Patient Stratification for Antibiotic Prescriptions Based on
the Bound-Free Phase Detection Immunoassay of C-Reactive
Protein in Serum Samples

J 2023

Patient Stratification for Antibiotic Prescriptions Based on the Bound-Free Phase Detection Immunoassay of C-Reactive Protein in Serum Samples

JOHANNSEN, Benita, Desiree BAUMGARTNER, Michal KARPÍŠEK, David STEJSKAL, Noemie BOILLAT-BLANCO et. al.

Basic information

Original name

Patient Stratification for Antibiotic Prescriptions Based on the Bound-Free Phase Detection Immunoassay of C-Reactive Protein in Serum Samples

Authors

JOHANNSEN, Benita, Desiree BAUMGARTNER, Michal KARPÍŠEK (203 Czech Republic, belonging to the institution), David STEJSKAL, Noemie BOILLAT-BLANCO, Jose KNUESLI, Marcus PANNING, Nils PAUST, Roland ZENGERLE and Konstantinos MITSAKAKIS (guarantor)

Edition

BIOSENSORS-BASEL, Basel, MDPI, 2023, 2079-6374

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30104 Pharmacology and pharmacy

Country of publisher

Switzerland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 5.400 in 2022

RIV identification code

RIV/00216224:14160/23:00133242

Organization unit

Faculty of Pharmacy

DOI

http://dx.doi.org/10.3390/bios13121009

UT WoS

001132725700001

Keywords in English

immunoassay; bound-free phase; C-reactive protein; clinical samples; diagnostics; biomarkers; patient stratification; respiratory tract infections

Abstract

V originále

C-reactive protein is a well-studied host response biomarker, whose diagnostic performance depends on its accurate classification into concentration zones defined by clinical scenario-specific cutoff values. We validated a newly developed, bead-based, bound-free phase detection immunoassay (BFPD-IA) versus a commercial CE-IVD enzyme-linked immunosorbent assay (ELISA) kit and a commercial CE-IVD immunoturbidimetric assay (ITA) kit. The latter was performed on a fully automated DPC Konelab 60i clinical analyzer used in routine diagnosis. We classified 53 samples into concentration zones derived from four different sets of cutoff values that are related to antibiotic prescription scenarios in the case of respiratory tract infections. The agreements between the methods were ELISA/ITA at 87.7%, ELISA/BFPD-IA at 87.3%, and ITA/-BFPD-IA at 93.9%, reaching 98-99% in all cases when considering the calculated relative combined uncertainty of the single measurement of each sample. In a subgroup of 37 samples, which were analyzed for absolute concentration quantification, the scatter plot slopes' correlations were as follows: ELISA/ITA 1.15, R-2 = 0.97; BFPD-IA/ELISA 1.12, R-2 = 0.95; BFPD-IA/ITA 0.95, R-2 = 0.93. These very good performances and the agreement between BFPD-IA and ITA (routine diagnostic), combined with BFPD-IA's functional advantages over ITA (and ELISA)-such as quick time to result (similar to 20 min), reduced consumed reagents (only one assay buffer and no washing), few and easy steps, and compatibility with nucleic-acid-amplification instruments-render it a potential approach for a reliable, cost-efficient, evidence-based point-of-care diagnostic test for guiding antibiotic prescriptions.

Citovat

JOHANNSEN, Benita, Desiree BAUMGARTNER, Michal KARPÍŠEK, David STEJSKAL, Noemie BOILLAT-BLANCO, Jose KNUESLI, Marcus PANNING, Nils PAUST, Roland ZENGERLE and Konstantinos MITSAKAKIS. Patient Stratification for Antibiotic Prescriptions Based on the Bound-Free Phase Detection Immunoassay of C-Reactive Protein in Serum Samples. BIOSENSORS-BASEL. Basel: MDPI, 2023, vol. 13, No 12, p. 1-15. ISSN 2079-6374. Available from: https://dx.doi.org/10.3390/bios13121009.

