幾種丙型肝炎抗體酶聯免疫診斷試劑質量分析

【摘 要】 目的：了解目前臨床上常用的幾種丙型肝炎抗體（抗-HCV）酶聯免疫診斷試劑的質量情況。方法：選用三種國內不同廠家生產的抗-HCV酶聯免疫診斷試劑盒，對40份來自醫院的抗-HCV陽性病人血清（以雅培i1000檢測結果為準）、40份常規體檢抗-HCV陰性血清、1份上海市臨檢中心抗-HCV室內質控品進行檢測。從而對三種試劑的靈敏度、特異性、相對符合率及精密度進行分析。結果：三種國產試劑靈敏度均達100%。其中試劑盒A和試劑盒C的相對特異性均為97.5%，相對符合率均為98.75%。試劑盒B的相對特異性與相對總符合率均為100%。三家廠家試劑CV分別為14.8%、13.3%、10.9%。結論：國產抗-HCV酶聯免疫試劑靈敏度已符合要求，特異性及精密度的提高依然是主要問題。影響試劑盒質量的因素是多方面的，不同批次試劑盒在使用前應注意抽檢，以確保檢測結果的可靠。陽性結果應做兩次檢驗，避免假陽性結果的報出。

【關鍵詞】 肝炎病毒；HCV；抗-HCV抗體；酶聯免疫法；試劑盒

【中圖分類號】 R446.6 【文獻標識碼】 B

QUALITY ANALYSIS OF SEVERAL ANTI-HCV EIA KITS

Zhang Qianlan Zhang Jian Liu Xiaoyan*

（Shanghai Obstetrics and Gynecology Hospital， Fudan University， Huangpu ，Shanghai， 200011）

【Abstract】 Objective： To investigate the quality of several anti-HCV EIA kits in common market. Methods： 40 patients sera which were positive for anti-HCV（confirmed with Abbott i1000），40 samples which were negative for anti-HCV and one quality control materials of Shanghai Centre for Clinical Laboratory were detected by using three kinds of anti-HCV EIA kits which made of different manufactories. So the sensitivity and specificity and precision of each kit were calculated and the ability of each kit to detect the anti-HCV was also analyzed. Results： The sensitivity of three domestic anti-HCV EIA kits all reached 100%.The specificity of kit A and kit C reached 97.5% which of kit B reached 100%.The compliance rate of kit A and kit C reached 98.75% which of kit B reached 100%.The CV values of kits were 14.8%，13.3% and 10.9%. Conclusion： The sensitivity of domestic anti-HCV kits has already meet the requirements. But those kits still need improve the specificity. The factors which affect the quality of kit are variety. We should make the quality analysis before that kit of different batch number being used to ensure the reliable results. The positive results should be detected twice to avoid the 1 positive.

【Keywords】 hepatitis virus； HCV； anti-HCV； ELISA；EIA kits

1 材料與方法

1.1 樣本 從各家醫院收集的肝炎病人抗-HCV陽性血清（-20℃保存）26份（已用雅培i1000檢測確認，無溶血、乳糜標本），從中隨機各抽取200μl血清兩兩混合，組成混合陽性血清14份（每份400μl）。（見表1）

全部陽性血清編號為1-40；上海市臨檢中心2009年正常體檢標本40份（已用雅培i1000檢測確認），編號為41-80；上海市臨檢中心抗-HCV室內調查品1份（批號1001）。2℃-8℃冰箱保存。

1.2 材料

1.2.1 試劑 北京某廠家生產抗-HCV試劑盒（96孔），批號2009090810，編號試劑A；上海某廠家生產抗-HCV試劑盒（96孔），批號201001021，編號試劑B；上海某廠家生產抗-HCV試劑盒（96孔），批號20100101，編號試劑C。……