上海医药
上海醫藥
상해의약
SHANGHAI MEDICAL & PHARMACEUTICAL JOURNAL
2015年
1期
30-32
,共3页
5’-核苷酸酶%诊断试剂%临床研究
5’-覈苷痠酶%診斷試劑%臨床研究
5’-핵감산매%진단시제%림상연구
5’-nucleotidase%clinical research%diagnostic reagent
目的：评价自主研发的5’-核苷酸酶试剂（速率法）在自动化检测血清或血浆中5’-核苷酸酶活性的应用。方法：采用奥林巴斯AU680全自动生化分析仪，通过重复性、线性试验、测定血清或血浆中5’-核苷酸酶活性，进行方法学评价并与美国Diazyme 5’-核苷酸酶试剂（速率法）比较。结果：两个水平质控中酶活性的变异系数（CV）分别为2.83%和1.96%，在5～200 U/L酶活范围内，线性良好。两种试剂测定血清5’-核苷酸酶活性的相关系数较好，相关系数r为0.995。结论：自主研发的5’-核苷酸酶试剂盒操作简便、快速、准确、稳定，结果准确，可满足大批量临床样本的常规和自动化分析，是一种值得推广的方法。
目的：評價自主研髮的5’-覈苷痠酶試劑（速率法）在自動化檢測血清或血漿中5’-覈苷痠酶活性的應用。方法：採用奧林巴斯AU680全自動生化分析儀，通過重複性、線性試驗、測定血清或血漿中5’-覈苷痠酶活性，進行方法學評價併與美國Diazyme 5’-覈苷痠酶試劑（速率法）比較。結果：兩箇水平質控中酶活性的變異繫數（CV）分彆為2.83%和1.96%，在5～200 U/L酶活範圍內，線性良好。兩種試劑測定血清5’-覈苷痠酶活性的相關繫數較好，相關繫數r為0.995。結論：自主研髮的5’-覈苷痠酶試劑盒操作簡便、快速、準確、穩定，結果準確，可滿足大批量臨床樣本的常規和自動化分析，是一種值得推廣的方法。
목적：평개자주연발적5’-핵감산매시제（속솔법）재자동화검측혈청혹혈장중5’-핵감산매활성적응용。방법：채용오림파사AU680전자동생화분석의，통과중복성、선성시험、측정혈청혹혈장중5’-핵감산매활성，진행방법학평개병여미국Diazyme 5’-핵감산매시제（속솔법）비교。결과：량개수평질공중매활성적변이계수（CV）분별위2.83%화1.96%，재5～200 U/L매활범위내，선성량호。량충시제측정혈청5’-핵감산매활성적상관계수교호，상관계수r위0.995。결론：자주연발적5’-핵감산매시제합조작간편、쾌속、준학、은정，결과준학，가만족대비량림상양본적상규화자동화분석，시일충치득추엄적방법。
Objective:To evaluate the application of the independent innovation reagent in the automatic determination of 5’-nucleotidase (5’-NT) activity in the clinical serum or plasma samples.Methods: 5’-NT activities were determined with Olympus AU680 automatic biochemical analyzer by repeatability and linearity tests, the evaluation of methodology was carried out and the results were compared with those determined by the reagent of Diazyme Laboratories.Results: The coefficients of variation (CV) of the enzyme activity at two levels of quality control were 2.83% and 1.96%. The determination of enzyme activity showed a good linearity over the range of 5~200 U/L. There was a good correlation between two reagents (r=0.995). Conclusion:The 5’-nucleotidase reagent made by our company can provide a simple, quick, accurate and stable method for the determination of 5′-NT activity in the clinical serum or plasma samples and meet the requirement of the automated analysis of mass clinical samples. This method may be worthy of promotion.
