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野战快速检验系统(A型)生化模块检测性能及野战适用性评价

     

摘要

Objective To evaluate the performance of emergency test and the applicability under complex field conditions of biochemical modules of field point-of-care test ( POCT ) system ( type A ) .Methods The precision and anti-interference ability of albumin ( ALB ) , total bilirubin ( TBIL ) , alanine transaminase ( ALT ) , aspartate transaminase (AST),blood area nitrogen(BUN),creatinine(CREA),uric acid(UA),lactate dohydrogenase(LDH),creatine kinase ( CK) ,and glucose( GLU) detected by field POCT system( A) were analyzed according to standards formulated by National Committee for Clinical Laboratory Standards(NCCLS).Field POCT system(A) and Coulter Beckman AU2700 automatic biochemical analyzer were used to detect the serum of 22 clinical cases respectively.After simulating the field environment by adjusting the temperature and humidity, we compared the results of mixed serum under different environment conditions. Results The coefficients of variation in total precision of ALB,TBIL,ALT,AST,BUN,CREA,UA,LDH,CK,and GLU detected by field POCT system(A) were 3.34%,6.54%,6.01%,4.80%,3.95%,5.59%,3.33%,6.19%,7.40%,and 4.56%(LevelⅠ);and 3.08%,4.47%,4.02%,4.31%,3.76%,4.22%,2.93%,5.25%,6.39%,and 4.35%(LevelⅡ) respectively.When triglycerides( TG) level was at 21 mmol/L, the interference rate was below 10%.When bilirubin level was at 120 μmol/L, the interference rate of ALT,AST and CREA was -33.33%,-22.99%,20.00%(LevelⅠ), and -22.13%,-14.55%,and 8.70%(LevelⅡ),respectively.When its level was at 240 μmol/L, the interference rate of UA was -16.67%and -24.69%, respectively at two levels;if hemoglobin( Hb) was at 170 mg/dl, the interference rate of TBIL and LDH was 20.00%,and 99.26%(LevelⅠ),and 15.38%,and 40.79%(LevelⅡ),respectively;if it was at 340 mg/dl, the interference rate of ALT and AST was 9.84% and 13.79%(LevelⅠ), and 12.30%,and 12.27%(LevelⅡ),respectively;if it was at 510 mg/dl, the interference rate of CREA,UA and Ck in LevelⅠwas 26.67%, 16.67%,and 11.74%.The R2 of linear regression between field POCT system( A) and AU2700 automatic biochemical analyzer were 0.961,0.995,0.989,0.995,0.990,0.989,0.989,0.963,0.978,and 0.993, respectively.The POCT system could not work at 35℃ or higher temperature, and there was no difference in the results of detection between temperatures of 10-30℃or RH of 70%-90% and normal temperature and humidity(20℃,RH 50%) (P>0.05). However, the result of ALT and CK at high temperature and humidity was significantly higher than at normal temperature and humidity(P<0.001,and P=0.011, respectively).Conclusion The biochemical module of field POCT system(A) has a good correlation with the common large biochemical analyzer, and its precision meets the requirement of laboratory detection, but jaundice and hemolytsis can interfere in several tests to varying degrees.The POCT system can basically ensure accurate detection under field conditions of temperature and humidity, but should not work under extreme environments.%目的:对野战快速检验系统( POCT,A型)生化模块急诊项目检测性能及野外复杂条件下的适用性进行评价。方法根据美国国家临床实验室标准委员会( NCCLS)标准对野战POCT( A型)检测白蛋白( ALB)、总胆红素(TBIL)、丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、血尿素氮(BUN)、肌酐(CREA)、血尿素(UA)、乳酸脱氢酶(LDH)、肌酸激酶(CK)、葡萄糖(GLU)的精密度及抗干扰能力进行系统分析;使用野战POCT(A型)与Coulter Beckman AU2700型全自动生化分析仪分别检测随机选取的22例临床血清标本,并对检测结果进行一致性分析;通过调节温湿度模拟野战环境,对不同环境下混合血清检测结果进行比较。结果野战POCT( A型)上述10项指标的总精密度变异系数分别为3.34%、6.54%、6.01%、4.80%、3.95%、5.59%、3.33%、6.19%、7.40%、4.56%(水平Ⅰ);3.08%、4.47%、4.02%、4.31%、3.76%、4.22%、2.93%、5.25%、6.39%、4.35%(水平Ⅱ)。当甘油三酯浓度为21 mmol/L 时,所有项目干扰率均<10%;胆红素浓度为120μmol/L 时, ALT、AST、CREA 干扰率分别为-33.33%、-22.99%、20.00%(水平Ⅰ),-22.13%、-14.55%、8.70%(水平Ⅱ);胆红素浓度为240μmol/L时, UA两水平干扰率分别为-16.67%、-24.69%;血红蛋白(Hb)浓度为170 mg/dl 时,TBIL、LDH干扰率分别为20.00%、99.26%(水平Ⅰ),15.38%、40.79%(水平Ⅱ),Hb为340 mg/dl浓度时,ALT、AST干扰率分别为9.84%、13.79%(水平Ⅰ),12.30%、12.27%(水平Ⅱ),Hb为510 mg/dl 浓度时,水平ⅠCREA、UA、CK 干扰率分别为26.67%、16.67%、11.74%。与AU2700型全自动生化分析仪检测结果比较各项目直线回归R2分别为0.961、0.995、0.989、0.995、0.990、0.989、0.989、0.963、0.978、0.993。在气温35℃时仪器超出温度范围无法进行检测,在10~30℃或相对湿度(RH)70%~90%时与常温常湿(20℃, RH 50%)各项目检测结果差异无统计学意义(P>0.05),在高温高湿环境(30℃,RH 90%)ALT和CK结果显著增高(P<0.001,P=0.011)。结论野战POCT(A型)生化模块与常规大型生化仪检测结果相关性好,精密度符合临床实验室要求,但黄疸及溶血标本对个别项目检测有不同程度干扰,仪器能基本满足野战温湿度条件下的准确检测,但应尽量避免将其置于极端环境下工作。

著录项

  • 来源
    《军事医学》|2016年第1期|55-59|共5页
  • 作者单位

    成都军区总医院检验科;

    高湿医学全军重点实验室;

    成都 610083;

    成都军区总医院检验科;

    高湿医学全军重点实验室;

    成都 610083;

    成都军区总医院医疗科;

    成都 610083;

    成都军区总医院中心实验室;

    成都 610083;

    成都军区总医院检验科;

    高湿医学全军重点实验室;

    成都 610083;

    成都军区总医院检验科;

    高湿医学全军重点实验室;

    成都 610083;

    成都军区总医院检验科;

    高湿医学全军重点实验室;

    成都 610083;

  • 原文格式 PDF
  • 正文语种 chi
  • 中图分类 军队临床医学;
  • 关键词

    即时检验; 野战卫勤保障; 干式生化分析仪; 性能验证;

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