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Analytical performance of a platform for point-of-care CRP testing in adults consulting for lower respiratory tract infection in primary care

Analytical performance of a platform for point-of-care CRP testing in adults consulting for lower respiratory tract infection in primary care
Analytical performance of a platform for point-of-care CRP testing in adults consulting for lower respiratory tract infection in primary care

C-reactive protein (CRP) is a biomarker widely used for disease severity assessment and treatment of inflammatory conditions. Point-of-care testing (POCT) devices should ideally be rapid and provide similar results to standard tests done in laboratories. Two thousand nine hundred twenty-two serum samples were obtained from adult patients presenting to primary care with symptoms of lower respiratory infection in a European diagnostic study. The analytic performance of the CRP QuikRead POCT device (Orion Diagnostica) was evaluated by comparing results with a central laboratory method (Dimension Vista, Siemens), with both tests performed in a laboratory setting. For a CRP cut-off concentration of ≥ 30 mg/L, the QuikRead test had a sensitivity of 92.2%, and specificity of 99.4%. The mean difference between the QuikRead and the central lab test was 0.4 mg/L. The slope of the Passing-Bablok regression was 0.94 (95% CI 0.93–0.95) indicating an underestimation of CRP levels of 6% by QuikRead. CRP estimates obtained from the QuikRead test correlate well with a central laboratory assay and the measurement displays low inter-assay variation. Therefore, the QuikRead test is a good candidate for CRP testing in primary care.

Bedside test, C-reactive protein, Point-of-care test, Rapid test, Respiratory infection
0934-9723
1-5
Matheeussen, Veerle
2aa034a4-d519-4b94-b610-644a0a9fa9dc
van Hoof, Viviane
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Loens, Katherine
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Lammens, Christine
5c95854e-7ed4-4932-a4c1-55c3555d5bb5
Vanderstraeten, Anouk
ce20fff4-7f66-486e-ba58-518c98a12830
Coenen, Samuel
3d0dc4e0-e5ba-4d66-ba92-15900ccc551e
Butler, Chris C.
f8e17dfa-839f-42b4-9463-c5331b025149
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Verheij, Theo J.M.
0164f6e4-2c95-4233-8c2e-29b616c8ff66
Goossens, Herman
31f8e1ae-7da0-473c-bd49-f911c2187451
Ieven, Margareta
c138048d-d838-4c8e-848d-a43e309f4cf0
on behalf of the GRACE consortium
Matheeussen, Veerle
2aa034a4-d519-4b94-b610-644a0a9fa9dc
van Hoof, Viviane
c89cbe09-2acd-4d74-890c-e6d612b33e07
Loens, Katherine
4c3dc94c-70c4-47d4-bde5-9a41d2d904f3
Lammens, Christine
5c95854e-7ed4-4932-a4c1-55c3555d5bb5
Vanderstraeten, Anouk
ce20fff4-7f66-486e-ba58-518c98a12830
Coenen, Samuel
3d0dc4e0-e5ba-4d66-ba92-15900ccc551e
Butler, Chris C.
f8e17dfa-839f-42b4-9463-c5331b025149
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Verheij, Theo J.M.
0164f6e4-2c95-4233-8c2e-29b616c8ff66
Goossens, Herman
31f8e1ae-7da0-473c-bd49-f911c2187451
Ieven, Margareta
c138048d-d838-4c8e-848d-a43e309f4cf0

Matheeussen, Veerle, van Hoof, Viviane, Loens, Katherine, Lammens, Christine, Vanderstraeten, Anouk, Coenen, Samuel, Butler, Chris C., Little, Paul, Verheij, Theo J.M., Goossens, Herman and Ieven, Margareta , on behalf of the GRACE consortium (2018) Analytical performance of a platform for point-of-care CRP testing in adults consulting for lower respiratory tract infection in primary care. European Journal of Clinical Microbiology & Infectious Diseases, 1-5. (doi:10.1007/s10096-018-3253-3).

Record type: Article

Abstract

C-reactive protein (CRP) is a biomarker widely used for disease severity assessment and treatment of inflammatory conditions. Point-of-care testing (POCT) devices should ideally be rapid and provide similar results to standard tests done in laboratories. Two thousand nine hundred twenty-two serum samples were obtained from adult patients presenting to primary care with symptoms of lower respiratory infection in a European diagnostic study. The analytic performance of the CRP QuikRead POCT device (Orion Diagnostica) was evaluated by comparing results with a central laboratory method (Dimension Vista, Siemens), with both tests performed in a laboratory setting. For a CRP cut-off concentration of ≥ 30 mg/L, the QuikRead test had a sensitivity of 92.2%, and specificity of 99.4%. The mean difference between the QuikRead and the central lab test was 0.4 mg/L. The slope of the Passing-Bablok regression was 0.94 (95% CI 0.93–0.95) indicating an underestimation of CRP levels of 6% by QuikRead. CRP estimates obtained from the QuikRead test correlate well with a central laboratory assay and the measurement displays low inter-assay variation. Therefore, the QuikRead test is a good candidate for CRP testing in primary care.

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GRACE CRP POCT - Accepted Manuscript
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Accepted/In Press date: 5 April 2018
e-pub ahead of print date: 10 May 2018
Keywords: Bedside test, C-reactive protein, Point-of-care test, Rapid test, Respiratory infection

Identifiers

Local EPrints ID: 421432
URI: http://eprints.soton.ac.uk/id/eprint/421432
ISSN: 0934-9723
PURE UUID: 77df770d-34cc-4224-a56c-1f30acd57656

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Date deposited: 11 Jun 2018 16:30
Last modified: 17 Dec 2019 05:25

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Contributors

Author: Veerle Matheeussen
Author: Viviane van Hoof
Author: Katherine Loens
Author: Christine Lammens
Author: Anouk Vanderstraeten
Author: Samuel Coenen
Author: Chris C. Butler
Author: Paul Little
Author: Theo J.M. Verheij
Author: Herman Goossens
Author: Margareta Ieven

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