Introduction

The development of lateral-flow assays has provided a convenient and inexpensive means for identification of target substances in biological specimens. The market for lateral-flow assays is enormous and growing. These test strips and devices have found numerous applications in testing of drugs of abuse, infectious diseases, and pregnancy, just to name a few. New tests and applications are being developed virtually on a daily basis. A test strip typically consists of a plastic backing holding together a sample pad for deposition of sample fluids, a conjugate pad pretreated with sample detection particles (see Chapter 5), a microporous membrane (see Chapter 4) containing sample

From: Forensic Science and Medicine: Drugs of Abuse: Body Fluid Testing Edited by R. C. Wong and H. Y. Tse © Humana Press Inc., Totowa, NJ

capturing reagents, and an absorbent pad at the distal end serving to collect excess fluids. The enormous demand for such testing devices necessitates a good understanding of the tenets of manufacturing and automation. This chapter provides a comprehensive discussion on many of these issues.

It is understandably important, during the development stage of a product's evolution, to evaluate and carefully consider all aspects of its manufacture. These include scalability, the efficient transition from lab scale to clinical and limited-manufacturing scale to fully automated commercial-scale manufacturing. Each material, each procedure, each process must be compared and contrasted to ensure that the end product is functional, reliable, and rugged. In the extremely competitive marketplace of lateral-flow assays, it is a virtual certainty that automated manufacturing processes will be a necessity and not a luxury. With automation comes improved efficiencies, lower scrap rates, higher yields, and lower manufacturing costs. Automation also provides opportunities for automated inspections, thus greatly improving overall quality of the finished product.

In planning for automation, one may want to consider consulting with one or more quality automation equipment suppliers early in the development phase. Most reputable automation companies are willing to discuss design and development issues relating to product or process at little or no cost. It is best when considering automation vendors to find ones with knowledge and experience specific to the application. Test-strip manufacturing is not as simple as it appears on the surface; failure to select a company with specific experience may be costly or even disastrous in the long run.

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