A diagnostic platform for rapid, simultaneous quantification of procalcitonin and C-reactive protein in human serum.

TitleA diagnostic platform for rapid, simultaneous quantification of procalcitonin and C-reactive protein in human serum.
Publication TypeJournal Article
Year of Publication2022
AuthorsCao XElvis, Ongagna-Yhombi SY, Wang R, Ren Y, Srinivasan B, Hayden JA, Zhao Z, Erickson D, Mehta S
Date Published2022 Feb
KeywordsBacterial Infections, Biomarkers, C-Reactive Protein, Humans, Procalcitonin, Sepsis

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.

Alternate JournalEBioMedicine
PubMed ID35149284
PubMed Central IDPMC8841998
Grant ListR01 EB021331 / EB / NIBIB NIH HHS / United States
Related Faculty: 
Zhen Zhao, Ph.D.

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