Diagnostic assays

Diagnostic Assays for Infectious

Validation is a process that determines the fitness of an assay, which has been properly developed, 6 optimised and standardised, for an intended purpose. Validation 8 includes estimates of the analytical and diagnostic performance 10 characteristics of a test. In the context of this chapter, an assay that 12 has completed the first three stages of the validation pathway (see 14 Figure 1 below)...

Rapid diagnostic HCV antibody assays.

Approximately 4.1 million Americans have been infected with HCV and 45-85% of chronically infected persons are unaware of their status. Rapid anti-HCV assays can assist and expedite the identification of those unaware of their infection. Performance characteristics of pre-market rapid anti-HCV assays (Chembio, MedMira and OraSure) have been evaluated. Their sensitivity (78.9-99.3%) and specific...

Diagnostic assays for HIV-1 infection.

orldwide, a total 40 million people were estimated to be living with HIV/AIDS through the end of 2003.1 According to the World Health Organization and the Joint United Nations Programme on HIV/ AIDS, over 5 million new infections occurred in 2003, which translates to roughly 14,000 new infections daily. Since the first case of HIV infection was diagnosed in the United States in 1981, there have...

Specificity and performance of diagnostic PCR assays.

Advances in Diagnostic Assays for Tuberculosis.

Approximately one-third of the global burden of tuberculosis (TB) remains undiagnosed each year and the vast majority of cases of multidrug-resistant TB remain undetected. Many countries still place heavy reliance on outdated technologies that are blunt and ineffective tools for controlling this epidemic. However, during the past 10 years, there has been substantial progress within the TB diagn...