A proof-of-concept point-of-care test for the serodiagnosis of human amebic liver abscess
Background Amebic liver abscess (ALA), caused by an extraintestinal invasion of the virulent protozoan Entamoeba histolytica, is important among parasitic causes of morbidity and mortality, especially in the tropics. Clinical symptoms, medical-imaging abnormalities of the liver and serological tests...
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PeerJ Inc.
2025-03-01
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| author | Rutchanee Rodpai Penchom Janwan Lakkhana Sadaow Patcharaporn Boonroumkaew Oranuch Sanpool Tongjit Thanchomnang Hiroshi Yamasaki Toshihiro Mita Pewpan M. Intapan Wanchai Maleewong |
| author_facet | Rutchanee Rodpai Penchom Janwan Lakkhana Sadaow Patcharaporn Boonroumkaew Oranuch Sanpool Tongjit Thanchomnang Hiroshi Yamasaki Toshihiro Mita Pewpan M. Intapan Wanchai Maleewong |
| author_sort | Rutchanee Rodpai |
| collection | DOAJ |
| description | Background Amebic liver abscess (ALA), caused by an extraintestinal invasion of the virulent protozoan Entamoeba histolytica, is important among parasitic causes of morbidity and mortality, especially in the tropics. Clinical symptoms, medical-imaging abnormalities of the liver and serological tests are normally made for supportive diagnosis. Serum-based enzyme-linked immunosorbent assay (ELISA) has been conventionally used for diagnosing ALA but is time-consuming and sophisticated equipment is required. Therefore, we sought to develop a new and rapid innovative point-of-care immunochromatographic test (ICT) that can use whole blood as an alternative to serum-based ELISA. An ICT tool using simulated whole-blood samples was developed for immunoglobulin G antibody detection, and its diagnostic efficiency was evaluated in comparison with serum-based ELISA. Methods Both methods were tested to assess their diagnostic performance using a total of 253 serum samples. These came from ALA patients (n = 13), healthy individuals (n = 40), and patients with other diseases (n = 200). Results Amebiasis-ICT exhibited 100% (95% confidential interval (CI) [75.3–100.0]) sensitivity and 97.1% (95% CI [94.1–98.8]) specificity, whereas ELISA gave the same sensitivity (100% 95% CI [75.3 –100.0]) and slightly lower specificity (95.8% 95% CI [92.5–98.0]). There were no significant differences in sensitivity and specificity between the two tests (Exact McNemar’s test; p > 0.05), with Cohen’s kappa agreement 96.44% (κ-value = 0.771, p < 0.001) indicating substantial agreement. Conclusion This ICT tool using simulated whole-blood samples has a high possibility of being used with real whole blood. Therefore, since there is no need to separate serum, this can be considered an innovative diagnostic tool to replace serum-based ELISA in clinics and field surveys in remote areas where medical facilities are limited. |
| format | Article |
| id | doaj-art-e6f367d840db46c7939b3faedcd5f952 |
| institution | DOAJ |
| issn | 2167-8359 |
| language | English |
| publishDate | 2025-03-01 |
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| spelling | doaj-art-e6f367d840db46c7939b3faedcd5f9522025-08-20T03:06:19ZengPeerJ Inc.PeerJ2167-83592025-03-0113e1918110.7717/peerj.19181A proof-of-concept point-of-care test for the serodiagnosis of human amebic liver abscessRutchanee Rodpai0Penchom Janwan1Lakkhana Sadaow2Patcharaporn Boonroumkaew3Oranuch Sanpool4Tongjit Thanchomnang5Hiroshi Yamasaki6Toshihiro Mita7Pewpan M. Intapan8Wanchai Maleewong9Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen, ThailandMekong Health Science Research Institute, Khon Kaen University, Khon Kaen, ThailandMekong Health Science Research Institute, Khon Kaen University, Khon Kaen, ThailandMekong Health Science Research Institute, Khon Kaen University, Khon Kaen, ThailandMekong Health Science Research Institute, Khon