Measurement of dabigatran

previously demonstrated Hemoclot® Thrombin Inhibitor assay reagent instability on Sysmex CS-2100i is no longer an issue

Willemijn J Comuth, Louise Faaborg, Linda Ø Henriksen, Anna-Marie B Münster

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

The Hemoclot® Thrombin Inhibitor (HTI) assay has been recommended for measurement of dabigatran concentrations in specific clinical situations. Traditionally, reagents for biochemical assays are prepared from instructions found in the package insert. For the HTI reagents the manufacturer recommends incubating the reagents much longer than indicated in the package insert. These recommendations are added to the application sheets designed for different analyzers. Many clinicians and laboratory personnel may be unaware of the discrepancy between the two instructions, resulting in incorrect handling of the reagents. The aim of this study was to investigate the effect of the two different preparation methods on reagent stability and test results. For the standard concentration range, reagent stability on Sysmex CS-2100i was only two hours instead of the eight hours indicated by the producer when following package insert instructions (incubation time: 15 min). Stability was increased to five hours when following the application sheet (incubation time: 60 min). Two years later, the study was repeated using samples of patients treated with dabigatran etexilate. This time, reagent stability was at least six hours. Since the reagent composition was unchanged, the increased stability could be due to changed logistics by the supplier, with stock and transfer closer by. Previously demonstrated HTI reagent instability is no longer an issue at our laboratory. The reliability of results of clinical studies in which the assay has been used is potentially compromised.

OriginalsprogEngelsk
TidsskriftScandinavian Journal of Clinical & Laboratory Investigation
Vol/bind78
Udgave nummer1-2
Sider (fra-til)149-152
ISSN0036-5513
DOI
StatusUdgivet - 2018

Fingeraftryk

Product Labeling
Dabigatran
Reproducibility of Results

Citer dette

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title = "Measurement of dabigatran: previously demonstrated Hemoclot{\circledR} Thrombin Inhibitor assay reagent instability on Sysmex CS-2100i is no longer an issue",
abstract = "The Hemoclot{\circledR} Thrombin Inhibitor (HTI) assay has been recommended for measurement of dabigatran concentrations in specific clinical situations. Traditionally, reagents for biochemical assays are prepared from instructions found in the package insert. For the HTI reagents the manufacturer recommends incubating the reagents much longer than indicated in the package insert. These recommendations are added to the application sheets designed for different analyzers. Many clinicians and laboratory personnel may be unaware of the discrepancy between the two instructions, resulting in incorrect handling of the reagents. The aim of this study was to investigate the effect of the two different preparation methods on reagent stability and test results. For the standard concentration range, reagent stability on Sysmex CS-2100i was only two hours instead of the eight hours indicated by the producer when following package insert instructions (incubation time: 15 min). Stability was increased to five hours when following the application sheet (incubation time: 60 min). Two years later, the study was repeated using samples of patients treated with dabigatran etexilate. This time, reagent stability was at least six hours. Since the reagent composition was unchanged, the increased stability could be due to changed logistics by the supplier, with stock and transfer closer by. Previously demonstrated HTI reagent instability is no longer an issue at our laboratory. The reliability of results of clinical studies in which the assay has been used is potentially compromised.",
keywords = "Journal Article, antidotes, atrial fibrillation, hematologic tests, anticoagulants, laboratories, Dabigatran, thrombin time, Dabigatran/analysis, Humans, Antithrombins/analysis, Indicators and Reagents, Blood Coagulation Tests/instrumentation",
author = "Comuth, {Willemijn J} and Louise Faaborg and Henriksen, {Linda {\O}} and M{\"u}nster, {Anna-Marie B}",
year = "2018",
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journal = "Scandinavian Journal of Clinical & Laboratory Investigation",
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publisher = "Taylor & Francis",
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Measurement of dabigatran : previously demonstrated Hemoclot® Thrombin Inhibitor assay reagent instability on Sysmex CS-2100i is no longer an issue. / Comuth, Willemijn J; Faaborg, Louise; Henriksen, Linda Ø; Münster, Anna-Marie B.

I: Scandinavian Journal of Clinical & Laboratory Investigation, Bind 78, Nr. 1-2, 2018, s. 149-152.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Measurement of dabigatran

T2 - previously demonstrated Hemoclot® Thrombin Inhibitor assay reagent instability on Sysmex CS-2100i is no longer an issue

AU - Comuth, Willemijn J

AU - Faaborg, Louise

AU - Henriksen, Linda Ø

AU - Münster, Anna-Marie B

PY - 2018

Y1 - 2018

N2 - The Hemoclot® Thrombin Inhibitor (HTI) assay has been recommended for measurement of dabigatran concentrations in specific clinical situations. Traditionally, reagents for biochemical assays are prepared from instructions found in the package insert. For the HTI reagents the manufacturer recommends incubating the reagents much longer than indicated in the package insert. These recommendations are added to the application sheets designed for different analyzers. Many clinicians and laboratory personnel may be unaware of the discrepancy between the two instructions, resulting in incorrect handling of the reagents. The aim of this study was to investigate the effect of the two different preparation methods on reagent stability and test results. For the standard concentration range, reagent stability on Sysmex CS-2100i was only two hours instead of the eight hours indicated by the producer when following package insert instructions (incubation time: 15 min). Stability was increased to five hours when following the application sheet (incubation time: 60 min). Two years later, the study was repeated using samples of patients treated with dabigatran etexilate. This time, reagent stability was at least six hours. Since the reagent composition was unchanged, the increased stability could be due to changed logistics by the supplier, with stock and transfer closer by. Previously demonstrated HTI reagent instability is no longer an issue at our laboratory. The reliability of results of clinical studies in which the assay has been used is potentially compromised.

AB - The Hemoclot® Thrombin Inhibitor (HTI) assay has been recommended for measurement of dabigatran concentrations in specific clinical situations. Traditionally, reagents for biochemical assays are prepared from instructions found in the package insert. For the HTI reagents the manufacturer recommends incubating the reagents much longer than indicated in the package insert. These recommendations are added to the application sheets designed for different analyzers. Many clinicians and laboratory personnel may be unaware of the discrepancy between the two instructions, resulting in incorrect handling of the reagents. The aim of this study was to investigate the effect of the two different preparation methods on reagent stability and test results. For the standard concentration range, reagent stability on Sysmex CS-2100i was only two hours instead of the eight hours indicated by the producer when following package insert instructions (incubation time: 15 min). Stability was increased to five hours when following the application sheet (incubation time: 60 min). Two years later, the study was repeated using samples of patients treated with dabigatran etexilate. This time, reagent stability was at least six hours. Since the reagent composition was unchanged, the increased stability could be due to changed logistics by the supplier, with stock and transfer closer by. Previously demonstrated HTI reagent instability is no longer an issue at our laboratory. The reliability of results of clinical studies in which the assay has been used is potentially compromised.

KW - Journal Article

KW - antidotes

KW - atrial fibrillation

KW - hematologic tests

KW - anticoagulants

KW - laboratories

KW - Dabigatran

KW - thrombin time

KW - Dabigatran/analysis

KW - Humans

KW - Antithrombins/analysis

KW - Indicators and Reagents

KW - Blood Coagulation Tests/instrumentation

U2 - 10.1080/00365513.2017.1403037

DO - 10.1080/00365513.2017.1403037

M3 - Journal article

VL - 78

SP - 149

EP - 152

JO - Scandinavian Journal of Clinical & Laboratory Investigation

JF - Scandinavian Journal of Clinical & Laboratory Investigation

SN - 0036-5513

IS - 1-2

ER -