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。 Objective To evaluate the detection performance of biochemical module emergency program of field rapid test system (POCT, A type) and the applicability in field complex conditions. Methods The levels of albumin, total bilirubin (TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were measured according to the National Committee for Clinical Laboratory Standards (NCCLS) ), BUN, CREA, UA, LDH, CK and GLU were analyzed systematically. Twenty-two clinical serum samples were randomly selected by field POCT (type A) and Coulter Beckman AU2700 automatic biochemical analyzer, and the consistency of test results was analyzed. By adjusting the temperature and humidity to simulate the field environment, Serum test results were compared. Results The coefficients of variation (CV) of total POCT (A type) in the above 10 indexes were 3.34%, 6.54%, 6.01%, 4.80%, 3.95%, 5.59%, 3.33%, 6.19%, 7.40%, 4.56% I); 3.08%, 4.47%, 4.02%, 4.31%, 3.76%, 4.22%, 2.93%, 5.25%, 6.39%, 4.35% (Level II). When the triglyceride concentration was 21 mmol / L, the interference rates of all the projects were less than 10% and the interference rates of ALT, AST and CREA were -33.33%, -22.99% and 20.00% respectively when the concentration of bilirubin was 120μmol / (Level Ⅰ), -22.13%, -14.55% and 8.70% (level Ⅱ) respectively. The interference rates of UA at the concentration of 240 μmol / L were -16.67% and -24.69%, respectively; the concentrations of hemoglobin The interference rates of ALT and AST for TBIL and LDH were 170.00%, 99.26% (level Ⅰ), 15.38% and 40.79% (level Ⅱ) when the concentration of TBIL and LDH was 170 mg / dl and 340 mg / dL respectively The levels of Ⅰ CREA, UA and CK were 26.67%, 16.67% and 11.74% when the concentration of Hb was 510 mg / dl, 9.84%, 13.79%, 12.30% and 12.27%, respectively. And AU2700 automatic biochemical analyzer test results compared to each project linear regression R2 were 0.961,0.995,0.989,0.995,0.990,0.989,0.989,0.963,0.978,0.993. When the temperature is 35 ℃, the instrument can not be tested beyond the temperature range. There is no statistical difference between the test results of the items at 10 ~ 30 ℃ or relative humidity (RH) of 70% ~ 90% and normal temperature and humidity (20 ℃, RH 50% (P> 0.05). The results of ALT and CK were significantly higher in high temperature and high humidity environment (30 ℃, RH 90%) (P <0.001, P = 0.011). Conclusion The biochemical module of POCT (A type) has good correlation with the results of conventional large biochemical analyzer. The precision meets the requirements of clinical laboratories. However, jaundice and hemolysis specimens have different degrees of interference with the detection of individual items. The instrument can basically meet the requirements of field temperature and humidity Under the accurate detection, but should try to avoid placing it in extreme environments.