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 ; Indicators and Reagents ; Reagent Kits, Diagnostic ; Technology

From the perspective of technical review, this paper made statistics on the supplement contents of
Chemistry, Clinical/standards* ; China ; Indicators and Reagents ; Reagent Kits, Diagnostic/standards*

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 ; Indicators and Reagents/administration & dosage* ; Reagent Kits, Diagnostic

No abstract available.
Indicators and Reagents*

No abstract available.
Indicators and Reagents*

In this paper, some significant problems, which were found frequently in the products of autoimmune
Indicators and Reagents

BACKGROUND: There are some previous reports about partial D in Korea. However, the frequency of the partial D in Korea is still unknown. In this study, subtypes of partial D were analyzed by the use of various commercially available anti-D reagents. METHODS: We collected 273 cases determined as RhD negative by RhD typing using the tube method with monoclonal IgM/IgG anti-D reagent (Bioscot. Livingston, UK) from 80,062 cases that were screened between January 2004 and August 2007. The cases were divided into three periods (I, II, III), according to the manufacturers and numbers of anti-D reagents used. A weak D test was performed by using the tube method with various anti-D reagents. The cases with different reactivity between anti-D reagents were determined as partial D, and further analyzed the subtypes by reactivity patterns according to the target epitope of anti-D reagents. An additional test using the ID-Partial D Typing Card (DiaMed, Cressier, Switzerland) was conducted during period III. RESULTS: Five cases showed reactivity patterns of weak D and 16 cases showed reactivity patterns of partial D. Ten cases of partial D were typed as DVI and three cases were typed as DFR. During period III, five cases were typed as DVI and one case was typed as DFR. These results were different from the results obtained with the use of the ID-Partial D Typing Card. CONCLUSION: DVI, which is the most common subtype of partial D, is also common in Korea. Therefore, RhD typing and a weak D test should be performed using combined anti-D reagents that enable the differentiation of DVI from other subtypes.
Indicators and Reagents* ; Korea

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 ; Indicators and Reagents ; standards

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 ; Indicators and Reagents

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 ; Toxicity ; Indicators and Reagents