β2-微球蛋白质控品产品技术要求baiding

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β2-微球蛋白测定试剂盒(免疫比浊法)产品技术要求北检

β2-微球蛋白测定试剂盒（免疫比浊法）-微球蛋白的含量。

适用范围：本产品用于体外定量测定人血清或尿液中β21.1 规格具体产品规格见下表:1.2 组成成分1.2.1 试剂的组成试剂1：缓冲液0.1mol/L试剂2：缓冲液0.1mol/L-MG抗体的胶乳颗包被有β2粒0.12% 1.2.2 校准品的组成（选配）-微球蛋白血清：在水中添加β2水平1：β-微球蛋2白 (0.50～2.00) mg/L水平2：β-微球蛋2白 (2.00～4.00) mg/L -微球蛋水平3：β2白 (4.00～8.00) mg/L水平4：β-微球蛋白 (8.00～216.00) mg/L水平5：β-微球蛋白 (16.00～220.00) mg/L-微球蛋白尿液：在水中添加β2水平1：β-微球蛋2白 (0.05～0.25) mg/L水平2：β-微球蛋2白 (0.10～0.50) mg/L -微球蛋水平3：β2白 (0.25～1.00) mg/L -微球蛋水平4：β2白 (0.50～2.00) mg/L -微球蛋水平5：β2白 (1.00～3.00) mg/L1.2.3 质控品的组成（选配）血清：-微球蛋水平1：β2白 (0.50～2.00) mg/L -微球蛋白 (2.01～水平2：β220.00) mg/L该血清质控品为血清基质质控品尿液：水平1：β-微球蛋2白 (0.03～0.30) mg/L水平2：β-微球蛋2白 (0.31～3.00) mg/L该尿液质控品为水基质质控品校准品、质控品有批特异性，具体靶值见靶值表。

2.1 外观2.1.1 外包装完整无破损；2.1.2 试剂1：无色澄清透明液体；2.1.3 试剂2：乳白色悬浊液体；2.1.4 校准品：无色或淡黄色澄清透明液体；2.1.5 质控品：无色或淡黄色澄清透明液体。

2.2 净含量净含量不低于标示值。

2.3 试剂空白吸光度在主波长570nm、副波长800nm、37℃条件下，试剂空白吸光度不大于1.5。

β2-微球蛋白(β2-MG)测定试剂盒(化学发光免疫分析法)产品技术要求北方

β2-微球蛋白（β2-MG）测定试剂盒（化学发光免疫分析法）
适用范围：用于体外定量测定人血清、尿样中β
2-微球蛋白（β
2
-MG）的含量。

1.1包装规格
本试剂盒包装规格为96人份/盒，具体组成见表1：
表1 试剂盒主要组成成分
2.1物理性能
试剂盒液体组分应澄清透明、无沉淀或絮状物，包被抗体板的真空封袋应无破损漏气现象。

各组分装量不少于表1中要求。

2.2准确性
回收率应在90%~110%范围内。

2.3线性
用百分结合率对数（Log-Logit）数学模型拟合，在0.02~10µg/ml范围内，剂量-反应曲线相关系数（r）应不低于0.9900。

2.4精密度
2.4.1分析内精密度（CV%）应不高于15.0%。

2.4.2批间精密度（CV%）应不高于20.0%。

2.5空白检测限
应不高于0.010μg/ml。

2.6特异性
2.7稳定性
将试剂盒在2～8℃放置12个月，测定结果应符合上述2.1~2.6项要求。

β2-微球蛋白测定试剂盒(免疫比浊法)技术要求

β2-微球蛋白测定试剂盒（免疫比浊法）技术要求1、产品型号/规格及其划分说明2.1外观试剂1为无色澄清液体，试剂2为微黄色或乳白色液体。

试剂盒标签标识清晰，外包装完整无损。

2.2装量不少于瓶签标示量。

2.3试剂空白在540nm（500～600nm）处测定试剂空白吸光度，应≤0.80。

2.4分析灵敏度测试3mg/L的被测物时，吸光度变化：0.01≤△A≤0.4。

2.5准确度待检系统与比对系统测值的相关系数r≥0.975；血清/血浆：在（0，5）mg/L区间内，绝对偏差不超过±0.75mg/L；在[5，18] mg/L区间内，相对偏差不超过±15%。

