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High incidence of discrepancies in new Siemens assay - A comparison of cardiac troponin I assays

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Hasselbalch, Rasmus Bo ; Kristensen, Jonas Henrik ; Jørgensen, Nicoline ; Strandkjær, Nina ; Alaour, Bashir ; Afzal, Shoaib ; Marber, Michael ; Bundgaard, Henning ; Iversen, Kasper Karmark. / High incidence of discrepancies in new Siemens assay - A comparison of cardiac troponin I assays. I: Clinical Chemistry and Laboratory Medicine. 2022 ; Bind 60, Nr. 6. s. 921-929.

Bibtex

@article{cb349119ab39466db0c7bbbc6c06048f,
title = "High incidence of discrepancies in new Siemens assay - A comparison of cardiac troponin I assays",
abstract = "OBJECTIVES: Cardiac troponin (cTn) is the biochemical gold standard for diagnosing myocardial infarction (MI). We compared the Siemens ADVIA Centaur High-Sensitivity (hs-cTnI) assay with the Siemens Ultra assay (cTnI-U).METHODS: Over 3 months cTnI-U and hs-cTnI were measured simultaneously at Herlev-Gentofte Hospital. Acute myocardial injury was diagnosed using the 4th universal definition. Disputed cases were adjudicated using clinical data. We compared diagnostic accuracy using area under the curve (AUC) of the receiver operating characteristic. Outliers in between-assay differences were defined as a factor-5 difference and ≥1 measurement >40 ng/L. Patients with outlier differences were invited for re-sampling and tested with serial dilution and heterophilic blocking tubes.RESULTS: From the 18th January to the 20th April 2019, 4,369 samples on 2,658 patients were included. cTnI-U measured higher concentrations than hs-cTnI (mean 23%, -52-213%), resulting in a higher frequency of acute myocardial injury, 255 (9.6%) vs. 203 (7.6%), p<0.001. This remained significant after adjudication, 212 vs 197, p<0.001. AUC for the prediction of MI for was 0.963 for cTnI-U and 0.959 for hs-cTnI, p=0.001. Outlier differences were seen in 35 (1.2%) patients, primarily with elevated hs-cTnI (n=33, 94%). On two re-samplings (median 144 and 297 days since inclusion), 16 of 20 (80%) and 11 of 11 had sustained elevation of hs-cTnI. The samples showed no signs of heterophilic antibodies.CONCLUSIONS: Using hs-cTnI resulted in a subset of patients with large, discrepant elevations in concentration. These patients still had elevated hs-cTnI 6-10 months post admission but no heterophilic antibodies.",
keywords = "acute coronary syndrome, bbiomarkers, cardiovascular disease, troponin",
author = "Hasselbalch, {Rasmus Bo} and Kristensen, {Jonas Henrik} and Nicoline J{\o}rgensen and Nina Strandkj{\ae}r and Bashir Alaour and Shoaib Afzal and Michael Marber and Henning Bundgaard and Iversen, {Kasper Karmark}",
note = "{\textcopyright} 2022 Walter de Gruyter GmbH, Berlin/Boston.",
year = "2022",
month = may,
day = "25",
doi = "10.1515/cclm-2022-0034",
language = "English",
volume = "60",
pages = "921--929",
journal = "Clinical Chemistry and Laboratory Medicine",
issn = "1434-6621",
publisher = "Walter/de Gruyter GmbH & Co. KG",
number = "6",

}

RIS

TY - JOUR

T1 - High incidence of discrepancies in new Siemens assay - A comparison of cardiac troponin I assays

AU - Hasselbalch, Rasmus Bo

AU - Kristensen, Jonas Henrik

AU - Jørgensen, Nicoline

AU - Strandkjær, Nina

AU - Alaour, Bashir

AU - Afzal, Shoaib

AU - Marber, Michael

AU - Bundgaard, Henning

AU - Iversen, Kasper Karmark

N1 - © 2022 Walter de Gruyter GmbH, Berlin/Boston.

