Mahajan Supriya, Thapar Shalini, Khillan Vikas, Gupta Pradheer, Rastogi Archana, Gupta Ekta
Department of Clinical Virology, Institute of Liver and Biliary Sciences, Delhi, India.
Department of Radiology, Institute of Liver and Biliary Sciences, Delhi, India.
J Lab Physicians. 2020 Aug;12(2):98-102. doi: 10.1055/s-0040-1716460. Epub 2020 Sep 2.
The purpose of this study is to determine the diagnostic efficacy of enzyme-linked immunosorbent assay (ELISA) in radiologically confirmed liver mass lesions for the diagnosis of hepatic hydatid disease (HHD) and to compare the diagnostic performance of ELISA with fine needle aspiration cytology (FNAC) (taken as standard) for HHD diagnosis. This retrospective study included blood samples of 223 patients with radiologically confirmed liver mass lesions in which immunoglobulin G (IgG) anti- antibodies were tested using a commercial IgG ELISA (RIDASCREEN, R-Biopharm AG, Darmstadt, Germany). Results of ELISA, ultrasonography, FNAC, and liver function tests were obtained from the hospital information system. ELISA results were compared with those of FNAC to analyze the diagnostic efficacy of ELISA for HHD diagnosis. Comparison of the results obtained from ELISA was performed with respect to FNAC results (taken as standard) to analyze the diagnostic efficacy of ELISA for HHD detection. Data has been represented as median (range) or in frequencies. Wilson score was used to assess 95% confidence interval of diagnostic parameters. The analysis was performed using SPSS Version 22.0 (IBM Corp.) and Open Epi (version 3.01). Out of 223 cases with liver mass lesions, IgG was reactive in 62 (28%) cases and FNAC was positive in 16 (7.2%) cases. Since two cases were FNAC-positive but IgG-nonreactive, total HHD cases were 64 (28.7%). IgG reactive cases were seen more in the extremes of age group, that is, 1 to 10 years and 81 to 90 years. Taking FNAC as the standard, the sensitivity, specificity, positive predictive value, and negative predictive value of ELISA were 87.5, 76.8, 22.6, and 98.7%, respectively. Cytology-positive cases demonstrated a mean ELISA optical density/cut-off (OD/CO) of 4.2 ± 3 standard deviation. ELISA in radiologically confirmed liver mass cases is highly sensitive in detecting HHD and hence should be used along with ultrasonography for the screening of HHD followed by confirmation with cytology even in cases with a higher OD/CO of ELISA.
本研究的目的是确定酶联免疫吸附测定(ELISA)在经放射学确诊的肝脏肿块病变中对肝包虫病(HHD)诊断的效能,并比较ELISA与细针穿刺细胞学检查(FNAC,作为标准方法)对HHD诊断的性能。
这项回顾性研究纳入了223例经放射学确诊为肝脏肿块病变患者的血样,使用商用IgG ELISA(RIDASCREEN,R - Biopharm AG,德国达姆施塔特)检测其中的免疫球蛋白G(IgG)抗体。ELISA、超声检查、FNAC和肝功能检查的结果均来自医院信息系统。将ELISA结果与FNAC结果进行比较,以分析ELISA对HHD诊断的效能。
将ELISA获得的结果与FNAC结果(作为标准)进行比较,以分析ELISA对HHD检测的诊断效能。数据以中位数(范围)或频率表示。采用Wilson评分评估诊断参数的95%置信区间。分析使用SPSS 22.0版(IBM公司)和Open Epi(3.01版)进行。
在223例肝脏肿块病变病例中,62例(28%)IgG呈反应性,16例(7.2%)FNAC呈阳性。由于有2例FNAC阳性但IgG无反应性,HHD总病例数为64例(28.7%)。IgG反应性病例在年龄组两端更为常见,即1至10岁和81至90岁。以FNAC为标准,ELISA的敏感性、特异性、阳性预测值和阴性预测值分别为87.5%、76.8%、22.6%和98.7%。细胞学阳性病例的ELISA平均光密度/临界值(OD/CO)为4.2±3标准差。
在经放射学确诊的肝脏肿块病例中,ELISA对HHD检测具有高度敏感性,因此即使在ELISA的OD/CO较高的病例中,也应与超声检查一起用于HHD的筛查,随后通过细胞学检查进行确诊。