{"id":1844,"date":"2023-05-15T15:27:20","date_gmt":"2023-05-15T07:27:20","guid":{"rendered":"https:\/\/transnovo.com\/?p=1844"},"modified":"2023-06-02T13:52:23","modified_gmt":"2023-06-02T05:52:23","slug":"%e5%9b%bd%e5%86%85%e9%a6%96%e5%ae%b6%ef%bc%81fda%e6%89%b9%e5%87%86%e4%ba%91%e6%b3%bd%e8%87%aa%e4%b8%bb%e7%a0%94%e5%8f%91%e4%bb%96%e5%85%8b%e8%8e%ab%e5%8f%b8%e6%a3%80%e6%b5%8b%e8%af%95%e5%89%82","status":"publish","type":"post","link":"https:\/\/transnovo.com\/en\/news\/%e5%9b%bd%e5%86%85%e9%a6%96%e5%ae%b6%ef%bc%81fda%e6%89%b9%e5%87%86%e4%ba%91%e6%b3%bd%e8%87%aa%e4%b8%bb%e7%a0%94%e5%8f%91%e4%bb%96%e5%85%8b%e8%8e%ab%e5%8f%b8%e6%a3%80%e6%b5%8b%e8%af%95%e5%89%82\/","title":{"rendered":"First in China! FDA approves Yunze's self-developed tacrolimus test kit"},"content":{"rendered":"
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Preface<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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A few days ago, independently developed by Yunze BiologicalTacrolimus test kit<\/span>Approved by the FDA asThe first one in China to obtain both U.S. FDA and EU CE certificates.<\/span>The tacrolimus drug concentration test kit.<\/strong><\/p>\n

The development of this kit is based on the principle of latex-enhanced turbidimetric assay for small molecule competitive immunization, which requires only about 6 minutes for sample processing, and results are available within 10 minutes after sample loading, and at the same time, high throughput sample testing can be performed according to the high throughput characteristics of different biochemical analyzers.<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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FDA Approval Number<\/strong><\/section>\n<\/section>\n
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Tacrolimus (Tac), also known as FK506, belongs to the category of calmodulin phosphatase inhibitors and is currently the clinical first-line drug for anti-rejection after organ transplantation. However, it has a narrow therapeutic window, large individual differences in pharmacokinetics, and adverse effects such as nephrotoxicity and neurotoxicity, so blood concentration monitoring of tacrolimus is necessary.<\/p>\n

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Introduction to tacrolimus assay<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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Liquid chromatography tandem mass spectrometry (LC-MS\/MS) is the gold-standard method for drug concentration monitoring, but it is expensive, requires high equipment and operators, and is rarely carried out in domestic clinical laboratories at present. At this stage, FK506 blood drug concentration detection is mainly carried out by immunoassay, including chemiluminescence microparticle immunoassay and enzyme amplification immunoassay.<\/p>\n

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Advantages of Yunze tacrolimus test kit<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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In terms of detection performance, the tacrolimus test kit independently developed by Yunze Biologicals has consistent or better detection performance than the international authoritative FK506 test reagent in terms of detection sensitivity, precision, linearity, stability, detection throughput and time and other major parameters. Compared with Abbott Prokofo test kit, this product is simple in composition, short in detection time, and suitable for all types of open automatic biochemistry instruments.<\/p>\n

Meanwhile, the price of this product is about 30% lower than the imported kits overall, helping to reduce the financial burden of patients.<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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Tacrolimus test kit<\/strong><\/p>\n

FDA Repeatability Verification<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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For precision testing, intra-batch and inter-batch precision testing was performed on clinical samples and quality control samples, respectively. Sample testing at the same indoor location included 4 clinical samples and 3 QC samples, 2 batches were tested daily, and each batch of single samples was repeated 2 times for a total of 20 days. Sample testing at different locations was performed at three locations, including 3 clinical samples and 3 QC samples, with 2 batches tested daily and 3 repetitions of a single sample in each batch, for a total of 5 days.<\/p>\n

The results showed that the tacrolimus kit had good assay precision, with intra- and inter-lot coefficients of variation CVs of less than 10% for all samples from a single site and multiple sites.<\/span><\/strong><\/p>\n

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Tacrolimus test kit with Abbott<\/strong><\/p>\n

Comparison of the consistency of the results of mass spectrometry and<\/strong><\/p>\n<\/section>\n

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Two hundred and twenty-five clinical samples (106 kidney transplants, 119 liver transplants) were assayed on a biochemical platform using this kit and the results were compared for consistency with Abbott and LC-MS\/MS assays.Both comparisons demonstrated good agreement, with correlation coefficients greater than 0.98 with Abbott and LC-MS\/MS comparison results, as detailed in Figure 1-2 below.<\/span><\/strong><\/p>\n

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Figure 1. Comparison of Yunze tacrolimus kit and Abbott test results<\/span><\/strong><\/p>\n

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Fig. 2. Comparison of the results of Yunze tacrolimus kit and LC-MS\/MS assay<\/span><\/strong><\/p>\n

In addition to the Tacrolimus kit, the Yunze Drug Concentration Monitoring (TDM) kit can also be used to test clinically used immunosuppressants such as cyclosporine, rapamycin and mycophenolic acid.<\/p>\n

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The production of the above drug concentration test kits is carried out in a standardized production plant. The plant has two class 10,000 production workshops and one class 100,000 production workshop, and is equipped with modern production and inspection equipment, professional technical team and perfect production quality management system. All the kits have passed the ISO 13485 system certification, which is applicable to the medical device industry, formulated by the International Organization for Standardization (ISO).<\/p>\n

Swipe left and right to see more<\/span><\/p>\n<\/section>\n

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Yunze Biotechnology Co.<\/span><\/strong><\/p>\n

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Summary<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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  1. Yunze Tacrolimus test kit has the advantages of accuracy, rapidity, high automation, high throughput, low cost, etc. Compared with Abbott Prokofo test kit, the reagent composition of this kit is simple, and the test time is short. <\/li>\n
  2. The results of this kit are in good agreement with the immunoassay and LC-MS\/MS gold standard currently used in clinical practice. <\/li>\n
  3. The development of this kit is based on the latex turbidimetric assay platform, which can be used in conjunction with the widely available fully automated biochemistry instrument, realizing the substitution of imported kits, and providing accurate FK506 drug concentration detection for the majority of transplantation patients.<\/li>\n<\/ol>\n<\/section>\n<\/section>\n<\/section>\n
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    Scan the code to follow us<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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    Micro Signal\uff5cTx New Solution<\/p>\n

    Jianfeng Medicine, focus on transplant industry<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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    This article is from WeChat: Tx New Solutions<\/p><\/blockquote>\n<\/div>\n

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     <\/p>","protected":false},"excerpt":{"rendered":"

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