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High sensitivity, contemporary and point-of-care cardiac troponin assays: educational aids developed by the IFCC Committee on Clinical Application of Cardiac Bio-Markers

  • Paul O. Collinson , Amy K. Saenger , Fred S. Apple EMAIL logo and on behalf of the IFCC C-CB
Published/Copyright: December 11, 2018
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 57 Issue 5

Abstract

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) formed a Task Force on the Application of Cardiac Bio-markers (TF-CB) in 2008, re-designated in 2018 as a committee (C-CB), to produce educational materials on cardiac biomarkers. Established in June 2017, definitive tables covering the majority of high-sensitivity, contemporary and point-of-care (POC) cTn assays have been developed by the C-CB and are available on the IFCC website. These tables provide extensive information about assays’ analytical characteristics and encompass information on diagnostic discriminants, particularly the 99th percentiles, as provided by the manufacturers.

Keywords: 99th percentiles; cardiac troponin; education; high sensitivity assays; myocardial injury; point-of-care

The Global Task Force for Fourth Universal Definition of Myocardial Infarction (MI) utilizes cardiac troponin (cTn) as the standard biomarker for the detection of myocardial injury [1]. An increased cTn concentration above the upper reference limit (URL) defines myocardial injury, with cTn URLs specified as sex-specific 99th percentiles of a normal healthy reference population, defined by sex, age, racial and ethnic diversity [1], [2], [3], [4]. Prior to 2000, the definition of MI utilized a different diagnostic discriminant, the 97.5th percentile of a reference population, for a ‘cardiac enzyme’, typically total creatine kinase (CK) or its MB isoenzyme (CK-MB) [5].

When first introduced into routine clinical practice, cTn assays were evaluated against the WHO diagnostic criteria for MI as the diagnostic gold standard. Using the WHO criteria as the diagnostic standard resulted in a relatively high diagnostic discriminant, typically 10–50 times the cTn 99th percentile. Shortly after, the redefinition of MI guidelines endorsed the preferred diagnostic discriminant as cTn, with a statement that cTn assays should ideally have a 10% coefficient of variation (CV) at the assay’s 99th percentile URL concentration [6]. Assays were considered to be clinically acceptable if they had a %CV at the 99th percentile ≤20%, as patients would not be misclassified at this concentration [7]. Introduction of cTn assays into routine clinical use was accompanied by a range of different proposed diagnostic URLs for the diagnosis of MI, likely due to the misunderstanding of the intent and recommendations within the guidelines. Surveys of laboratory practice revealed that there was still use of a range of biomarkers other than cTn and a great deal of uncertainty as to what diagnostic URL (WHO equivalent, 10% or 20% CV concentration, or the 99th percentile) was appropriate [8].

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) formed a Task Force on the Application of Cardiac Bio-markers (TF-CB) in 2008, re-designated in 2018 as a committee (C-CB), to produce educational materials on cardiac biomarkers [3], [4], [5]. Since the 2007 survey [2], [3], [4], there has been progressive improvement in assay analytical sensitivity, culminating in the development and global clinical implementation of high-sensitivity (hs) cTn assays [2], [3], [4]. Subsequent surveys, most recently in 2016, have shown that although there has been a shift to cTn as the preferred and primary biomarker, there remains a lack of a consistent approach to the interpretation of cTn measurements [9]. Although the IFCC C-CB has defined the analytical characteristics to define ‘high sensitivity’, there also continues to be confusion as to what defines an hs-cTn assay and how to optimally use hs-cTn assays clinically.

The current environment is partly due to both the rapid pace in assay development and to the legacy of the varied range of diagnostic URLs for MI. The IFCC C-CB seeks to address the broader educational needs of the laboratory and clinical community and to provide authoritative, explanatory reference documents for global widespread use. The C-CB has academic, clinical and industry membership and works collaboratively with other clinical and laboratory medicine groups, such as the European Federation of Laboratory Medicine (EFLM) and the Academy of the American Association of Clinical Chemists (AACC). To date, several peer reviewed manuscripts have been produced to explain the concept of hs-cTn assays [2], [3]. The top eight analytical and top three clinical key components for the implementation of hs-cTn assays have been summarized as educational aids on a poster and a mouse pad and are currently available for distribution (poster) from by the IFCC if desired.

