Multi-center validation of the Response Biomedical Corporation RAMP® NT-proBNP assay with comparison to the Roche Diagnostics GmbH Elecsys® proBNP assay

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• 作者：Elizabeth Lee-Lew ; rowski ; James L. Januzzi ; S ; y M. Green ; Bakhos Tannous ; Alan H.B. Wu ; Andrew Smith ; Alicia Wong ; MaryAnn M. Murakami ; Jason Kaczmarek ; Fred S. Apple ; Wayne L. Miller ; Karen Hartman
• 关键词：NT-proBNP ; Point-of-care ; RAMP® ; Biomedical ; Heart failure ; Method validation
• 刊名：Clinica Chimica Acta
• 出版年：2007
• 期刊代码：54_00098981
• 类别：med
• 出版时间：November-December 2007
• 卷：386
• 期：1-2
• 页码：20-24
• 文件大小：334 K

摘要

NT-proBNP measurements aid in the evaluation of patients with suspected heart failure (HF) and may facilitate risk stratification in patients with HF and acute coronary syndrome (ACS). Point-of-care (POC) assays may provide more timely results and potentially improve patient outcomes.

Methods

We evaluated the analytical performance of the Response Biomedical Corporation whole blood RAMP amino-terminal pro-B type natriuretic peptide (NT-proBNP) POC assay compared to the Roche Elecsys proBNP (NT-proBNP) assay.

Results

Intra-day and total imprecision (%CV) ranged from 5.5%to 10.3%at 140, 449 and 1675 ng/L. The lowest concentration that yields a 20%CV was 57 ng/L. The lower limit of detection was 18 ng/L. The upper limit of linearity was validated to 23,428 ng/L with an average recovery of 95%. Correlation by Passing and Bablok regression yielded RAMP = 1.01 Elecsys + 14.6, r = 0.98 (n = 540; range of Elecsys values < 5 to > 35,000). Concordance of RAMP versus Elecsys using cut-offs of 125 ng/L for subjects < 75 years and 450 ng/L for subjects ≥ 75 was 92%(95%CI 89–94%) for a group consisting of 127 apparently healthy individuals and 208 non-healthy subjects without HF, and 99%(95%CI 97–100%) for patients with HF, using the New York Heart Association (NYHA) functional classification. Overall, 80%, 87%, 97%and 100%of the RAMP results and 77%, 85%, 96%and 100%of the Elecsys results were greater than the age appropriate cut-off for NYHA I, II, III or IV groups. For both the RAMP and Elecsys results, the median NT-proBNP value was statistically correlated (increasing) with NYHA I, II, III or IV groups, respectively (p < 0.0001), with no significant difference between the two methods.

Conclusions

The POC Response Biomedical RAMP NT-proBNP assay provides comparable results that measured on the FDA cleared Roche Elecsys central laboratory platform.