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. Preprints2021, 2021110407. https://doi.org/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. https://doi.org/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. Preprints2021, 2021110407. https://doi.org/10.20944/preprints202111.0407.v1
APA Style
Abdelmalek, S., Hamed, W., Nagy, N., Shokry, K., & Abdelrahman, H. (2021). Evaluation of the Diagnostic Values and Utility of Helicobacter Pylori Stool Antigen Lateral Immunochromatography Assay. Preprints. https://doi.org/10.20944/preprints202111.0407.v1
Chicago/Turabian Style
Abdelmalek, S., Karim Shokry and Hisham Abdelrahman. 2021 "Evaluation of the Diagnostic Values and Utility of Helicobacter Pylori Stool Antigen Lateral Immunochromatography Assay" Preprints. https://doi.org/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 and Pharmacology, Gastroenterology and Hepatology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