Established in June 2017, definitive tables covering the majority of high-sensitivity (Table 1), contemporary (Table 2) and point-of-care (POC) (Table 3) cTn assays have been developed by the C-CB and are available on the IFCC website [10], [11], [12]. These tables provide extensive information about assays’ analytical characteristics and encompass information on diagnostic discriminants, particularly the 99th percentiles, as provided by the manufacturers. In addition, a table that addresses the effects of hemolysis and biotin on cTn assays has been published [13] and posted to the IFCC website [14]. All tables will be updated on a quarterly basis. Further, tables summarizing analytical characteristics of natriuretic peptides (NP) [15] and effects of hemolysis and biotin on NP assays [16] are also found on the website. An educational document for NPs, paralleling the cTn document, is under development by the C-CB.

Table 1:

High-sensitivitya cardiac troponin I and T assay analytical characteristics designated by manufacturer – IFCC Committee on Clinical Applications of Cardiac Bio-Markers (C-CB).

Company/platform/assayLoB, ng/LLoD, ng/L% CV at 99th percentileConc at 20% CV, ng/LConc at 10% CV, ng/LReference population n, Age, sex99th percentile overall M/F, ng/LSpecimen typePercent normals measured ≥LoD Overall

M/F		Statistic used to calc 99th percentile% RCVEpitopes recognized by antibodiesCountry of package insert: version date
Abbott/ARCHITECT i Systems/ARCHITECT STAT high sensitive troponin-I; commercial0.7–1.31.1Overall: 4.0%

F: 5.3%

M: 3.5%

1.34.7Overall

n =1531

21–75 years



F: 764

21–75 years



M: 766

21–73 years

Overall: 26.2

F: 15.6

M: 34.2		Lithium heparin (with/without separator), K2 EDTA, K3 EDTA, serum (with/without separator), serum with thrombin-based clot activatorOverall: 85%

F: 78%

M: 92%		RobustNPNPOUS only: G5-6634/R01 April 2015
Beckman Coulter/Access 2, DxI/Access hsTnI; commercial – OUS0.0–1.71.0–2.3Overall: 3.7%

F: 4.2%

M: 3.6%		1.0–2.35.6Overall

n=1089

21–99 years

F: 595

M: 494		Overall: 17.5

F: 11.6

M: 19.8		Heparin plasma>50%Non-parametricNPNPOUS B52699/ C11140

Sept 2017
Beckman Coulter/Access 2, /Access hsTnI; commercial – US: LiHep plasma0.0–0.81.0–2.0Overall: 3.7%

F: 4.2%

M: 3.6%		0.9–2.34.1Overall

n=1089

21–99 years

F: 595

M: 494		Overall: 17.5

F: 11.6

M: 19.8		Heparin plasma>50%Non-parametricNPNPUS B52699/C09449

June 2018
Beckman Coulter/Access 2, /Access hsTnI; commercial – US: Serum0.0–0.81.0–2.0Overall: 6.0%

F: 6.9%

M: 5.8%		0.9–2.34.1Overall

n=1088

21–99 years

F: 595

M: 493		Overall: 18.2

F: 11.8

M: 19.7		Serum>50%Non-parametricNPNPUS B52699/C09449

June 2018
Beckman Coulter/DxI, Access hsTnI; commercial – US: LiHep plasma0.0–1.71.5–2.3Overall: 5.2%

F: 5.6%

M: 5.0%		1.2–2.35.6Overall

n=1088

21–99 years

F: 593

M: 495		Overall: 17.9

F: 14.9

M: 19.8		Heparin plasma>50%Non-parametricNPNPUS B52699/C09448

June 2018
Beckman Coulter/DxI, Access hsTnI; commercial – US: Serum0.0–1.71.5–2.3Overall: 6.2%

F: 6.5%

M: 6.1%		1.2–2.35.6Overall

n=1085

21–99 years

F: 592

M: 493		Overall: 18.1

F: 13.6

M: 19.8		Serum>50%Non-parametricNPNPUS B52699/C09448

June 2018
bioMérieux VIDAS High Sensitive Troponin I; commercial1.93.27.0%4.9NPOverall

n=815

41–80 years

F: 368:

