Evaluation of the diagnostic performance and the utility of Helicobacter pylori stool antigen lateral immunochromatography assay
Background: Helicobacter pylori causes 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). Evaluating HpSA-LFIA is of crucial for ensuring accur...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-03-01
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| Series: | Heliyon |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2405844022004777 |
| _version_ | 1818327836417589248 |
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| author | Shaymaa Abdelmalek Wafy Hamed Neven Nagy Karim Shokry Hisham Abdelrahman |
| author_facet | Shaymaa Abdelmalek Wafy Hamed Neven Nagy Karim Shokry Hisham Abdelrahman |
| author_sort | Shaymaa Abdelmalek |
| collection | DOAJ |
| description | Background: Helicobacter pylori causes 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). 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. Methodology: 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. Results and conclusion: 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. |
| first_indexed | 2024-12-13T12:22:36Z |
| format | Article |
| id | doaj.art-f00b42fb67404f379949747e2d861993 |
| institution | Directory Open Access Journal |
| issn | 2405-8440 |
| language | English |
| last_indexed | 2024-12-13T12:22:36Z |
| publishDate | 2022-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Heliyon |
| spelling | doaj.art-f00b42fb67404f379949747e2d8619932022-12-21T23:46:33ZengElsevierHeliyon2405-84402022-03-0183e09189Evaluation of the diagnostic performance and the utility of Helicobacter pylori stool antigen lateral immunochromatography assayShaymaa Abdelmalek0Wafy Hamed1Neven Nagy2Karim Shokry3Hisham Abdelrahman4Microbiology, Immunology Department, Faculty of Veterinary Medicine, Cairo University, Egypt; Corresponding author.Microbiology Department, Faculty of Veterinary Medicine, Sadat City University, Sadat City, EgyptMicrobiology, Immunology Department, Faculty of Veterinary Medicine, Cairo University, EgyptMicrobiology, Immunology Department, Faculty of Veterinary Medicine, Cairo University, EgyptDepartment of Veterinary Hygiene and Management, Faculty of Veterinary Medicine, Cairo University, EgyptBackground: Helicobacter pylori causes 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). 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. Methodology: 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. Results and conclusion: 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.http://www.sciencedirect.com/science/article/pii/S2405844022004777HpSAH. pyloriDiagnostic performanceSensitivitySpecificityAccuracy |
| spellingShingle | Shaymaa Abdelmalek Wafy Hamed Neven Nagy Karim Shokry Hisham Abdelrahman Evaluation of the diagnostic performance and the utility of Helicobacter pylori stool antigen lateral immunochromatography assay Heliyon HpSA H. pylori Diagnostic performance Sensitivity Specificity Accuracy |
| title | Evaluation of the diagnostic performance and the utility of Helicobacter pylori stool antigen lateral immunochromatography assay |
| title_full | Evaluation of the diagnostic performance and the utility of Helicobacter pylori stool antigen lateral immunochromatography assay |
| title_fullStr | Evaluation of the diagnostic performance and the utility of Helicobacter pylori stool antigen lateral immunochromatography assay |
| title_full_unstemmed | Evaluation of the diagnostic performance and the utility of Helicobacter pylori stool antigen lateral immunochromatography assay |
| title_short | Evaluation of the diagnostic performance and the utility of Helicobacter pylori stool antigen lateral immunochromatography assay |
| title_sort | evaluation of the diagnostic performance and the utility of helicobacter pylori stool antigen lateral immunochromatography assay |
| topic | HpSA H. pylori Diagnostic performance Sensitivity Specificity Accuracy |
| url | http://www.sciencedirect.com/science/article/pii/S2405844022004777 |
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