1.Research on Application of Intelligent Tracing System for IVD Reagents Based on Blockchain Technology.
Ya GONG ; Qiuxia SHI ; Deling DUAN ; Zhiqiang LIU
Chinese Journal of Medical Instrumentation 2021;45(1):105-108
In recent years, the IVD industry has developed rapidly based on the increasing market demand, and plays an important role in disease prevention, clinical diagnosis, health monitoring and guiding treatment. Therefore, followed quality and safety issues are highly concerned. The unique advantages of blockchain technology, decentralization, distrust and non-tampering, can write into trusted node data in every link covering production, circulation and usage of IVD reagents, and establish a distributed ledger with full backup, which makes the anti-conterfeiting and traceability for IVD reagents possible. We discuss whole process intelligent tracing system for IVD reagents based on blockchain technology. Through the strong mechanism of pre-supervision and post-punishment, the source of reagents can be traced, quality and responsibility can be investigated, and the medical inspection quality and diagnostic safety can be guarded.
Blockchain
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Indicators and Reagents
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Reagent Kits, Diagnostic
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Technology
2.Analysis of Class II Common Problems in the Registration of
Xiaohe YANG ; Qinfang DONG ; Wenwu ZHU ; Hui ZHEN
Chinese Journal of Medical Instrumentation 2020;44(6):537-540
From the perspective of technical review, this paper made statistics on the supplement contents of
Chemistry, Clinical/standards*
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China
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Indicators and Reagents
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Reagent Kits, Diagnostic/standards*
3.Analysis of Quality Management of in Vitro Diagnostic Reagent Clinical Trials.
Man LYU ; Dunyao BAI ; Luan CHEN ; Jieli LUO
Chinese Journal of Medical Instrumentation 2020;44(5):436-438
Clinical trial is an important step of in vitro diagnostic reagents research and development. Based on the Guiding Principles and the key points of inspect on the spot, combined with the actual work experience, the article focuses on the prominent problems in the whole process of in vitro diagnostic reagent clinical trials. It is helpful to improve the level of hospital drug clinical trial centre and the quality of in vitro diagnostic reagent clinical trials by analyzing the issues.
Clinical Trials as Topic
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Indicators and Reagents/administration & dosage*
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Reagent Kits, Diagnostic
4.A comparison study of three reagents using microplate anti-HIV1/-HIV2 EIA.
Dong Il WON ; Hyon Suk KIM ; Hyun Ok KIM ; Oh Hun KWON
Korean Journal of Blood Transfusion 1993;4(2):217-222
No abstract available.
Indicators and Reagents*
5.A comparison study of three reagents using microplate anti-HIV1/-HIV2 EIA.
Dong Il WON ; Hyon Suk KIM ; Hyun Ok KIM ; Oh Hun KWON
Korean Journal of Blood Transfusion 1993;4(2):217-222
No abstract available.
Indicators and Reagents*
6.Thoughts and Suggestions on Review of Autoimmune Test Reagents.
Wenzhu FU ; Yao CAI ; Jiafa XU
Chinese Journal of Medical Instrumentation 2021;45(2):215-218
In this paper, some significant problems, which were found frequently in the products of autoimmune
Indicators and Reagents
7.Efficacy of unithiol and naturenze in the treatment of rabbits suffered toxicity of mixture of yperite and lewisit through some biochemical indicators
Journal of Practical Medicine 2002;435(11):29-31
Treatment of rabbits, exposed to mix of yperite and lewisite with unithiol and naturenze showed that unithol reduced concentration of SGOT (serum glutamat-oxaloacetat-transaminase), SGPT (serum glutamat-pyruvat-transaminase), urea and creatinine in serum but concentration of these components was still high. Using unithiol in combination with naturenze for treatment, concentration of SGOT, SGPT, urea and creatinine was decreased lower than treatment of single unithiol.
Unithiol
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Toxicity
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Indicators and Reagents
8.Study on some alterations of biochemical indicators in rabbit suffered the toxicity due to the single diclodietyl or clovininyl diclorasin or their combination
Journal of Practical Medicine 2002;435(11):46-48
Concentration of SGOT, SGPT, ure and creatinine was increased in serum of rabbits, exposed to diclodietylsulfid and clovinyldiclorasin. We realized that there were synergic effects between diclodietylsulfid and clovinyldiclorasin, caused increase of ure and creatinie in rabbits higher than effect of single agent. Concentration of glucose was increased at the third day and decreased at the 7th day in rabbits exposed to mix of clovinyldiclorasin and diclodietylsulfid.
Indicators and Reagents
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Toxicity
9.Some indicators of platelet and their correlation
Journal of Practical Medicine 2002;435(11):27-29
A study on the determination of level of indicators of platelet and their correlation in normal people and patients has shown that the platelet (PLT), mean platelet volume (MPV), plateleterit (PCT) and platelet distribution width (PDW) were determined which used as reference indicators. There were some differences of indicators of platelet between men and women. If patients had low platelet, they would have big MPV and reversely. When excessive increased or reduced platelet comparing with normal range, the PDW will be bigger which indicated that the unequal range of platelet size.
Blood Platelets
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Indicators and Reagents
10.The Situation and Countermeasures of the Undocumented in Vitro Diagnostic Reagents Urgently Needed in Clinical.
Minjie QIU ; Geng DONG ; Xiaoyuan XU
Chinese Journal of Medical Instrumentation 2015;39(5):356-366
We found that the number of institutions made use of the undocumented in vitro diagnostic reagent in the survey. The phenomenon poses some risks and problems. In use this paper, we analyzed the situation and the reasons for the use of the undocumented in vitro diagnostic reagents, and put forward the corresponding measures.
Humans
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Indicators and Reagents
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standards