41–80 years

M: 447

41–80 years		Overall: 19

F: 11

M: 25		Serum or heparin plasmaNPNPNPC: 41–49, 24–40

D: 87–95		France

Dec 23rd 2015
ET Healthcare Pylon hsTnI assay; research0.81.2–1.410%210Overall

n=763

15–91 years

F: 437

M: 281

(AACC Universal

Sample Bank)		Overall: 26

F: 19

M: 28		EDTA plasma, EDTA whole blood, serumOverall: 90%

F: 86%

M: 94%		NPNPC: 27–40

D: 41–49		ChiNP, 2017
Fujirebio Lumipulse G G1200 and G600II hsTnI1.22.1≤4.6%NP7.3Overall n=1018, 18–90 years

F: 428

M: 590		Overall: 28.6

F: 22.4

M: 32.9

Serum overall: 26.9

F: 21.4

M: 29.4

Li heparin plasma Overall: 29.6

F: 27.8

M: 32.8		Red top serum, serum separator tube, rapid clotting tubes; disodium EDTAa, dipotassium EDTAa, lithium heparin, sodium heparin, sodium citrate, PST with lithium heparinOverall: 68.3%

Serum: 68.1%

Li heparin plasma: 65.0%		RobustNPNPEnglish

FRI0030, Feb 2017 Ver.01
LSI Medience (formerly Mitsubishi) PATHFAST cTnI; commercialNP1<6%23.1Overall

n=474

18–86 years

F: 236

M: 238		Overall: 15.48

M: 16.91

F: 11.46		Whole blood, plasmaOverall: 76.3%Non-parametricNPC: 41–49

D: 71–116, 163–209		WW except US and Japan: Ver.6, 2017.10
LSI Medience (former Mitsubishi) PATHFAST hs-cTnI/PATHFAST cTnI-II1.232.336.1415Overall

n=734

Age >18

F: 352

M: 382		Overall: 27.9

F: 20.3

M: 29.7		Whole blood,

plasma		Total: 66.3%

F: 52.8%

M: 78.8%		Non-parametricNDC:41–49

D: 71–116, 163–209		hs-cTnI: WW except US and Japan

Ver.1, May 2018

cTnI-II: US, ver.4 Mar 2015
Ortho/VITROS/Immunodiagnostic hs Troponin I prelim data; research0.31.0<10%1.74.3Overall

n=480

16–88 years

F: 236

M: 244		Overall: 21

F: 9

M: 26		Serum; lithium heparin plasmaNPNon-parametricNPC: 87–91

D: 24–40, 41–49		In development
Roche/cobas e601, e602, E170/cTnT-hs 18-min; commercial1.36; (2.16 for e411)2.05; (4.72 for e411)<10%2.204.49Overall

n=533

20–71 years

F: 49.7%		Overall:14

F: 9

M: 16		Serum, plasma: EDTA, heparinOverall: 71.5%NPNPC: 125–131

D: 136–147		EU (upcoming PI version)
Roche/cobas e601, e602, E170/cTnT-hs STAT; commercial2.26; 2.57 for e4112.85; 4.88 for e411<10%2.815.03Overall

n=533

20–71 years

F: 49.7%		Overall: 14

F: 9

M: 16		Serum, plasma: EDTA, heparinOverall: 58.9%NPNPC: 125–131

D: 136–147		EU (upcoming PI version)
Roche/cobas e801/ cTnT-hs 18-min and STAT; commercial2.53<10%618-min: 3.83 STAT: 5.48Overall

n=533

20–71 years

F: 49.7%		Overall: 14

F: 9

M: 16		Serum, plasma: EDTA, heparinOverall: 57.4%NPNPC: 125–131

D: 136–147		EU, v2
Roche/cobas e601, e602, E170/TnT Gen 5 STAT

^specified value;

