CAJ | 학술논문

目的：对北京倍肯公司研发的野战(应急)快速检验系统生化分析模块(SP4430)基本性能进行综合评价。方法：对野战(应急)快速检验系统生化分析模块分别在室内环境与模拟野战环境下进行精密度评价，并对其在两种不同环境下的检测结果进行对比；对野战(应急)快速检验系统生化分析模块与日本OLYMPUS AU5421全自动生化分析仪所测定结果进行比较，分析二者之间有无差异。结果：生化分析模块GLU、UA、ALB、REA、ALT、TBIL、LDH、AMS在室内的CV(%)分别为2.08、2.89、1.56、2.38、4.10、2.36、3.19、6.33；在模拟野战环境下的CV(%)分别为2.31、3.12、2.11、2.32、4.80、2.57、4.51、7.14；GLU(mmol/L)、UA(umol/L)、ALB(g/L)、CREA(umol/L)、ALT(U/L)、TBIL(umol/L)、LDH(U/L)、AMS(U/L)在室内结果分别为5.91±2.03、269.50±111.50、35.89±7.55、94.08±22.150、42.71±27.62、10.30±5.75、173.60±59.99、67.45±25.06，在模拟野战环境下的结果分别为6.33±2.31、273.38±120.56、34.90±6.99、94.85±23.15、37.73±24.64、10.18±5.71、170.43±61.74、68.02±25.14；所有项目室内与模拟野战环境的检测结果采用配对t检验比较，P值均＞0.05；结果表明生化分析模块与OLYMPUS AU5421所测GLU、UA、ALB结果差异无统计学意义(P＞0.05)，而CREA、ALT、TBIL、LDH、AMS所测结果差异有统计学意义(P＜0.01)。两种仪器所有检测结果的相关系数均＞0.90。结论：在室内、模拟野战环境下，野战(应急)快速检验系统生化分析模块精密度良好，结果比较无显著差异；生化分析模块与实验室常规生化分析仪检测结果相关性良好，由于检测方法不同，部分结果差异较大，但仍然具有可比性。
목적：대북경배긍공사연발적야전(응급)쾌속검험계통생화분석모괴(SP4430)기본성능진행종합평개。방법：대야전(응급)쾌속검험계통생화분석모괴분별재실내배경여모의야전배경하진행정밀도평개，병대기재량충불동배경하적검측결과진행대비；대야전(응급)쾌속검험계통생화분석모괴여일본OLYMPUS AU5421전자동생화분석의소측정결과진행비교，분석이자지간유무차이。결과：생화분석모괴GLU、UA、ALB、REA、ALT、TBIL、LDH、AMS재실내적CV(%)분별위2.08、2.89、1.56、2.38、4.10、2.36、3.19、6.33；재모의야전배경하적CV(%)분별위2.31、3.12、2.11、2.32、4.80、2.57、4.51、7.14；GLU(mmol/L)、UA(umol/L)、ALB(g/L)、CREA(umol/L)、ALT(U/L)、TBIL(umol/L)、LDH(U/L)、AMS(U/L)재실내결과분별위5.91±2.03、269.50±111.50、35.89±7.55、94.08±22.150、42.71±27.62、10.30±5.75、173.60±59.99、67.45±25.06，재모의야전배경하적결과분별위6.33±2.31、273.38±120.56、34.90±6.99、94.85±23.15、37.73±24.64、10.18±5.71、170.43±61.74、68.02±25.14；소유항목실내여모의야전배경적검측결과채용배대t검험비교，P치균＞0.05；결과표명생화분석모괴여OLYMPUS AU5421소측GLU、UA、ALB결과차이무통계학의의(P＞0.05)，이CREA、ALT、TBIL、LDH、AMS소측결과차이유통계학의의(P＜0.01)。량충의기소유검측결과적상관계수균＞0.90。결론：재실내、모의야전배경하，야전(응급)쾌속검험계통생화분석모괴정밀도량호，결과비교무현저차이；생화분석모괴여실험실상규생화분석의검측결과상관성량호，유우검측방법불동，부분결과차이교대，단잉연구유가비성。
Objective: To evaluate the performance of biochemistry analysis module of Biochem POCT Solutions. Methods:The precision of the biochemistry analysis module of Biochem POCT Solutions was estimated indoor and in simulated field environment, and then compared the results. Fresh blood samples of 200 patients were detected with the biochemistry analysis module and OLYMPUS AU5421 automatic biochemical analyzer respectively, and the results were compared. Results:GLU, UA, ALB, CREA, ALT, TBIL, LDH and AMS variation coefficients (CVs) were 2.08%, 2.89%, 1.56%, 2.38%, 4.10%, 2.36%, 3.19%and 6.33%indoor, and in simulated field environment CVs were 2.31%, 3.12%, 2.11%, 2.32%, 4.80%, 2.57%, 4.51%and 7.14%. GLU(mmol/L), UA(umol/L), ALB(g/L), CREA(umol/L), ALT(U/L), TBIL(umol/L), LDH(U/L) and AMS(U/L) were 5.91±2.03, 269.50±111.50, 35.89±7.55, 94.08±22.150, 42.71±27.62, 10.30±5.75, 173.60±59.99 and 67.45±25.06 indoor, and results in simulated field environment were 6.33±2.31, 273.38±120.56, 34.90±6.99, 94.85±23.15, 37.73±24.64, 10.18±5.71, 170.43±61.74 and 68.02±25.14. The value of P>0.05 in all items. All of the eight biochemistry test results are highly relevant with each other between the biochemistry analysis module and OLYMPUS AU5421 automatic biochemical analyzer. The results of GLU,UA and ALB were not significantly different(P>0.05), but the difference was significant in that of CREA, ALT, TBIL, LDH and AMS(P<0.01). Conclusion:In indoor or simulated field environment, biochemical analysis module of Biochem POCT Solutions has good precision, and the results have no significant difference between two environments. The results of the biochemistry analysis module and OLYMPUS AU5421 automatic biochemical analyzer correlated well. Due to the different detection methods, some results quite different, but still comparable.