Analytical performance of 17 commercially available point-of-care tests for CRP to support patient management at lower levels of the health system

Serafina Calarco; B Leticia Fernandez-Carballo; Thomas Keller; Stephan Weber; Meike Jakobi; Patrick Marsall; Nicole Schneiderhan-Marra; Sabine Dittrich

doi:10.1371/journal.pone.0267516

Analytical performance of 17 commercially available point-of-care tests for CRP to support patient management at lower levels of the health system

PLoS One. 2023 Jan 20;18(1):e0267516. doi: 10.1371/journal.pone.0267516. eCollection 2023.

Authors

Serafina Calarco¹, B Leticia Fernandez-Carballo¹, Thomas Keller², Stephan Weber², Meike Jakobi³, Patrick Marsall³, Nicole Schneiderhan-Marra³, Sabine Dittrich¹

Affiliations

¹ FIND, Geneva, Switzerland.
² ACOMED Statistik, Leipzig, Germany.
³ NMI Natural and Medical Sciences Institute at the University of Tübingen, Reutlingen, Germany.

Abstract

Accurate and precise point-of-care (POC) testing for C-reactive protein (CRP) can help support healthcare providers in the clinical management of patients. Here, we compared the analytical performance of 17 commercially available POC CRP tests to enable more decentralized use of the tool. The following CRP tests were evaluated. Eight quantitative tests: QuikRead go (Aidian), INCLIX (Sugentech), Spinit (Biosurfit), LS4000 (Lansionbio), GS 1200 (Gensure Biotech), Standard F200 (SD Biosensor), Epithod 616 (DxGen), IFP-3000 (Xincheng Biological); and nine semi-quantitative tests: Actim CRP (ACTIM), NADAL Dipstick (nal von minden), NADAL cassette (nal von minden), ALLTEST Dipstick (Hangzhou Alltest Biotech), ALLTEST Cassette cut-off 10-40-80 (Hangzhou Alltest Biotech), ALLTEST Cassette cut-off 10-30 (Hangzhou Alltest Biotech), Biotest (Hangzhou Biotest Biotech), BTNX Quad Line (BTNX), BTNX Tri Line (BTNX). Stored samples (n = 660) had previously been tested for CRP using Cobas 8000 Modular analyzer (Roche Diagnostics International AG, Rotkreuz, Switzerland (reference standards). CRP values represented the clinically relevant range (10-100 mg/L) and were grouped into four categories (<10 mg/L, 10-40 mg/L or 10-30 mg/L, 40-80 mg/L or 30-80 mg/L, and > 80mg/L) for majority of the semi-quantitative tests. Among the eight quantitative POC tests evaluated, QuikRead go and Spinit exhibited better agreement with the reference method, showing slopes of 0.963 and 0.921, respectively. Semi-quantitative tests with the four categories showed a poor percentage agreement for the intermediate categories and higher percentage agreement for the lower and upper limit categories. Analytical performance varied considerably for the semi-quantitative tests, especially among the different categories of CRP values. Our findings suggest that quantitative tests might represent the best choice for a variety of use cases, as they can be used across a broad range of CRP categories.

Copyright: © 2023 Calarco et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

C-Reactive Protein*
Government Programs
Health Personnel
Humans
Medical Assistance
Point-of-Care Systems
Point-of-Care Testing*

Substances

C-Reactive Protein

Grants and funding

This work was supported with funds from the Dutch and the Australian Government. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.