上海乾思生物科技有限公司
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進口ELISA試劑盒
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ELISA試劑盒的選擇

時間：2011/11/4閱讀：524
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 ELISA試劑盒選擇應(yīng)注意以下幾點：

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)濟性作出全面的評價。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)同時考察線性范圍
4、簡便性：指在不影響試劑的前三項指標的前題下，實驗和測定步驟越少越好，在定性試驗中結(jié)果判斷簡單明了，）定量試驗結(jié)果計算也應(yīng)簡單
5、穩(wěn)定性：試劑在規(guī)定條件下能儲存的時間，一般采用破壞性試驗即將試劑存放于37℃保存，定期測定其靈敏度，特異性和精密度等指標，直到其質(zhì)量指標開始下降為止，通常認為37℃每穩(wěn)定一天相當于4-10℃保存一個半月。
6、經(jīng)濟性：試劑在同等質(zhì)量條件下通過大規(guī)模生產(chǎn)或技術(shù)進步降低成本而市場價格比較合理。
7、安全性：指試劑對操作者和環(huán)境安全無害傳染性。
8、試劑評價需要有的血清考核盤（Panel）進行檢測，一般實驗室不易從生檢所或臨檢中心取得，每進一次試劑評價一次也很麻煩?？梢酝ㄟ^間接的信息對試劑進行選擇。
9、參考室間質(zhì)評評價報告中對試劑的評價結(jié)果，這比較客觀公正，因為統(tǒng)計數(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告，了解其質(zhì)量水平，按照質(zhì)量計劃選擇靈敏度高的或特異性高的試劑；
12、根據(jù)部門發(fā)布的試劑評價結(jié)果，了解市場上試劑的質(zhì)量優(yōu)劣。
 

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