全自動血液凝固分析装置コアプレスタ2000の導入および24時間緊急検査対応の検討
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1 Basic examination of an automated coagulation analyzer, Coapresta 2000, and introduction to 24-hour emergency service Yuji Oikawa, Nobuaki Matsumoto, Yukiko Seki and Makoto Suzuki Recently, in addition to accuracy and reliability, clinical laboratories have also been under pressure to produce results with speed around the clock, A novel automated coagulation analyzer, Coapresta 2000 (CP2000: Sekisui Medical Co., Ltd.), has enabled them to meet those requirements. In order to start a 24-hour emergency service of coagulation and fibrinolysis tests, we conducted a basic examination of the following tests: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, hepaplastin, antithrombin (AT ), fibrin degradation products (FDP), D-dimer and soluble fibrin monomer complex (SFMC) with the CP2000. In the CP2000, these test items were investigated for within-run and between-day reproducibility, and the linearity of test results. The coefficient of variation of within-run assays was less than 3.0% while that of between-day was less than 4.7% in each test item. The linear response ranges were 0 to 750 mg/dl in fibrinogen, 0 to 13 g/ml in FDP, 0.3 to 120 g/ml in D-dimer, and 17 to 100 g/ml in SFMC. A comparison study was conducted between the evaluation method (Coapresta 2000) and the present method (Coagrex-800, Sysmex Corporation). Except for APTT, significant correlations were observed in all test items (correlation coefficients were all higher than 0.993, p<0.001). We concluded that Coapresta 2000 was able to provide 24-hour emergency service in coagulation and fibrinolysis tests. Coapresta 2000, Coagulation and fibrinolysis tests, Soluble fibrin monomer complex (SFMC), 24-hour emergency service
2 生 物 試 料 分 析 チパネルによる入力方式 操作ナビゲーション 検査の測定ができず これら検査の24時間体制 機能の搭載などユーザーフレンドリーな操作簡 はCR800の故障時を考えると実施が不可能であ 易性にあり 試薬 キャリブレーター コント った そこで 我々は PT APTTに加え 凝 ロールのバーコード管理機能が搭載されるなど 固因子としてフィブリノゲンとヘパプラスチン 入力時のヒューマンエラーを徹底して排除した ビタミンK依存性凝固因子 抗凝固因子とし 自動分析装置である Fig. 1 てアンチトロンビンⅢ ATⅢ さらに 線溶 東邦大学医療センター大橋病院は循環器内科 検査としてフィブリン分解産物 FDP Dダイ 心臓血管外科 脳神経外科 整形外科 外科 マー さらに 新しい凝血学的分子マーカーと 糖尿病 代謝内科 産科などの診療科を擁する して可溶性フィブリンモノマー複合体 soluble 地域中核の総合病院である また 第二次救急 fibrin monomer complex SFMC の検査を夜間 医療機関として24時間体制の救急医療を実施し 緊急項目に加え24時間体制で実施するべく ている 臨床検査部も休日 平日および夜間に CP2000を２台導入して完全バックアップ体制を おける緊急検査業務に対応している 血液検査 確立した 導入時におけるCR800との比較検討 凝固検査 プロトロンビン時間と活性化部分ト の成績を報告する ロンボプラスチン時間 生化学的検査 免疫 学的検査および微生物学的検査を実施している Ⅱ. 方法 が 本院の診療科の特色から潜在的血栓準備病 態にある症例への対応が求められている 1. 試料 本検査部が保有する分析装置はシスメックス 検査終了後の検体 クエン酸Na加患者血漿 株式会社のコアグレックス800 Coagrex 試料について CP2000 導入評価法 と CR800 現行法 を用いて凝固線溶検査成績 以下 CR800 2, 3)とコアグレックス700の２台で PT APTT フィブリノゲン ヘパプラスチ あり どちらの装置も凝固時間法を原理とする ン ATⅢ FDP Dダイマー SFMC の比較 プロトロンビン時間 PT と活性化部分トロン 検討を行った 本研究は大橋病院倫理委員会指 ボプラスチン時間 APTT 検査の24時間測定 針 個人情報の連結不可能 匿名化 に従い実 バックアップ体制の確立 が可能であった 施した 認証番号 しかし コアグレックス700は合成基質法やラテ ックス比濁法を原理とする抗凝固因子や線溶系 Fig. 1 Foto of Coapresta
3 Assays (Reagents) PT (Coagpia PT-N) APTT (Coagpia APTT-N) Fibrinogen (Coagpia Fbg) Hepaplastin (Complex factor H [Kokusai]) AT III (Testzym S ATIII ) D dimer (Nanopia D-dimer) FDP (Nanopia P-FDP) SFMC (Nanopia SF) Control materials FDP Control LOW FDP Control HIGH FDP Control LOW FDP Control HIGH SF Control LOW SF Control HIGH Within-run (10 times) % (0.9%) INR (0.9%) % (1.4%) INR (1.2%) sec (0.9%) sec (0.8%) mg/dl (2.2%) mg/dl (3.0%) % (0.8%) % (1.2%) % (2.0%) % (2.2%) g/ml (1.3%) g/ml (0.9%) g/ml (1.9%) g/ml (0.6%) g/ml (2.6%) g/ml (2.2%) Between-day (10 days) % (1.9%) INR (0.9%) % (3.9%) INR (2.5%) sec (0.9%) sec (0.5%) mg/dl (2.9%) mg/dl (2.8%) % (4.7%) % (2.8%) % (3.0%) % (2.0%) g/ml (3.7%) g/ml (2.3%) g/ml (1.4%) g/ml (1.4%) g/ml (4.0%) g/ml (3.7%) All values are mean SD (CV). Assays (Reagents) PT (Coagpia PT-N) APTT (Coagpia APTT-N) Fibrinogen (Coagpia Fbg) Hepaplastin (Complex factor H [Kokusai]) AT III (Testzym S ATIII ) D dimer (Nanopia D-dimer) FDP (Nanopia P-FDP) SFMC (Nanopia SF) Control materials (%) (INR) (%) (INR) (sec) (sec) (mg/dl) (mg/dl) (%) (%) (%) (%) FDP Control LOW ( g/ml) FDP Control HIGH ( g/ml) FDP Control LOW ( g/ml) FDP Control HIGH ( g/ml) SF Control LOW ( g/ml) SF Control HIGH ( g/ml) Time (hour) after calibration Calibration stability was assessed by measuring control materials at 6-hour intervals on Coapresta 2000 without recalibration.
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5 Date Patients SFMC ( g/ml) 12/29 Orthopedics (inpatient) /30 Orthopedics (inpatient) /30 Orthopedics (inpatient) /01 Orthopedics (inpatient) /02 Orthopedics (inpatient) /02 Pediatrics (outpatient) /03 Pediatrics (outpatient) 10.2 Reference value for SFMC is less than 7.0 g/ml in our hospital.
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A. 測定項目コード番号 凝固コード表 2011 年 12 月改訂 項目コード 分類 項目名 単位 2B030 0 プロトロンビン時間 秒 PT-Sec 2B030 1 プロトロンビン時間 % PT-% 2B030 2 プロトロンビン時間 INR PT-INR 2B020 0 活性トロンボプラスチン時間 秒 APTT 2B100 0 フィブリノゲン mg/dl FIB 2B100 1 フィブリノゲン
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