@article{2365861,
   author = {Johannsen, Benita and Baumgartner, Desiree and Karpíšek, Michal and Stejskal, David and BoillatandBlanco, Noemie and Knuesli, Jose and Panning, Marcus and Paust, Nils and Zengerle, Roland and Mitsakakis, Konstantinos},
   article_location = {Basel},
   article_number = {12},
   doi = {http://dx.doi.org/10.3390/bios13121009},
   keywords = {immunoassay; bound-free phase; C-reactive protein; clinical samples; diagnostics; biomarkers; patient stratification; respiratory tract infections},
   language = {eng},
   issn = {2079-6374},
   journal = {BIOSENSORS-BASEL},
   title = {Patient Stratification for Antibiotic Prescriptions Based on the Bound-Free Phase Detection Immunoassay of C-Reactive Protein in Serum Samples},
   url = {https://www.mdpi.com/2079-6374/13/12/1009},
   volume = {13},
   year = {2023}
}

TY  - JOUR
ID  - 2365861
AU  - Johannsen, Benita - Baumgartner, Desiree - Karpíšek, Michal - Stejskal, David - Boillat-Blanco, Noemie - Knuesli, Jose - Panning, Marcus - Paust, Nils - Zengerle, Roland - Mitsakakis, Konstantinos
PY  - 2023
TI  - Patient Stratification for Antibiotic Prescriptions Based on the Bound-Free Phase Detection Immunoassay of C-Reactive Protein in Serum Samples
JF  - BIOSENSORS-BASEL
VL  - 13
IS  - 12
SP  - 1-15
EP  - 1-15
PB  - MDPI
SN  - 20796374
KW  - immunoassay
KW  - bound-free phase
KW  - C-reactive protein
KW  - clinical samples
KW  - diagnostics
KW  - biomarkers
KW  - patient stratification
KW  - respiratory tract infections
UR  - https://www.mdpi.com/2079-6374/13/12/1009
N2  - C-reactive protein is a well-studied host response biomarker, whose diagnostic performance depends on its accurate classification into concentration zones defined by clinical scenario-specific cutoff values. We validated a newly developed, bead-based, bound-free phase detection immunoassay (BFPD-IA) versus a commercial CE-IVD enzyme-linked immunosorbent assay (ELISA) kit and a commercial CE-IVD immunoturbidimetric assay (ITA) kit. The latter was performed on a fully automated DPC Konelab 60i clinical analyzer used in routine diagnosis. We classified 53 samples into concentration zones derived from four different sets of cutoff values that are related to antibiotic prescription scenarios in the case of respiratory tract infections. The agreements between the methods were ELISA/ITA at 87.7%, ELISA/BFPD-IA at 87.3%, and ITA/-BFPD-IA at 93.9%, reaching 98-99% in all cases when considering the calculated relative combined uncertainty of the single measurement of each sample. In a subgroup of 37 samples, which were analyzed for absolute concentration quantification, the scatter plot slopes' correlations were as follows: ELISA/ITA 1.15, R-2 = 0.97; BFPD-IA/ELISA 1.12, R-2 = 0.95; BFPD-IA/ITA 0.95, R-2 = 0.93. These very good performances and the agreement between BFPD-IA and ITA (routine diagnostic), combined with BFPD-IA's functional advantages over ITA (and ELISA)-such as quick time to result (similar to 20 min), reduced consumed reagents (only one assay buffer and no washing), few and easy steps, and compatibility with nucleic-acid-amplification instruments-render it a potential approach for a reliable, cost-efficient, evidence-based point-of-care diagnostic test for guiding antibiotic prescriptions.
ER  -

JOHANNSEN, Benita, Desiree BAUMGARTNER, Michal KARPÍŠEK, David STEJSKAL, Noemie BOILLAT-BLANCO, Jose KNUESLI, Marcus PANNING, Nils PAUST, Roland ZENGERLE and Konstantinos MITSAKAKIS. Patient Stratification for Antibiotic Prescriptions Based on the Bound-Free Phase Detection Immunoassay of C-Reactive Protein in Serum Samples. \textit{BIOSENSORS-BASEL}. Basel: MDPI, 2023, vol.~13, No~12, p.~1-15. ISSN~2079-6374. Available from: https://dx.doi.org/10.3390/bios13121009.

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