TY - JOUR
T1 - A multicenter evaluation of a point of care CRP Test
AU - Scharnhorst, Volkher
AU - Noordzij, Peter G
AU - Lutz, Andrea
AU - Graser, Uwe
AU - Püntener, Daniel
AU - Alquézar-Arbé, Aitor
N1 - Publisher Copyright:
© 2019 Roche Diagnostics International Ltd
PY - 2019/9
Y1 - 2019/9
N2 - BACKGROUND: Point-of-care (POC) C-reactive protein (CRP) testing in the primary healthcare setting is a cost-effective approach for reducing antibiotic prescriptions, but has yet to be widely adopted.METHODS: Analytical performance of the cobas CRP Test on the cobas b 101 system was evaluated at three POC sites and one reference laboratory. Within-run (repeatability), within-laboratory (intermediate precision), and between-laboratory precision (reproducibility) were assessed. Method comparison (reference test: CRPNX reagent [cobas c 501 module]) and matrix/lot-to-lot comparison experiments were conducted using prospectively collected blood samples from 217 adults (apparently healthy or with clinically relevant conditions). Usability and reliability were assessed by questionnaire and error reporting.RESULTS: Coefficients of variation (CV) for repeatability and intermediate precision ranged from 1.7%-4.0% and 1.9%-4.5%, respectively, for human serum pools containing CRP 4.7-350.7 mg/L; repeatability in clinical samples ranged from 1.6%-5.9% (3.3-360.3 mg/L). CVs for reproducibility ranged from 2.5%-4.0% (4.7-344.3 mg/L). CRP concentrations were comparable for capillary whole blood, serum, Li-heparin whole blood/plasma, K2 and K3 EDTA whole blood/plasma (Pearson's r ≥ 0.996), and among three CRP Test lots (r ≥ 0.993). Clinically relevant CRP concentrations measured with the CRP Test showed good agreement with those measured by CRPNX reagent (serum, weighted Deming regression y = 0.97× + 0.11; Pearson's r ≥ 0.996). The overall mean usability score was 4.18/5 and the error rate across 9378 tests was 1.00%.CONCLUSIONS: The cobas CRP Test on the cobas b 101 system demonstrates robust analytic performance when used by healthcare professionals in the POC setting.
AB - BACKGROUND: Point-of-care (POC) C-reactive protein (CRP) testing in the primary healthcare setting is a cost-effective approach for reducing antibiotic prescriptions, but has yet to be widely adopted.METHODS: Analytical performance of the cobas CRP Test on the cobas b 101 system was evaluated at three POC sites and one reference laboratory. Within-run (repeatability), within-laboratory (intermediate precision), and between-laboratory precision (reproducibility) were assessed. Method comparison (reference test: CRPNX reagent [cobas c 501 module]) and matrix/lot-to-lot comparison experiments were conducted using prospectively collected blood samples from 217 adults (apparently healthy or with clinically relevant conditions). Usability and reliability were assessed by questionnaire and error reporting.RESULTS: Coefficients of variation (CV) for repeatability and intermediate precision ranged from 1.7%-4.0% and 1.9%-4.5%, respectively, for human serum pools containing CRP 4.7-350.7 mg/L; repeatability in clinical samples ranged from 1.6%-5.9% (3.3-360.3 mg/L). CVs for reproducibility ranged from 2.5%-4.0% (4.7-344.3 mg/L). CRP concentrations were comparable for capillary whole blood, serum, Li-heparin whole blood/plasma, K2 and K3 EDTA whole blood/plasma (Pearson's r ≥ 0.996), and among three CRP Test lots (r ≥ 0.993). Clinically relevant CRP concentrations measured with the CRP Test showed good agreement with those measured by CRPNX reagent (serum, weighted Deming regression y = 0.97× + 0.11; Pearson's r ≥ 0.996). The overall mean usability score was 4.18/5 and the error rate across 9378 tests was 1.00%.CONCLUSIONS: The cobas CRP Test on the cobas b 101 system demonstrates robust analytic performance when used by healthcare professionals in the POC setting.
KW - Antibiotic use
KW - C-reactive protein
KW - Diagnostic equipment
KW - Infection
KW - Inflammation
KW - Laboratory medicine
KW - POC CRP Test
KW - Point-of-care testing
UR - http://www.scopus.com/inward/record.url?scp=85068072746&partnerID=8YFLogxK
U2 - 10.1016/j.clinbiochem.2019.06.009
DO - 10.1016/j.clinbiochem.2019.06.009
M3 - Article
C2 - 31233734
SN - 0009-9120
VL - 71
SP - 38
EP - 45
JO - Clinical biochemistry
JF - Clinical biochemistry
ER -