登革热 NS1 快速检测、定性酶联免疫吸附试验和定量酶联免疫吸附试验结果的比较

Manali Nilekeri, S. Taklikar
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引用次数: 0

摘要

背景:非结构性糖蛋白-1(NS1非结构性糖蛋白-1(NS1)是早期诊断登革热的有用生物标志物。NS-1抗原酶联免疫吸附试验可用于登革热急性期的早期诊断。由于定性 ELISA 的假阴性率较高,定量方法更适用于流行病环境:该研究在获得机构伦理委员会(IEC/DISS/17118)批准后启动。研究对 280 名到医院门诊部和综合门诊部就诊的登革热症状患者进行了检查。患者采用定性 ELISA 方法进行检测,排除了钩端螺旋体抗体、疟疾或基孔肯雅病 IgM 抗体的患者。年龄、性别、症状、合并症、白细胞总数、血小板计数和风险类别都是与患者相关的参数。记录患者相关参数,使用 Microsoft excel 收集数据并进行统计分析:大多数患者年龄在2-40岁之间,男性居多,有发热、畏寒和全身疼痛症状,243人(86.8%)的ELISA NS1检测呈阳性。定量酶联免疫吸附试验与快速抗原 NS1 检测结果有统计学意义的相关性(P=0.015)。其 AUC 为 0.883(p=0.0001),临界值为(>109.1),灵敏度为 96.9%,特异度为 13.64%。与定性 ELISA NS1 相比,定量 ELISA NS1 的 AUC 为 0.853,具有统计学意义(p74.34),该检测的灵敏度为 92.59%,特异性为 75.68%:定性 ELISA NS1 检测法的特异性更高,灵敏度相似,因此在筛查方面优于快速抗原检测法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparison of rapid dengue NS1, qualitative ELISA, and quantitative ELISA result
Background: Non-structural glycoprotein-1 (NS1) is a useful biomarker for early diagnosis of dengue fever. NS-1 antigen ELISA can be used for the early diagnosis of dengue fever in the acute stage. Quantitative methods are better for epidemic settings due to high false negative rates in qualitative ELISA. Methods: The study was initiated after approval from the institutional ethics council (IEC/DISS/17118). Study examined 280 patients with dengue symptoms who presented to the hospital's OPDs and IPDs. Patients were tested using qualitative ELISA, and those with Leptospira antibody, malaria, or Chikungunya IgM antibody were excluded. Age, gender, symptoms, comorbidities, total leucocyte count, platelet count, and risk category were all patient-related parameters. Patient-related parameters were recorded, and data was collected using Microsoft excel and analysed statistically. Results: Most patients aged 2-40 with male predominance had fever, chills, and body aches, 243 (86.8%) tested positive for ELISA NS1. Quantitative ELISA test showed a statistically significant correlation with rapid antigen NS1 result (p=0.015). Its AUC was 0.883 (p=0.0001), and its cut-off was (>109.1) with 96.9% sensitivity and 13.64% specificity. The AUC of quantitative ELISA NS1 against qualitative ELISA NS1 was 0.853 which was statistically significant (p<0.0001). At the cut-off >74.34, the test's sensitivity was 92.59% and specificity was 75.68%. Conclusions: Qualitative ELISA NS1 test is better than rapid antigen test for screening due to its higher specificity and similar sensitivity.
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