^^including e411 data; commercial		2.5^; 3 for e4113^; 5 for e411<10%6^^11^^Overall

n=1301

21–89 years

F: 50.4%		Overall: 19

F: 14

M: 22		Plasma heparinOverall: 55.1%NPNPC: 125–131

D: 136–147		USA, v1
Siemens ATELLICA high-sensitivity TnI (TnIH), US and OUS; commercial0.501.6<4.0%2.50<6.0Overall

n=2001

22–91 years

F: 1007

M: 994		Overall: 45.4

F: 38.6

M: 53.5		Li heparin serumOverall: 75%

F: 62%

M: 89%		Non-parametricNPC: 41–50, 171–190

D: 29–34		CE-marked

March 2017

FDA 510k

July 2018
Siemens ADVIA Centaur XP/XPT high-sensitivity TnI (TNIH), US and OUS; commercial0.501.6<4.9%2.50<6.0Overall

n=1990

22–91 years

F: 1006

M: 984		Overall: 46.5

F: 39.6

M: 58.0		Li heparin serumOverall: 63%

F: NP

M: NP		Non-parametricNPC: 41–50, 171–190

D: 29–34		CE-marked

March 2017

FDA 510k

July 2018
Siemens dimension VISTA high-sensitivity TnI (TNIH), OUS; commercial1.02.0<5.0%3.010.0Overall

n=2014

22–91 years

F: 1013

M: 1001		Overall: 57.9

F: 51.1

M: 74.9		Li heparin serumOverall: 81.8%

F: NP

M: NP		Non-parametricNPD: 41–50

171–190

C: 29–34		CE-marked 2017
Siemens dimension ExL high-sensitivity TnI (TNIH), OUS; commercial1.12.7<5.0%4.012.0Overall

n=2014

22–91 years

F: 1013

M: 1001		Overall: 58.2

F: 47.8

M: 71.8		Li heprin serumOverall: 51.5%

F: NP

M: NP		Non-parametricNPD: 41–50

171–190

C: 29–34		CE-marked 2017
Singulex Clarity cTnI; commercial0.020.082.39%0.140.53Overall

n=536

18–84 years

F: 262

M: 274		Overall: 8.67

F: 8.76

M: 9.23		EDTA plasmaOverall: 99%

F: 99%

M: 100%		Non-parametricNPC: 41–49, 24–40

D: 190–196, 86–90		European Union.

Version 1

  1. LoB, limit of blank; LoD, limit of detection; NP, not provided; C, capture antibody; D, detection antibody; M, male; F, female; Conc, concentration; WW, worldwide; OUS, outside the United States; RCV, reference change value; n, number. All data have been listed as provided by the manufacturer. aPlease note manufacturers may have submitted assays they claim to be ‘high sensitivity’ that do not meet the IFCC requirements of: a) ≤10% CV at the 99th percentile and b) ≥50% measurable concentrations ≥LOD for both males and female separately.

Table 2:

Contemporary cardiac troponin I and T assay analytical characteristics designated by manufacturer – IFCC Committee on Clinical Applications of Cardiac Bio-Markers (C-CB).

Company/platform/assayLoB, μg/LLoD, μg/L% CV at 99th percentileConc at 20% CV, μg/LConc at 10% CV, μg/LReference population n, Age, sexSpecimen type99th percentile, μg/LPercent normals measured ≥LoDStatistic used to calc 99th percentileEpitopes recognized by antibodiesCountry of package insert: version date
Abbott/ARCHITECT i systems/ARCHITECT STAT Troponin-I≤0.010.00914%NP0.032Overall n=449

18–63 years

F: 225

18–62 years

M: 224

18–63 years		Serum, heparin plasmaOverall: 0.028

F: 0.013

M: 0.033		2%RobustC: 87–91, 24–40

D: 41–49		US only: G1-0467/R11, revised June 2015
Beckman/Access 2/AccuTnI+3, US<0.010.0120%0.020.04Overall n=527

18–94 years

59.8% Female		Lithium heparin plasma0.02NPNon-parametricC: 41–49

D: 24–40		US B16315

2013
Beckman/DxI/AccuTnI+3, US<0.010.0120%0.030.04Overall n=527

18–94 years

59.8% Female		Lithium heparin plasma<0.03NPNon-parametricC: 41–49 D: 24–40US B16316

2013
Beckman/Access 2/AccuTnI+3, OUS<0.010.0110%0.020.04Overall n=998

>40 years

56.6% Female		Serum0.04NPNon-parametricC: 41–49 D: 24–40OUS A90435

2013
Beckman/DxI/AccuTnI+3, OUS<0.010.0110%0.020.04Overall n=998

>40 years

56.6% Female		Serum0.04NPNon-parametricC: 41–49 D: 24–40OUS B00495

2013
Ortho/VITROS/Immunodiagnostic troponin I ES0.0070.01210%0.0120.034>10,000Serum, plasma (Li heparin, EDTA)0.0344%Non-parametricC: 24–40 41–49

