Development and Evaluation of a Quantitative Fluorescent Lateral Flow Immunoassay for Cystatin-C, a Renal Dysfunction Biomarker

The diagnosis, prognosis, and control of chronic kidney disease rely on an understanding of the glomerular filtration rate (GFR). The renal clearance of the cystatin-C is closely associated with the GFR. Cystatin-C is a more suitable GFR marker than the commonly used creatinine. General techniques f...

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Main Authors: Satheesh Natarajan, Maria C. DeRosa, Malay Ilesh Shah, Joseph Jayaraj
Format: Article
Language:English
Published: MDPI AG 2021-05-01
Series:Sensors
Subjects:
Online Access:https://www.mdpi.com/1424-8220/21/9/3178
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author Satheesh Natarajan
Maria C. DeRosa
Malay Ilesh Shah
Joseph Jayaraj
author_facet Satheesh Natarajan
Maria C. DeRosa
Malay Ilesh Shah
Joseph Jayaraj
author_sort Satheesh Natarajan
collection DOAJ
description The diagnosis, prognosis, and control of chronic kidney disease rely on an understanding of the glomerular filtration rate (GFR). The renal clearance of the cystatin-C is closely associated with the GFR. Cystatin-C is a more suitable GFR marker than the commonly used creatinine. General techniques for cystatin-C calculation, such as particle-enhanced turbidimetric and nephelometric assay, are time-consuming and tedious. Here, we propose a rapid, quantitative immunoassay for the detection of cystatin-C. A fluorescence-based lateral-flow kit was developed in a sandwich format by using a monoclonal antibody. A Linear calibration was obtained over the clinical diagnostic range of 0.023–32 µg/mL and the limit of detection (LOD) was 0.023 µg/mL and the limit of quantification (LOQ) was 0.029 µg/mL. Average recoveries from spiked urine samples ranged from 96–100% and the coefficient of variation was less than 4% for both intra and inter-day assays with excellent repeatability. With the comparison with an ELISA kit, the developed kit is highly sensitive, performs well over the detection range, provides repeatable results in a short time, and can easily be used at point-of-care (POC), making it an ideal candidate for rapid testing in early detection, community screening for renal function disorders.
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spelling doaj.art-5c9c36af72f34068ae1af96661de2f1e2023-11-21T18:15:08ZengMDPI AGSensors1424-82202021-05-01219317810.3390/s21093178Development and Evaluation of a Quantitative Fluorescent Lateral Flow Immunoassay for Cystatin-C, a Renal Dysfunction BiomarkerSatheesh Natarajan0Maria C. DeRosa1Malay Ilesh Shah2Joseph Jayaraj3Healthcare Technology Innovation Centre, Indian Institute of Technology Madras, Chennai 600113, IndiaDepartment of Chemistry, Carleton University, Ottawa, ON K1S 5B6, CanadaHealthcare Technology Innovation Centre, Indian Institute of Technology Madras, Chennai 600113, IndiaDepartment of Electrical Engineering, Indian Institute of Technology, Madras, Chennai 600113, IndiaThe diagnosis, prognosis, and control of chronic kidney disease rely on an understanding of the glomerular filtration rate (GFR). The renal clearance of the cystatin-C is closely associated with the GFR. Cystatin-C is a more suitable GFR marker than the commonly used creatinine. General techniques for cystatin-C calculation, such as particle-enhanced turbidimetric and nephelometric assay, are time-consuming and tedious. Here, we propose a rapid, quantitative immunoassay for the detection of cystatin-C. A fluorescence-based lateral-flow kit was developed in a sandwich format by using a monoclonal antibody. A Linear calibration was obtained over the clinical diagnostic range of 0.023–32 µg/mL and the limit of detection (LOD) was 0.023 µg/mL and the limit of quantification (LOQ) was 0.029 µg/mL. Average recoveries from spiked urine samples ranged from 96–100% and the coefficient of variation was less than 4% for both intra and inter-day assays with excellent repeatability. With the comparison with an ELISA kit, the developed kit is highly sensitive, performs well over the detection range, provides repeatable results in a short time, and can easily be used at point-of-care (POC), making it an ideal candidate for rapid testing in early detection, community screening for renal function disorders.https://www.mdpi.com/1424-8220/21/9/3178quantitative fluorescent immunoassaynon-invasive lateral flow assayPoint-of-Care Cystatin-C test
spellingShingle Satheesh Natarajan
Maria C. DeRosa
Malay Ilesh Shah
Joseph Jayaraj
Development and Evaluation of a Quantitative Fluorescent Lateral Flow Immunoassay for Cystatin-C, a Renal Dysfunction Biomarker
Sensors
quantitative fluorescent immunoassay
non-invasive lateral flow assay
Point-of-Care Cystatin-C test
title Development and Evaluation of a Quantitative Fluorescent Lateral Flow Immunoassay for Cystatin-C, a Renal Dysfunction Biomarker
title_full Development and Evaluation of a Quantitative Fluorescent Lateral Flow Immunoassay for Cystatin-C, a Renal Dysfunction Biomarker
title_fullStr Development and Evaluation of a Quantitative Fluorescent Lateral Flow Immunoassay for Cystatin-C, a Renal Dysfunction Biomarker
title_full_unstemmed Development and Evaluation of a Quantitative Fluorescent Lateral Flow Immunoassay for Cystatin-C, a Renal Dysfunction Biomarker
title_short Development and Evaluation of a Quantitative Fluorescent Lateral Flow Immunoassay for Cystatin-C, a Renal Dysfunction Biomarker
title_sort development and evaluation of a quantitative fluorescent lateral flow immunoassay for cystatin c a renal dysfunction biomarker
topic quantitative fluorescent immunoassay
non-invasive lateral flow assay
Point-of-Care Cystatin-C test
url https://www.mdpi.com/1424-8220/21/9/3178
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