PY - 2022/5/25

Y1 - 2022/5/25

N2 - OBJECTIVES: Cardiac troponin (cTn) is the biochemical gold standard for diagnosing myocardial infarction (MI). We compared the Siemens ADVIA Centaur High-Sensitivity (hs-cTnI) assay with the Siemens Ultra assay (cTnI-U).METHODS: Over 3 months cTnI-U and hs-cTnI were measured simultaneously at Herlev-Gentofte Hospital. Acute myocardial injury was diagnosed using the 4th universal definition. Disputed cases were adjudicated using clinical data. We compared diagnostic accuracy using area under the curve (AUC) of the receiver operating characteristic. Outliers in between-assay differences were defined as a factor-5 difference and ≥1 measurement >40 ng/L. Patients with outlier differences were invited for re-sampling and tested with serial dilution and heterophilic blocking tubes.RESULTS: From the 18th January to the 20th April 2019, 4,369 samples on 2,658 patients were included. cTnI-U measured higher concentrations than hs-cTnI (mean 23%, -52-213%), resulting in a higher frequency of acute myocardial injury, 255 (9.6%) vs. 203 (7.6%), p<0.001. This remained significant after adjudication, 212 vs 197, p<0.001. AUC for the prediction of MI for was 0.963 for cTnI-U and 0.959 for hs-cTnI, p=0.001. Outlier differences were seen in 35 (1.2%) patients, primarily with elevated hs-cTnI (n=33, 94%). On two re-samplings (median 144 and 297 days since inclusion), 16 of 20 (80%) and 11 of 11 had sustained elevation of hs-cTnI. The samples showed no signs of heterophilic antibodies.CONCLUSIONS: Using hs-cTnI resulted in a subset of patients with large, discrepant elevations in concentration. These patients still had elevated hs-cTnI 6-10 months post admission but no heterophilic antibodies.

AB - OBJECTIVES: Cardiac troponin (cTn) is the biochemical gold standard for diagnosing myocardial infarction (MI). We compared the Siemens ADVIA Centaur High-Sensitivity (hs-cTnI) assay with the Siemens Ultra assay (cTnI-U).METHODS: Over 3 months cTnI-U and hs-cTnI were measured simultaneously at Herlev-Gentofte Hospital. Acute myocardial injury was diagnosed using the 4th universal definition. Disputed cases were adjudicated using clinical data. We compared diagnostic accuracy using area under the curve (AUC) of the receiver operating characteristic. Outliers in between-assay differences were defined as a factor-5 difference and ≥1 measurement >40 ng/L. Patients with outlier differences were invited for re-sampling and tested with serial dilution and heterophilic blocking tubes.RESULTS: From the 18th January to the 20th April 2019, 4,369 samples on 2,658 patients were included. cTnI-U measured higher concentrations than hs-cTnI (mean 23%, -52-213%), resulting in a higher frequency of acute myocardial injury, 255 (9.6%) vs. 203 (7.6%), p<0.001. This remained significant after adjudication, 212 vs 197, p<0.001. AUC for the prediction of MI for was 0.963 for cTnI-U and 0.959 for hs-cTnI, p=0.001. Outlier differences were seen in 35 (1.2%) patients, primarily with elevated hs-cTnI (n=33, 94%). On two re-samplings (median 144 and 297 days since inclusion), 16 of 20 (80%) and 11 of 11 had sustained elevation of hs-cTnI. The samples showed no signs of heterophilic antibodies.CONCLUSIONS: Using hs-cTnI resulted in a subset of patients with large, discrepant elevations in concentration. These patients still had elevated hs-cTnI 6-10 months post admission but no heterophilic antibodies.

KW - acute coronary syndrome

KW - bbiomarkers

KW - cardiovascular disease

KW - troponin

UR - http://www.scopus.com/inward/record.url?scp=85129074415&partnerID=8YFLogxK

U2 - 10.1515/cclm-2022-0034

DO - 10.1515/cclm-2022-0034

M3 - Journal article

C2 - 35411761

VL - 60

SP - 921

EP - 929

JO - Clinical Chemistry and Laboratory Medicine

JF - Clinical Chemistry and Laboratory Medicine

SN - 1434-6621

IS - 6

ER -

ID: 77626144