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Showing posts from August, 2022

What is Molecular POCT- point-of-care Test?

Molecular  point-of-care Testing (POCT) A point-of-care test (POCT) is a laboratory test performed near the patient's point of care. POCT provides rapid test results and can improve patient care. However, if performed incorrectly or used incorrectly, POCT can produce misleading results and require additional monitoring, increasing costs and risk to patients. Although most POCTs were eliminated in the Federal Clinical Laboratory Improvement Amendments of 1988, several considerations challenge their implementation. This chapter will focus on the advantages and limitations of POCT and describe how to manage the quality of POCT to achieve optimal patient outcomes. What are the point-of-care devices for under-detection of drug abuse?  Point-of-care testing (POCT) devices are available at the bedside or in the doctor's office to test for drugs using a urine sample or oral fluid.  The advantage of this test is the quick availability of results. The POCT unit uses immunoassay and lat

What is NPMA Registration in China?

China NMPA (National Medical Product Administration) Registration The People's Republic of China is the fastest growing market for health and beauty products in the world and offers huge commercial potential for international manufacturers of medical devices, pharmaceuticals and cosmetics. Entering the Chinese market can be challenging due to complex regulations, language barriers and intense competition.  Cisema has handled hundreds of projects and can help you meet China's NMPA requirements.  What is Chinese NMPA registration?  It is the registration procedure of China's NMPA (National Medical Products Administration, formerly CFDA - China Food and Drug Administration), in which the following product categories are certified according to the guidelines:   ► Cosmetics ► Medicines, pharmaceutical packaging and ingredients ►  Medical devices (including IVDs) ► Breast milk substitute ►  Food for special medical purposes ► Healthy food (food supplements and f

What is BioFire® (bioMérieux) FilmArray® System?

Elimination of Guesswork with the BioFire® FilmArray® System (bioMérieux) The BioFire System performs syndromic PCR tests that detect infectious agents at the molecular level. With a revolutionary syndromic approach and the broadest target menu on the market, the bioMérieux or  BioFire® FilmArray® Panels empower healthcare providers to choose the right test, the first time. Traditional infectious diseases diagnostic procedures leave many infections undiagnosed, which result in  downstreaming of  tests and procedures, compromised care and patient dissatisfaction. What is the new name for Biofire? The new name for Biofire is bioMérieux.   For several years BioFire was continuing to maintain its brand identity and operations. BioFire was acquired in 2014 by bioMérieux SA, which they claim being a global leader in in vitro diagnostics for more than 55 years. They then reached a critical point in our development where it made sense to them to align more closely with bioMérieux,” expl