PMID- 31743687
OWN - NLM
STAT- MEDLINE
DCOM- 20201117
LR  - 20201117
IS  - 1873-2933 (Electronic)
IS  - 0009-9120 (Linking)
VI  - 78
DP  - 2020 Apr
TI  - Multi-platform analytical evaluation of the Beckman Coulter Access 
      high-sensitivity troponin I assay across different laboratory sites using 
      Barricor plasma.
PG  - 25-31
LID - S0009-9120(19)30943-9 [pii]
LID - 10.1016/j.clinbiochem.2019.10.014 [doi]
AB  - OBJECTIVES: Previous analytical evaluations of the Beckman Coulter Access high 
      sensitivity troponin (hsTn) I assay have focused on single platforms and 
      laboratory sites. The purpose of this study was to determine assay robustness 
      across different platforms at multiple sites, platform-specific characteristics, 
      and equivalence to other hsTn methods in a large laboratory network. METHODS: 
      Barricor plasma was used to assess imprecision, linearity, sensitivity (limit of 
      blank and detection, LOB/LOD), and comparability to the conventional AccuTnI+3 
      and other hsTn assays. Various studies were conducted across a total of 9 
      laboratories using Beckman DxI800 and Access2 platforms. RESULTS: 
      Within-laboratory precision was <10% across all target patient pool 
      concentrations, however, DxI800 mean values were 20% higher than Access2 in the 
      range of 3.6-44.9 ng/L. LOBs and LODs were lower on DxI800, 0.27 and 0.90 ng/L, 
      respectively, compared to 2.9 and 3.2 ng/L, on Access2. Both showed excellent 
      linearity across the full range. In method comparison to AccuTnI+3, DxI800 had a 
      higher slope (0.9417 versus 0.8495) and positive bias (+18.1% versus -9.9%) 
      compared to Access2, a trend further pronounced at concentrations <150 ng/L. At 
      values <150 ng/L, there was good agreement with Abbott hsTnI (slope = 1.017, 
      r = 0.932), but poor agreement with the Roche hsTnT assay (slope = 1.687, 
      r = 0.589). Inter-laboratory split sample comparisons across 2 DxI800 and 7 
      Access2 sites showed close agreement, except at low concentrations <10 ng/L where 
      DxI800 was 2.8 ng/L higher (p<0.001). CONCLUSIONS: The Beckman hsTnI assay showed 
      robust analytical performance across different laboratories and platforms. 
      However, discrepancies between platforms were found at low concentrations where 
      rapid acute myocardial infarction (AMI) rule-out decisions occur. These 
      differences have important implications for AMI risk assessment, suggesting that 
      laboratories should develop platform-specific parameters rather than using them 
      interchangibly.
CI  - Copyright (c) 2019 The Canadian Society of Clinical Chemists. Published by Elsevier 
      Inc. All rights reserved.
FAU - Raizman, Joshua E
AU  - Raizman JE
AD  - Alberta Precision Laboratories, North Sector, Edmonton, Alberta, Canada; 
      Department of Laboratory Medicine & Pathology, University of Alberta, Edmonton, 
      Alberta, Canada. Electronic address: josh.raizman@albertaprecisionlabs.ca.
FAU - Tsui, Albert K Y
AU  - Tsui AKY
AD  - Alberta Precision Laboratories, North Sector, Edmonton, Alberta, Canada; 
      Department of Laboratory Medicine & Pathology, University of Alberta, Edmonton, 
      Alberta, Canada.
FAU - Goudreau, Bobbi-Lynn
AU  - Goudreau BL
AD  - Alberta Precision Laboratories, North Sector, Edmonton, Alberta, Canada.
FAU - Fuzery, Anna K
AU  - Fuzery AK
AD  - Alberta Precision Laboratories, North Sector, Edmonton, Alberta, Canada; 
      Department of Laboratory Medicine & Pathology, University of Alberta, Edmonton, 
      Alberta, Canada.
FAU - Estey, Mathew
AU  - Estey M
AD  - Department of Laboratory Medicine & Pathology, University of Alberta, Edmonton, 
      Alberta, Canada; DynaLIFE Medical Labs, Edmonton, Alberta, Canada.
FAU - Sadrzadeh, Hossein
AU  - Sadrzadeh H
AD  - Department of Pathology & Laboratory Medicine, University of Calgary, Calgary, 
      Alberta, Canada; Alberta Precision Laboratories, South Sector, Calgary, Alberta, 
      Canada.
FAU - Higgins, Trefor
AU  - Higgins T
AD  - Alberta Precision Laboratories, North Sector, Edmonton, Alberta, Canada; 
      Department of Laboratory Medicine & Pathology, University of Alberta, Edmonton, 
      Alberta, Canada.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20191116
PL  - United States
TA  - Clin Biochem
JT  - Clinical biochemistry
JID - 0133660
RN  - 0 (Biomarkers)
RN  - 0 (Troponin I)
SB  - IM
MH  - Biomarkers/blood
MH  - Blood Chemical Analysis/*methods
MH  - Female
MH  - Humans
MH  - Limit of Detection
MH  - Male
MH  - Sensitivity and Specificity
MH  - Troponin I/*blood
OTO - NOTNLM
OT  - Beckman Coulter
OT  - High-sensitivity troponin I
OT  - Method evaluation
OT  - Multi-site
OT  - Rapid rule-out
EDAT- 2019/11/20 06:00
MHDA- 2020/11/18 06:00
CRDT- 2019/11/20 06:00
PHST- 2019/08/27 00:00 [received]
PHST- 2019/10/22 00:00 [revised]
PHST- 2019/10/22 00:00 [accepted]
PHST- 2019/11/20 06:00 [pubmed]
PHST- 2020/11/18 06:00 [medline]
PHST- 2019/11/20 06:00 [entrez]
AID - S0009-9120(19)30943-9 [pii]
AID - 10.1016/j.clinbiochem.2019.10.014 [doi]
PST - ppublish
SO  - Clin Biochem. 2020 Apr;78:25-31. doi: 10.1016/j.clinbiochem.2019.10.014. Epub 
      2019 Nov 16.