尿液：在（0，2）mg/L区间内，绝对偏差不超过±0.3mg/L；在[2，5.5]mg/L区间内，相对偏差不超过±15%。

2.6线性2.6.1血清/血浆：在（0，18]mg/L区间内，线性相关系数r≥0.990；尿液：在（0，5.5]mg/L区间内，线性相关系数r≥0.990；2.6.2血清/血浆：在（0，5)mg/L区间内，线性绝对偏差不超过±0.75mg/L；在[5，18]mg/L区间内，线性相对偏差不超过±15%。

尿液：在（0，2)mg/L区间内，线性绝对偏差不超过±0.3mg/L；在[2，5.5]mg/L区间内，线性相对偏差不超过±15%。

2.7精密度2.7.1重复性检测高、中、低三个浓度水平的样本，变异系数CV不大于5%。

2.7.2批间差随机抽取三批试剂盒，测试同一份样本，批间极差不大于10%。

2.8稳定性该产品在2℃～8℃条件下贮存有效期为12个月，取效期末的产品进行检测，应符合2.1、2.3、2.4、2.5、2.6、2.7.1的要求。

9076-16 快速试剂盒-B2-微球蛋白使用说明书

DIAGNOSTIC AUTOMATION, INC.23961 Craftsman Road, Suite D/E/F,Calabasas, CA 91302Tel: (818) 591-3030 Fax: (818) 591-8383See external label 2°C-8°C Σ=96 tests Cat # 9076-16CHEMILUMINESCENCEENZYME IMMUNOASSAY (CLIA)BETA-2 MICROGLOBULIN (B2MG)B2-MicroglobulinCat # 9076-16Enzyme Immunoassay for the Quantitative Measurement ofBeta-2 Microglobulin (B2MG) Human Serum.INTRODUCTION OF CHEMILUMINESCENCE IMMUNOASSAY Chemiluminescence Immunoassay (CLIA) detection using Microplate luminometers provides a sensitive, high throughput, and economical alternative to conventional colorimetric methodologies, such as Enzyme-linked immunosorbent assays (ELISA).ELISA employs a label enzyme and a colorimetric substrate to produce an amplified signal for antigen, haptens or antibody quantitation. This technique has been well established and considered as the technology of choice for a wide variety of applications in diagnostics, research, food testing, process quality assurance and quality control, and environmental testing. The most commonly used ELISA is based on colorimetric reactions of chromogenic substrates, (such as TMB) and label enzymes.Recently, a chemiluminescent immunoassay has been shown to be more sensitive than the conventional colorimetric method(s), and does not require long incubations or the addition of stopping reagents, as is the case in some colorimetric assays. Among various enzyme assays that employ light-emitting reactions, one of the most successful assays is the enhanced chemiluminescent immunoassay involving a horseradish peroxidase (HRP) labeled antibody or antigen and a mixture of chemiluminescent substrate, hydrogen peroxide, and enhancers.The CLIA Kits are designed to detect glow-based chemiluminescent reactions. The kits provide a broader dynamic assay range, superior low-end sensitivity, and a faster protocol than the conventional colorimetric methods. The series of the kits covers Thyroid panals, such as T3, T4, TSH, Hormone panals, such as hCG, LH, FSH, and other panals. They can be used to replace conventional colorimetric ELISA that havebeen widely used in many research and diagnostic applications. Furthermore, with the methodological advantages, Chemiluminescent immunoassay will play an important part in the Diagnostic and Research areas that ELISAs can not do.The CLIA Kits have been validated on the MPL2 microplate luminometer from Berthold Detection System, Lus2 microplate luminometer from Anthos, Centro LB960 microplate luminometer from Berthold Technologies, and Platelumino from Stratec Biomedical Systems AG. We got acceptable results with all of those luminometers.INTRODUCTION OF B2 MG IMMUNOASSAYBeta-2-microglobulin (β2-MG) is expressed by the nucleated cells of the body and on many tumor lines. Human β2-MG is a low molecular weight protein (MW 11600) consisting of a single polypeptide chain of 99 amino acids. It is identical to the small chain of the HLA-A, -B, and -C major histocompatibility complex antigens. In structure and amino acid sequence, it resembles the CH3 region of IgG, though it is antigenically distinct.