CAJ | 학술논문

目的研究甜菜碱(betaine)在不同温度下对人血清中ALT酶活性的稳定作用,并评估添加甜菜碱的人血清在各检测系统中的基质效应.方法血清中添加终浓度为1 mol/L的甜菜碱,检测37 ℃、25 ℃、4 ℃、-20 ℃下放置不同时间的血清中的ALT酶活力.根据美国临床和实验室标准协会(CLSI)EP14-A文件进行基质效应实验,以4个被评价检测系统为被比较系统,以罗氏公司试剂-日立仪器检测系统为比较系统,用比较系统和被评价系统检测40个患者血清样品以及添加了1 mol/L甜菜碱的3个血清(高、中、低浓度)样本的ALT酶活力;用直线回归方法统计数据,以回归直线的(-Y)估计值(^/Y)的95%可信区间估计这3个添加了甜菜碱的样品在4种检测系统中的基质效应.结果 37 ℃添加甜菜碱的血清48 h后ALT酶活力稳定为99%,对照血清降至42%;25 ℃添加甜菜碱的血清4 d后ALT酶活力稳定为98%,对照血清降至86%;4 ℃添加甜菜碱的血清4周后ALT酶活力稳定为97%,对照血清1周后已降至71%;-20 ℃添加甜菜碱的血清4个月后ALT酶活力稳定为99%,对照血清1个月后已降至79%.添加了甜菜碱的3个样本的值均在回归直线的(-Y)估计值(^/Y)的95%可信区间内,即其在4个被评价系统和比较系统中均无明显基质效应.结论甜菜碱可作为一个较好的血清ALT酶活力的稳定剂用于血清酶ALT的校准品的研制中.
목적 연구첨채감(betaine)재불동온도하대인혈청중ALT매활성적은정작용,병평고첨가첨채감적인혈청재각검측계통중적기질효응.방법 혈청중첨가종농도위1 mol/L적첨채감,검측37 ℃、25 ℃、4 ℃、-20 ℃하방치불동시간적혈청중적ALT매활력.근거미국림상화실험실표준협회(CLSI)EP14-A문건진행기질효응실험,이4개피평개검측계통위피비교계통,이라씨공사시제-일립의기검측계통위비교계통,용비교계통화피평개계통검측40개환자혈청양품이급첨가료1 mol/L첨채감적3개혈청(고、중、저농도)양본적ALT매활력;용직선회귀방법통계수거,이회귀직선적(-Y)고계치(^/Y)적95%가신구간고계저3개첨가료첨채감적양품재4충검측계통중적기질효응.결과 37 ℃첨가첨채감적혈청48 h후ALT매활력은정위99%,대조혈청강지42%;25 ℃첨가첨채감적혈청4 d후ALT매활력은정위98%,대조혈청강지86%;4 ℃첨가첨채감적혈청4주후ALT매활력은정위97%,대조혈청1주후이강지71%;-20 ℃첨가첨채감적혈청4개월후ALT매활력은정위99%,대조혈청1개월후이강지79%.첨가료첨채감적3개양본적치균재회귀직선적(-Y)고계치(^/Y)적95%가신구간내,즉기재4개피평개계통화비교계통중균무명현기질효응.결론 첨채감가작위일개교호적혈청ALT매활력적은정제용우혈청매ALT적교준품적연제중.
Objective To investigate the stabilization of betaine on the enzyme activity of ALT in human serum at different temperatures, and to evaluate the matrix effects of human serum with betaine among different analytical systems. Methods The enzyme activity of ALT in human serums with l mol/L betaine stored at 37 ℃, 25 ℃, 4 ℃ and - 20 ℃ respectively were measured. The matrix effect experiment was carried out according to the procedures specified in Clinical and Laboratory Standards Institute (CLSI)document EP14-A. Four analytical systems were the candidates for evaluation, and Roche Diagnostics (Roche)-Hitachi analytical system served as the reference system. The enzyme activity of ALT of 40 patient specimens and 3-level specimens ( high, medium and low) with 1 mol/L betaine were measured using the evaluated methods and the reference method respectively. The linear regression analysis was performed to compare the mean y value of 3-level specimens with the statistically defined limits ( the two-tailed 95% prediction interval) derived from 40 patient specimen data. Results The enzyme activity of ALT could be stabilized with betaine in serum, which remained to be 99% for 48 h at 37 ℃, 98% for4 d at 25 ℃, 97%for 4 weeks at 4 ℃, and 99% for 4 months at - 20 ℃. The enzyme activity of control serum decreased to 42%, 86%, 71%, 79% respectively. The mean y values of three specimens with the betaine were within the 95% prediction interval of the estimated mean y values, which suggested no obvious matrix effects in serum. Conclusion Betaine can be used in the development of enzyme ALT calibrator as its stabilizer.