A-018 Diagnostic Performance of the Novel Beckman-Coulter NT-proBNP-assay in the Early Diagnosis of Acute Heart Failure

Abstract Background The diagnostic performance of the novel Beckman Coulter N-terminal pro-B-type natriuretic peptide (NT-proBNP) assay in the early diagnosis of acute heart failure (AHF) is unknown. Methods This major unmet clinical need was addressed in a secondary analysis using frozen plasma sam...

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Veröffentlicht in:Clinical chemistry (Baltimore, Md.) Md.), 2024-10, Vol.70 (Supplement_1)
Hauptverfasser: Hammerer-Lercher, A, Maria, B, Wussler, D, Lopez-Ayala, P, Strebel, I, Kozhuharov, N, Sabti, Z, Shrestha, S, Prepoudis, A, Schäfer, I, Mork, C, Wildi, K, du Fay de Lavallaz, J, Koechlin, L, Zimmermann, T, Nestelberger, T, Boeddinghaus, J, Breithardt, T, Mueller, C
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container_issue Supplement_1
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container_title Clinical chemistry (Baltimore, Md.)
container_volume 70
creator Hammerer-Lercher, A
Maria, B
Wussler, D
Lopez-Ayala, P
Strebel, I
Kozhuharov, N
Sabti, Z
Shrestha, S
Prepoudis, A
Schäfer, I
Mork, C
Wildi, K
du Fay de Lavallaz, J
Koechlin, L
Zimmermann, T
Nestelberger, T
Boeddinghaus, J
Breithardt, T
Mueller, C
description Abstract Background The diagnostic performance of the novel Beckman Coulter N-terminal pro-B-type natriuretic peptide (NT-proBNP) assay in the early diagnosis of acute heart failure (AHF) is unknown. Methods This major unmet clinical need was addressed in a secondary analysis using frozen plasma samples obtained in a prospective diagnostic study, enrolling patients presenting with acute dyspnea to the emergency department (ED). Two independent cardiologists/internists centrally adjudicated the final diagnosis using all individual patient's information. NT-proBNP-Beckman Coulter plasma concentrations were measured blinded and directly compared to NT-proBNP-Elecsys concentrations. Agreement analysis was performed by Bland Altman plot. The primary endpoints were the diagnostic accuracy of both assays using the Area-under-the-Receiver-Operating-Curve and the comparison of the performance for diagnosing AHF using the validated NT-proBNP-Elecsys clinical decision values (450/900/1800ng/L for rule-in). The secondary endpoint included the application of the recently suggested NT-proBNP-Elecsys clinical decision values for obese patients. Results 1400 patients (46% 3women, median age 76 years, BMI 25.9m2/kg, LVEF 53%) had both NT-proBNP measurements on presentation to the ED. Of those 744 (53%) had an adjudicated diagnosis of AHF. The agreement analysis showed overall higher concentrations for the NT-proBNP-Beckman assay. The diagnostic accuracy of both assays was excellent (AUC: 0.915 vs 0.922; P = 0.006, respectively). In the clinical application less patients were ruled-out using the Beckman assay compared to the Elecsys assay (18.7% vs 26.3%) with comparable sensitivities (98.9% vs 98.5%). Regarding rule-in NT-proBNP-Elecsys had a significantly higher specificity (78.8% vs 70.9%) and positive predictive value (83.1% vs 78.7%; both P
doi_str_mv 10.1093/clinchem/hvae106.018
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Methods This major unmet clinical need was addressed in a secondary analysis using frozen plasma samples obtained in a prospective diagnostic study, enrolling patients presenting with acute dyspnea to the emergency department (ED). Two independent cardiologists/internists centrally adjudicated the final diagnosis using all individual patient's information. NT-proBNP-Beckman Coulter plasma concentrations were measured blinded and directly compared to NT-proBNP-Elecsys concentrations. Agreement analysis was performed by Bland Altman plot. The primary endpoints were