PMID- 17854790
OWN - NLM
STAT- MEDLINE
DCOM- 20080109
LR  - 20191210
IS  - 0009-8981 (Print)
IS  - 0009-8981 (Linking)
VI  - 386
IP  - 1-2
DP  - 2007 Nov-Dec
TI  - Multi-center validation of the Response Biomedical Corporation RAMP NT-proBNP 
      assay with comparison to the Roche Diagnostics GmbH Elecsys proBNP assay.
PG  - 20-4
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 > or =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.
FAU - Lee-Lewandrowski, Elizabeth
AU  - Lee-Lewandrowski E
AD  - Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA.
FAU - Januzzi, James L
AU  - Januzzi JL
FAU - Green, Sandy M
AU  - Green SM
FAU - Tannous, Bakhos
AU  - Tannous B
FAU - Wu, Alan H B
AU  - Wu AH
FAU - Smith, Andrew
AU  - Smith A
FAU - Wong, Alicia
AU  - Wong A
FAU - Murakami, MaryAnn M
AU  - Murakami MM
FAU - Kaczmarek, Jason
AU  - Kaczmarek J
FAU - Apple, Fred S
AU  - Apple FS
FAU - Miller, Wayne L
AU  - Miller WL
FAU - Hartman, Karen
AU  - Hartman K
FAU - Jaffe, Allan S
AU  - Jaffe AS
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Validation Study
DEP - 20070725
PL  - Netherlands
TA  - Clin Chim Acta
JT  - Clinica chimica acta; international journal of clinical chemistry
JID - 1302422
RN  - 0 (Biomarkers)
RN  - 0 (Peptide Fragments)
RN  - 0 (Reagent Kits, Diagnostic)
RN  - 0 (pro-brain natriuretic peptide (1-76))
RN  - 114471-18-0 (Natriuretic Peptide, Brain)
SB  - IM
MH  - Acute Disease
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Biological Assay/*methods
MH  - Biomarkers/analysis
MH  - Coronary Disease/*blood/diagnosis
MH  - Female
MH  - Heart Failure/blood/diagnosis
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Natriuretic Peptide, Brain/*blood
MH  - Peptide Fragments/*blood
MH  - *Point-of-Care Systems
MH  - *Reagent Kits, Diagnostic
MH  - Reference Values
MH  - Reproducibility of Results
MH  - Sample Size
MH  - Sensitivity and Specificity
MH  - Time Factors
EDAT- 2007/09/15 09:00
MHDA- 2008/01/10 09:00
CRDT- 2007/09/15 09:00
PHST- 2007/06/06 00:00 [received]
PHST- 2007/07/12 00:00 [revised]
PHST- 2007/07/12 00:00 [accepted]
PHST- 2007/09/15 09:00 [pubmed]
PHST- 2008/01/10 09:00 [medline]
PHST- 2007/09/15 09:00 [entrez]
AID - S0009-8981(07)00382-8 [pii]
AID - 10.1016/j.cca.2007.07.015 [doi]
PST - ppublish
SO  - Clin Chim Acta. 2007 Nov-Dec;386(1-2):20-4. doi: 10.1016/j.cca.2007.07.015. Epub 
      2007 Jul 25.