Performance of Colorimetric Lateral Flow Immunoassays for Renal Function Evaluation with Human Serum Cystatin C
Chronic kidney disease (CKD) is associated with heart failure and neurological disorders. Therefore, point-of-care (POC) detection of CKD is essential, allowing disease monitoring from home and alleviating healthcare professionals’ workload. Lateral flow immunoassays (LFIAs) facilitate POC testing f...
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MDPI AG
2025-07-01
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| Series: | Biosensors |
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| Online Access: | https://www.mdpi.com/2079-6374/15/7/445 |
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| author | Xushuo Zhang Sam Fishlock Peter Sharpe James McLaughlin |
| author_facet | Xushuo Zhang Sam Fishlock Peter Sharpe James McLaughlin |
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| description | Chronic kidney disease (CKD) is associated with heart failure and neurological disorders. Therefore, point-of-care (POC) detection of CKD is essential, allowing disease monitoring from home and alleviating healthcare professionals’ workload. Lateral flow immunoassays (LFIAs) facilitate POC testing for a renal function biomarker, serum Cystatin C (CysC). LF devices were fabricated and optimised by varying the diluted sample volume, the nitrocellulose (NC) membrane, bed volume, AuNPs’ OD value and volume, and assay formats of partial or full LF systems. Notably, 310 samples were analysed to satisfy the minimum sample size for statistical calculations. This allowed for a comparison between the LFIAs’ results and the general Roche standard assay results from the Southern Health and Social Care Trust. Bland–Altman plots indicated the LFIAs measured 0.51 mg/L lower than the Roche assays. With the 95% confidence interval, the Roche method might be 0.24 mg/L below the LFIAs’ results or 1.27 mg/L above the LFIAs’ results. In summary, the developed non-fluorescent LFIAs could detect clinical CysC values in agreement with Roche assays. Even though the developed LFIA had an increased bias in low CysC concentration (below 2 mg/L) detection, the developed LFIA can still alert patients at the early stages of renal function impairment. |
| format | Article |
| id | doaj-art-7a8fe3f8a23845a4affc98ee4d5b57fd |
| institution | Kabale University |
| issn | 2079-6374 |
| language | English |
| publishDate | 2025-07-01 |
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| series | Biosensors |
| spelling | doaj-art-7a8fe3f8a23845a4affc98ee4d5b57fd2025-08-20T03:32:24ZengMDPI AGBiosensors2079-63742025-07-0115744510.3390/bios15070445Performance of Colorimetric Lateral Flow Immunoassays for Renal Function Evaluation with Human Serum Cystatin CXushuo Zhang0Sam Fishlock1Peter Sharpe2James McLaughlin3Nanotechnology Integrated Bioengineering Centre (NIBEC), Ulster University, Shore Road, Newtownabbey, County Antrim BT37 0QB, UKNanotechnology Integrated Bioengineering Centre (NIBEC), Ulster University, Shore Road, Newtownabbey, County Antrim BT37 0QB, UKSouthern Health & Social Care Trust (SHSCT), Craigavon Area Hospital, 68 Lurgan Road, Portadown BT63 5QQ, UKNanotechnology Integrated Bioengineering Centre (NIBEC), Ulster University, Shore Road, Newtownabbey, County Antrim BT37 0QB, UKChronic kidney disease (CKD) is associated with heart failure and neurological disorders. Therefore, point-of-care (POC) detection of CKD is essential, allowing disease monitoring from home and alleviating healthcare professionals’ workload. Lateral flow immunoassays (LFIAs) facilitate POC testing for a renal function biomarker, serum Cystatin C (CysC). LF devices were fabricated and optimised by varying the diluted sample volume, the nitrocellulose (NC) membrane, bed volume, AuNPs’ OD value and volume, and assay formats of partial or full LF systems. Notably, 310 samples were analysed to satisfy the minimum sample size for statistical calculations. This allowed for a comparison between the LFIAs’ results and the general Roche standard assay results from the Southern Health and Social Care Trust. Bland–Altman plots indicated the LFIAs measured 0.51 mg/L lower than the Roche assays. With the 95% confidence interval, the Roche method might be 0.24 mg/L below the LFIAs’ results or 1.27 mg/L above the LFIAs’ results. In summary, the developed non-fluorescent LFIAs could detect clinical CysC values in agreement with Roche assays. Even though the developed LFIA had an increased bias in low CysC concentration (below 2 mg/L) detection, the developed LFIA can still alert patients at the early stages of renal function impairment.https://www.mdpi.com/2079-6374/15/7/445gold nanoparticlesserum Cystatin Clateral flow immunoassaypoint-of-care |
| spellingShingle | Xushuo Zhang Sam Fishlock Peter Sharpe James McLaughlin Performance of Colorimetric Lateral Flow Immunoassays for Renal Function Evaluation with Human Serum Cystatin C Biosensors gold nanoparticles serum Cystatin C lateral flow immunoassay point-of-care |
| title | Performance of Colorimetric Lateral Flow Immunoassays for Renal Function Evaluation with Human Serum Cystatin C |
| title_full | Performance of Colorimetric Lateral Flow Immunoassays for Renal Function Evaluation with Human Serum Cystatin C |
| title_fullStr | Performance of Colorimetric Lateral Flow Immunoassays for Renal Function Evaluation with Human Serum Cystatin C |
| title_full_unstemmed | Performance of Colorimetric Lateral Flow Immunoassays for Renal Function Evaluation with Human Serum Cystatin C |
| title_short | Performance of Colorimetric Lateral Flow Immunoassays for Renal Function Evaluation with Human Serum Cystatin C |
| title_sort | performance of colorimetric lateral flow immunoassays for renal function evaluation with human serum cystatin c |
| topic | gold nanoparticles serum Cystatin C lateral flow immunoassay point-of-care |
| url | https://www.mdpi.com/2079-6374/15/7/445 |
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