温湿度对高通量ELISA检测系统检测梅毒螺旋体抗体影响的分析  

Influence of Temperature and Humidity on Detection of Treponema Pallidum Antibodies with High-Throughput ELISA System

作　　者：李晓霞[1] 迟伟群[1] 姚玉虹[1] 于晓斐[1] 江跃红[1] 许铁[1] 姜晓峰[1] 

机构地区：[1]哈尔滨医科大学附属第四医院检验科,哈尔滨150001

出　　处：《标记免疫分析与临床》2015年第1期46-51,共6页Labeled Immunoassays and Clinical Medicine

基　　金：卫生部医药卫生科技发展研究中心;课题编号:28-10-1

摘　　要：目的 探讨环境温湿度对高通量酶联免疫吸附试验（ELISA）检测系统检测梅毒螺旋体抗体产生的影响。方法选择两种不同厂家的高通量ELISA检测系统,首先,对这两种检测系统进行性能验证。然后,自2012年12月1日2013年11月30日期间,每日应用室内定值弱阳性质控分别在这两种系统上对梅毒螺旋体抗体进行检测;记录每日室内温湿度及定值弱阳性质控的S/CO值。最后,对数据进行统计学分析。结果 对于高通量Addcare ELISA 600检测系统,根据温湿度不同进行分组,将各组定值弱阳性质控值（S/CO值）进行单因素方差分析,结果显示：按温度分组时差异具有统计学意义（F=6.05,P=0.0001）,按湿度分组时差异具有统计学意义（F=3.23,P=0.0043）;利用多变量线性回归分析温湿度对检测系统的影响,结果显示：在湿度相同的情况下,温度每升高1℃,S/CO值增加0.043,在温度相同的情况下,湿度每增加1%,S/CO值减少0.007。对于高通量Freedom evolzyer检测系统,根据温湿度不同进行分组,将各组定值弱阳性质控值（S/CO值）进行单因素方差分析,结果显示：按温度分组时差异具有统计学意义（F=30.27,P〈0.0001）,按湿度分组时差异具有统计学意义（F=11.99,P〈0.0001）;利用多变量线性回归分析温湿度对检测系统的影响,结果显示：在湿度相同的情况下,温度每升高1℃,S/CO增加0.037,在温度相同的情况下,湿度每增加1%,S/CO减少0.005。,结论（1）温度在18~22℃及湿度在20%~29%、30%~39%时检测值与预期值差异无统计学意义,温度在8~12℃、13~17℃,及湿度在10%~19%时检测值与预期值差异具有统计学意义;（2）温度与S/CO值成正相关,湿度与S/CO值成负相关。Objective To investigate the effect of temperature and humidity on detection of Treponema pallidum antibodies via high-throughput ELISA detection system. Methods Two high-throughput ELISA detection systems from different manufacturers were selected for performance verification. Daily detection of fixed value quality weak positive control materials was used to qualify these two systems. Temperature, humidity and S/CO values were recorded and data were used for statistically analyze. Results For Addcare ELISA 600 detection system, the univariate analysis of variance of weak positive control values （S/CO） showed a significant difference in either temperature group （F = 6. 05, P = 0. 0001 ） or humidity group （ F = 3.23, P = 0. 0043 ）. At the same humidity conditions, temperature increased by I℃, the S/CO increased 0.043. While under same temperature, when the humidity increased 1%, S/CO value reduced 0. 007. For Freedom evolzyer detection system, the univariate analysis of variance of weak positive control values （S/CO） also showed a significant difference when grouped by temperature （ F = 30. 27, P 〈 0. 0001 ） or by humidity （ F = 11. 99, P 〈 0. 000）. At the same humidity conditions, temperature increased by 1 ℃, the S/CO value increased 0. 037. While under same temperature, when the humidity increased 1%, S/CO value reduced 0.005. Conclusion No significant difference was captured between detection value and the expected value when temperature was 18-22℃ ,while humidity was 20%-29%, or 30%-39%. The expected value was significantly different with detected value when temperature range were 8- 12℃ or 13-17℃, while the humidity was 10%- 19%. There is a positive correlation between temperature and the S/CO values, while it＇ s a positive correlation for humidity and S/CO values.

关 键 词：温度 湿度 高通量酶联免疫吸附试验 梅毒螺旋体抗体 

分 类 号：R446.6[医药卫生—诊断学]