的影响。方法用TP-AD法和TPPA法对梅毒抗体血清盘进行检测,将单人模式和双人模式对梅毒结果判读的差异进行比较分析。结果 TP-AD法双人模式最好结果与单人及双人模式最差结果差异有统计学意义(P<0.05),TPPA法双人模式最差结果、双人模式最好结果、单人模式最好结果与单人模式最差结果差异有统计学意义(P<0.05),两种模式中双人模式结果比单人模式结果符合率更高,差异有统计学意义(P<0.05)。结论 TP-AD法和TPPA法对梅毒阳性标本的敏感度虽然不同,但不同人对阳性结果的判读也存在差异,尤其是处于临界状态的结果。工作经验丰富或对试剂性能比较了解的检验师判读结果符合率更高,双人判读模式的结果比单人判读模式的结果符合率更高。
Objective To investigate the effect of different interpretation modes on the accuracy of Treponema pallidum antibody detection(TP-AD) and Treponema pallidum particle assay(TPPA). Method The detection of syphilis antibody sera was carried out by using TP-AD and TPPA. The difference of syphilis result interpretation between single person model and double person model was compared and analyzed. Results There was significant difference between the best result double person mode and the worst result of single and double person mode of TP-AD(P<0.05). There were significant differences between the worst results of the two person model, the best results of the two person model, the best results of the single person model and the worst results of the single person model of TPPA(P<0.05). The coincidence rate of the two person model was higher than that of the single person model, and the difference was statistically significant(P<0.05).Conclusion Although the sensitivity of TP-AD and TPPA is different to the positive TP specimens, different people on the positive results also have different interpretation, especially the results in the critical state.The clinical laboratory physicians who have rich work experience or have a good understanding of the per formance of the reagents have higher compliance rates. The results interpreted by two physicians have higher compliance rates than the results interpreted by one physician.
Objective To investigate the effect of different interpretation modes on the accuracy of Treponema pallidum antibody detection(TP-AD) and Treponema pallidum particle assay(TPPA). Method The detection of syphilis antibody sera was carried out by using TP-AD and TPPA. The difference of syphilis result interpretation between single person model and double person model was compared and analyzed. Results There was significant difference between the best result double person mode and the worst result of single and double person mode of TP-AD(P<0.05). There were significant differences between the worst results of the two person model, the best results of the two person model, the best results of the single person model and the worst results of the single person model of TPPA(P<0.05). The coincidence rate of the two person model was higher than that of the single person model, and the difference was statistically significant(P<0.05).Conclusion Although the sensitivity of TP-AD and TPPA is different to the positive TP specimens, different people on the positive results also have different interpretation, especially the results in the critical state.The clinical laboratory physicians who have rich work experience or have a good understanding of the per formance of the reagents have higher compliance rates. The results interpreted by two physicians have higher compliance rates than the results interpreted by one physician.
引文
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[5]戴艳,王红,王静,等.扬州市2013-2015年梅毒母婴传播阻断工作临床干预情况[J].中国艾滋病性病,2017,23(12):1135-1137.
[6]Newman L,Rowley J,Hoorn SV,et al.Global Estimates of the Prevalence and Incidence of Four Curable Sexually Transmitted Infections in 2012 Based on Systematic Review and Global Reporting[J].PLoSOne,2015,10(12):e0143304.
[7]Zhang XY,Zhang T,Pei J,et al.Time Series Modelling of Syphilis Incidence in China from 2005 to 2012[J].PLoS One,2016,11(2):e0149401.
[8]Li DD,Chen ZY,Tao CM.Comparison of three syphilis algorithms in West China[J].Clinica Chimica Acta,2018(488):76-80.
[9]S ommese L,Sabia C,Esposito A,et al.Comparison of performance of two Treponema pallidum automated chemiluminescent immunoassays in blood donors[J].Infectious Diseases(Lond),2016,48(6):483-487.
[10]Li LX,Cai B,Tao CM,et al.Performance Evaluation of CLIA for Treponema Pallidum Specific Antibodies Detection in Comparison with ELISA[J].Journal of Clinical Laboratory Analysis,2016,30(3):216-222.
[11]吴文其,王继昌,郭伟,等.外科手术前7 392例患者梅毒血清学及生物学假阳性临床分析[J].广东医学,2008(9):1525-1527.
[12]Johnson PC,Farnie MA.Testing for syphilis[J].Dermatol Clin,1994,12(1):9-17.
[13]Park IU,Fakile YF,Chow JM,et al.Performance of treponemal tests for the diagnosis of syphilis[J].Clin Infect Dis,2018.
[2]Wijesooriya NS,Rochat RW,Kamb ML,et al.Global burden of maternal and congenital syphilis in 2008 and 2012:a health systems modelling study[J].Lancet Global Health,2016,4(8):e525-e533.
[3]Karen V.Lithgow and Caroline E.Cameron.Vaccine development for syphilis[J].Expert Review Vaccines,2017,16(1):37-44.
[4]高红,刘春艳,陈明.梅毒孕妇不同治疗时期梅毒螺旋体DNA检测分析[J].中国预防医学杂志,2018,19(1):18-20.
[5]戴艳,王红,王静,等.扬州市2013-2015年梅毒母婴传播阻断工作临床干预情况[J].中国艾滋病性病,2017,23(12):1135-1137.
[6]Newman L,Rowley J,Hoorn SV,et al.Global Estimates of the Prevalence and Incidence of Four Curable Sexually Transmitted Infections in 2012 Based on Systematic Review and Global Reporting[J].PLoSOne,2015,10(12):e0143304.
[7]Zhang XY,Zhang T,Pei J,et al.Time Series Modelling of Syphilis Incidence in China from 2005 to 2012[J].PLoS One,2016,11(2):e0149401.
[8]Li DD,Chen ZY,Tao CM.Comparison of three syphilis algorithms in West China[J].Clinica Chimica Acta,2018(488):76-80.
[9]S ommese L,Sabia C,Esposito A,et al.Comparison of performance of two Treponema pallidum automated chemiluminescent immunoassays in blood donors[J].Infectious Diseases(Lond),2016,48(6):483-487.
[10]Li LX,Cai B,Tao CM,et al.Performance Evaluation of CLIA for Treponema Pallidum Specific Antibodies Detection in Comparison with ELISA[J].Journal of Clinical Laboratory Analysis,2016,30(3):216-222.
[11]吴文其,王继昌,郭伟,等.外科手术前7 392例患者梅毒血清学及生物学假阳性临床分析[J].广东医学,2008(9):1525-1527.
[12]Johnson PC,Farnie MA.Testing for syphilis[J].Dermatol Clin,1994,12(1):9-17.
[13]Park IU,Fakile YF,Chow JM,et al.Performance of treponemal tests for the diagnosis of syphilis[J].Clin Infect Dis,2018.