Validation of B·R·A·H·M·S PCT direct, a new sensitive point-of-care testing device for rapid quantification of procalcitonin in emergency department patients: a prospective multinational trial

Abstract

Introduction Procalcitonin (PCT) is increasingly the standard in the emergency department (ED) for the diagnostic and prognostic workup of patients with suspected infections. Recently, B-R-A-H-M-S PCT direct, a new high-sensitive point-of-care test, has been developed for fast PCT measurement on capillary or venous blood samples with a measuring range of 0.1 to 10.0 μg/l. Methods This is a prospective, comparative international study conducted in three European EDs. Consecutive patients with suspicion of bacterial infection were included. Duplicate determination of PCT was performed on two distinct B-R-A-H-M-S PCT direct test devices on capillary (fingertip) and venous whole blood (EDTA), and compared with the reference method (B-R-A-H-M-S PCT sensitive Kryptor or Elecsys B-R-A-H-M-S PCT, respectively). The diagnostic accuracy was evaluated by correlation and concordance analyses. Results A total of 303 patients were included over a 6-month period (60.4% male, median age 65.2 years). The correlation between capillary or venous whole blood and the reference method was excellent: r2 = 0.96 and 0.97, sensitivity 88.1% and 93.0%, specificity 96.5% and 96.8%, concordance 93% and 95% respectively at a 0.25 μg/l threshold. No significant bias was observed (-0.04 and -0.02 for capillary and venous whole blood) although there were 6.8% and 5.1% outliers, respectively. B-R-A-H-M-S PCT direct had a shorter time to result as compared with the reference method (25 vs. 147 minutes, difference 122 minutes, 95% CI = 110 to 134 minutes, P <0.0001). Conclusion This study found a high diagnostic accuracy and a faster time to result of the PCT direct in the ED setting. The B-R-A-H-M-S PCT direct may allow a more widespread use of PCT tests in outpatient clinics and smaller institutions.