A diagnostic platform for rapid, simultaneous quantification of procalcitonin and C-reactive protein in human serum
Summary: Background: Early and accurate determination of bacterial infections as a potential cause for a patient's systemic inflammatory response is required for timely administration of appropriate treatment and antibiotic stewardship. Procalcitonin (PCT) and C-reactive protein (CRP) have bot...
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Format: | Article |
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Elsevier
2022-02-01
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Series: | EBioMedicine |
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Online Access: | http://www.sciencedirect.com/science/article/pii/S2352396422000512 |
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author | Xiangkun Elvis Cao Serge Y. Ongagna-Yhombi Ruisheng Wang Yue Ren Balaji Srinivasan Joshua A. Hayden Zhen Zhao David Erickson Saurabh Mehta |
author_facet | Xiangkun Elvis Cao Serge Y. Ongagna-Yhombi Ruisheng Wang Yue Ren Balaji Srinivasan Joshua A. Hayden Zhen Zhao David Erickson Saurabh Mehta |
author_sort | Xiangkun Elvis Cao |
collection | DOAJ |
description | Summary: Background: Early and accurate determination of bacterial infections as a potential cause for a patient's systemic inflammatory response is required for timely administration of appropriate treatment and antibiotic stewardship. Procalcitonin (PCT) and C-reactive protein (CRP) have both been used as biomarkers to infer bacterial infections, particularly in the context of sepsis. There is an urgent need to develop a platform for simultaneous quantification of PCT and CRP, to enable the potential use of these biomarkers at the point-of-care. Methods: A multiplexed lateral flow assay (LFA) and a fluorescence optical reader were developed. Assay performance was validated by testing spiked antigens in the buffer, followed by a validation study comparing results with conventional assays (Roche Cobas e411 Elecsys PCT and Siemens ADVIA XPT CRP) in 25 archived remnant human serum samples. Findings: A linear regression correlation of 0·97 (P < 0·01) was observed for PCT, and a correlation of 0·95 (P < 0·01) was observed for CRP using direct patient samples. We also validated our platform's ability to accurately quantify high-dose CRP in the hook effect range where excess unlabeled analytes occupy binding sites at test lines. Interpretation: A fluorescence reader-based duplex LFA for simultaneous quantification of PCT and CRP was developed and successfully validated with clinical samples. The rapid, portable, and low-cost nature of the platform offers potential for differentiation of bacterial and viral infections in emergency and low-resource settings at the point-of-care. Funding: NIH/NIBIB Award 1R01EB021331, and Academic Venture Fund from the Atkinson Center for a Sustainable Future at Cornell University. |
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issn | 2352-3964 |
language | English |
last_indexed | 2024-12-24T03:00:22Z |
publishDate | 2022-02-01 |
publisher | Elsevier |
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series | EBioMedicine |
spelling | doaj.art-f2be8d4bc82441d29862674394e55d7f2022-12-21T17:18:14ZengElsevierEBioMedicine2352-39642022-02-0176103867A diagnostic platform for rapid, simultaneous quantification of procalcitonin and C-reactive protein in human serumXiangkun Elvis Cao0Serge Y. Ongagna-Yhombi1Ruisheng Wang2Yue Ren3Balaji Srinivasan4Joshua A. Hayden5Zhen Zhao6David Erickson7Saurabh Mehta8Sibley School of Mechanical and Aerospace Engineering, Cornell University, Ithaca, NY, United StatesSibley School of Mechanical and Aerospace Engineering, Cornell University, Ithaca, NY, United States; Division of Nutritional Sciences, Cornell University, Ithaca, NY, United StatesMeinig School of Biomedical Engineering, Cornell University, Ithaca, NY, United StatesSibley School of Mechanical and Aerospace Engineering, Cornell University, Ithaca, NY, United StatesDivision of Nutritional Sciences, Cornell University, Ithaca, NY, United States; Institute for Nutritional Sciences, Global Health, and Technology, Cornell University, Ithaca, NY, United StatesDepartment of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, NY, United StatesDepartment of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, NY, United