β2-MG is eliminated via the kidneys. After filtration through the glomeruli, it is reabsorbed and catabolized by the proximal tubular cells through endocytosis. It is found at low levels in the serum andurine of normal individuals. Typically only trace amounts of β2-MGare excreted in the urine and higher rates are interpreted as evidence of tubular dysfunction. Urinary excretion is markedly increased in tubulointerstitial disorders, and where aminoglycosides and anti-inflammatory compounds are present. β2-MG is also excreted in increased amounts in the urine of patients with upper urinary tract infections10 and connective-tissue diseases such as rheumatoid arthritis and Sjogren’s syndrome.Elevated serum concentrations in the presence of normal glomerular filtration rate suggest increased β2-MG production or release. In patients with rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis and some viral diseases including cytomegalovirus, non-A and non-B hepatitis and infectious mononucleosis, the β2-MG serum level changes in relation to disease activity.TEST PRINCIPLEThe B2 MG EIA test is a solid phase two-site immunoassay. One monoclonal antibody is coated on the surface of the microtiter wells and another monoclonal antibody labeled with horseradish peroxidase is used as the tracer. The B2 MG molecules present in the standard solution or serum are "sandwiched" between the two antibodies. Following the formation of the coated antibody-antigen-antibody-enzyme complex, the unbound antibody-enzyme labels are removed by washing. The horseradish peroxidase activity bound in the wells is then assayed by adding the substrate reagents and undergoing the chemiluminescent reactions. The intensity of the emitting light from the associated well is proportional to the amount of enzyme present and is directly related to the amount of B2 MG antigen in the sample. By reference to a series of B2 MG standards assayed in the same way, the concentration of B2 MG in the unknown sample is quantified.MATERIALS AND COMPONENTSMaterials provided with the test kits:1. Anti-B2 MG antibody coated 96 well microtiter plate.2. Sample Diluent, 100 ml.3. Enzyme conjugate reagent, 22 ml.4. B2 MG reference standards, containing 0, 0.5, 2.0,5.0, 10 and20 µg/ml B2 MG, 1:100 prediluted liquid, ready for use.5. 50x Wash Buffer Concentrate, 15 ml6. Chemiluminescence Reagent A, 6.0 ml7. Chemiluminescence Reagent B, 6.0 mlMaterials required but not provided:1. Distilled water.2. Precision pipettes: 0.5~10µl, 0.05~ 0.2ml,1.0ml3. Disposable pipette tips.4. Glass tube or flasks to mix Reagent A and B.5. Microtiter well luminometer.6. Vortex mixer or equivalent.7. Absorbent paper.8. Graph paper.REAGENT PREPARATION1. To prepare substrate solution, make a 1:1 mixing of Reagent A with Reagent B right before use. Mixgently to ensure complete mixing. Discard excess after use.2. Dilute 1 volume of Wash Buffer (50x) with 49 volumes of distilled water. For example, Dilute 15 ml ofWash Buffer (50x) into 735 ml of distilled water to prepare 750 ml of washing buffer (1x). Mix well before use.ASSAY PROCEDUREImportant Note:The B2 MG standards have already been prediluted and are ready for use. Please DO NOT dilute again!1. Patient serum and control serum should be diluted, 101 fold, before use. Prepare a series of smalltubes (such as 1.5 ml microcentrifuge tubes)and mix 10 µl serum with 1.0 ml Sample Diluent.2. Secure the desired number of coated wells in the holder. Dispense 5µl of B2MG standards, dilutedspecimens, and diluted controls into appropriate wells. Dispense 200 µl Sample