Expert consensus regarding standardization of sample preparation for clotting time assays

Ieko, Masahiro; Komiyama, Yutaka; Yamazaki, Satoshi; Katagiri, Hisako; Shimazu, Chisato; Naito, Sumiyoshi; Matsuda, Masato; Yuki, Yoichi; Miyata, Kazuyoshi; Arai, Rika; Kumano, Osamu; Emmi, Mari; Yoshida, Tsutomu; Tanaka, Hideaki; Okuhara, Toshihiko; Yamashita, Tetsuji; Sekine, Yasuji; Homma, M; Kawai, Yohko; Tohyama, Kaoru

doi:10.1007/s12185-020-02983-x

Cited by 5 publications

(3 citation statements)

References 7 publications

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“…The plasma samples were measured at Health Sciences University of Hokkaido or at the institution that collected the samples, if available. When the measurements were performed in Health Sciences University of Hokkaido, the frozen samples were transported there according to the expert consensus for the sample preparation 15 …”

Section: Methodsmentioning

confidence: 99%

“…When the measurements were performed in Health Sciences University of Hokkaido, the frozen samples were transported there according to the expert consensus for the sample preparation. 15 We used following PT reagents for the assessment of the reactivity of PT assay responding to direct FXa inhibitors: (1) mdPT reagent, which was developed based on the clotting time principle with the dPT method in Sysmex Corporation (Kobe, Japan) 11,14 Two types of basic evaluations were performed. First, for the within-run precision and the between-day precision, the standard deviation (SD) and coefficient of variation % (CV%) were calculated.…”

Section: Data Sampling Pt Assays and The Reagents And Measurement Of ...mentioning

confidence: 99%

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Evaluation of newly‐developed modified diluted prothrombin time reagent in non‐valvular atrial fibrillation patients with direct oral anticoagulants: A comparative study with conventional reagents

Kumano

Suzuki

Yamazaki

et al. 2022

Int J Lab Hematology

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Introduction A single assay to assess the effect of the direct FXa inhibitor is needed clinically because prothrombin (PT) assay is not yet sensitive enough for accurate evaluation. We developed modified diluted prothrombin time (mdPT) assay showing a high reactivity to direct FXa inhibitors based on prothrombin time (PT) reagent. The purpose of this study was to evaluate the reactivity of mdPT to direct FXa inhibitors comparing to that of commercial PT reagents and diluted prothrombin time (dPT). Methods The correlation and slopes of mdPT against the drug concentrations by anti‐Xa assay were compared to those of the four commercial reagents of PT or dPT in 275, 257, and 243 clinical samples collected from non‐valvular atrial fibrillation (NVAF) patients who are prescribed apixaban, edoxaban or rivaroxaban for stroke prevention, respectively. Results The correlation coefficient (95% confidence interval) of mdPT against apixaban, edoxaban, and rivaroxaban was 0.818 (0.775–0.854), 0.914 (0.892–0.932), and 0.814 (0.766–0.852), respectively. The slope (95% confidence interval) of mdPT for apixaban, edoxaban, and rivaroxaban was 0.0068 (0.0063–0.0075), 0.0076 (0.0072–0.0080), and 0.0072 (0.0065–0.0078), respectively, which were higher than that of four commercial PT and dPT reagents, ranging within 0.0006–0.0023, 0.0017–0.0038, and 0.0016–0.0057 (all, p < 0.001), respectively. Conclusion Compared with other PT and dPT reagents, mdPT reagent showed sharper slope to all direct FXa inhibitors, and higher correlation to apixaban and comparable correlation to edoxaban and rivaroxaban. This new reagent is expected to be a coagulation screening assay having a consistently high response to any types of direct FXa inhibitors.

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Section: Methodsmentioning

confidence: 99%

Section: Data Sampling Pt Assays and The Reagents And Measurement Of ...mentioning

confidence: 99%

Evaluation of newly‐developed modified diluted prothrombin time reagent in non‐valvular atrial fibrillation patients with direct oral anticoagulants: A comparative study with conventional reagents

Kumano

Suzuki

Yamazaki

et al. 2022

Int J Lab Hematology

Self Cite

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“…The conditions for blood collection in this study were in accordance with recommendations for sample preparation for clotting time of the Japanese Society of Laboratory Haematology, 12 which were based on the Clinical and Laboratory Standards Institute H21-A5. 13 Residual blood samples from routine laboratory examinations will be used at the first visit, 7±1 days later and possibly at the time of discharge from patients with AIS or TIA.…”

Section: Measurement Of C-type Lectin-like Receptormentioning

confidence: 99%

Soluble C-type lectin-like receptor 2 in stroke (CLECSTRO) study: protocol of a multicentre, prospective cohort of a novel platelet activation marker in acute ischaemic stroke and transient ischaemic attack

Uchiyama,

Suzuki-Inoue,

Wada

et al. 2023

BMJ Open

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IntroductionSoluble C-type lectin-like receptor 2 (sCLEC-2) is a new biomarker for platelet activation, which can be easily measured by usual blood collection. We conducted the CLECSTRO, a prospective, observational cohort study, to evaluate the clinical implications of sCLEC-2 in patients with acute ischaemic stroke (AIS) and transient ischaemic attack (TIA).Methods and analysisThe participants are patients with AIS/TIA and control patients required for differentiation from AIS/TIA. The target population is 600, including the patients and controls, who would be recruited from eight stroke centres across Japan. The inclusion criteria are AIS within 24 hours of onset and a modified Rankin Scale (mRS) score of 0–2, TIA within 7 days of onset, and contemporary patients required for differentiation from AIS/TIA. Plasma sCLEC-2 will be measured by high-sensitive chemiluminescent enzyme immunoassay using residual blood samples from routine laboratory examinations at the first visit in all patients and 7 days later or at discharge in patients with AIS/TIA. The outcomes include plasma levels of sCLEC-2 in patients with AIS/TIA and controls, sCLEC-2/D-dimer ratio in non-cardioembolic and cardioembolic AIS/TIA, correlation of sCLEC-2 with recurrence or worsening of stroke, severity of stroke, infarct size, ABCD2score in TIA and outcome (mRS) at 7 days and 3 months.Ethics and disseminationThis study was approved by the Ethical Committee of the University of Yamanashi as the central ethical committee in agreement with the ethical committees of all collaborative stroke centres. Informed consent will be obtained by an opt-out form from the patients at each stroke centre according to the Ethical Guidelines for Medical and Biological Research Involving Human Subjects by the Japanese Ministry of Health, Labour and Welfare.Trial registration numbersNCT05579405, UMIN000048954

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Measurement of coagulation factor antibody levels is useful for diagnosis and determining therapeutic efficacy in hemorrhagic patients with autoantibodies to coagulation factor VIII and factor V: results from a single center in Japan

et al. 2021

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Expert consensus regarding standardization of sample preparation for clotting time assays

Cited by 5 publications

References 7 publications

Evaluation of newly‐developed modified diluted prothrombin time reagent in non‐valvular atrial fibrillation patients with direct oral anticoagulants: A comparative study with conventional reagents

Evaluation of newly‐developed modified diluted prothrombin time reagent in non‐valvular atrial fibrillation patients with direct oral anticoagulants: A comparative study with conventional reagents

Soluble C-type lectin-like receptor 2 in stroke (CLECSTRO) study: protocol of a multicentre, prospective cohort of a novel platelet activation marker in acute ischaemic stroke and transient ischaemic attack

Measurement of coagulation factor antibody levels is useful for diagnosis and determining therapeutic efficacy in hemorrhagic patients with autoantibodies to coagulation factor VIII and factor V: results from a single center in Japan

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