StatesSibley School of Mechanical and Aerospace Engineering, Cornell University, Ithaca, NY, United States; Division of Nutritional Sciences, Cornell University, Ithaca, NY, United States; Institute for Nutritional Sciences, Global Health, and Technology, Cornell University, Ithaca, NY, United States; Corresponding authors at: David Erickson, Sibley School of Mechanical and Aerospace Engineering, Cornell University, Ithaca, NY, United States. Saurabh Mehta, Division of Nutritional Sciences, Cornell University, Ithaca, NY, United States.Division of Nutritional Sciences, Cornell University, Ithaca, NY, United States; Institute for Nutritional Sciences, Global Health, and Technology, Cornell University, Ithaca, NY, United States; Corresponding authors at: David Erickson, Sibley School of Mechanical and Aerospace Engineering, Cornell University, Ithaca, NY, United States. Saurabh Mehta, Division of Nutritional Sciences, Cornell University, Ithaca, NY, United States.Summary: Background: Early and accurate determination of bacterial infections as a potential cause for a patient's systemic inflammatory response is required for timely administration of appropriate treatment and antibiotic stewardship. Procalcitonin (PCT) and C-reactive protein (CRP) have both been used as biomarkers to infer bacterial infections, particularly in the context of sepsis. There is an urgent need to develop a platform for simultaneous quantification of PCT and CRP, to enable the potential use of these biomarkers at the point-of-care. Methods: A multiplexed lateral flow assay (LFA) and a fluorescence optical reader were developed. Assay performance was validated by testing spiked antigens in the buffer, followed by a validation study comparing results with conventional assays (Roche Cobas e411 Elecsys PCT and Siemens ADVIA XPT CRP) in 25 archived remnant human serum samples. Findings: A linear regression correlation of 0·97 (P < 0·01) was observed for PCT, and a correlation of 0·95 (P < 0·01) was observed for CRP using direct patient samples. We also validated our platform's ability to accurately quantify high-dose CRP in the hook effect range where excess unlabeled analytes occupy binding sites at test lines. Interpretation: A fluorescence reader-based duplex LFA for simultaneous quantification of PCT and CRP was developed and successfully validated with clinical samples. The rapid, portable, and low-cost nature of the platform offers potential for differentiation of bacterial and viral infections in emergency and low-resource settings at the point-of-care. Funding: NIH/NIBIB Award 1R01EB021331, and Academic Venture Fund from the Atkinson Center for a Sustainable Future at Cornell University.http://www.sciencedirect.com/science/article/pii/S2352396422000512SepsisPoint-of-care diagnosticsBacterial and viral infectionsMultiplexed lateral flow assayProcalcitonin (PCT)C-reactive protein (CRP) |
spellingShingle | Xiangkun Elvis Cao Serge Y. Ongagna-Yhombi Ruisheng Wang Yue Ren Balaji Srinivasan Joshua A. Hayden Zhen Zhao David Erickson Saurabh Mehta A diagnostic platform for rapid, simultaneous quantification of procalcitonin and C-reactive protein in human serum EBioMedicine Sepsis Point-of-care diagnostics Bacterial and viral infections Multiplexed lateral flow assay Procalcitonin (PCT) C-reactive protein (CRP) |
title | A diagnostic platform for rapid, simultaneous quantification of procalcitonin and C-reactive protein in human serum |
title_full | A diagnostic platform for rapid, simultaneous quantification of procalcitonin and C-reactive protein in human serum |
title_fullStr | A diagnostic platform for rapid, simultaneous quantification of procalcitonin and C-reactive protein in human serum |
title_full_unstemmed | A diagnostic platform for rapid, simultaneous quantification of procalcitonin and C-reactive protein in human serum |
title_short | A diagnostic platform for rapid, simultaneous quantification of procalcitonin and C-reactive protein in human serum |
title_sort | diagnostic platform for rapid simultaneous quantification of procalcitonin and c reactive protein in human serum |
topic | Sepsis Point-of-care diagnostics Bacterial and viral infections Multiplexed lateral flow assay Procalcitonin (PCT) C-reactive protein (CRP) |
url | http://www.sciencedirect.com/science/article/pii/S2352396422000512 |
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