QuantideX® qPCR BCR-ABL IS Kit
Assessing complete molecular response requires the highest possible assay sensitivity. The FDA-cleared QuantideX® qPCR BCR-ABL IS Kit takes chronic myeloid leukemia (CML) monitoring to a new level of sensitivity – 0.002% IS (MR4.7). It’s a qPCR-based in vitro Diagnostic test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive CML patients expressing e13a2 and/or e14a2 fusion transcripts.
Features & Benefits
The QuantideX qPCR BCR-ABL IS Kit’s unprecedented level of sensitivity coupled to a simple-to-run, singlicate test, allows labs to reliably and reproducibly monitor much deeper molecular response.
Reduced ComplexityEase-of-data analysis and reporting:
- Direct reporting on the International Scale (IS): No sample exchange or conversion factor calculations required
- Data analysis software eliminates manual intervention to provide automated calculations and streamlined reporting
Optimized WorkflowValuable operator hands-on time has been significantly reduced through:
- Multiplexed design amplifies and detects both fusion and control gene in the same reaction
- All-inclusive reagents sourced and Quality Controlled together from a single vendor
- Pre-mixed reagents leading to fewer pipetting steps in the mastermix preparation
Quality PerformanceDetecting BCR-ABL Transcripts robustly, reliably with a highly sensitive assay:
- Limit of Detection (LOD) of MR4.7 (0.002%IS): 95% detection at LOD as determined using human RNA specimens
- Increased analytical sensitivity without compromising analytical specificity: Non-CML (major) transcripts not detected in assay
- Armored RNA®-based standards providing true RNA quantification for a quantitative RNA assay
- Robust performance as indicated by minimum variability of replicate measurements
Analytical Characteristics
- Proven sensitivity based on rigorous testing criterion (Table 1)
- Minimal variability across entire dynamic range of %IS values (Table 2)
- Multiplexed design leads to workflow and cost efficiency (Figure 1)
Proven Sensitivity Based on Rigorous Testing CriterionTable 1: LOD as determined by CLSI EP17-A2 guidelines by testing Human RNA dilutions ranging from MR4.4 to MR6: 60 replicates of each dilution for a total of 1680 data points
Minimal Variability Across Entire Dynamic Range of %IS ValuesTable 2: Precision evaluated by testing 5 different MR levels, using 3 operators, 9 runs for a total of 450 data points*The fold change column represents summarized data for clarification purpose only. To see full precision data, please refer to Table 4 of the Instruction for Use.
Multiplexed Design Leads to Workflow and Cost Efficiency
Figure 1: Comparison of a plate layout for 8 sample run on Asuragen plate (left) and an alternate non-multiplex assay (right): 19 reactions for Asuragen setup vs. 60-64 reactions on a non-multiplex assay setup
Additional Resources
Videos
Defining the Standard of Care: FDA-Cleared, Clinically Proven CML Monitoring at the MR 4.7 Level
Analytical Validation of a BCR-ABL1 Monitoring System that Surpasses Current Testing Requirements
Simple, Sensitive, and Scalable Patient Monitoring with the QuantideX® qPCR BCR-ABL IS Kit
Posters
BCR-ABL1 Monitoring on the IS Using a Clinically and Analytically Validated Multiplex Assay Directly Aligned to the WHO Primary Standards and that Unifies Reporting FormatsView full poster
Modifications to RNA Isolation Protocols Meet Requirements for Modern CML Monitoring of BCR-ABL1 Transcript LevelsView full poster
Validation of BCR-ABL1 Test Performance from Whole Blood Stored up to 72 Hours Facilitates Operational Flexibility and Expanding Locally Managed CML MonitoringView full poster
Publications
Establishment of the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL mRNA. White et. al. Blood. 2010;116(22):e111-7. doi: 10.1182/blood-2010-06-291641. Epub 2010 Aug 18
Establishment of a standardized multiplex assay with the analytical performance required for quantitative measurement of BCR-ABL1 on the international reporting scale. Brown et. al. Blood Cancer J. 2011;1(3):e13. doi: 10.1038/bcj.2011.10. Epub 2011 Mar 25
Establishment and validation of analytical reference panels for the standardization of BCR-ABL1 quantitative measurements on the international scale. White et. al. Clin Chem. 2013 Mar 7. [Epub ahead of print]
Browse all Publications
The test is not intended for the diagnosis of CML or for monitoring rare transcripts resulting from t(9;22).
