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GUIDELINE

Expert consensus regarding standardization of sample preparation for clotting time assays Masahiro Ieko1   · Yutaka Komiyama2 · Satoshi Yamazaki3 · Hisako Katagiri4 · Chisato Shimazu5 · Sumiyoshi Naito6 · Masato Matsuda7 · Yoichi Yuki8 · Kazuyoshi Miyata9 · Rika Arai10 · Osamu Kumano11 · Mari Emmi12 · Tatsuya Yoshida13 · Hideaki Tanaka14 · Toshihiko Okuhara15 · Tetsuji Yamashita16 · Yasuji Sekine17 · Masaru Homma18 · Yohko Kawai19 · Kaoru Tohyama20 · The working group for standardization of sample preparation for clotting time assays, Japanese society for laboratory hematology. · Masahiro Ieko · Yutaka Komiyama · Satoshi Yamazaki · Hisako Katagiri · Chisato Shimazu · Sumiyoshi Naito · Masato Matsuda · Yoichi Yuki · Kazuyoshi Miyata · Rika Arai · Osamu Kumano · Mari Emmi · Tatsuya Yoshida · Hideaki Tanaka · Toshihiko Okuhara · Tetsuji Yamashita · Yasuji Sekine · Masaru Homma · Yohko Kawai · Kaoru Tohyama Received: 9 March 2020 / Revised: 31 July 2020 / Accepted: 25 August 2020 / Published online: 14 September 2020 © Japanese Society of Hematology 2020

Abstract Accurate clotting time assay results are vital, as the test is employed to indicate the amount of oral anticoagulant to be pre‑ scribed, while it is also used for screening the hemorrhagic and thrombotic diseases. The procedure chosen for preparation of a patient blood sample including centrifugation can contribute to significant differences in the results obtained. Thus, for the purpose of proposing a standardized method to appropriately prepare blood samples prior to assay, the Japanese Society of Laboratory Hematology organized the Working Group for Standardization of Sample Preparation for Clotting Time Assays (WG). Following reviews of previously announced guidelines and original experimental results, consensus was obtained by the WG, with the main findings as follows. (1) The recommended anticoagulant in the blood collection tube is sodium citrate solution at 0.105–0.109 M (3.13–3.2%). (2) Whole blood samples should be stored at room temperature (18–25 ˚C) within 1 h of collection from the patient. (3) For plasma preparation, centrifugation at 1500 × g should be performed for at least 15 min or at 2000 × g for at least 10 min at room temperature. (4) After the plasma sample is prepared, it should be stored at room temperature and assayed within 4 h. Keywords  Clotting time assay · Plasma sample · Centrifugation condition · Sample store condition

Introduction In a clotting time test, a blood coagulation reaction is caused by adding various reagents to a plasma sample prepared from whole blood added to sodium citrate as an anticoagu‑ lant, with the time until fibrin precipitation then determined. Such a test is frequently used as screening for bleeding and thrombotic diseases, as well as monitoring anticoagula‑ tion therapy, and occasionally considered useful to provide The working group for standardization of sample preparation for clotting time assays, Japanese society for laboratory hematology. * Masahiro Ieko iekom@hoku‑iryo‑u.ac.jp Extended