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

Autor: 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. saram6756@gmail.com., 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 DA; Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Jazyk: angličtina
Zdroj: Acta parasitologica [Acta Parasitol] 2024 Dec; Vol. 69 (4), pp. 1926-1936. Date of Electronic Publication: 2024 Oct 02.
DOI: 10.1007/s11686-024-00917-9
Abstrakt: 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.
Competing Interests: Declarations. Ethics Approval and Consent to Participate: This study was reviewed and approved by both the Research Ethics Committee, Faculty of Medicine, Ain Shams University, study protocol (FMASU MS248/ 2020), and the ethics committee of Theodor Bilhariz Research Institute (TBRI, No. 05/09/16). Each participant in the current study provided full medical history and informed consent. All relevant guidelines and regulations concerning animal’s manipulation as immunization of target antigens, myeloma and plasma cells fusion procedure and large scale production of monoclonal antibody were carried out. Consent for Publication: All the authors have approved the manuscript and agree with submission to journal. Competing Interests: The authors declare no competing interests.
(© 2024. The Author(s).)
Databáze: MEDLINE
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