the diagnostic accuracy of both assays using the Area-under-the-Receiver-Operating-Curve and the comparison of the performance for diagnosing AHF using the validated NT-proBNP-Elecsys clinical decision values (&lt;300ng/L for rule-out, age-adjusted &gt;450/900/1800ng/L for rule-in). The secondary endpoint included the application of the recently suggested NT-proBNP-Elecsys clinical decision values for obese patients. Results 1400 patients (46% 3women, median age 76 years, BMI 25.9m2/kg, LVEF 53%) had both NT-proBNP measurements on presentation to the ED. Of those 744 (53%) had an adjudicated diagnosis of AHF. The agreement analysis showed overall higher concentrations for the NT-proBNP-Beckman assay. The diagnostic accuracy of both assays was excellent (AUC: 0.915 vs 0.922; P = 0.006, respectively). In the clinical application less patients were ruled-out using the Beckman assay compared to the Elecsys assay (18.7% vs 26.3%) with comparable sensitivities (98.9% vs 98.5%). Regarding rule-in NT-proBNP-Elecsys had a significantly higher specificity (78.8% vs 70.9%) and positive predictive value (83.1% vs 78.7%; both P&lt;0.001; Figure 1). Similar findings were obtained in recently suggested cutoffs for obese patients. Conclusions In comparison to established NT-proBNP-Elecsys cutoffs, a derivation of Beckman-specific cutoffs is needed to implement NT-proBNP-Beckman Coulter clinical decision values providing a higher rule-out proportion and an optimal specificity for diagnosing AHF.</description><identifier>ISSN: 0009-9147</identifier><identifier>EISSN: 1530-8561</identifier><identifier>DOI: 10.1093/clinchem/hvae106.018</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><ispartof>Clinical chemistry (Baltimore, Md.), 2024-10, Vol.70 (Supplement_1)</ispartof><rights>Association for Diagnostics &amp; Laboratory Medicine 2024. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. 2024</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids></links><search><creatorcontrib>Hammerer-Lercher, A</creatorcontrib><creatorcontrib>Maria, B</creatorcontrib><creatorcontrib>Wussler, D</creatorcontrib><creatorcontrib>Lopez-Ayala, P</creatorcontrib><creatorcontrib>Strebel, I</creatorcontrib><creatorcontrib>Kozhuharov, N</creatorcontrib><creatorcontrib>Sabti, Z</creatorcontrib><creatorcontrib>Shrestha, S</creatorcontrib><creatorcontrib>Prepoudis, A</creatorcontrib><creatorcontrib>Schäfer, I</creatorcontrib><creatorcontrib>Mork, C</creatorcontrib><creatorcontrib>Wildi, K</creatorcontrib><creatorcontrib>du Fay de Lavallaz, J</creatorcontrib><creatorcontrib>Koechlin, L</creatorcontrib><creatorcontrib>Zimmermann, T</creatorcontrib><creatorcontrib>Nestelberger, T</creatorcontrib><creatorcontrib>Boeddinghaus, J</creatorcontrib><creatorcontrib>Breithardt, T</creatorcontrib><creatorcontrib>Mueller, C</creatorcontrib><title>A-018 Diagnostic Performance of the Novel Beckman-Coulter NT-proBNP-assay in the Early Diagnosis of Acute Heart Failure</title><title>Clinical chemistry (Baltimore, Md.)</title><description>Abstract Background The diagnostic performance of the novel Beckman Coulter N-terminal pro-B-type natriuretic peptide (NT-proBNP) assay in the early diagnosis of acute heart failure (AHF) is unknown. Methods This major unmet clinical need was addressed in a secondary analysis using frozen plasma samples obtained in a prospective diagnostic study, enrolling patients presenting with acute dyspnea to the emergency department (ED). Two independent cardiologists/internists centrally adjudicated the final diagnosis using all individual patient's information. NT-proBNP-Beckman Coulter plasma concentrations were measured blinded and directly compared to NT-proBNP-Elecsys concentrations. Agreement analysis was performed by Bland Altman plot. The primary endpoints were the diagnostic accuracy of both assays