scholarly journals The principle of in vitro diagnostic system based on mobile Internet terminal and the implementation of data acquisition subsystem

2016 ◽  
Author(s):  
Wu Fan ◽  
Liu Hong ◽  
Qin Tao ◽  
Lan Zengmei ◽  
Li Zhihua ◽  
...  
Keyword(s):  
Data Acquisition ◽  
Diagnostic System ◽  
Mobile Internet ◽  
In Vitro Diagnostic

scholarly journals Highly Sensitive in Vitro Diagnostic System of Pandemic Influenza A (H1N1) Virus Infection with Specific MicroRNA as a Biomarker

ACS Omega ◽  
2019 ◽  
Vol 4 (11) ◽  
pp. 14560-14568 ◽  
Author(s):  
Jaewoo Lim ◽  
Jihyun Byun ◽  
Kyeonghye Guk ◽  
Seul Gee Hwang ◽  
Pan Kee Bae ◽  
...  
Keyword(s):  
Virus Infection ◽  
Pandemic Influenza ◽  
Influenza A ◽  
H1n1 Virus ◽  
Diagnostic System ◽  
Highly Sensitive ◽  
Influenza A H1n1 ◽  
In Vitro Diagnostic ◽  
H1n1 Virus Infection

A Review of In-Vitro Diagnostic Kits and Their Regulations in the Indian Market

2020 ◽  
Vol 07 ◽  
Author(s):  
Kokila Chadha ◽  
Kritika Goswami ◽  
Rohit Bhatia ◽  
Pawankumar Jaggi ◽  
Arti R. Thakkar
Keyword(s):  
High Risk ◽  
Diagnostic System ◽  
Indian Market ◽  
Risk Class ◽  
Diagnostic Kits ◽  
Class A ◽  
In Vitro Diagnostic ◽  
New Guidelines

Abstract:: The present review lays emphasise on history, regulations and process involved in approval of In-Vitro Diagnostic (IVD) kits in Indian Market. Diagnostic system or apparatus used for diagnosis are called diagnostic kits. Some important types of kits, based on their mechanism of actions are, (i) Immunoassay diagnostic kits; (ii) Polymerase chain reaction diagnostic kits; (iii) Displacement polynucleotide assay employing polyether and diagnostic kits; (iv)Diagnostic kit as well as diagnostic method utilizing carbohydrate receptors; (v) One-step detection of matrix metalloproteinase activity using a fluorogenic peptide probe-immobilized diagnostic kits. Previously, as per Drugs and Cosmetics Act 1940, IVD kits were classified as notified and non-notified category. Notified category IVDs are, In-Vitro Diagnostic Devices for HIV; In-Vitro Diagnostic Devices for HBV; In-Vitro Diagnostic Devices for HCV and In-Vitro Blood grouping sera. Recently, on November 1, 2017, Central Drug Standard Control Organization (CDSCO) has published risk based classification of medical devices and IVD kits on the origin of their intended use. The guideline has been implemented with effect from January 1, 2018. As per new guidelines the IVD kits have been categorised in four categories based on their level of risk, such as Class A (low risk); Class B (low moderate risk); Class C (moderate high risk) and Class D (high risk). Class A and B are processed and regulated through State Licensing Authority while C and D are processed and regulated by Central Licensing Authority. New guideline is not only limited to IVDs but also regulates the In-Vivo diagnostics. New guidelines are very well aligned in terms of regulations of western countries and it is a significant and revolutionary step in regulations of IVDs in Indian market.

scholarly journals 1015. Enhanced Detection of Bloodstream Pathogens From Positive Blood Culture Specimens With an Improved Multiplex PCR Molecular Diagnostic System

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S302-S302
Author(s):  
Jeremy Green ◽  
Caitlin Carter ◽  
Craig Chandler ◽  
Angela Clark ◽  
Stephanie Thatcher
Keyword(s):  
Blood Culture ◽  
Positive Blood Culture ◽  
Culture Media ◽  
Diagnostic System ◽  
Molecular Diagnostic ◽  
Pathogen Identification ◽  
In Vitro Diagnostic ◽  
Culture Identification ◽  
Slow Growing

Abstract Background Timely bloodstream infection (BSI) pathogen identification requires robust sample purification and testing methods that can accommodate the wide variety of blood culture media used for growing positive blood culture (PBC) specimens. Sensitive molecular methods are needed for identification of all organisms present in PBD, especially polymicrobial cultures which can be difficult to identify with standard methods. Multiple types of BD and BioMérieux blood culture media commonly used in hospital laboratories were used to evaluate the performance of a prototype BioFire® FilmArray® Blood Culture Identification 2 (BCID2) Panel with PBCs. Methods Fungi (seven) and bacteria (19) were independently seeded in blood samples, inoculated into as many as eight different types of blood culture bottles, and incubated on the recommended instrument. Time to positivity (TTP) was recorded for all PBCs. Subsets of PBCs were enumerated and tested on the BioFire BCID2 Panel and BioFire® FilmArray® Blood Culture Identification (BCID) panel. Polymicrobial testing was performed by seeding fast and slow growing organisms into the same bottles. Results Over 750 PBCs were enumerated; ~500 PBCs were tested on the BioFire BCID2, and over 200 were also tested on the BioFire BCID. 100% of seeded PBCs tested on the BioFire Panels resulted in correct pathogen identification. Across all bottle types, fungi grew to levels ranging from 8E+05 to 5E+07 CFU/mL, Gram-positive bacteria titers ranged from 7E+06 to 2E+09, and Gram-negative bacteria titers ranged from 9E+07 to 3E+09. Polymicrobial PBCs (30) had reduced titers of slow growing organisms when seeded with fast growing organisms but were detected by both BioFire BCID Panels at a rate of 99%. Conclusion This study demonstrates that a prototype BioFire BCID2 Panel, and the BioFire BCID Panel, robustly detect and identify (100%) BSI pathogens over a multitude of common blood culture media and systems. Results confirm PBC (single and polymicrobial) titers are above the levels of sensitivity for both BioFire panels. An expanded menu of targets (organism and resistance) and faster run time with the BioFire BCID2 Panel will offer a flexible and comprehensive aid in the diagnosis of BSIs. The BioFire® BCID2 Panel has not yet been evaluated by the FDA or other regulatory agencies for in vitro diagnostic use. Disclosures J. Green, BioFire Diagnostics, LLC: Employee, Salary. C. Carter, BioFire Diagnostics, LLC: Employee, Salary. C. Chandler, BioFire Diagnostics, LLC: Employee, Salary. A. Clark, BioFire Diagnostics, LLC: Employee, Salary. S. Thatcher, BioFire Diagnostics, LLC: Employee, Salary.

Post Marketing Surveillance of in vitro Diagnostic System in the European Union

2020 ◽  
Vol 07 ◽  
Author(s):  
Himadri Singh
Keyword(s):  
European Union ◽  
Medical Device ◽  
Diagnostic System ◽  
The European Union ◽  
Post Marketing Surveillance ◽  
In Vitro Diagnostic ◽  
Clinical Benefits ◽  
Post Marketing ◽  
And Performance

: Advances in medical device technology and regulatory authorization adapt to changing requirements and market conditions. The assessment of safety and performance in real world scenario will help us in understanding of clinical benefits and help in evolution of the medical device and in vitro diagnostic devices. The paradigm shift in evaluation of medical devices and in vitro diagnostic devices will ensure that the device deliver intended benefits. This articles discusses the new approach of the post marketing surveillance in the context of new in vitro diagnostic regulation in the European Union.

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