臨床實(shí)驗(yàn)室標(biāo)本溶血檢測(cè)與應(yīng)用

專(zhuān)家共識(shí)（征求意見(jiàn)稿）

標(biāo)本溶血是臨床實(shí)驗(yàn)室（簡(jiǎn)稱(chēng)實(shí)驗(yàn)室）最常見(jiàn)的誤差來(lái)源，是標(biāo)本拒收的主要原因[1-2]。因標(biāo)本溶血發(fā)出錯(cuò)誤結(jié)果報(bào)告可能造成誤診誤治，重新抽血給患者增加痛苦、報(bào)告周期延長(zhǎng)，復(fù)測(cè)造成人力、物力、經(jīng)濟(jì)損失[3-5]。

目前國(guó)際上已有標(biāo)本溶血相關(guān)檢測(cè)與應(yīng)用標(biāo)準(zhǔn)、共識(shí)發(fā)布[6-8]。由于經(jīng)濟(jì)水平、文化習(xí)慣上的差異，國(guó)際相關(guān)標(biāo)準(zhǔn)、指南難以符合各國(guó)的實(shí)際需求，有必要制定適合國(guó)情的標(biāo)本溶血檢測(cè)與臨床應(yīng)用專(zhuān)家共識(shí)，以指導(dǎo)相關(guān)檢驗(yàn)及臨床實(shí)踐[9-11]。中國(guó)醫(yī)師協(xié)會(huì)檢驗(yàn)醫(yī)師分會(huì)中醫(yī)檢驗(yàn)醫(yī)學(xué)專(zhuān)委會(huì)、中華中醫(yī)藥學(xué)會(huì)檢驗(yàn)醫(yī)學(xué)分會(huì)、北京中醫(yī)藥學(xué)會(huì)中醫(yī)檢驗(yàn)專(zhuān)委會(huì)組織專(zhuān)家討論，制定《臨床實(shí)驗(yàn)室標(biāo)本溶血檢測(cè)與臨床應(yīng)用專(zhuān)家共識(shí)》，主要基于目前血清(或血漿)標(biāo)本溶血檢測(cè)與臨床應(yīng)用的相關(guān)研究文獻(xiàn)及我國(guó)實(shí)際，以滿(mǎn)足臨床需求為導(dǎo)向，對(duì)現(xiàn)有資料不足、爭(zhēng)議較大問(wèn)題采用專(zhuān)家共識(shí)的方法解決。本共識(shí)的主要目的是利用現(xiàn)有的循證醫(yī)學(xué)依據(jù)，為規(guī)范臨床實(shí)驗(yàn)室標(biāo)本溶血檢測(cè)及臨床應(yīng)用提供指導(dǎo)和幫助。隨著技術(shù)發(fā)展、認(rèn)識(shí)深化，本共識(shí)將持續(xù)更新，以滿(mǎn)足檢驗(yàn)及臨床實(shí)踐需求。

1.1標(biāo)本溶血干擾檢驗(yàn)結(jié)果

標(biāo)本溶血紅細(xì)胞破壞，由于細(xì)胞內(nèi)容物釋放、光學(xué)干擾、與試劑成分發(fā)生化學(xué)反應(yīng)等機(jī)制對(duì)檢驗(yàn)結(jié)果產(chǎn)生干擾，可導(dǎo)致檢驗(yàn)結(jié)果假性升高或降低，對(duì)臨床診療產(chǎn)生不良影響[12-13]。

1.2標(biāo)本溶血干擾閾值

標(biāo)本溶血干擾閾值是指溶血造成檢驗(yàn)結(jié)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(biāo)本溶血干擾閾值因檢驗(yàn)項(xiàng)目及檢測(cè)系統(tǒng)、方法而異，制造商推薦的標(biāo)本溶血干擾閾值的檢驗(yàn)結(jié)果改變?cè)试S偏差通常為10%[14-16]。

2.1目測(cè)法

2.1.1目測(cè)法觀察標(biāo)本溶血程度簡(jiǎn)單易行，當(dāng)儀器法溶血指數(shù)不可用時(shí)，可利用標(biāo)本溶血比色卡目測(cè)溶血程度，實(shí)驗(yàn)室應(yīng)對(duì)使用標(biāo)本溶血比色卡的人員進(jìn)行培訓(xùn)、能力評(píng)估[6-8，17]。

2.1.2實(shí)驗(yàn)室應(yīng)評(píng)估所選用標(biāo)本溶血比色卡適用于所用檢測(cè)系統(tǒng)，標(biāo)本溶血比色卡溶血程度分級(jí)應(yīng)與所用檢測(cè)系統(tǒng)溶血指數(shù)對(duì)應(yīng)[7-8,18]。示例見(jiàn)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(cè)標(biāo)本溶血，常用測(cè)定標(biāo)本血紅蛋白特定波長(zhǎng)吸光度值法檢測(cè)血紅蛋白濃度，結(jié)果以溶血指數(shù)表示，檢測(cè)準(zhǔn)確、快速，可避免目測(cè)法個(gè)體差異大，結(jié)果準(zhǔn)確性差、重復(fù)性差缺陷[19-20]。實(shí)驗(yàn)室應(yīng)首選儀器法檢測(cè)標(biāo)本溶血指數(shù)[21-22]。

2.2.2實(shí)驗(yàn)室應(yīng)開(kāi)展儀器法檢測(cè)標(biāo)本溶血指數(shù)的性能驗(yàn)證、校準(zhǔn)、室內(nèi)質(zhì)控，參加實(shí)驗(yàn)室間比對(duì)計(jì)劃[23-26]。

