Home-Made Lateral Flow Test Strip Versus POC-CCA Assay for Detection of Active Schistosomiasis in Egypt

Theodor Bilharz Research Institute

Bibliographic Information

Authors: Kamel M.; Salah F.; Demerdash Z.; Maher S.; El-Baz H.; Zakaria N.; Abu-Shady R.; Saad A.; Hassan S.; Aziz D.A.

Journal: Acta Parasitologica

Publisher: Springer Science and Business Media Deutschland GmbH

Publication Date: 2 October 2024

Volume / Issue: Volume 69 / Issue 4

Pages: 1926–1936

ISSN: 12302821

DOI: 10.1007/s11686-024-00917-9

Scopus: View on Scopus

PubMed: 39356423

Document Type: Article

Access: All Open Access; Green Open Access; Hybrid Gold Open Access

Authors and Affiliations

Kamel M., Immunology Department, Theodor Bilharz Research Institute, Kornish El Nil Street, Giza, Egypt; Salah F., Immunology Department, Theodor Bilharz Research Institute, Kornish El Nil Street, Giza, Egypt; Demerdash Z., Immunology Department, Theodor Bilharz Research Institute, Kornish El Nil Street, Giza, Egypt; Maher S., Immunology Department, Theodor Bilharz Research Institute, Kornish El Nil Street, Giza, Egypt; El-Baz H., Immunology Department, Theodor Bilharz Research Institute, Kornish El Nil Street, Giza, Egypt; Zakaria N., Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt; Abu-Shady R., Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt; Saad A., Immunology Department, Theodor Bilharz Research Institute, Kornish El Nil Street, Giza, Egypt; Hassan S., Immunology Department, Theodor Bilharz Research Institute, Kornish El Nil Street, Giza, Egypt; Aziz D.A., Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt

Abstract

Background: For years, the Kato-Katz (KK) technique has been considered the gold standard for diagnosing schistosomiasis. The aim of this study was to compare the effectiveness of our previously developed gold nanoparticle-based lateral flow test strip (AuNPs-LFTS) for diagnosing active Schistosoma mansoni with that of the commercially available point-of-care Circulating Cathodic Antigen detection (POC-CCA) kit. Methods: In this study, we collected sixty positive and twenty negative urine samples from patients in endemic hot spots in the Nile Delta, as well as from patients visiting the internal medicine clinic at Theodor Bilharz Research Institute (TBRI). We produced monoclonal antibodies (MAbs) against S. mansoni soluble egg antigen (SEA) from cloned hybridoma cells (4D/1D). These MAbs were conjugated with gold and mesoporous silica nanoparticles, and used to develop the LFTS. Results: The LFTS demonstrated a limit of detection (LoD) of 3 ng/ml. The sensitivity and specificity of the developed LFTS were found to be 96.7% and 95%, respectively, compared to 85% and 90% for the POC-CCA detection kit. The cases were divided into groups based on egg count in the stool, categorized as light, moderate, and heavy infections. The sensitivity of the LFTS in the group with light infection was higher than that of the POC-CCA. When using the KK technique (eggs per gram of stool sample [EPG]) as the reference test, the kappa value for the nano-based strips was 0.902, compared to 0.672 for the CCA strips, indicating an almost perfect agreement between KK and our developed LFTS. Conclusion: These results confirm the reliability and effectiveness of the LFTS compared to commercially available kits for rapid, sensitive, and early diagnosis of schistosomiasis. However, it is recommended to conduct further assessments of the developed strip on a larger scale with a broader range of cases before considering its introduction to local or international markets. © The Author(s) 2024.

Keywords

Lateral flow test; Monoclonal antibodies; Nanoparticles; Schistosomiasis; Animals; Antibodies, Monoclonal; Antigens, Helminth; Egypt; Feces; Gold; Humans; Limit of Detection; Metal Nanoparticles; Parasite Egg Count; Point-of-Care Systems; Reagent Strips; Schistosoma mansoni; Schistosomiasis mansoni; Sensitivity and Specificity; metal nanoparticle; monoclonal antibody; parasite antigen; animal; chemistry; comparative study; diagnosis; human; immunology; isolation and purification; parasitology; point of care system; procedures; test strip; urine

Citation Information

Scopus Citations: 0

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