Diluent. Gently mix for 20 seconds.3. Incubate at 37°C for 30 min.4. Remove the incubation mixture by emptying the plate content into a waste container.5. Rinse and flick the microtiter wells 5 times with washing buffer(1X).6. Strike the wells sharply onto absorbent paper to remove residual water droplets.7. Dispense 200µl of enzyme conjugate reagent into each well.Gently mix for 10 seconds.8. Incubate at 37°C for 30 min.9. Remove the contents and wash the plate as described in step 4, 5 and 6 above.10. Dispense 100µl Chemiluminescence substrate solution into each well. Gently mix for 5 seconds.11. Read wells with a chemiluminescence microwell reader 5 minuters later. (between 5 and 20 min. afterdispensing the substrates).Important Note:1. The wash procedure is critical. Insufficient washing will result in poor precision and falsely elevatedabsorbance readings.2. It is recommended that no more than 32 wells be used for each assay run, if manual pipetting is used,since pipetting of all standards, specimens and controls should be completed within 5 minutes. A full plate of 96 wells may be used if automated pipetting is available.3. Duplication of all standards and specimens, although not required, is recommended. CALCULATION OF RESULTS1. Calculate the average read relative light units (RLU) for each set of reference standards, control, andsamples.2. We recommend using proper software to calculate the results. The best curve fitting used in theassays are 4-parameter regrassion or cubic spline regaression. If the software is not available,construct a standard curve by plotting the mean RLU obtained for each reference standard against B2 MG concentration in µg/ml on linear graph paper, with RLU on the vertical (y) axis and concentration on the horizontal (x) axis.3. Using the mean absorbance value for each sample, determine the corresponding concentration of B2MG in µg/ml from the standard curve.EXAMPLE OF STANDARD CURVEResults of a typical standard run are shown below. This standard curve is for the purpose of illustration only, and should not be used to calculate unknowns. It is required that running assay together with a standard curve each time. The calculation of the sample values must be based on the particular curve, which is runing at the same time.B2 MG (µg/ml) Relative Light Units (RLU)(105)0 0.050.5 0.632 2.135 4.2410 7.7720 9.52EXPECTED VALUES AND SENSITIVITYHealthy individuals are expected to have B2MG values below 2.0 µg/mL.REFERENCES1. Berggard I and Beam AG: 1968. Isolation and properties of a low molecular weight ß2-globulinoccurring in human biological fluids. J Biol Chem 243: 4095-4103.2. Grey HM, Kubo RT, Colon SM, Poulik MD, Cresswell P, Springer T, Turner M and Strominger JL: 1973. he small subunit of HL-A antigens is ß2-microglobulin. J Exp Med 138: 1608-1612.3. Nakamuro K, Tanigaki N and Pressman D: 1973. Multiple common properties of human ß2-icroglobulin and the common portion fragment derived from HL-A antigen molecules. Proc Natl AcadSci 70: 2863-2865.4. Evrin PE and Wibell L: 1972. The serum levels and urinary excretion of ß2-microglobulin in apparentlyhealthy subjects. Scand J Clin Lab Invest 29: 69-74.5. Crisp AJ, Coughlan RJ, Mackintosh D, Clark B and Panayi, GS: 1983. ß2-microglobulin plasma levelsreflect disease activity in rheumatoid arthritis. J Rheumatol 10: 954-956.Date Adopted : Reference No.2007-07-21 DA-B2-Microglobulin-2009DIAGNOSTIC AUTOMATION, INC.23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302Tel: (818) 591-3030 Fax: (818) 591-8383ISO 13485-2003Revision Date: 02/16/09。