2.2.3儀器法檢測(cè)標(biāo)本溶血程度不影響檢驗(yàn)項(xiàng)目報(bào)告周期、檢驗(yàn)工作效率，不增加實(shí)驗(yàn)室成本[27-28]。

3.1實(shí)驗(yàn)室應(yīng)建立所開(kāi)展檢驗(yàn)項(xiàng)目的標(biāo)本溶血干擾說(shuō)明，包括標(biāo)本溶血干擾閾值及溶血干擾檢驗(yàn)結(jié)果改變?nèi)缟摺⒔档突驘o(wú)顯著改變等方向趨勢(shì)信息[6,29-31]。

3.2檢驗(yàn)項(xiàng)目標(biāo)本溶血干擾說(shuō)明信息可通過(guò)制造商、學(xué)術(shù)組織、實(shí)驗(yàn)室內(nèi)部研究等獲得,實(shí)驗(yàn)室應(yīng)評(píng)估其適用性[28-29,32-34]。示例見(jiàn)附表1。

▼附表1  檢驗(yàn)項(xiàng)目溶血干擾信息表示例

3.3檢驗(yàn)項(xiàng)目標(biāo)本溶血干擾信息因檢驗(yàn)方法、檢驗(yàn)系統(tǒng)而異，實(shí)驗(yàn)室應(yīng)評(píng)估所選用標(biāo)本溶血干擾信息的適用性[35-36]。

3.4實(shí)驗(yàn)室發(fā)布標(biāo)本溶血檢驗(yàn)報(bào)告前，應(yīng)結(jié)合實(shí)測(cè)標(biāo)本溶血指數(shù)、溶血干擾閾值及必要的臨床信息審核,標(biāo)本溶血指數(shù)低于檢驗(yàn)項(xiàng)目溶血干擾閾值，實(shí)驗(yàn)室應(yīng)報(bào)告檢驗(yàn)結(jié)果，不應(yīng)拒收標(biāo)本[37-38]。

3.5標(biāo)本溶血指數(shù)高于溶血干擾閾值的檢驗(yàn)項(xiàng)目：實(shí)驗(yàn)室應(yīng)建議重新采集標(biāo)本送檢；可報(bào)告結(jié)果并應(yīng)標(biāo)注標(biāo)本溶血，干擾說(shuō)明信息明確的應(yīng)備注溶血干擾檢驗(yàn)結(jié)果的解釋性注釋?zhuān)皶r(shí)與臨床作必要聯(lián)系溝通[39-40]。示例見(jiàn)附圖5-7。

▲附圖5  標(biāo)本溶血檢驗(yàn)報(bào)告?zhèn)渥⑻崾臼纠?

▲附圖6  標(biāo)本溶血檢驗(yàn)報(bào)告?zhèn)渥⑻崾臼纠?

▲附圖7  標(biāo)本溶血檢驗(yàn)報(bào)告?zhèn)渥⑻崾臼纠?

3.6實(shí)驗(yàn)室如發(fā)布包含標(biāo)本溶血指數(shù)結(jié)果檢驗(yàn)報(bào)告，應(yīng)向臨床提供溶血指數(shù)臨床意義及相關(guān)說(shuō)明[7]。

3.7以溶血指數(shù)干擾檢測(cè)結(jié)果回歸方程計(jì)算矯正檢測(cè)結(jié)果，僅可用于臨床咨詢(xún)參考，不建議用作報(bào)告糾正后的檢驗(yàn)結(jié)果[6,8,41]。

3.8可整合編制審核規(guī)則，將標(biāo)本溶血指數(shù)、干擾報(bào)警閾值信息傳輸至檢驗(yàn)信息系統(tǒng)，自動(dòng)選擇審核檢驗(yàn)結(jié)果、添加備注提示信息[42-45]。

4.1目測(cè)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(biāo)如溶血率、溶血指數(shù)中位數(shù)等，可作為評(píng)價(jià)檢驗(yàn)前過(guò)程工作能力水平的客觀量化指標(biāo)[47-49]。

4.3實(shí)驗(yàn)室應(yīng)與相關(guān)人員溝通，分析溶血指數(shù)質(zhì)量指標(biāo)結(jié)果，結(jié)合采血人員技能、患者人群、工作模式等客觀實(shí)際，查找缺陷原因，采取針對(duì)性改進(jìn)措施[50-53]。

實(shí)驗(yàn)室質(zhì)量體系文件應(yīng)包含標(biāo)本溶血檢測(cè)及檢測(cè)結(jié)果臨床應(yīng)用的操作規(guī)程、記錄等要求內(nèi)容[54-55]。

本專(zhuān)家共識(shí)（征求意見(jiàn)稿）由中華中醫(yī)藥學(xué)會(huì)檢驗(yàn)醫(yī)學(xué)分會(huì)授權(quán)發(fā)布。歡迎各位檢驗(yàn)同仁在留言區(qū)提出寶貴意見(jiàn)。

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《臨床實(shí)驗(yàn)室標(biāo)本溶血檢測(cè)與臨床應(yīng)用專(zhuān)家共識(shí)》課題組

中國(guó)醫(yī)師協(xié)會(huì)檢驗(yàn)醫(yī)師分會(huì)中醫(yī)檢驗(yàn)醫(yī)學(xué)專(zhuān)業(yè)委員會(huì)

中華中醫(yī)藥學(xué)會(huì)檢驗(yàn)醫(yī)學(xué)分會(huì)

北京中醫(yī)藥學(xué)會(huì)中醫(yī)檢驗(yàn)專(zhuān)委會(huì)

2018年6月