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

Elizabeth Lee-Lewandrowski, James L. Januzzi, Sandy 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, Allan S Jaffe

Research output: Contribution to journalArticle

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Abstract

Background: 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.

Original languageEnglish (US)
Pages (from-to)20-24
Number of pages5
JournalClinica Chimica Acta
Volume386
Issue number1-2
DOIs
StatePublished - Nov 2007

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Point-of-Care Systems
Assays
Heart Failure
Industry
Brain Natriuretic Peptide
Acute Coronary Syndrome
Limit of Detection
pro-brain natriuretic peptide (1-76)
Blood
Recovery

Keywords

  • Biomedical
  • Heart failure
  • Method validation
  • NT-proBNP
  • Point-of-care
  • RAMP®

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry

Cite this

Multi-center validation of the Response Biomedical Corporation RAMP® NT-proBNP assay with comparison to the Roche Diagnostics GmbH Elecsys® proBNP assay. / Lee-Lewandrowski, Elizabeth; Januzzi, James L.; Green, Sandy M.; Tannous, Bakhos; Wu, Alan H B; Smith, Andrew; Wong, Alicia; Murakami, MaryAnn M.; Kaczmarek, Jason; Apple, Fred S.; Miller, Wayne L.; Hartman, Karen; Jaffe, Allan S.

In: Clinica Chimica Acta, Vol. 386, No. 1-2, 11.2007, p. 20-24.

Research output: Contribution to journalArticle

Lee-Lewandrowski, E, Januzzi, JL, Green, SM, Tannous, B, Wu, AHB, Smith, A, Wong, A, Murakami, MM, Kaczmarek, J, Apple, FS, Miller, WL, Hartman, K & Jaffe, AS 2007, 'Multi-center validation of the Response Biomedical Corporation RAMP® NT-proBNP assay with comparison to the Roche Diagnostics GmbH Elecsys® proBNP assay', Clinica Chimica Acta, vol. 386, no. 1-2, pp. 20-24. https://doi.org/10.1016/j.cca.2007.07.015
Lee-Lewandrowski, Elizabeth ; Januzzi, James L. ; Green, Sandy M. ; Tannous, Bakhos ; Wu, Alan H B ; Smith, Andrew ; Wong, Alicia ; Murakami, MaryAnn M. ; Kaczmarek, Jason ; Apple, Fred S. ; Miller, Wayne L. ; Hartman, Karen ; Jaffe, Allan S. / Multi-center validation of the Response Biomedical Corporation RAMP® NT-proBNP assay with comparison to the Roche Diagnostics GmbH Elecsys® proBNP assay. In: Clinica Chimica Acta. 2007 ; Vol. 386, No. 1-2. pp. 20-24.
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abstract = "Background: 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.",
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T1 - Multi-center validation of the Response Biomedical Corporation RAMP® NT-proBNP assay with comparison to the Roche Diagnostics GmbH Elecsys® proBNP assay

AU - Lee-Lewandrowski, Elizabeth

AU - Januzzi, James L.

AU - Green, Sandy M.

AU - Tannous, Bakhos

AU - Wu, Alan H B

AU - Smith, Andrew

AU - Wong, Alicia

AU - Murakami, MaryAnn M.

AU - Kaczmarek, Jason

AU - Apple, Fred S.

AU - Miller, Wayne L.

AU - Hartman, Karen

AU - Jaffe, Allan S

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N2 - Background: 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.

AB - Background: 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.

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KW - NT-proBNP

KW - Point-of-care

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