English
The Beckman Coulter Access NT-proBNP assay represents a significant advancement in natriuretic peptide testing, delivering exceptional analytical performance through comprehensive validation studies conducted in accordance with Clinical and Laboratory Standards Institute (CLSI) guidelines. This novel automated immunoenzymatic assay utilizes proprietary monoclonal antibodies targeting specific epitopes of NT-proBNP, demonstrating good precision, accuracy, and reliability across the complete analytical measurement range. Independent analytical characterization confirms the assay's fitness for critical heart failure diagnostic applications, establishing new benchmarks for laboratory excellence in cardiac biomarker testing.
Key Study Findings:
- Outstanding analytical sensitivity with limit of detection (LoD) of 4.8 ng/L and limit of quantitation (LoQ) of 4.8 ng/L, enabling precise measurement at clinically relevant low concentrations
- Good method correlation with established reference method (Elecsys) showing Passing-Bablok regression equation: Access = 0.92 × Elecsys - 1.20 ng/L (r = 0.99)
- Excellent precision performance with total reproducibility CVs ranging from 2.7% to 7.9% across NT-proBNP concentrations from 38 ng/L to 23,848 ng/L, within the 8% specification
- Extended analytical range with demonstrated linearity up to 25,000 ng/L, covering the full spectrum of clinical NT-proBNP values