D: 87–91		USA: Version 7; 2016-01-06
Philips electronics

The NetherlandsBV/Minicare I-20/Minicare cTnI		0.0080.01818.6%0.038NPOverall n=750

18–86 years



F: 377

M: 373		Li-heparin

whole blood, capillary whole blood, Li-heparin plasma		0.0435.1% for capillaryNon-parametricC: 41–49

D: 20–100, cTnC MAb		IFU cTnI EN Issue #512230

12922*2017-03

Doc.t v3.0
Radiometer AQT90 FLEX TnINP0.00912.3%NP0.027Overall n=231

F: 106

M: 128		EDTA and heparinized whole blood and plasma0.023NPNon-parametricC: 41–49, 190–196

D: 137–149		990-872

OUS

201608X
Radiometer AQT90 FLEX TnTNP0.00815.2%NP0.026Overall n=260

F: 132

M: 128		EDTA and heparinized whole blood and plasma0.017NPNon-parametricC: 125–131

D: 136–147		995-639

OUS

201608H
Roche cobas e411*/Roche E170/cobas e601/602/cobas e801 cTnI (18 min and STAT)

*STAT only		0.10.16NPNP0.30Overall n=839

20–79 years		Serum, plasma (EDTA/heparin)0.161.0%NPC: 87–91, 190–196

D: 23–29, 27–43		EU
Roche cobas e411*/Roche E170/cobas e601/602 cTnI (18 min and STAT)

*STAT only		<0.30<0.30NPNP0.30Overall n=839

20–79 years		Serum, plasma (EDTA/heparin)<0.31.0%NPC: 87–91, 190–196

D: 23–29, 27–43		US
Roche cobas e411/Roche E170/cobas e601/602 cTnT (18 min STAT)NP0.010NPNP0.03Overall n=1951Serum, plasma (EDTA, heparin, citrate)<0.010NPNPC: 125–131

D:136–147		US
Siemens

Atellica

TnI-Ultra		0.0070.015<10%0.015<0.020Overall n=1974

22–91 years

F: 993

M: 981		Serum, plasma (EDTA, Li-heparin)0.020NPNPC: 41–49, 87–89

D: 27–40		CE 10995428_EN Rev. 01, 2017-05
Siemens

ADVIA Centaur Systems

TnI-Ultra		0.006NP<8%0.0170.03Overall n=648

17–91 years		Serum, plasma (EDTA, Li-heparin)0.040NPNPC: 41–49, 87–89

D: 27–40		CE

10629901_EN Rev. L,

2014-08
Siemens

Dimension Vista Systems

LOCI cTnI		0.015NP<10%NP<0.04Overall n=199Serum, Li-heparin plasma0.045NPNPC: 27–32

D: 41–56		CE

2015-03-27 E PN 781421.001
Siemens

Dimension EXL Systems

LOCI cTnI		0.0100.017<10%NP0.05Overall n=241Serum, plasma (EDTA, Li-heparin)0.056NPNPC: 27–32

D: 41–56		CE

2015-02-09 D PN 741621.001
Tosoh AIA cTnI

3rd Gen		0.0080.02<20%0.010.035Overall n=343 AsianSerum, plasma (EDTA/heparin)0.04NPNPNPEU rev.cTNI-011111

  1. LoB, limit of blank; LoD, limit of detection; NP, not provided; C, capture antibody; D, detection antibody; M, male; F, female; Conc, concentration; WW, worldwide; OUS, outside United States; n, number. All data have been listed as provided by the manufacturer, except Tosoh assay that was abstracted from package insert due to lack of correspondence from manufacturer.

Table 3:

Point-of-care cardiac troponin I and T assay analytical characteristics designated by manufacturer – IFCC Committee on Clinical Applications of Cardiac Bio-Markers (C-CB).