using the Area-under-the-Receiver-Operating-Curve and the comparison of the performance for diagnosing AHF using the validated NT-proBNP-Elecsys clinical decision values (&lt;300ng/L for rule-out, age-adjusted &gt;450/900/1800ng/L for rule-in). The secondary endpoint included the application of the recently suggested NT-proBNP-Elecsys clinical decision values for obese patients. Results 1400 patients (46% 3women, median age 76 years, BMI 25.9m2/kg, LVEF 53%) had both NT-proBNP measurements on presentation to the ED. Of those 744 (53%) had an adjudicated diagnosis of AHF. The agreement analysis showed overall higher concentrations for the NT-proBNP-Beckman assay. The diagnostic accuracy of both assays was excellent (AUC: 0.915 vs 0.922; P = 0.006, respectively). In the clinical application less patients were ruled-out using the Beckman assay compared to the Elecsys assay (18.7% vs 26.3%) with comparable sensitivities (98.9% vs 98.5%). Regarding rule-in NT-proBNP-Elecsys had a significantly higher specificity (78.8% vs 70.9%) and positive predictive value (83.1% vs 78.7%; both P&lt;0.001; Figure 1). Similar findings were obtained in recently suggested cutoffs for obese patients. Conclusions In comparison to established NT-proBNP-Elecsys cutoffs, a derivation of Beckman-specific cutoffs is needed to implement NT-proBNP-Beckman Coulter clinical decision values providing a higher rule-out proportion and an optimal specificity for diagnosing AHF.</description><issn>0009-9147</issn><issn>1530-8561</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNqNkM1OAjEUhRujiYi-gYu-QKF_87cEBDEhyIL95NK5ldFhStoZDG_PILB3dXNuzncWHyGvgg8Ez9TQVGVttrgbbg-AgscDLtI70hOR4iyNYnFPepzzjGVCJ4_kKYTvLuokjXvkd8S6Mn0r4at2oSkNXaG3zu-gNkidpc0W6dIdsKJjND_dm01cWzXo6XLN9t6NlysGIcCRlvVfeQq-Ot4Gy3DeGJm2QTpH8A2dQVm1Hp_Jg4Uq4Mv19sl6Nl1P5mzx-f4xGS2YSaOUxQlyVUSWK4hkAZBoYROrZSY2RkUgDchMRkpriwm3ptCFTDcWrNRcSpsq1Sf6Mmu8C8Gjzfe-3IE_5oLnZ3f5zV1-dZd3OjpseMFcu_8fcQK1-HX8</recordid><startdate>20241002</startdate><enddate>20241002</enddate><creator>Hammerer-Lercher, A</creator><creator>Maria, B</creator><creator>Wussler, D</creator><creator>Lopez-Ayala, P</creator><creator>Strebel, I</creator><creator>Kozhuharov, N</creator><creator>Sabti, Z</creator><creator>Shrestha, S</creator><creator>Prepoudis, A</creator><creator>Schäfer, I</creator><creator>Mork, C</creator><creator>Wildi, K</creator><creator>du Fay de Lavallaz, J</creator><creator>Koechlin, L</creator><creator>Zimmermann, T</creator><creator>Nestelberger, T</creator><creator>Boeddinghaus, J</creator><creator>Breithardt, T</creator><creator>Mueller, C</creator><general>Oxford University Press</general><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20241002</creationdate><title>A-018 Diagnostic Performance of the Novel Beckman-Coulter NT-proBNP-assay in the Early Diagnosis of Acute Heart Failure</title><author>Hammerer-Lercher, A ; Maria, B ; Wussler, D ; Lopez-Ayala, P ; Strebel, I ; Kozhuharov, N ; Sabti, Z ; Shrestha, S ; Prepoudis, A ; Schäfer, I ; Mork, C ; Wildi, K ; du Fay de Lavallaz, J ; Koechlin, L ; Zimmermann, T ; Nestelberger, T ; Boeddinghaus, J ; Breithardt, T ; Mueller, C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c858-67e03d5f03a52daa741f7f4291bc35a2ca2925344fe70fcd4d28bfaf24022f833</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hammerer-Lercher, A</creatorcontrib><creatorcontrib>Maria, B</creatorcontrib><creatorcontrib>Wussler, D</creatorcontrib><creatorcontrib>Lopez-Ayala, P</creatorcontrib><creatorcontrib>Strebel, I</creatorcontrib><creatorcontrib>Kozhuharov, N</creatorcontrib><creatorcontrib>Sabti, Z</creatorcontrib><creatorcontrib>Shrestha, S</creatorcontrib><creatorcontrib>Prepoudis, A</creatorcontrib><creatorcontrib>Schäfer, I</creatorcontrib><creatorcontrib>Mork, C</creatorcontrib><creatorcontrib>Wildi, K</creatorcontrib><creatorcontrib>du Fay de Lavallaz, J</creatorcontrib><creatorcontrib>Koechlin, L</creatorcontrib><creatorcontrib>Zimmermann, T</creatorcontrib><creatorcontrib>Nestelberger, T</creatorcontrib><creatorcontrib>Boeddinghaus, J</creatorcontrib><creatorcontrib>Breithardt, T</creatorcontrib><creatorcontrib>Mueller, C</creatorcontrib><collection>CrossRef</collection><jtitle>Clinical chemistry (Baltimore, Md.