Abdelmalek Shaymaa, Hamed Wafy, Nagy Neven, Shokry Karim, Abdelrahman Hisham
Microbiology, Immunology Department, Faculty of Veterinary Medicine, Cairo University, Egypt.
Microbiology Department, Faculty of Veterinary Medicine, Sadat City University, Sadat City, Egypt.
Heliyon. 2022 Mar 25;8(3):e09189. doi: 10.1016/j.heliyon.2022.e09189. eCollection 2022 Mar.
causes the most common human gastric infection. Stool Antigen Lateral Flow Immunochromatography assay (HpSA-LFIA) is considered one of the most cost-effective and rapid non-invasive assays (active tests). Evaluating HpSA-LFIA is of crucial for ensuring accuracy and utility assurance. This study aimed to evaluate the polyclonal antibody-based HpSA-LFIA in comparison to a monoclonal antibody-based ELISA kit.
Stool samples were collected from 200 gastric patients for HpSA-LFIA and semiquantitative HpSA-ELISA tests. A statistical analysis of the diagnostic performance was performed using MedCalc software. Chi-square tests were performed to determine the effects of gender and age.
The results showed that HpSA-LFIA achieved remarkable sensitivity (93.75%) and NPV (98.00%). However, it had poor specificity, PPV, and accuracy of 59.76%, 31.25%, and 65.31%, respectively. LR+ and LR-were 2.33% & 0.1%, respectively. Gender didn't affect the diagnostic performance of HpSA-LFIA. Age groups had irrelevant sensitivity; however, specificity was significantly higher in patients aged >45 years. We can conclude that HpSA-LFIA was not accurate enough to be the sole test for diagnosis and suggest developing other confirmatory tests in case of positive conditions.
是人类最常见的胃部感染病因。粪便抗原侧向流动免疫层析测定法（HpSA-LFIA）被认为是最具成本效益且快速的非侵入性检测方法之一（活性检测）。评估HpSA-LFIA对于确保准确性和实用性至关重要。本研究旨在将基于多克隆抗体的HpSA-LFIA与基于单克隆抗体的ELISA试剂盒进行比较评估。
从200名胃部疾病患者中采集粪便样本，进行HpSA-LFIA和半定量HpSA-ELISA检测。使用MedCalc软件对诊断性能进行统计分析。进行卡方检验以确定性别和年龄的影响。
结果显示，HpSA-LFIA具有显著的敏感性（93.75%）和阴性预测值（98.00%）。然而，其特异性、阳性预测值和准确性较差，分别为59.76%、31.25%和65.31%。阳性似然比和阴性似然比分别为2.33%和0.1%。性别不影响HpSA-LFIA的诊断性能。各年龄组的敏感性无关；然而，45岁以上患者的特异性显著更高。我们可以得出结论，HpSA-LFIA作为唯一的诊断检测方法不够准确，并建议在检测结果为阳性的情况下开展其他确证性检测。
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