A rapid B-type natriuretic peptide assay accurately diagnoses left ventricular dysfunction and heart failure: a multicenter evaluation.

BACKGROUND B-Type natriuretic peptide (BNP), a protein released from the left ventricle in response to volume expansion and pressure overload, has emerged as the first whole blood marker for the identification of individuals with congestive heart failure (CHF). OBJECTIVE The purpose of this study was to assess the performance of a point-of-care assay to diagnose and evaluate the severity of CHF on the basis of the New York Heart Association (NYHA) classification system. METHODS Through a prospective, multicenter trial, whole blood samples were collected from a total of 1050 inpatients, outpatients, and healthy control patients. Participants were divided into subgroups for BNP analysis: patients without cardiovascular CHF (n = 473), patients with hypertension and no cardiovascular disease (n = 168), NYHA class I CHF (n = 73), class II CHF (n = 135), class III CHF (n = 141), and class IV CHF (n = 60). RESULTS Circulating BNP concentrations determined from the bedside assay increased with CHF severity, as determined by the NYHA classification system, but were only statistically significant (P <.001) between individuals with and without CHF. Individuals without CHF had a median BNP concentration of 9.29 pg/mL. Median BNP values, with their corresponding interquartile ranges, for NYHA classification I through IV were 83.1 pg/mL (49.4-137 pg/mL), 235 pg/mL (137-391 pg/mL), 459 pg/mL (200-871 pg/mL), and 1119 pg/mL (728->1300 pg/mL), respectively. With the use of a decision threshold of 100 pg/mL, the assay demonstrated 82% sensitivity and 99% specificity for distinguishing control patients and patients with CHF. CONCLUSIONS BNP concentrations obtained from whole blood samples are useful in the diagnosis of CHF and staging the severity of the disease.