AACC 2019 -- The requirements from IFCC (International Federation of Clinical Chemistry) to qualify a cardiac Troponin assay to be qualified as a high sensitive assay are that the, Assay must have analytical imprecision of <10% at the 99th percentile, Assay must be able to measure cTn above the LOD in >50% of the patients and the 99th percentile should be established with 300 M and 300 F. In this study, we evaluated the performance of two FDA approved Troponin HS assays (Siemens Centaur and Beckman DxI Assays) and two CE marked Troponin HS assays (Abbott Architect and Fujirebio Lumipulse Assays).

1. Presented at AACC 2019
Evaluation of Troponin I High Sensitive (HS) Assay Across Beckman DxI,
Siemens Centaur, Abbott Architect and Fujirebio Lumipulse Platforms
Satya Nandana Narla1, Lauryn Pritchard1, Sarah Augustain1, Amanda Didier1, Philippe Frantz2, Severnie Thabuis2 and Martine Florent2
Immunology Department, Covance Central Laboratories, 1Indianapolis, IN, USA; 2Geneva, Switzerland
Abstract
Troponin I HS
Units: ng/L
Siemens
Centaur
Beckman
DxI
Abbott
Architect
Fujirebio
Lumipulse
Limit of Detection
(LOD)
1.6 2.0 1.1 2.1
Lower Limit of
Quantification
(LLOQ)
2.5 2.3 10.0 8.6
% of results >LOD
or LLOQ
Serum 42%* 67%* 60% 90%
LH Plasma 42%* 67%* 59% 87%
99th percentile as
per the
Manufacturer
Serum
F=39.59,
M=58.05,
O=46.47
F=13.6,
M=19.8,
O= 18.1
F=15.6,
M=34.2,
O=26.2
F=21.4,
M=29.
O= 26.9
LH Plasma
F=36.99,
M=57.27
O=47.34
F=14.9,
M=19.8,
O=17.9
F=15.6,
M=34.2,
O=26.2
F=27.8,
M=32.8
O=29.6
CV at or below
99th percentile
(n=40)
Serum
3% at
26.7
5% at
13.9
8% at
13.0 SNP
LH Plasma
3% at
34.7 8% at 9.1
8% at
12.5 SNP
Background:
The requirements from IFCC (International Federation of
Clinical Chemistry) to qualify a cardiac Troponin assay to be
qualified as a high sensitive assay are that the, Assay must
have analytical imprecision of <10% at the 99th percentile,
Assay must be able to measure cTn above the LOD in >50%
of the patients and the 99th percentile should be established
with 300 M and 300 F. In this study, we evaluated the
performance of two FDA approved Troponin HS assays
(Siemens Centaur and Beckman DxI Assays) and two CE
marked Troponin HS assays (Abbott Architect and Fujirebio
Lumipulse Assays).
Experiments:
Lithium Heparin Plasma and Serum were collected from
healthy subjects (30 Female and 22 Male). All the 52
samples for each sample type collected were tested across
four different platforms on the (DxI, Centaur, Architect and
Fujirebio) to determine the percent of samples that these
platforms can detect troponin above the LOD. Five levels of
LH plasma and serum samples were prepared covering the
LLOQ and the 99th percentile range by spiking with high
native troponin I plasma and serum samples respectively.
These samples were tested in replicates of 4 per day over
10 days on three different platforms to evaluate the CV at or
below the 99th percentile.
Results:
SNP: Study Not Performed
*the instrument gave results as less than for any result below LLOQ
Conclusion:
DxI, Architect and Lumipulse assays were able to detect
troponin >50% of subjects tested, the results from Centaur
were inconclusive as the instrument did not give results
between LLOQ and LOD. All three assays tested DxI,
Architect and the Centaur assays have %CV <10% at the
99th percentile concentration. Overall all assays evaluated
meet the IFCC requirements to be qualified as a HS
Troponin assay.
Architect Centaur DxI Lumipulse
SerumPlasma
Architect Centaur DxI
SerumPlasma
0%
5%
10%
15%
20%
0.0 20.0 40.0 60.0 80.0
%CV
Concentration, ng/L
0
0.01
0.02
0.03
0.04
0.05
0.06
0 20 40 60 80
%CV
Concentration, ng/L
0
0.01
0.02
0.03
0.04
0.05
0.06
0.07
0.08
0 20 40 60 80
%CV
Concentration, ng/L
0
0.01
0.02
0.03
0.04
0.05
0.06
0.07
0.08
0.09
0 50 100
%CV
Concentration, ng/L
0%
2%
4%
6%
8%
10%
12%
14%
0.0 50.0 100.0 150.0
%CV
Concentation, ng/L
0%
2%
4%
6%
8%
10%
12%
14%
0.0 50.0 100.0 150.0
%CV
Concentation, ng/L
Experiment
▶ Experiment 1: Assay must be able to measure cTn above the LOD in >50% of the patients
− LH Plasma and Serum were collected from 22 Male 30 Female normal subjects
− Samples analyzed on all platforms (Architect, Centaur, DxI and Lumipulse)
− Determine the percent of samples >LOD of respective platform
▶ Experiment 2: Assay must have analytical imprecision of <10% at the 99th percentile
− 5 levels samples are prepared by spiking native troponin into Plasma (LH) and Serum from the above 99th percentile level to the
LOD level for three instruments
− Samples were analyzed in replicates of 4 over 10 days.
Results
Troponin I HS Matrix
Siemens
Centaur
Beckman
DxI
Abbott
Architect
Fujirebio
Lumipulse
% of results >LOD or
LLOQ
Serum 42%* 67%* 60% 90%
LH Plasma 42%* 67%* 59% 87%
*the instrument gave results as less than for any result below LLOQ
Percent Results Above the LOD
%CV at the 99th Percentile
Architect, Serum
Mean SD CV
0.4 0.5 123%
0.6 0.6 100%
13.0 1.0 8%
24.1 1.4 6%
72.1 2.9 4%
Centaur, Serum
Mean SD CV
14.4 0.7 5%
26.7 0.8 3%
75.4 1.3 2%
DxI, Serum
Mean SD CV
2.9 0.4 12%
3.1 0.5 16%
13.9 0.8 5%
23.1 1.2 5%
59.2 2.3 4%
DxI, Plasma
Mean SD CV
3.0 0.5 18%
2.9 0.4 13%
9.1 0.8 8%
27.1 1.4 5%
72.4 3.7 5%
Centaur, Plasma
Mean SD CV
16.9 2.1 12%
34.7 1.2 3%
96.1 1.5 2%
Architect, Plasma
Mean SD CV
0.3 0.5 155%
0.3 0.3 119%
12.5 1.1 8%
32.2 1.6 5%
93.9 3.7 4%
Conclusions
▶ DxI, Architect and Lumipulse assays were able to detect troponin >50% of subjects tested.
▶ Results from Centaur were inconclusive as the instrument did not give results between LLOQ and LOD.
▶ All three assays tested DxI, Architect and the Centaur assays have %CV <10% at the 99th percentile concentration.
▶ All assays evaluated meet the IFCC requirements to be qualified as a HS Troponin assay.
Troponin I HS Matrix Siemens Centaur Beckman DxI Abbott Architect
CV at or below 99th
percentile
Serum 3% at 26.7 5% at 13.9 8% at 13.0
LH Plasma 3% at 34.7 8% at 9.1 8% at 12.5
Acknowledgement
The authors thank Dr. Yusheng Zhu, Pennsylvania State University
Hershey Medical Center, for providing high troponin samples.