Ordering
Product Name | Number of Reactions | Catalog Number |
---|---|---|
QuantideX® qPCR BCR-ABL IS Kit | 60 | 49574 |
T 1-877-777-1874; 512-681-5200 F 512-681-5202 E orders@asuragen.com
QuantideX® qPCR BCR-ABL IS Kit
There’s only one way to detect complete molecular response (CMR) – with a more sensitive assay. The QuantideX® qPCR BCR-ABL IS Kit takes chronic myeloid leukemia (CML) monitoring to a new level of sensitivity – 0.002% IS (MR4.7). It’s a qPCR-based in vitro Diagnostic test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive CML patients expressing e13a2 and/or e14a2 fusion transcripts.
Features & Benefits
The QuantideX qPCR BCR-ABL IS Kit provides labs with a robust and reliable method for monitoring leukemia patients, also allowing them to keep pace with the advances in TKI therapy.
Reduced ComplexityEase-of-data analysis and reporting:
- Direct reporting on the International Scale (IS): No sample exchange or conversion factor calculations required
- Data analysis software eliminates manual intervention to provide automated calculations and streamlined reporting
Optimized WorkflowValuable operator hands-on time has been significantly reduced through:
- Multiplexed assay design that amplifies and detects both fusion and control gene in the same reaction
- All-inclusive reagents sourced and Quality Controlled together from a single vendor
- Pre-mixed tubes leading to fewer pipetting steps in the mastermix preparation
Quality PerformanceDetecting BCR-ABL Transcripts robustly, reliably with a highly sensitive assay:
- Sensitivity of MR4.7 (0.002%IS): 95% positivity at this LOD as determined by testing human RNA specimens
- Increased sensitivity without compromising specificity: Non-CML (major) transcripts not detected by the assay
- Armored RNA based standards providing true RNA quantification for a quantitative RNA assay
- Robust performance as indicated by minimum variability of replicate measurements
Analytical Characteristics
- Proven sensitivity based on rigorous testing criterion (Figure 1)
- Minimal variability across the entire dynamic range of % IS values (figure 2)
- Multiplexed design leads to workflow and cost efficiency (figure 3)
Proven Sensitivity Based on Rigorous Testing Criterion
Figure 1: LOD as determined by CLSI EP17-A2 guidelines by testing Human RNA dilutions ranging from MR4.4 to MR6: 60 replicates of each dilution for a total of 1260 data points
Minimal Variability Across Entire Dynamic Range of %IS Values
Figure 2. Precision was evaluated by using 5 different levels of positive specimen, tested by 3 operators over 20 runs. Each level was tested 40 times to obtain Standard Deviations
Multiplexed Design Leads to Workflow and Cost Efficiency
Figure 3: Comparison of a plate layout for 8 sample run on Asuragen plate (left) and an alternate non-multiplex assay (right): 19 reactions for Asuragen setup vs. 60-64 reactions on a non-multiplex assay setup
Additional Resources
Videos
Defining the Standard of Care: FDA-Cleared, Clinically Proven CML Monitoring at the MR 4.7 Level
Analytical Validation of a BCR-ABL1 Monitoring System that Surpasses Current Testing Requirements
Simple, Sensitive, and Scalable Patient Monitoring with the QuantideX® qPCR BCR-ABL IS Kit
Posters
BCR-ABL1 Monitoring on the IS Using a Clinically and Analytically Validated Multiplex Assay Directly Aligned to the WHO Primary Standards and that Unifies Reporting FormatsView full poster
Modifications to RNA Isolation Protocols Meet Requirements for Modern CML Monitoring of BCR-ABL1 Transcript LevelsView full poster
Validation of BCR-ABL1 Test Performance from Whole Blood Stored up to 72 Hours Facilitates Operational Flexibility and Expanding Locally Managed CML MonitoringView full poster
Publications
Establishment of the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL mRNA. White et. al. Blood. 2010;116(22):e111-7. doi: 10.1182/blood-2010-06-291641. Epub 2010 Aug 18
Establishment of a standardized multiplex assay with the analytical performance required for quantitative measurement of BCR-ABL1 on the international reporting scale. Brown et. al. Blood Cancer J. 2011;1(3):e13. doi: 10.1038/bcj.2011.10. Epub 2011 Mar 25
Establishment and validation of analytical reference panels for the standardization of BCR-ABL1 quantitative measurements on the international scale. White et. al. Clin Chem. 2013 Mar 7. [Epub ahead of print]
Browse all Publications
The test is not intended for the diagnosis of CML or for monitoring rare transcripts resulting from t(9;22).