Company/platform/assayLoB, μg/LLoD, μg/L% CV at 99th percentileConc at 20% CV, μg/LConc at 10% CV, μg/LReference population n, Age, sexSpecimen type99th percentile, μg/LPercent normals measured ≥LoDStatistic used to calc 99th percentileEpitopes recognized by antibodiesCountry of package insert: version date
Abbott i-STAT0.02NP16.5%0.070.1Overall n=162Sodium and lithium heparinized whole blood and plasmaOverall: 0.08NPNPNPUS: Rev. Date: 01-Jul-13
LSI Medience (formerly Mitsubishi) PATHFAST cTnI; commercialNP1<6%23.1Overall n=474

18–86 years

F: 236

M: 238		Overall: 15.48

M: 16.91

F: 11.46		Whole blood, plasmaOverall: 76.3%Non-parametricC: 41–49,

D: 71–116, 163–209		WW except US and Japan:

Ver.6,2017.10
LSI Medience (former Mitsubishi)

PATHFAST hs-cTnI/PATHFAST cTnI-II		1.232.336.1415Overall n=734

Age >18

F: 352

M: 382		Overall: 27.9

F: 20.3

M: 29.7		Whole blood, plasmaTotal: 66.3%

F: 52.8%

M: 78.8%		Non-parametricC:41–49,

D: 71–116, 163–209		hs-cTnI: WW except US and Japan

Ver.1, May 2018

cTnI-II: US, ver.4 Mar 2015
Philips electronics

The Netherlands BV/Minicare I-20/Minicare cTnI		0.00850.01818.6%0.038NPOverall n=750

18–86 years

F: 377

M: 373		Li-heparin whole blood, capillary whole blood and plasmaOverall: 0.043Overall: 5.1% for capillaryNon-parametricC: 41–49

D: 20–100 anti cTnC MAb		IFU cTnI EN

Issue #5122300

12922*2017-03

Document version 3.0
Quidel/Alere Triage Cardiac PanelNP0.050NP16.3% at 0.120NPOverall n=323

F: 168

M: 155		EDTA whole blood or plasmaNPNPNPNPUSA, 2014, rev. D
Quidel/Alere Triage SOBNP0.050NP16.3% at 0.120NPOverall n=323

F: 168

M: 155		EDTA whole blood or plasmaNPNPNPNPUSA, 2014, rev. D
Quidel/Alere Triage Cardio0.0020.01NP0.0200.040Overall n=989EDTA whole blood or plasmaOverall: 0.020Overall: 11.8%Non-parametricNPUSA, 2014, rev. D
Radiometer AQT90 FLEX TnINP0.00912.3%NP0.027Overall n=231

F: 106

M: 128		EDTA and heparinized whole blood and plasmaOverall: 0.023NPNon-parametricC: 41–49, 190–196

D:137–149		990-872

InterNPtioNPl

201608X
Radiometer AQT90 FLEX TnTNP0.00815.2%NP0.026Overall n=260

F: 132

M: 128		EDTA and heparinized whole blood and plasmaOverall: 0.017NPNon-parametricC:125–131

D:136–147		990-872

InterNPtioNPl

201608H
Response Biomedical RAMP Troponin INP0.0320.0%0.100.21Overall n=180Only EDTA whole bloodOverall: <0.10NPNPNPEu IFU 90012-1.2
Roche CARDIAC POC Troponin T – Roche cobas h 232NP0.04NP0.04–2.09.3% between 0.04–0.2Overall n=302Heparinized whole bloodNPNPNPD: 125–131

C: 136–147		EU, 2016-05
Siemens

Stratus CS

Acute care cTnI test pack		<0.03NP8.2%0.030.06Overall n=101

No age

No sex		Whole blood (Li or NP heparin) or plasma Li or Na heparinOverall: 0.07NPNPC: 27–32

D: 41–56		CE, 2008-04

  1. LoB, limit of blank; LoD, limit of detection; NP, not provided; C, capture antibody; D, detection antibody; M, male; F, female; Conc, concentration; WW, worldwide; n, number. All data have been listed as provided by the manufacturer, except Response Biomedical assay that was abstracted from package insert due to lack of correspondence from manufacturer.

A series of industry sponsored workshops are being planned at major congresses, and started with the 2018 AACC annual meeting in Chicago. Most importantly, the C-CB wishes to encourage educational feedback from the laboratory and clinical communities on what they and their clinical colleagues find challenging in routine clinical use of cardiac biomarkers, specifically high sensitivity cTn assays.

