全血凝集法检测乙型肝炎病毒表面抗原

对武汉生物制品研究所生产的三批乙型肝炎病毒表面抗原（ＨＢｓＡｇ）全血凝集试剂进行实验室检定、临床考核以观察稳定性。结果表明ＨＢｓＡｇ全血凝集试剂盒的检测敏感性为１μｇ／Ｌ；凝集血球的模式呈片状；试剂盒能用于各种血型血样的检测。未梢血、各种抗凝血皆通用。ＨＢｓＡｇ强阳性样品无前滞漏检。１０μｇ／Ｌ弱阳性血样１０份，重复检测５次，重复率为１０００％。甲型肝炎病毒、丙型肝炎病毒、日本血吸虫病、类风湿因子阳性患者血样对检测无干扰，试剂有很好的特异性。用市售国产酶标试剂盒对照检测１７１２份，总符合率为９８５％。２６份两种方法不符合样品中的１８份进行了中和确证，全血凝集试剂假阳性１份，漏检３份，漏检的ＨＢｓＡｇ浓度皆为１～２μｇ／Ｌ；酶标法假阳性６份，漏检８份，漏检样品中有６份为ＨＢｓＡｇ强阳性。稳定性观察结果，全血凝集试剂４℃及２２℃保存，一年活性未见下降。３５℃放置４５天后活性开始下降。乙型肝炎病毒表面抗原全血凝集试剂有很好的稳定性。

HBsAg autologous red cell agglutination assay

Three lot of HBsAg autologous red cell agglutination kits (ARCA kit) have been qualified in lab, clinical trial and the stability confirmation have been performed. The sensitivity of the kits is 1ng/ml HBsAg. A, B, O, AB type of peripheral blood or antiagglutinated specimens can be used for assay. No Holk effect has been found. The repeated rate of 10 samples assayed for five times reached 100%. The specimens collected from HAV, HCV, Schistosoma Japonicum infected patients or RF positive patients do not interfere the test. The specificity of the kits is very high. 1712 clinical specimens were inspected comparing with the EIA kits in market. The relativity between the two methods is 0.985. 18 of the 26 specimens which two methods did not accord with each other have been confirmed. The false positive and missing detected for ARCA kits is 1, 3 and for EIA kits are 6, 8 respectively. ARCA kits are stable in 4 degrees C and 22 degrees C for more than one year. The kits can stand in 35 degrees C, 45 degrees C for 45 and 10 days without losing activity respectively.