Ordering
Product Name | Number of Reactions | Catalog Number |
---|---|---|
QuantideX® qPCR BCR-ABL IS Kit | 60 | 86003 |
T 1-877-777-1874; 512-681-5200 F 512-681-5202 E orders@asuragen.com
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微球的制备方法是给药途径选择和控制药物释放的关键。目前,海藻酸钠微球的制备方法主要有乳化离子交联法、微乳法、复凝聚法、锐孔凝固浴法、静电滴法,以及对上述方法的改良制法等。
1.乳化离子交联法该法系指将药物与海藻酸钠溶液混合均匀后滴加至一定的油相中搅拌,制得W/O乳剂,然后加入离子交联剂交联固化,搅拌,分离得载药微球[4]。刘善奎等[5]利用此法制备了DNA疫苗海藻酸钠微球,李国明等[6]在交联固化后,继续与壳聚糖溶液反应制备了盐酸阿米替林海藻酸钠-壳聚糖微球。Ramesh等[7]改良此法,制备了利心平海藻酸钠-甲基纤维素(MC)共混微球,研究表明,随着微球中MC量的增加,微球的吸水性降低,MC的量与微球的释药速率有一定的关系,这类微球密度较低,可以在胃环境下保留12h以上,有效地提高了利心平的生物利用度。
2.微乳法此法系将一定量的海藻酸钠、药物溶于蒸馏水中搅拌互混,在超声和高速搅拌的条件下将一定量混合液逐滴加入到油相中,形成微乳体系。再将CaCl2溶液逐滴加入到上述混合液中,继续搅拌,进行洗涤,冷冻干燥保存,即得海藻酸钠载药微球。该法多用于磁性微球的制备,以获得粒径小、均匀、靶向性强的载药磁微球。颜秋平等[8]应用该法制得具强磁响应性和缓释效果的阿霉素磁性纳米微球,研究发现此微球粒径小,分散性好,具磁靶向功能,有望成为一种优良靶向肿瘤的药物载体。苏科等[9]对此法进行了进一步改良,在已获得的阿霉素磁性微球基础上,又加入水溶性二亚胺和单抗人转蛋白进行旋转混合,分离、冷冻干燥后获得了人转铁蛋白修饰海藻酸钠载阿霉素药物纳米微球(TDA)。此外,Chuah等[10]在此基础上改进,应用甲基纤维素乳化法联合外部凝胶法制得了大小均一的海藻酸钠微球。
3.复凝聚法由于海藻酸钠为阴离子聚合物,可与阳离子聚合物用复凝聚法制备复合微球。目前常用来与海藻酸盐复凝聚成球的主要有壳聚糖,此外还常与聚赖氨酸一起制备复合微球。这样得到的微球的膜壁强度较强,适合实际应用。此法系将海藻酸钠固体用蒸馏水溶解并分散均匀,加入表面活性剂,继续搅拌形成W/O型乳液。将壳聚糖以乙酸溶解,再加入CaCl2及药物于分液漏斗中,搅拌下逐滴加入到上述W/O型乳液中。加入戊二醛固化后,加正丁醇,充分振摇后放置,离心得沉淀物,即为壳聚糖-海藻酸钠载药微球。李柱来等[11]以壳聚糖-海藻酸钠为基质材料,在乳化体系中以复凝聚法制备头孢曲松微球,该微球具有良好的溶胀和缓释性能。王津等[12]应用复凝聚法制备了出球形度好,均匀圆整,粒径小,包封率较高,稳定性较好和具明显缓释作用的布洛芬壳聚糖-海藻酸钠缓释微球。
