CAJ | 학술논문

对人全血 IL -1βELISA 法在医疗器械热原体外检测中应用的可行性进行了验证，并用该法对样品直接接触法和浸提液法这两种不同接触方法的检测结果进行了分析和比较。对于内毒素 O113，直接接触法测得的内毒素当量高于样品浸提液中的测得量；对于非内毒素热原脂磷壁酸（LTA），直接接触法测得值与浸提液测得值量相当。结果表明，人全血 IL -1βELISA 试验可用于体外检测医疗器械中的内毒素和非内毒素热原，且直接接触法优于浸提液法。
대인전혈 IL -1βELISA 법재의료기계열원체외검측중응용적가행성진행료험증，병용해법대양품직접접촉법화침제액법저량충불동접촉방법적검측결과진행료분석화비교。대우내독소 O113，직접접촉법측득적내독소당량고우양품침제액중적측득량；대우비내독소열원지린벽산（LTA），직접접촉법측득치여침제액측득치량상당。결과표명，인전혈 IL -1βELISA 시험가용우체외검측의료기계중적내독소화비내독소열원，차직접접촉법우우침제액법。
The feasibility of applying IL -1βELISA method with human whole blood into pyrogen test in vitro for medical devices was validated.Comparison and analysis of the results between the two contact methods with test articles,direct contact method and ex-tract method,was conducted.For LPS O113,the LPS equivalent of direct contact method was higher than that of extract method;as for non -endotoxin pyrogen LTA,the LPS equivalent of direct contact method was approximately equal with that of extract method.Ac-cording to the results,it can be concluded that IL -1βELISA method with human whole blood can be applied into pyrogen test in vitro for endotoxin pyrogen and non -endotoxin pyrogen of medical devices,the incubation method is more efficient than the extract method.