CAJ | 학술논문

目的：探讨 HP-083/4特定蛋白分析仪与目前临床实验室常规应用仪器的可比性和一致性。方法以目前临床实验室常规应用仪器作为比对体系,以 HP-083/4特定蛋白分析仪作为待验证仪器,收集该院血液标本及尿液标本各100份,分别检测抗链球菌溶血素 O(ASO)、超敏 C 反应蛋白(hsCRP)、D 二聚体(D-D)、糖化血红蛋白(HbA1c)、类风湿因子(RF)、尿微量清蛋白(mAlb)水平,计算2种方法的回归方程和相关系数(r),并分析其 Kappa(κ)值,以评估 HP-083/4特定蛋白分析仪的有效性。结果 HP-083/4特定蛋白分析仪与比对仪器检测 ASO、hsCRP、D-D、HbA1c、RF 及 mAlb 项目线性相关分析 r 分别为0.991、0.995、0.970、0.957、0.980及0.967,均大于0.950；κ值分别为0.830、0.957、0.601、0.720、0.920及0.694,κ值均大于0.6。结论HP-083/4特定蛋白分析仪检测 ASO、hsCRP、D-D、HbA1c、mAbl 及 RF 结果具有可靠性,可满足临床需求。
목적：탐토 HP-083/4특정단백분석의여목전림상실험실상규응용의기적가비성화일치성。방법이목전림상실험실상규응용의기작위비대체계,이 HP-083/4특정단백분석의작위대험증의기,수집해원혈액표본급뇨액표본각100빈,분별검측항련구균용혈소 O(ASO)、초민 C 반응단백(hsCRP)、D 이취체(D-D)、당화혈홍단백(HbA1c)、류풍습인자(RF)、뇨미량청단백(mAlb)수평,계산2충방법적회귀방정화상관계수(r),병분석기 Kappa(κ)치,이평고 HP-083/4특정단백분석의적유효성。결과 HP-083/4특정단백분석의여비대의기검측 ASO、hsCRP、D-D、HbA1c、RF 급 mAlb 항목선성상관분석 r 분별위0.991、0.995、0.970、0.957、0.980급0.967,균대우0.950；κ치분별위0.830、0.957、0.601、0.720、0.920급0.694,κ치균대우0.6。결론HP-083/4특정단백분석의검측 ASO、hsCRP、D-D、HbA1c、mAbl 급 RF 결과구유가고성,가만족림상수구。
Objective To compare the performance of HP-083/4 and rational used instrument on detecting six items.Methods The rational instruments were used as contrast instrument,HP-083/4 was the verified instrument.A total of 100 blood specimens and 100 urine specimens were collected,and the levels of antistreptolysin O(ASO),hypersensitive C reactive protein (hsCRP),D-di-mer(D-D),glycosylated hemoglobin(HbA1c),rheumatoid factor(RF)and urine microalbumin(mAlb)were detected.The regression equation and correlation coefficient(r)of the two methods were calculated,and the Kappa values(κ)were analyzed to evaluate the performance of HP-083/4.Results There was a good linear correlation (r >0.950)for the two methods in detecting the serum ASO,hsCRP,D-D,HbA1c,RF and mAlb,r were 0.991,0.995,0.970,0.957,0.980 and 0.967 respectively.Besides,they had good concordance(κ>0.6),theκ values were 0.830,0.957,0.601,0.720,0.920 and 0.694 respectively.Conclusion HP-083/4 is effec-tive in detecting ASO,hsCRP,D-D,HbA1c,RF and mAlb,which should be suitable for clinical application.