Quality Considerations for a Successful Diagnostic Assay Launch

By Fortis Life Sciences LLC

The increasing prevalence of infectious diseases has heightened demand for an in vitro diagnostic (IVD) that is low complexity, portable, rapid, and inexpensive to manufacture.

Lateral flow immunoassays (LFA) have helped to address this demand as demonstrated by the use of COVID-19 rapid tests to combat the global pandemic. LFAs are capable of being used at the point-of-care (POC) without training and expensive instrumentation while still being able to provide clear and accurate results.

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