4.锐孔凝固浴法该法系将药物加入到海藻酸钠溶液中,搅拌均匀,将混合物通过注射器或微孔硅胶管滴入到CaCl2溶液中,搅拌固化,分离微球移至壳聚糖溶液中,继续搅拌交联,分离微球并用蒸馏水洗涤干燥后得载药微球。高春凤等[13]应用此法制得雷公藤多苷提取物壳聚糖-海藻酸钠缓释微球,研究表明海藻酸钠浓度、壳聚糖浓度、CaCl2浓度以及海藻酸钠和药物质量之比对包埋率、载药量和体外释放均有影响,而交联固化时间对包埋率和载药量有影响,对体外释放影响不明显。黄岚等[14]将阳离子-β环糊精聚合物(CP-β-CD)与胰岛素形成复合物后,制备了含有此复合物的海藻酸钠/壳聚糖微球系统,并应用于胰岛素口服系统,结果表明CP-β-CD的加入,能有效的提高胰岛素的包封率以及在模拟肠液中的释放,是一种非常有前景的胰岛素口服制剂的助剂。
5.静电滴法该法系将囊材与药液搅拌混合,搅拌条件下加进海藻酸钠溶液,在注射器推动力和电场力作用下,原料液滴入低温CaCl2溶液,
迅速固化,形成海藻酸钙凝胶微球,浸泡,清洗,真空避光室温干燥。谷继伟等[15]用此法制得粒径小于1mm的奥沙普秦壳聚糖-海藻酸钠缓释微球。
满意请采纳谢谢展开
最近想做小鼠微循环的检测,参照了DissectingtheEffectsofIschemiaandReperfusionontheCoronaryMicrocirculationinaRatModelofAcuteMyocardialInfarction这篇文献,想做荧光微球。但是不知道这个荧光微球具体该怎么用,要怎么处理,文献写的不详细,问了厂家也是不太清楚,希望有大神可以指点,提供详细些的实验步骤。多谢。
我理解就是一个是包裹,一个是镶嵌
各位老师,在用凝集法或去溶剂法制备BSA的纳米微球,查阅相关文献,使用100mg的BSA溶于10ml的去离子水中,配成1wt%的水溶液,然后在磁力搅拌下,以1ml/min或2ml/min的速度加入乙醇40ml。在加入过程中,溶液变成乳白色,然后在加入就逐渐变清凉,但同时有沉淀出现,请问各位实验过程有啥问题啊?采取哪些措施可以避免出现沉定?另外制备纳米颗粒的过程,对BSA有具体的要求吗
各位大侠,微球作为局部缓释药物,怎么储藏呢,微球不是散开的吗,怎么形成像凝胶状的呢
1、该制剂为肌肉注射;
2、制备该微球过程中用到了二氯甲烷、乙醇、正庚烷、二甲基硅油。国家药典有机溶剂残留规定:二氯甲烷残留限度为0.06%;乙醇残留限度为0.5%;正庚烷残留限度0.5%;二甲基硅油药典中还为収载。目前自制微球的二氯甲烷残留约0.2%左右,正庚烷残留1.0%左右,乙醇残留0.3%左右,二甲基硅油暂未检测。很明显:二氯甲烷和正庚烷超标。后来测了一下原研制剂的有机溶剂残留:二氯甲烷残留约0.1%左右,正庚烷残留1.5%左右,乙醇残留0.2%左右。本人也制剂新手,请各位大神帮帮忙,积极发言。我这个长效缓释PLGA微球制剂中有机溶剂残留限应该定多少合适,我后期优化工艺时对上述有机残留应该控制到多少一下合适。
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