臨床實驗室標本溶血檢測與應用

專家共識（征求意見稿）

標本溶血是臨床實驗室（簡稱實驗室）最常見的誤差來源，是標本拒收的主要原因[1-2]。因標本溶血發(fā)出錯誤結果報告可能造成誤診誤治，重新抽血給患者增加痛苦、報告周期延長，復測造成人力、物力、經(jīng)濟損失[3-5]。

目前國際上已有標本溶血相關檢測與應用標準、共識發(fā)布[6-8]。由于經(jīng)濟水平、文化習慣上的差異，國際相關標準、指南難以符合各國的實際需求，有必要制定適合國情的標本溶血檢測與臨床應用專家共識，以指導相關檢驗及臨床實踐[9-11]。中國醫(yī)師協(xié)會檢驗醫(yī)師分會中醫(yī)檢驗醫(yī)學專委會、中華中醫(yī)藥學會檢驗醫(yī)學分會、北京中醫(yī)藥學會中醫(yī)檢驗專委會組織專家討論，制定《臨床實驗室標本溶血檢測與臨床應用專家共識》，主要基于目前血清(或血漿)標本溶血檢測與臨床應用的相關研究文獻及我國實際，以滿足臨床需求為導向，對現(xiàn)有資料不足、爭議較大問題采用專家共識的方法解決。本共識的主要目的是利用現(xiàn)有的循證醫(yī)學依據(jù)，為規(guī)范臨床實驗室標本溶血檢測及臨床應用提供指導和幫助。隨著技術發(fā)展、認識深化，本共識將持續(xù)更新，以滿足檢驗及臨床實踐需求。

1.1標本溶血干擾檢驗結果

標本溶血紅細胞破壞，由于細胞內(nèi)容物釋放、光學干擾、與試劑成分發(fā)生化學反應等機制對檢驗結果產(chǎn)生干擾，可導致檢驗結果假性升高或降低，對臨床診療產(chǎn)生不良影響[12-13]。

1.2標本溶血干擾閾值

標本溶血干擾閾值是指溶血造成檢驗結果顯著改變，超出允許偏差的血清（或血漿）血紅蛋白濃度值（常以溶血指數(shù)表示）。標本溶血干擾閾值因檢驗項目及檢測系統(tǒng)、方法而異，制造商推薦的標本溶血干擾閾值的檢驗結果改變允許偏差通常為10%[14-16]。

2.1目測法

2.1.1目測法觀察標本溶血程度簡單易行，當儀器法溶血指數(shù)不可用時，可利用標本溶血比色卡目測溶血程度，實驗室應對使用標本溶血比色卡的人員進行培訓、能力評估[6-8，17]。

2.1.2實驗室應評估所選用標本溶血比色卡適用于所用檢測系統(tǒng)，標本溶血比色卡溶血程度分級應與所用檢測系統(tǒng)溶血指數(shù)對應[7-8,18]。示例見附圖1-4。

▲附圖1  溶血比色卡示例1

▲附圖2  溶血比色卡示例2

▲附圖3  溶血比色卡示例3

▲附圖4  溶血比色卡示例4

2.2儀器法

2.2.1儀器法檢測標本溶血，常用測定標本血紅蛋白特定波長吸光度值法檢測血紅蛋白濃度，結果以溶血指數(shù)表示，檢測準確、快速，可避免目測法個體差異大，結果準確性差、重復性差缺陷[19-20]。實驗室應首選儀器法檢測標本溶血指數(shù)[21-22]。

2.2.2實驗室應開展儀器法檢測標本溶血指數(shù)的性能驗證、校準、室內(nèi)質(zhì)控，參加實驗室間比對計劃[23-26]。

2.2.3儀器法檢測標本溶血程度不影響檢驗項目報告周期、檢驗工作效率，不增加實驗室成本[27-28]。

3.1實驗室應建立所開展檢驗項目的標本溶血干擾說明，包括標本溶血干擾閾值及溶血干擾檢驗結果改變?nèi)缟?、降低或無顯著改變等方向趨勢信息[6,29-31]。

3.2檢驗項目標本溶血干擾說明信息可通過制造商、學術組織、實驗室內(nèi)部研究等獲得,實驗室應評估其適用性[28-29,32-34]。示例見附表1。

▼附表1  檢驗項目溶血干擾信息表示例

3.3檢驗項目標本溶血干擾信息因檢驗方法、檢驗系統(tǒng)而異，實驗室應評估所選用標本溶血干擾信息的適用性[35-36]。

3.4實驗室發(fā)布標本溶血檢驗報告前，應結合實測標本溶血指數(shù)、溶血干擾閾值及必要的臨床信息審核,標本溶血指數(shù)低于檢驗項目溶血干擾閾值，實驗室應報告檢驗結果，不應拒收標本[37-38]。

3.5標本溶血指數(shù)高于溶血干擾閾值的檢驗項目：實驗室應建議重新采集標本送檢；可報告結果并應標注標本溶血，干擾說明信息明確的應備注溶血干擾檢驗結果的解釋性注釋，及時與臨床作必要聯(lián)系溝通[39-40]。示例見附圖5-7。

▲附圖5  標本溶血檢驗報告?zhèn)渥⑻崾臼纠?

▲附圖6  標本溶血檢驗報告?zhèn)渥⑻崾臼纠?

▲附圖7  標本溶血檢驗報告?zhèn)渥⑻崾臼纠?

3.6實驗室如發(fā)布包含標本溶血指數(shù)結果檢驗報告，應向臨床提供溶血指數(shù)臨床意義及相關說明[7]。

3.7以溶血指數(shù)干擾檢測結果回歸方程計算矯正檢測結果，僅可用于臨床咨詢參考，不建議用作報告糾正后的檢驗結果[6,8,41]。

3.8可整合編制審核規(guī)則，將標本溶血指數(shù)、干擾報警閾值信息傳輸至檢驗信息系統(tǒng)，自動選擇審核檢驗結果、添加備注提示信息[42-45]。

4.1目測法輕度溶血檢出率低，容易低估溶血率[18,46]。

4.2儀器法溶血指數(shù)質(zhì)量指標如溶血率、溶血指數(shù)中位數(shù)等，可作為評價檢驗前過程工作能力水平的客觀量化指標[47-49]。

4.3實驗室應與相關人員溝通，分析溶血指數(shù)質(zhì)量指標結果，結合采血人員技能、患者人群、工作模式等客觀實際，查找缺陷原因，采取針對性改進措施[50-53]。

實驗室質(zhì)量體系文件應包含標本溶血檢測及檢測結果臨床應用的操作規(guī)程、記錄等要求內(nèi)容[54-55]。

本專家共識（征求意見稿）由中華中醫(yī)藥學會檢驗醫(yī)學分會授權發(fā)布。歡迎各位檢驗同仁在留言區(qū)提出寶貴意見。

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《臨床實驗室標本溶血檢測與臨床應用專家共識》課題組

中國醫(yī)師協(xié)會檢驗醫(yī)師分會中醫(yī)檢驗醫(yī)學專業(yè)委員會

中華中醫(yī)藥學會檢驗醫(yī)學分會

北京中醫(yī)藥學會中醫(yī)檢驗專委會

2018年6月