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2018-11-11
Accepted: 2018-11-12
Published Online: 2018-12-11
Published in Print: 2019-04-24

©2019 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Cardiac biomarkers – 2019
  4. Reviews
  5. Current understanding and future directions in the application of TIMP-2 and IGFBP7 in AKI clinical practice
  6. Serum cytokines, adipokines and ferritin for non-invasive assessment of liver fibrosis in chronic liver disease: a systematic review
  7. Opinion Papers
  8. Detection capability of quantitative faecal immunochemical tests for haemoglobin (FIT) and reporting of low faecal haemoglobin concentrations
  9. Should phosphatidylethanol be currently analysed using whole blood, dried blood spots or both?
  10. IFCC Papers
  11. High sensitivity, contemporary and point-of-care cardiac troponin assays: educational aids developed by the IFCC Committee on Clinical Application of Cardiac Bio-Markers
  12. Cardiac troponin and natriuretic peptide analytical interferences from hemolysis and biotin: educational aids from the IFCC Committee on Cardiac Biomarkers (IFCC C-CB)
  13. Genetics and Molecular Diagnostics
  14. Droplet digital PCR for the simultaneous analysis of minimal residual disease and hematopoietic chimerism after allogeneic cell transplantation
  15. General Clinical Chemistry and Laboratory Medicine
  16. Commutable whole blood reference materials for hemoglobin A1c validated on multiple clinical analyzers
  17. When results matter: reliable creatinine concentrations in hyperbilirubinemia patients
  18. Mass spectrometry based analytical quality assessment of serum and plasma specimens with patterns of endo- and exogenous peptides
  19. Association of serum sphingomyelin profile with clinical outcomes in patients with lower respiratory tract infections: results of an observational, prospective 6-year follow-up study
  20. Effect of an activated charcoal product (DOAC Stop™) intended for extracting DOACs on various other APTT-prolonging anticoagulants
  21. Hematology and Coagulation
  22. Commutability assessment of reference materials for the enumeration of lymphocyte subsets
  23. Circulating platelet-neutrophil aggregates as risk factor for deep venous thrombosis
  24. Reference Values and Biological Variations
  25. A comparison of complete blood count reference intervals in healthy elderly vs. younger Korean adults: a large population study
  26. Indirect determination of hematology reference intervals in adult patients on Beckman Coulter UniCell DxH 800 and Abbott CELL-DYN Sapphire devices
  27. Cancer Diagnostics
  28. Large platelet size is associated with poor outcome in patients with metastatic pancreatic cancer
  29. Cardiovascular Diseases
  30. Sample matrix and high-sensitivity cardiac troponin I assays
  31. Preoperative proteinuria and clinical outcomes in type B aortic dissection after thoracic endovascular aortic repair
  32. Infectious Diseases
  33. The rational specimen for the quantitative detection of Epstein-Barr virus DNA load
  34. Letters to the Editor
  35. Letter to the Editor on article Dimech W, Karakaltsas M, Vincini G. Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing. Clin Chem Lab Med 2018;56:1970–8
  36. Counterpoint to the Letter to the Editor by Badrick and Parvin in regard to Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing
  37. Is creatine kinase an ideal biomarker in rhabdomyolysis? Reply to Lippi et al.: Diagnostic biomarkers of muscle injury and exertional rhabdomyolysis (https://doi.org/10.1515/cclm-2018-0656)
  38. Blood neuron cell-derived microparticles as potential biomarkers in Alzheimer’s disease
  39. A fast, nondestructive, low-cost method for the determination of hematocrit of dried blood spots using image analysis
  40. Association of fibroblast growth factor 21 plasma levels with neonatal sepsis: preliminary results
  41. Impact of continuous renal replacement therapy (CRRT) and other extracorporeal support techniques on procalcitonin guided antibiotic therapy in critically ill patients with septic shock
  42. Determining the cutoff value of the APTT mixing test for factor VIII inhibitor
  43. Determining the cut-off value of the APTT mixing test for factor VIII inhibitor: reply
  44. Euthyroid Graves’ disease with spurious hyperthyroidism: a diagnostic challenge
  45. A pilot plasma-ctDNA ring trial for the Cobas® EGFR Mutation Test in clinical diagnostic laboratories
  46. MS-based proteomics: a metrological sound and robust alternative for apolipoprotein E phenotyping in a multiplexed test
https://doi.org/10.1515/cclm-2018-1211
Keywords for this article
99th percentiles; cardiac troponin; education; high sensitivity assays; myocardial injury; point-of-care

