基于登革热NS1抗原捕获ELISA的登革热NS1抗原侧流快速免疫分析方法的性能评价

IF 1.6 Q4 INFECTIOUS DISEASES Journal of clinical virology plus Pub Date : 2023-06-01 DOI:10.1016/j.jcvp.2023.100144

Mohammed Rashiku , Kapil Manoharan , Nitiksha Rani , Jasmine Samal , Ekta Gupta , Shantanu Bhattacharya

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引用次数: 1

摘要

登革热被列为最严重的病毒性疾病之一，需要快速、准确和早期的诊断才能更好地照顾患者。目的本研究涉及一种易于操作、价格合理的试剂盒的开发和临床验证，该试剂盒基于患者血清样本中的侧流免疫测定法检测登革热NS1抗原。研究设计使用开发的NS1检测试剂盒获得并分析临床上未表征的血清样本，并与ELISA结果进行比较。结果用NS1抗原阳性和阴性患者血清样品对试剂盒的性能进行了评估，发现试剂盒具有高度的特异性和敏感性。总体灵敏度为92.16%，特异性为97.25%。还进行了试剂盒稳定性测试，发现试剂盒的性能与实时测试相似。结论所研制的NS1检测试剂盒具有良好的可靠性，与ELISA结果相当。

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Performance evaluation of a rapid dengue NS1 antigen lateral flow immunoassay test with reference to dengue NS1 antigen-capture ELISA

Background

Dengue, ranked as one of the most critical viral diseases, requires rapid, accurate, and early diagnosis for better patient care.

Objectives

This study pertains to the development and clinical validation of an in house easy to do, affordable kit for the detection of dengue NS1 antigen based on lateral flow immunoassay in serum samples of patients.

Study Design

Clinically uncharacterized serum specimens were obtained and analyzed using the developed NS1 detection kit and compared against the ELISA results.

Results

The performance of the kit was evaluated with both positive and negative patients’ serum samples for NS1 antigen and found to be highly specific and sensitive. An overall sensitivity of 92.16 % and specificity of 97.25 % were recorded. Kit stability tests were also carried out and the performance of the kit was found to be similar to real time tests.