Department of Diagnostic Immunology, Pomeranian Medical University, Szczecin, Poland.
Immunology Laboratory Independent, Public Clinical Hospital No. 2, Szczecin, Poland.
Ann Agric Environ Med. 2022 Mar 21;29(1):63-71. doi: 10.26444/aaem/147277. Epub 2022 Mar 16.
Serological assays for Lyme disease (LD) routinely performed in laboratories often give inconclusive results, thereby making correct diagnosis difficult and delaying treatment. The aim of the study was to assess the usefulness of a commercial Optiplex (OB) assay in the serological diagnostics of LD. Based on the results obtained in a previous study on the seroreactivity of the sera of patients with LD to spp. antigens using enzyme immunoassays (ELISA) and immunoblotting (IB), the same sera were re-analyzed using the OB assay.
The assays carried out with the use of OB method showed a statistically significant lower number of positive/borderline results for the presence of IgM antibodies, compared to the ELISA assay. Moreover, statistically lower positive/borderline results were obtained for antibodies in the IgG class with use of the OB method, compared to the IB assay and a two-stage diagnostic protocol (ELISA with IB). The specificity analysis showed that in both the IB and OB assays, anti-OspC IgM and anti-p41 antibodies were detected. Additionally, high positive/borderline values were found in the OB assay for native antigens derived from lysate. The IB assay most frequently detected antibodies against OspC, p39 (BmpA) and VlsE proteins in the IgG class. There were fewer positives/borderlines for anti-p41-I antibodies in the OB assay and a higher number for antigens: VlsE-C6, p18 (DbpA), and p39 (BmpA).
Answering the question whether the OB assay could replace the traditional, two-step method of LD diagnostics, it can be concluded that it could not. It can be used to diagnose LD only as a complementary assay and not as an optimal and dedicated method of Borrelia spp. infection detection.
实验室中常规进行的莱姆病(LD)血清学检测常得出不确定的结果,从而使正确诊断变得困难并延误治疗。本研究旨在评估一种商业 Optiplex (OB)检测在 LD 血清学诊断中的有用性。基于之前使用酶联免疫吸附测定(ELISA)和免疫印迹(IB)对 LD 患者血清中 spp.抗原的血清反应性的研究结果,使用 OB 检测重新分析了相同的血清。
与 ELISA 检测相比,使用 OB 方法进行的检测显示 IgM 抗体存在的阳性/边界结果的数量具有统计学显著降低。此外,与 IB 检测和两步诊断方案(ELISA 与 IB)相比,使用 OB 方法获得的 IgG 类抗体的阳性/边界结果统计学上较低。特异性分析表明,在 IB 和 OB 检测中均检测到抗-OspC IgM 和抗-p41 抗体。此外,在 OB 检测中,从 裂解物中获得的天然抗原检测到高阳性/边界值。IB 检测最常检测到 IgG 类中的 OspC、p39(BmpA)和 VlsE 蛋白抗体。OB 检测中抗-p41-I 抗体的阳性/边界较少,而 VlsE-C6、p18(DbpA)和 p39(BmpA)的抗原阳性/边界较多。
回答 OB 检测是否可以替代 LD 诊断的传统两步法的问题,可以得出的结论是不能。它只能用作补充检测,而不能作为 Borrelia spp. 感染检测的最佳和专用方法。