Hermann Corinna, Gueinzius Katja, Oehme Albrecht, Von Aulock Sonja, Straube Eberhard, Hartung Thomas
Biochemical Pharmacology, University of Konstanz, 78457 Constance, Germany.
J Clin Microbiol. 2004 Jun;42(6):2476-9. doi: 10.1128/JCM.42.6.2476-2479.2004.
We previously reported a high degree of variation in the sensitivities of serodiagnostic kits for the detection of Chlamydophila pneumoniae in sera from healthy donors. Since a low predictive value of a test can impair its diagnostic value, we have extended our studies to samples from patients with pneumonia. We focused on the most promising enzyme-linked immunosorbent assays (ELISAs) (SeroCP and SeroCP Quant; Savyon) identified in our previous study and included a new ELISA (sELISA; Medac). The agreement between all ELISAs for immunoglobulin G (IgG) and a reference microimmunofluorescence (MIF) test for IgG (SeroFIA; Savyon) was > or = 90% for a collective of 80 patients. The positive predictive values were all > or = 93%. The negative predictive values ranged from 68 to 83%. False-negative results were obtained only for samples that had low titers in the MIF test. The correlation of the IgG antibody titers determined by the MIF and SeroCP Quant tests was high (r(sp) = 0.9). Since the semiquantitative SeroCP and quantitative SeroCP Quant ELISAs achieved the highest sensitivities, they were evaluated further by using a second batch of sera from 50 patients with predominantly medium and low antibody titers in the MIF test and a control collection of sera from 80 children with negative MIF results. Again, the tests showed a high concordance with the MIF results (96%), and the antibody titers in the SeroCP Quant and MIF tests correlated well (r(sp) = 0.8). The specificities determined with the negative sera were > or = 99% for the SeroCP Quant test and 86% for the SeroCP test. These results show that ELISAs that are fast and objective deliver seroprevalence results, sensitivities, and specificities that are very similar to those of the MIF test.
我们之前报道过,用于检测健康供体血清中肺炎衣原体的血清学诊断试剂盒的敏感性存在高度差异。由于检测的预测值较低会损害其诊断价值,我们将研究扩展至肺炎患者的样本。我们重点关注了在我们之前的研究中确定的最有前景的酶联免疫吸附测定(ELISA)(SeroCP和SeroCP Quant;Savyon),并纳入了一种新的ELISA(sELISA;Medac)。对于80名患者的总体样本,所有检测免疫球蛋白G(IgG)的ELISA与IgG的参考微量免疫荧光(MIF)检测(SeroFIA;Savyon)之间的一致性≥90%。阳性预测值均≥93%。阴性预测值范围为68%至83%。仅在MIF检测中滴度较低的样本获得了假阴性结果。通过MIF和SeroCP Quant检测确定的IgG抗体滴度之间的相关性较高(r(sp)=0.9)。由于半定量的SeroCP和定量的SeroCP Quant ELISA具有最高的敏感性,我们使用来自50名在MIF检测中抗体滴度主要为中低水平的患者的第二批血清以及来自80名MIF结果为阴性的儿童的对照血清样本进一步对它们进行了评估。同样,这些检测与MIF结果显示出高度一致性(96%),并且SeroCP Quant和MIF检测中的抗体滴度相关性良好(r(sp)=0.8)。用阴性血清确定的SeroCP Quant检测的特异性≥99%,SeroCP检测的特异性为86%。这些结果表明,快速且客观的ELISA所提供的血清流行率结果、敏感性和特异性与MIF检测非常相似。