Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Evaluation of the Diagnostic Values and Utility of Helicobacter Pylori Stool Antigen Lateral Immunochromatography Assay

Version 1 : Received: 19 November 2021 / Approved: 22 November 2021 / Online: 22 November 2021 (14:26:56 CET)

How to cite: Abdelmalek, S.; Hamed, W.; Nagy, N.; Shokry, K.; Abdelrahman, H. Evaluation of the Diagnostic Values and Utility of Helicobacter Pylori Stool Antigen Lateral Immunochromatography Assay. Preprints 2021, 2021110407 (doi: 10.20944/preprints202111.0407.v1). Abdelmalek, S.; Hamed, W.; Nagy, N.; Shokry, K.; Abdelrahman, H. Evaluation of the Diagnostic Values and Utility of Helicobacter Pylori Stool Antigen Lateral Immunochromatography Assay. Preprints 2021, 2021110407 (doi: 10.20944/preprints202111.0407.v1).

Abstract

Helicobacter pylori is the most common human gastric infection. H. pylori stool antigen lateral flow immunochromatography assay (HpSA-LFIA) is considered one of the most cost-effective and rapid non-invasive assays (active tests). The evaluation of this test is crucial for accuracy and utility assurance. This study aimed to evaluate the polyclonal antibody-based HpSA-LFIA in comparison to a monoclonal antibody-based ELISA kit. Methodology: Stool samples were collected from 200 gastric patients for HpSA-LFIA and semi-quantitative HpSA-ELISA. Statistical analysis of the diagnostic values was performed using MedCalc software. Chi-square tests were used to determine the effects of gender and age. Results: The obtained results found that HpSA-LFIA achieved promising sensitivity (93.75%) and NPV (98.00%). However, it had poor specificity, PPV, and accuracy, respectively, 59.76%, 31.25%, and 65.31%. LR+ & LR- were 2.33% & 0.1%, respectively. Gender had no significance on the di-agnostic parameters of HpSA-LFIA. Age groups had irrelevant sensitivity; however, specificity was significantly higher in patients over 45 years. Conclusion: It was concluded that HpSA-LFIA was not accurate enough to be the sole test for di-agnosis and needs other confirmatory tests in case of positive conditions

Keywords

HpSA; H. pylori; diagnostic values; sensitivity; specificity; accuracy; PPV; NPV

Subject

MEDICINE & PHARMACOLOGY, Gastroenterology

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