β2-微球蛋白(β2-MG)测定标准操作程序

β2-微球蛋白（β2-MG）测定标准操作程序1.摘要β2-微球蛋白检测常用于肾功能指标的监控.2.适用范围程序适用于日立7600自动生化分析仪检测血清、血浆中β2-MG的浓度。

3.职责使用日立7600自动生化分析仪进行测定β2-微球蛋白浓度的工作人员要严格按照本SOP 程序进行,室负责人监督管理；本SOP的改动，可由任一使用本SOP的工作人员提出，并报经生化室负责人、科主任签字批准生效。

4.检测方法上海科华生物工程股份有限公司生产的β2--微球蛋白（β2--MG）试剂盒采用的是乳胶增强免疫透射比浊法。

5.原理待测样本中β2微球蛋白（β2-MG）与试剂中包被于聚苯乙烯粒子上的β2-MG抗体结合，形成不溶性免疫复合物，该免疫复合物由于包被的聚苯乙烯粒子而使浊度进一步放大，在抗β2-MG抗体足量的情况下，其浊度与样本中β2-MG含量成一定比例关系，与相同条件下操作的校准品比较，通过剂量/反应曲线求出样本中β2-MG的含量。

6.仪器日立7600自动生化分析仪7.试剂7.1试剂来源：上海科华生物工程股份有限公司提供7.2试剂瓶内主要成分：缓冲液、PEG、防腐剂、包被了抗β2-MG抗体的乳胶颗粒7.3试剂稳定性：试剂避光保存于2-8℃，若无污染，可稳定至失效期，本试剂有效期为12个月。

试剂不可冰冻。

7.4试剂准备：试剂为即用式。

8.标准品和质量控制8.1校准程序：使用上海科华公司提供的标准品对自动分析仪进行校准。

按照公司标准品使用要求，并以9g/L氯化钠溶液或去离子水为空白，经校准测定，仪器自动对标准品响应量通过合适的数学模型绘制校准曲线。

8.2质控品：上海科华公司提供的质控血清做为室内质控品。

每日在测定前做一次质控。

该质控品为液体？？包装，在2-8℃冰箱可稳定到失效期。

8.3质控数据管理：按程序对检验后的质控后结果进行转换，及时质控数据进行分析处理，如出现失控值，应及时分析失控原因，并填写好相关失控记录。

β2-微球蛋白校准品产品技术要求lideman

β2-微球蛋白校准品
适用范围：与北京利德曼生化股份有限公司的β2微球蛋白试剂盒配套使用，用于检测系统的校准。

1.1 规格
校准品：1×1mL、校准品稀释液：1×3mL。

1.2 主要组成成分
校准品：单水平的液体校准品，β2微球蛋白抗原，Tris缓冲液（50mmol/L，pH=7.5），叠氮钠稳定剂<0.1%，靶值浓度范围：（4～30）mg/L。

校准品稀释液：Tris缓冲液（50mmol/L，pH=7.5），叠氮钠稳定剂<0.1%。

溯源：β2微球蛋白校准品可溯源至国际参考物质B2M（NIBSC）。

定值：定值浓度详见瓶签。

2.1外观
校准品及稀释液：无色至浅黄色澄清液体。

2.2 装量
液体试剂的净含量不得低于标示体积。

2.3准确度
用校准品配合试剂检测有证参考物质B2M（NIBSC），测定值与参考物质标示值的相对偏差应在±10%范围内。

2.4重复性
β2微球蛋白校准品批内变异系数CV＜10%。

2.5 溯源性
根据GB/T 21415及有关规定提供校准品的来源、赋值过程及测量不确定度等内容，β2微球蛋白校准品溯源至国际参考物质B2M（NIBSC）。

2.6稳定性
2.6.1效期稳定性
校准品在（2～8）℃条件下保存，有效期为12个月。

在效期满后检测，应符合2.1、2.3、2.4的要求。

2.6.2开瓶稳定性
校准品开瓶后，在（2～8）℃密封避光保存，可以稳定14天，在第15天进行检测，相对偏差应在±10%范围内。

微球蛋白(β2-MG)免疫均相发光检测试剂盒说明书

微球蛋白（β2-MG）免疫均相发光检测试剂盒说明书1β2-微球蛋白（β2-MG）免疫均相发光检测试剂盒说明书方法学：单线态氧传递均相发光免疫分析（双抗体夹心）剂型：液体双试剂【产品名称】通用名称：β2-微球蛋白（β2-MG）免疫均相发光检测试剂盒商品名称；β2-微球蛋白（β2-MG）免疫均相发光检测试剂盒英文名称：Luminescent oxygen channeling immunoassay to detect Beta2 MG)detection kit【预期用途】本试剂用于人体血清或尿液内的β2-微球蛋白体外定量测定，做辅助肾脏疾病.肿瘤疾病.病毒感染及自身免疫等疾病的诊断用。

【检验原理】特异性抗体包被受体微球和生物素标记抗体组成检测体系，将待检标本加入体系温育，待检抗原于液相中分别与两种抗体结合，于受体微球表面形成捕获抗体-待检抗原-生物素标记抗体复合物，链霉亲和素包被供体微球（通用试剂）与生物素结合，供体微球和受体微球相互靠拢，激发光照射诱导单线态氧的产生和传递，产生荧光信号，荧光信号的强度与待检抗原含量呈正向函数关系。

