酶联免疫吸附试验 (ELISA) 与性病研究实验室试验 (VDRL) 和快速血浆反应素试验 (RPR) 在孕妇梅毒筛查中的比较。

Enzyme-linked immunosorbent assay (ELISA) versus Venereal Disease Research Laboratory test (VDRL) and rapid plasma reagin test (RPR) for screening of syphilis in pregnant women.

机构信息

Department of Clinical Microbiology, Christian Medical College, Vellore, Tamil Nadu, India.

Department of Obstetrics and Gynaecology, Christian Medical College, Vellore, Tamil Nadu, India.

出版信息

Int J Gynaecol Obstet. 2020 Jul;150(1):103-107. doi: 10.1002/ijgo.13154. Epub 2020 Apr 23.

DOI:10.1002/ijgo.13154

PMID:32246772

Abstract

OBJECTIVE

To evaluate a treponemal enzyme-linked immunosorbent assay (ELISA) as an alternative screening test for syphilis in pregnant women.

METHODS

A cross-sectional study of diagnostic test accuracy was carried out in a large volume laboratory from a tertiary care center. A total of 416 serum samples, including 102 archived syphilis Treponema pallidum hemagglutination (TPHA)-positive samples and 314 samples from pregnant women, were used to determine the sensitivity and specificity of ELISA. All the samples were subjected to Venereal Disease Research Laboratory (VDRL), rapid plasma reagin (RPR), ELISA, and TPHA tests. Performance characteristics of VDRL, RPR, and ELISA were calculated with TPHA as a reference standard test.

RESULTS

VDRL and RPR exhibited higher false positivity of 10.5% and 9.6%, respectively, compared to 2.5% by ELISA. The sensitivity and specificity of ELISA were 98% and 97.5%, of VDRL were 71.6% and 89.5%, and of RPR were 73.5% and 90.5%, respectively. Moreover, ELISA had an excellent agreement (kappa=0.9) with TPHA compared to VDRL/RPR which had a moderate agreement (kappa=0.6) only.

CONCLUSION

ELISA has the potential to replace VDRL/RPR as a screening test for syphilis in centers that can perform ELISA, especially for antenatal screening.

摘要

目的

评估梅毒螺旋体酶联免疫吸附试验（ELISA）作为一种替代妊娠妇女梅毒筛查的检测方法。

方法

在一家大型三级医疗中心的大容量实验室进行了一项诊断试验准确性的横断面研究。共检测了 416 份血清样本，包括 102 份存档的梅毒螺旋体血凝试验（TPHA）阳性样本和 314 份孕妇样本，以确定 ELISA 的敏感性和特异性。所有样本均进行了性病研究实验室（VDRL）、快速血浆反应素（RPR）、ELISA 和 TPHA 检测。以 TPHA 为参考标准试验，计算 VDRL、RPR 和 ELISA 的性能特征。

结果

与 ELISA 的 2.5%相比，VDRL 和 RPR 的假阳性率分别为 10.5%和 9.6%。ELISA 的敏感性和特异性分别为 98%和 97.5%，VDRL 为 71.6%和 89.5%，RPR 为 73.5%和 90.5%。此外，ELISA 与 TPHA 具有极好的一致性（kappa=0.9），而 VDRL/RPR 只有中度一致性（kappa=0.6）。