乳酸脱氢酶测定试剂盒（乳酸底物法）

乳酸脱氢酶测定试剂盒（乳酸底物法）

贝克曼库尔特实验系统（苏州）有限公司

苏械注准20162400337

苏州工业园区苏虹西路181号

2021-04-22

2025-06-30

R1：甲基葡萄糖胺 127.0 g/L， 乳酸锂 9.60 g/L。 R2：β-烟酰胺腺嘌呤二核苷酸 26.5 g/L

用于体外定量检测人血清中的乳酸脱氢酶的含量。

2021-04-22产品储存条件和/或有效期变更 由“未开封的试剂贮存于2–8℃，其稳定性可达瓶子标签上所注明的效期（18个月）。开封后，在不超过效期的情况下，在仪器上可保持稳定30天。”变更为“未开封的试剂贮存于2–8℃，其稳定性可达瓶子标签上所注明的效期（18个月）。开封后，在不超过效期的情况下，在仪器上可保持稳定21天。”对产品说明书和/或产品技术要求中文字的修改，但不涉及技术内容的变更 由“说明书：【检验方法】3.仪器校准：使用贝克曼库尔特AU生化分析系统专用校准品（Cat. No. 66300）。在按照优良实验室规范 （GLP）进行校准之后，应立即进行质量控制程序。校准品值可溯源到IFCC 参考方法和 IRMM/IFCC-453。在更换分析仪的关键部件时，建议重新进行校准。在换用新批次的试剂时，建议进行试剂空白测定。5.数据计算：贝克曼库尔特AU生化分析系统自动计算各样本乳酸脱氢酶浓度。【参考文献】1.tThomas L. Lactate dehydrogenase (LD).In: Thomas L, ed. Clinical laboratory diagnostics. Use and assessment of clinical laboratory results. Frankfurt/ Main: THBooks Verlagsgesellschaft, 1998:89-94.2.tTietz NW, ed. Clinical guide to laboratory tests, 3rd ed. Philadelphia:WB Saunders Company,1995:385pp.3.tMoss DW, Henderson RA.Clinical enzymology.In: Burtis CA, Ashwood ER, eds.Tietz textbook of clinical chemistry. Philadelphia: WB Saunders Company, 1999;668-673.4.tBais R, Philcox M. International Federation of Clinical Chemistry (IFCC) Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes. Part 8. IFCC method for lactate dehydrogenase. Eur J Clin Chem Clin Biochem 1994;32:639-55.5.tEhret W, Heil W, Schmitt Y, T？pfer G, Wisser H, Zawta B, et al.Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood, Plasma and Serum Samples.WHO/DIL/LAB/99.1 Rev.2:36pp.6.tSchumann G, Klauke R. New IFCC reference procedures for the determination of catalytic activity concentrations of five enzymes in serum:preliminary upper reference limits obtained in hospitalised subjects. Clin Chim Acta 2003;327:69-79.7.tPainter PC, Cope JY, Smith JL.Reference information for the clinical laboratory.In:Burtis CA, Ashwood ER, eds.Tietz textbook of clinical chemistry.Philadelphia:WB Saunders Company, 1999;1822pp.8.tYoung DS.Effects of drugs on clinical laboratory tests, 5th ed. AACC Press, 2000. 9.tTietz, N. W., Clinical Guide to Laboratory Tests, 3rd Edition, W. B. Saunders, Philiadelphia, PA 1995.”变更为“说明书：【检验方法】3.仪器校准：使用贝克曼库尔特AU生化分析系统专用校准品（Cat. No. 66300）。在按照优良实验室规范 （GLP）进行校准之后，应立即进行质量控制程序。校准品值可溯源到IFCC 参考方法和 IRMM/IFCC-453。对分析仪进行了重要的预防性维护或更换了关键部件，请重新进行校准。换瓶，换试剂批次或质控值显著变化时，请重新进行校准。5.数据计算：贝克曼库尔特AU生化分析系统自动计算各样本乳酸脱氢酶活性。【参考文献】1.tThomas L. Lactate dehydrogenase (LD).In: Thomas L, ed. Clinical laboratory diagnostics. Use and assessment of clinical laboratory results. Frankfurt/ Main: THBooks Verlagsgesellschaft, 1998:89-94.2.tTietz NW, ed. Clinical guide to laboratory tests, 3rd ed. Philadelphia:WB Saunders Company,1995:385pp.3.tMoss DW, Henderson RA.Clinical enzymology.In: Burtis CA, Ashwood ER, eds.Tietz textbook of clinical chemistry. Philadelphia: WB Saunders Company, 1999;668-673.4.tBais R, Philcox M. International Federation of Clinical Chemistry (IFCC) Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes. Part 8. IFCC method for lactate dehydrogenase. Eur J Clin Chem Clin Biochem 1994;32:639-55.5.tEhret W, Heil W, Schmitt Y, T？pfer G, Wisser H, Zawta B, et al.Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood, Plasma and Serum Samples.WHO/DIL/LAB/99.1 Rev.2:36pp.6.tSchumann G, Klauke R. New IFCC reference procedures for the determination of catalytic activity concentrations of five enzymes in serum:preliminary upper reference limits obtained in hospitalised subjects. Clin Chim Acta 2003;327:69-79.7.tPainter PC, Cope JY, Smith JL.Reference information for the clinical laboratory.In:Burtis CA, Ashwood ER, eds.Tietz textbook of clinical chemistry.Philadelphia:WB Saunders Company, 1999;1822pp.8.tYoung DS.Effects of drugs on clinical laboratory tests, 5th ed. AACC Press, 2000.”

苏州工业园区苏虹西路181号

R1:4×40mL+R2:4×20mL

未开封的试剂贮存于2–8℃，其稳定性可达瓶子标签上所注明的效期（18个月）。开封后，在不超过效期的情况下，在仪器上可保持稳定21天。

第二类

原注册证号苏械注准20162400337。