根据标准品建立计量-反应曲线并建立数学模型，求出β2-微球蛋白浓度。

图1.双抗体夹心分析模式 LOCI 分析原理示意图1【测试参数】方法：单线态氧传递均相发光免疫分析（双抗体夹心）波长：615nm温度：37℃样品：新鲜无溶血现象的血清检测范围：0-0.1mg/ml【主要组成成分】试剂1（A）抗人β2-微球蛋白抗体包被的受体球1 mg/ml试剂2（B）生物素化抗人β2-微球蛋白抗体试剂3（D）链酶亲和素标记的供体球【试剂制备】即用型液体试剂，无需制备。

【样本要求】新鲜无溶血的血清。

血清.尿液样品在20~25℃可稳定2 天；2~8℃可稳定7 天；-20℃可保存3 个月。

【检验方法】加入试剂 A.试剂 B 液.样本各25μl，充分混匀，上机器37℃震荡温育15min。

避光加入125μl 试剂 D 液，充分混匀，上机器37℃震荡混匀10min。

β2-微球蛋白测定试剂盒(胶乳免疫比浊法)产品技术要求迪迈

β2-微球蛋白测定试剂盒（胶乳免疫比浊法）-微球蛋白浓度。

适用范围：本试剂盒用于体外定量测定人血清或尿液中β21.1 包装规格试剂1：1×40ml；试剂2：1×10ml试剂1：2×40ml；试剂2：1×20ml试剂1：1×60ml；试剂2：1×15ml试剂1：1×80ml；试剂2：1×20ml试剂1：3×80ml；试剂2：3×20ml试剂1：4×60ml；试剂2：3×20ml试剂1：2×80ml；试剂2：2×20ml试剂1：4×60ml；试剂2：4×15ml试剂1：4×60ml；试剂2：1×60ml试剂1：2×40ml；试剂2：2×10ml试剂1：8×60ml；试剂2：2×60ml试剂1：2×60ml；试剂2：2×15ml2.1 外观试剂1应无色澄清、无异物；试剂2应呈乳白色、无异物。

2.2 净含量试剂的净含量不少于标称装量。

2.3 试剂空白吸光度用生理盐水作为样本加入试剂测试时，试剂空白吸光度应＜1.200A。

2.4 分析灵敏度β-MG含量为2.5mg/L时，测定吸光度差值的绝对值应＞0.005△A。

22.5 检出限试剂（盒）检出限应≤0.25mg/L。

2.6 线性区间试剂（盒）线性在[0.5,18.0]mg/L区间内：2.6.1 线性相关系数（r）应不小于0.9900；2.6.2 [0.5,2.0]mg/L区间内，线性绝对偏差不超过±0.4mg/L；(2.0,18.0]mg/L 区间内，线性相对偏差不超过±20%。

2.7 精密度2.7.1 重复性分别用（0.8±0.08）mg/L、（2.0±0.2）mg/L和（4.0±0.4）mg/L 三个浓度的样本，各重复检测10次，其变异系数（CV）应不大于10%。

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β2-微球蛋白质控品
适用范围：与本公司生产的β2-微球蛋白测定试剂盒（免疫比浊法）配套使用，用于β2-微球蛋白的室内质量控制。

1. 产品型号/规格及其划分说明
0.5ml×2（液体，2水平）。

产品组成
磷酸盐缓冲液，浓度：20mmol/L；BSA，浓度：1g/L；
水平1：重组β2-微球蛋白，目标浓度范围：1.2mg/L-1.8mg/L；
水平2：重组β2-微球蛋白，目标浓度范围：3.5mg/L-4.5mg/L。

2.1 外观
2.1.1 试剂为液体,无色至淡黄色，无可见不溶物。

2.1.2 包装外观应整洁，标签字迹清晰，不易脱落。

2.2 装量
净含量不少于标示值。

2.3 赋值有效性
测试结果在质控范围内。

2.4 批内重复性
CV≤5%。

2.5 稳定性
2.5.1 开瓶稳定性
产品首次开封后2℃～8℃避光保存可稳定3天，稳定期过后4小时内进行测试，应符合2.3要求。

2.5.2 效期稳定性
原装产品在2℃～8℃避光保存，有效期12个月。

有效期满后1个月内测试结果应符合2.1、2.3和2.4要求。