Comparison of the Abbott Architect BRAHMS and the Biomérieux Vidas BRAHMS Procalcitonin Assays
| Autor: | Brittany Caddell, Nikolina Babic, Dan Wang, Frederick S. Nolte |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
congenital
hereditary and neonatal diseases and abnormalities 030213 general clinical medicine medicine.medical_specialty Concordance Clinical Decision-Making 030204 cardiovascular system & hematology Procalcitonin Food and drug administration Antimicrobial Stewardship 03 medical and health sciences 0302 clinical medicine Limit of Detection Sepsis Internal medicine parasitic diseases medicine Humans In patient Antibiotic use Respiratory Tract Infections Immunoassay medicine.diagnostic_test business.industry Clinical performance Bacterial Infections General Medicine Negative bias bacterial infections and mycoses Anti-Bacterial Agents Luminescent Measurements business Biomarkers hormones hormone substitutes and hormone antagonists |
| Zdroj: | The Journal of Applied Laboratory Medicine. 3:580-586 |
| ISSN: | 2475-7241 2576-9456 |
| Popis: | Background Procalcitonin (PCT) is a well-established marker for bacterial infection. Recently the US Food and Drug Administration approved the expanded use of this biomarker to guide clinical decisions for antibiotic treatment in patients with lower respiratory tract infections. Both the Architect BRAHMS PCT (PCT-A) and Vidas BRAHMS PCT (PCT-V) are approved for this indication. The aim of this study is to evaluate analytical performance of PCT-A in comparison to PCT-V. Methods PCT-A and PCT-V were evaluated for intra- and interassay precision and functional sensitivity. To assess the accuracy of PCT-A, 108 residual plasma specimens were randomly selected from routine hospital orders, and PCT was measured concurrently with PCT-A and PCT-V. Results Both assays demonstrated excellent precision, with intraassay precision ranging from 2.2% to 4.0% CV and interassay precision ranging from 2.5% to 3.6% CV. The functional sensitivity was verified at 0.01 ng/mL for PCT-A and at 0.05 ng/mL for PCT-V. The Passing–Bablok regression revealed approximately 20% negative bias of PCT-A compared to PCT-V (PCT-A = 0.042 + 0.79 × PCT-V, r = 0.995). The concordance of the 2 methods at diagnostically important cutoffs (0.10, 0.25, 0.50, and 2.0 ng/mL) was excellent, with overall agreement >93% at each threshold. Conclusion The results of our study show improved sensitivity and equivalent clinical performance of PCT-A compared to PCT-V. The availability of this test on common clinical immunoassay analyzers may help accelerate its adoption into antimicrobial stewardship programs and thereby improve antibiotic use and patient outcomes. |
| Databáze: | OpenAIRE |
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