两种梅毒螺旋体自动化化学发光免疫分析方法在献血者中的性能比较。

Comparison of performance of two Treponema pallidum automated chemiluminescent immunoassays in blood donors.

机构信息

a U.O.C. Immunohematology, Transfusion Medicine and Transplant Immunology, Department of Internal and Specialty Medicine , Azienda Ospedaliera Universitaria (AOU), Second University of Naples , Naples , Italy ;

b Institute of Diagnostic and Nuclear Development (SDN), IRCCS , Naples , Italy .

出版信息

Infect Dis (Lond). 2016;48(6):483-7. doi: 10.3109/23744235.2016.1142674. Epub 2016 Feb 9.

DOI:10.3109/23744235.2016.1142674

PMID:27030921

Abstract

The recrudescence of syphilis is leading to the development of new serological tests. The goal of this study was to compare the performance of the more recent Elecsys Syphilis assay, the Electro Chemiluminescence Immunoassay (ECLIA), with the former Architect Syphilis TP assay, the Chemiluminescent Microparticle Immunoassay (CMIA), for the detection of antibodies against Treponema pallidum in blood donors. Serum samples of 5543 voluntary blood donors were screened in parallel with two tests. All repeatedly reactive (RR) samples by one or both assays were further analysed for confirmation by immmunoblot INNO-LIA and TPHA. Of 32 RR samples by CMIA, 21 were confirmed positive; of 21 RR samples by ECLIA, 20 were confirmed positive. The sensitivities of CMIA and ECLIA were 100% and 95.24% (95% CI = 85.71-100), respectively, not significant (p > 0.05). The specificity and predictive positive value (PPV) of CMIA were 99.86% (95% CI = 99.74-99.94) and 72.41%, respectively, while the specificity and PPV of ECLIA were both 100%, being statistically significant (p = 0.01 for both). The overall agreement was 99.80% and the Cohen's kappa coefficients was 0.79. In conclusion, the recent Elecsys Syphilis assay could represent another reliable assay for blood donor screening.

摘要

梅毒的再现导致了新的血清学检测方法的发展。本研究的目的是比较最近的 Elecsys 梅毒检测法（电化学发光免疫分析法，ECLIA）与之前的 Architect 梅毒 TP 检测法（化学发光微粒子免疫分析法，CMIA）在献血者血液中检测抗梅毒螺旋体抗体的性能。5543 名自愿献血者的血清样本同时用两种方法进行平行筛查。所有一种或两种方法均呈重复反应性（RR）的样本进一步通过免疫印迹 INNO-LIA 和 TPHA 进行确认分析。在 32 份 CMIA 呈 RR 的样本中，21 份被确认为阳性；在 21 份 ECLIA 呈 RR 的样本中，20 份被确认为阳性。CMIA 和 ECLIA 的敏感性分别为 100%和 95.24%（95%CI=85.71-100），无显著差异（p>0.05）。CMIA 的特异性和阳性预测值（PPV）分别为 99.86%（95%CI=99.74-99.94）和 72.41%，而 ECLIA 的特异性和 PPV均为 100%，差异具有统计学意义（p=0.01）。总符合率为 99.80%，Cohen's kappa 系数为 0.79。综上所述，最近的 Elecsys 梅毒检测法可能是另一种用于献血者筛查的可靠方法。