Kaen University, Khon Kaen, ThailandMekong Health Science Research Institute, Khon Kaen University, Khon Kaen, ThailandDepartment of Parasitology, National Institute of Infectious Diseases, Tokyo, JapanDepartment of Tropical Medicine and Parasitology, Juntendo University School of Medicine, Tokyo, JapanMekong Health Science Research Institute, Khon Kaen University, Khon Kaen, ThailandMekong Health Science Research Institute, Khon Kaen University, Khon Kaen, ThailandBackground Amebic liver abscess (ALA), caused by an extraintestinal invasion of the virulent protozoan Entamoeba histolytica, is important among parasitic causes of morbidity and mortality, especially in the tropics. Clinical symptoms, medical-imaging abnormalities of the liver and serological tests are normally made for supportive diagnosis. Serum-based enzyme-linked immunosorbent assay (ELISA) has been conventionally used for diagnosing ALA but is time-consuming and sophisticated equipment is required. Therefore, we sought to develop a new and rapid innovative point-of-care immunochromatographic test (ICT) that can use whole blood as an alternative to serum-based ELISA. An ICT tool using simulated whole-blood samples was developed for immunoglobulin G antibody detection, and its diagnostic efficiency was evaluated in comparison with serum-based ELISA. Methods Both methods were tested to assess their diagnostic performance using a total of 253 serum samples. These came from ALA patients (n = 13), healthy individuals (n = 40), and patients with other diseases (n = 200). Results Amebiasis-ICT exhibited 100% (95% confidential interval (CI) [75.3–100.0]) sensitivity and 97.1% (95% CI [94.1–98.8]) specificity, whereas ELISA gave the same sensitivity (100% 95% CI [75.3 –100.0]) and slightly lower specificity (95.8% 95% CI [92.5–98.0]). There were no significant differences in sensitivity and specificity between the two tests (Exact McNemar’s test; p > 0.05), with Cohen’s kappa agreement 96.44% (κ-value = 0.771, p < 0.001) indicating substantial agreement. Conclusion This ICT tool using simulated whole-blood samples has a high possibility of being used with real whole blood. Therefore, since there is no need to separate serum, this can be considered an innovative diagnostic tool to replace serum-based ELISA in clinics and field surveys in remote areas where medical facilities are limited.https://peerj.com/articles/19181.pdfAmebic liver abscessEntamoeba histolyticaEnzyme-linked immunosorbent assayImmunochromatographic testSerodiagnosisPoint-of care test |
| spellingShingle | Rutchanee Rodpai Penchom Janwan Lakkhana Sadaow Patcharaporn Boonroumkaew Oranuch Sanpool Tongjit Thanchomnang Hiroshi Yamasaki Toshihiro Mita Pewpan M. Intapan Wanchai Maleewong A proof-of-concept point-of-care test for the serodiagnosis of human amebic liver abscess PeerJ Amebic liver abscess Entamoeba histolytica Enzyme-linked immunosorbent assay Immunochromatographic test Serodiagnosis Point-of care test |
| title | A proof-of-concept point-of-care test for the serodiagnosis of human amebic liver abscess |
| title_full | A proof-of-concept point-of-care test for the serodiagnosis of human amebic liver abscess |
| title_fullStr | A proof-of-concept point-of-care test for the serodiagnosis of human amebic liver abscess |
| title_full_unstemmed | A proof-of-concept point-of-care test for the serodiagnosis of human amebic liver abscess |
| title_short | A proof-of-concept point-of-care test for the serodiagnosis of human amebic liver abscess |
| title_sort | proof of concept point of care test for the serodiagnosis of human amebic liver abscess |
| topic | Amebic liver abscess Entamoeba histolytica Enzyme-linked immunosorbent assay Immunochromatographic test Serodiagnosis Point-of care test |
| url | https://peerj.com/articles/19181.pdf |
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