FDA Oversight of Laboratory-Developed Tests: Where Are We Now?

Reflection for the undergraduate on writing in the portfolio: where are we now and where are we going?

Introduction: The portfolio can be seen as a tool for assessmentof a variety of learning activities that differ in content, usage, andassessment. The portfolio not only meets the learner’s educationalneeds but also the political and public reassurance demand thatthe health professional has achieved the required competency ofthe curriculum that allows him or her to practice safely with orwithout...

The IGRA tests: where are we now?

In the early 1990s, WHO declared TB a global emergency [1]. Since that time after introduction of DOTS strategy and National TB Programs, the reduction of global incidence rate (2002), as well as of total number of TB cases (2006) were recorded. However, in 2012, about 8.6 million cases were established, of which only two third were registered. It means that 3 million cases were missed and untr...

FDA oversight of laboratory-developed tests: is it necessary, and how would it impact clinical laboratories?

In 2010 the US Food and Drug Administration (FDA) stated that it would issue guidance on its oversight of laboratory-developed tests (LDTs), and in July of that year the FDA held a public meeting to receive feedback on a risk-based application of LDT oversight (http:// www.fda.gov/MedicalDevices/NewsEvents/Workshops Conferences/ucm212830.htm). The FDA acknowledged that LDTs have been in existen...

Amyloidosis-where are we now and where are we heading?

CONTEXT Amyloidoses are disorders of diverse etiology in which deposits of abnormally folded proteins share distinctive staining properties and fibrillar ultrastructural appearance. Amyloidosis ultimately leads to destruction of tissues and progressive disease. With recent advances in the treatment of systemic amyloidoses the importance of an early diagnosis of amyloid, and a correct diagnosis ...

Where are we now? Where are we going?