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Cardiac biomarkers – 2019
  4. Reviews
  5. Current understanding and future directions in the application of TIMP-2 and IGFBP7 in AKI clinical practice
  6. Serum cytokines, adipokines and ferritin for non-invasive assessment of liver fibrosis in chronic liver disease: a systematic review
  7. Opinion Papers
  8. Detection capability of quantitative faecal immunochemical tests for haemoglobin (FIT) and reporting of low faecal haemoglobin concentrations
  9. Should phosphatidylethanol be currently analysed using whole blood, dried blood spots or both?
  10. IFCC Papers
  11. High sensitivity, contemporary and point-of-care cardiac troponin assays: educational aids developed by the IFCC Committee on Clinical Application of Cardiac Bio-Markers
  12. Cardiac troponin and natriuretic peptide analytical interferences from hemolysis and biotin: educational aids from the IFCC Committee on Cardiac Biomarkers (IFCC C-CB)
  13. Genetics and Molecular Diagnostics
  14. Droplet digital PCR for the simultaneous analysis of minimal residual disease and hematopoietic chimerism after allogeneic cell transplantation
  15. General Clinical Chemistry and Laboratory Medicine
  16. Commutable whole blood reference materials for hemoglobin A1c validated on multiple clinical analyzers
  17. When results matter: reliable creatinine concentrations in hyperbilirubinemia patients
  18. Mass spectrometry based analytical quality assessment of serum and plasma specimens with patterns of endo- and exogenous peptides
  19. Association of serum sphingomyelin profile with clinical outcomes in patients with lower respiratory tract infections: results of an observational, prospective 6-year follow-up study
  20. Effect of an activated charcoal product (DOAC Stop™) intended for extracting DOACs on various other APTT-prolonging anticoagulants
  21. Hematology and Coagulation
  22. Commutability assessment of reference materials for the enumeration of lymphocyte subsets
  23. Circulating platelet-neutrophil aggregates as risk factor for deep venous thrombosis
  24. Reference Values and Biological Variations
  25. A comparison of complete blood count reference intervals in healthy elderly vs. younger Korean adults: a large population study
  26. Indirect determination of hematology reference intervals in adult patients on Beckman Coulter UniCell DxH 800 and Abbott CELL-DYN Sapphire devices
  27. Cancer Diagnostics
  28. Large platelet size is associated with poor outcome in patients with metastatic pancreatic cancer
  29. Cardiovascular Diseases
  30. Sample matrix and high-sensitivity cardiac troponin I assays
  31. Preoperative proteinuria and clinical outcomes in type B aortic dissection after thoracic endovascular aortic repair
  32. Infectious Diseases
  33. The rational specimen for the quantitative detection of Epstein-Barr virus DNA load
  34. Letters to the Editor
  35. Letter to the Editor on article Dimech W, Karakaltsas M, Vincini G. Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing. Clin Chem Lab Med 2018;56:1970–8
  36. Counterpoint to the Letter to the Editor by Badrick and Parvin in regard to Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing
  37. Is creatine kinase an ideal biomarker in rhabdomyolysis? Reply to Lippi et al.: Diagnostic biomarkers of muscle injury and exertional rhabdomyolysis (https://doi.org/10.1515/cclm-2018-0656)
  38. Blood neuron cell-derived microparticles as potential biomarkers in Alzheimer’s disease
  39. A fast, nondestructive, low-cost method for the determination of hematocrit of dried blood spots using image analysis
  40. Association of fibroblast growth factor 21 plasma levels with neonatal sepsis: preliminary results
  41. Impact of continuous renal replacement therapy (CRRT) and other extracorporeal support techniques on procalcitonin guided antibiotic therapy in critically ill patients with septic shock
  42. Determining the cutoff value of the APTT mixing test for factor VIII inhibitor
  43. Determining the cut-off value of the APTT mixing test for factor VIII inhibitor: reply
  44. Euthyroid Graves’ disease with spurious hyperthyroidism: a diagnostic challenge
  45. A pilot plasma-ctDNA ring trial for the Cobas® EGFR Mutation Test in clinical diagnostic laboratories
  46. MS-based proteomics: a metrological sound and robust alternative for apolipoprotein E phenotyping in a multiplexed test
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