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        1. 上海乾思生物科技有限公司
          中級(jí)會(huì)員 | 第16年

          18916423352

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          自產(chǎn)ELISA試劑盒,試劑盒
          進(jìn)口ELISA試劑盒
          人細(xì)胞,人細(xì)胞系,人細(xì)胞株
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          ELISA質(zhì)量控制--質(zhì)量控制血清

          時(shí)間:2011/10/26閱讀:681
          分享:

           ELISA 是一種敏感性高、特異性強(qiáng)、重復(fù)性好的實(shí)驗(yàn)診斷方法,由于其試劑穩(wěn)定、易保存、操作簡便、結(jié)果判斷較客觀等因素,以及既適宜于大規(guī)模篩查試驗(yàn)又可以用于少量標(biāo)本的檢測,既可以做定性試驗(yàn)也可以做定量分析等優(yōu)點(diǎn),已廣泛應(yīng)用于微生物學(xué)、寄生蟲學(xué)、腫瘤學(xué)和細(xì)胞因子等領(lǐng)域。ELISA 的影響因素較多,加強(qiáng)質(zhì)量管理才能充分發(fā)揮其方法學(xué)的優(yōu)點(diǎn)。質(zhì)控血清是已有靶值的血清,在每次的常規(guī)檢驗(yàn)中加入一份或數(shù)份,通過所得結(jié)果來了解本次檢驗(yàn)的情況。質(zhì)控血清檢驗(yàn)的結(jié)果如能控制其誤差在一定范圍內(nèi),就說明該檢驗(yàn)沒有發(fā)生不允許的誤差。如果出現(xiàn)超過允許誤差范圍的異常結(jié)果,提示該檢驗(yàn)不合格,應(yīng)尋找原因,糾正后,重檢待測標(biāo)本。因此質(zhì)控血清在質(zhì)控工作中起重要作用。一、質(zhì)控血清的使用:衛(wèi)生部臨床檢驗(yàn)中心制備的乙肝標(biāo)志物質(zhì)控血清,可以在-20℃保持半年定值不變。冰凍狀態(tài)融化使用時(shí),應(yīng)先混勻,未用完部分可在4℃保存5天。不宜反復(fù)冰融或自行分裝。開展某項(xiàng)檢驗(yàn)的室內(nèi)質(zhì)控工作需要的質(zhì)控血清,一般按3-6個(gè)月用量準(zhǔn)備。自制的不定值質(zhì)控血清,在一批質(zhì)控血清將用完之前,需準(zhǔn)備下一批質(zhì)控血清。質(zhì)控血清要求性能穩(wěn)定,較長期內(nèi)效價(jià)不變,其理化性質(zhì)應(yīng)與病人樣本相近,這樣才能有效地起到監(jiān)測作用。二、臨界值質(zhì)控血清:質(zhì)控制血清分定值和未定值兩種。如只用一份質(zhì)控血清定值,一般定在正常值與異常值交界點(diǎn)上,定性測定時(shí)處于弱陽性水平,稱為臨界值。乙肝標(biāo)志物臨界值的制定,應(yīng)按臨床要求,為臨床提供統(tǒng)一的判斷弱陽性的標(biāo)準(zhǔn)。 臨界值質(zhì)控血清可以作為試劑盒中的陽性對(duì)照品和陰性對(duì)照品以外的第三個(gè)對(duì)照品,它可以靈敏地反映出試劑盒的檢出水平,確保弱陽性反應(yīng)的標(biāo)本不漏檢。三、質(zhì)控血清的制備:每個(gè)實(shí)驗(yàn)室可以根據(jù)自己的條件,選用臨床中心提供的質(zhì)控血清,或按以下方法自己制備本室使用的質(zhì)控血清(以乙肝質(zhì)控血清為例)。(1)收集新鮮的無溶血、無黃疸、無細(xì)菌污染的陽性血清。(2)56℃加熱10小時(shí)去活。(3)離心或過濾除去沉淀。(4)用10%的小牛血清或正常人血清(PBS緩沖液)將收集的血清稀釋至所需的濃度。如能用正常的人血清稀釋更好,因其成份更接近于檢測標(biāo)本。(5)抽濾除菌。按一次使用的量分裝小安瓿,封口,20℃保存?zhèn)溆?。不可反?fù)凍融。被檢物要求檢出的水平常被認(rèn)為是質(zhì)控血清應(yīng)選擇的水平。如果該試驗(yàn)還有其它要求,則應(yīng)加所要求濃度的質(zhì)控物。(6)標(biāo)定含量。20-30次測定結(jié)果刪除>±2SD數(shù)據(jù)的均值作為靶值,并與已知定值血清對(duì)比測定。

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