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        1. 上海乾思生物科技有限公司
          中級會員 | 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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          SIGMA現(xiàn)貨,SIGMA代理

          ELISA試劑盒的選擇

          時(shí)間:2011/11/4閱讀:526
          分享:

           ELISA試劑盒選擇應(yīng)注意以下幾點(diǎn):

          1、衛(wèi)生部規(guī)定乙肝,丙肝,艾滋病,梅毒試劑及血型試劑必須使用經(jīng)衛(wèi)生部生物制品檢定所檢定合格,并貼有防偽標(biāo)簽,試劑應(yīng)從靈敏度,精密度,穩(wěn)定性,簡便性,特異性,安全性及經(jīng)濟(jì)性作出全面的評價(jià)。指試劑正確檢定不存在的被檢物質(zhì)的能力(無假陽性),取決于包被抗原(體)及標(biāo)記抗原(體)的純度及特異性。
          2、特異性:靈敏度:包括1)為試劑檢出被檢物質(zhì)的zui低量的能力;2)為試劑對人群或大量樣品中陽性檢出的能力(假陰性越少越好),取決于包被物的全面性。
          3、精密度:ELISA試劑一般指其批內(nèi)CV,其值應(yīng)小于15%;定量試劑應(yīng)同時(shí)考察線性范圍
          4、簡便性:指在不影響試劑的前三項(xiàng)指標(biāo)的前題下,實(shí)驗(yàn)和測定步驟越少越好,在定性試驗(yàn)中結(jié)果判斷簡單明了,)定量試驗(yàn)結(jié)果計(jì)算也應(yīng)簡單
          5、穩(wěn)定性:試劑在規(guī)定條件下能儲存的時(shí)間,一般采用破壞性試驗(yàn)即將試劑存放于37℃保存,定期測定其靈敏度,特異性和精密度等指標(biāo),直到其質(zhì)量指標(biāo)開始下降為止,通常認(rèn)為37℃每穩(wěn)定一天相當(dāng)于4-10℃保存一個(gè)半月。
          6、經(jīng)濟(jì)性:試劑在同等質(zhì)量條件下通過大規(guī)模生產(chǎn)或技術(shù)進(jìn)步降低成本而市場價(jià)格比較合理。
          7、安全性:指試劑對操作者和環(huán)境安全無害傳染性。
          8、試劑評價(jià)需要有的血清考核盤(Panel)進(jìn)行檢測,一般實(shí)驗(yàn)室不易從生檢所或臨檢中心取得,每進(jìn)一次試劑評價(jià)一次也很麻煩??梢酝ㄟ^間接的信息對試劑進(jìn)行選擇。
          9、參考室間質(zhì)評評價(jià)報(bào)告中對試劑的評價(jià)結(jié)果,這比較客觀公正,因?yàn)榻y(tǒng)計(jì)數(shù)字均來自各參評醫(yī)院,反映了試劑在某一地區(qū)的使用情況;
          10、通過詢問試劑包被物的組成,如原料來源(基因工程或合成多肽),片段的組合(按比例混合或化學(xué)合成),片段的長短等判斷試劑的優(yōu)劣;
          11、根據(jù)該試劑生檢所批批檢定報(bào)告,了解其質(zhì)量水平,按照質(zhì)量計(jì)劃選擇靈敏度高的或特異性高的試劑;
          12、根據(jù)部門發(fā)布的試劑評價(jià)結(jié)果,了解市場上試劑的質(zhì)量優(yōu)劣。
           

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