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hammerer-Lercher, A</au><au>Maria, B</au><au>Wussler, D</au><au>Lopez-Ayala, P</au><au>Strebel, I</au><au>Kozhuharov, N</au><au>Sabti, Z</au><au>Shrestha, S</au><au>Prepoudis, A</au><au>Schäfer, I</au><au>Mork, C</au><au>Wildi, K</au><au>du Fay de Lavallaz, J</au><au>Koechlin, L</au><au>Zimmermann, T</au><au>Nestelberger, T</au><au>Boeddinghaus, J</au><au>Breithardt, T</au><au>Mueller, C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A-018 Diagnostic Performance of the Novel Beckman-Coulter NT-proBNP-assay in the Early Diagnosis of Acute Heart Failure</atitle><jtitle>Clinical chemistry (Baltimore, Md.)</jtitle><date>2024-10-02</date><risdate>2024</risdate><volume>70</volume><issue>Supplement_1</issue><issn>0009-9147</issn><eissn>1530-8561</eissn><abstract>Abstract Background The diagnostic performance of the novel Beckman Coulter N-terminal pro-B-type natriuretic peptide (NT-proBNP) assay in the early diagnosis of acute heart failure (AHF) is unknown. Methods This major unmet clinical need was addressed in a secondary analysis using frozen plasma samples obtained in a prospective diagnostic study, enrolling patients presenting with acute dyspnea to the emergency department (ED). Two independent cardiologists/internists centrally adjudicated the final diagnosis using all individual patient's information. NT-proBNP-Beckman Coulter plasma concentrations were measured blinded and directly compared to NT-proBNP-Elecsys concentrations. Agreement analysis was performed by Bland Altman plot. The primary endpoints were the diagnostic accuracy of both assays using the Area-under-the-Receiver-Operating-Curve and the comparison of the performance for diagnosing AHF using the validated NT-proBNP-Elecsys clinical decision values (&lt;300ng/L for rule-out, age-adjusted &gt;450/900/1800ng/L for rule-in). The secondary endpoint included the application of the recently suggested NT-proBNP-Elecsys clinical decision values for obese patients. Results 1400 patients (46% 3women, median age 76 years, BMI 25.9m2/kg, LVEF 53%) had both NT-proBNP measurements on presentation to the ED. Of those 744 (53%) had an adjudicated diagnosis of AHF. The agreement analysis showed overall higher concentrations for the NT-proBNP-Beckman assay. The diagnostic accuracy of both assays was excellent (AUC: 0.915 vs 0.922; P = 0.006, respectively). In the clinical application less patients were ruled-out using the Beckman assay compared to the Elecsys assay (18.7% vs 26.3%) with comparable sensitivities (98.9% vs 98.5%). Regarding rule-in NT-proBNP-Elecsys had a significantly higher specificity (78.8% vs 70.9%) and positive predictive value (83.1% vs 78.7%; both P&lt;0.001; Figure 1). Similar findings were obtained in recently suggested cutoffs for obese patients. Conclusions In comparison to established NT-proBNP-Elecsys cutoffs, a derivation of Beckman-specific cutoffs is needed to implement NT-proBNP-Beckman Coulter clinical decision values providing a higher rule-out proportion and an optimal specificity for diagnosing AHF.</abstract><cop>US</cop><pub>Oxford University Press</pub><doi>10.1093/clinchem/hvae106.018</doi></addata></record>
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title A-018 Diagnostic Performance of the Novel Beckman-Coulter NT-proBNP-assay in the Early Diagnosis of Acute Heart Failure
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