凝血因子Ⅷ质量检测异常的应急应用

Emergency measures against abnormal quality detection of coagulation factor Ⅷ

目的探讨凝血因子Ⅷ检测异常(检测结果不符合预期)时的应急应用措施,分析检测试剂可靠性。方法选取试剂A和试剂B 2个厂家,从定标和质控、批内不精密度试验、准确度试验、携带污染试验、线性范围试验、不同厂家试剂或不同实验室检测结果对比等多方面进行试验验证。结果检测结果显示定标和质控、批内不精密度试验、准确度试验、携带污染试验2家试剂均符合要求;对人类新鲜血浆检测,试剂A和试剂B检测结果均在正常范围(P<0.01),试剂A检测结果低于试剂B;对冷沉淀凝血因子、原料新鲜血浆和各自质控品检测,2个外单位实验室检测结果与试剂B相符合,试剂A结果明显偏低;试剂B线性范围验证符合要求。结论试剂A目前暂时不能用于血标本和血液制品中Ⅷ因子检测,试剂B符合使用要求。厂家提供的质控品不是唯一的判断标准,当检测结果异常时,应该更换其他厂家试剂对比测定,亦可送外单位实验室同时平行检测,比较检测结果是否存在偏差。

Objective To explore the emergency measures when coagulation factorⅧdetection do not meet the expectation,and analyze the reliability of detection reagents.Methods Reagent A and Reagent B from two manufacturers were selected for test and verification in terms of calibration and quality control,intra batch imprecision test,accuracy test,carryover contamination test,linear range test,and comparison of test results of reagents from different manufacturers or laboratories.Results The results showed that calibration and quality control,intra batch imprecision test,accuracy test and carryover contamination test of Regeat A and B both met the requirements;the test results of Reagent A,presenting lower results than Reagent B,were found to be in required limits for human fresh plasma(P<0.01);the test results of two laboratories outside our blood station were in full accordance with that of Reagent B when detecting cryoprecipitated antihemophilic factors,raw material fresh plasma and their respective quality control products,whereas Reagent A presented significantly lower results.The linear range of Reagent B met the requirements.Conclusion The detection ability targeted at factor VIII in blood samples and blood products can be reached by Reagent B,but not Reagent A at present.The quality control products provided by the manufacturer are not the only criterion.Using other manufacturers′reagents for comparative tests,or sending to laboratories outside the unit for parallel tests could be adopted when there are abnormal test results.