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Manufacturing the Next Generation of Highly Sensitive and Reproducible Lateral Flow Immunoassay

  • Thomas C. TisoneEmail author
  • Brendan O’Farrell
Chapter

Introduction

The lateral flow immunoassay (LFIA) format that emerged in the 1980s provided the industry with a relatively standardized, open platform that could accommodate a wide range of analytes for point-of-need (PON) testing. Figure 8.1 shows a typical configuration for a LFIA strip. LFIA has been applied in application areas as diverse as human clinical diagnostics, veterinary diagnostics, plant health, environmental health and safety, food safety, and biowarfare, just to name a few [1]. To date, the application of LFIA has largely been limited to threshold or yes/no formats due to the high levels of variation exhibited with the current designs and manufacturing processes. Despite this limitation, it is estimated that over 100 different tests are currently available in the market. The ability to adapt the LFIA to a quantitative format is predicted to increase the number of marketable tests significantly.

Keywords

Test Strip Roll Stock Plastic Housing Release Liner Lateral Flow Immunoassay 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. 1.
    O’Farrell, B. and Bauer, J. (Jun. 2006) Developing highly sensitive, more-reproducible lateral-flow assays. Part 1: New approaches to old problems. IVD Technology 12(5):41–49.Google Scholar
  2. 2.
    Tisone, T.C. (2000) In-line manufacturing for rapid-flow diagnostic devices. IVD Technology 6(3):43–60.Google Scholar
  3. 3.
    O’Farrell, B. and Bauer, J. (Jul. 2006) Developing highly sensitive, more reproducible lateral flow assays. Part 2: New challenges with new approaches. IVD Technology 12(6):67–75.Google Scholar
  4. 4.
  5. 5.
    O’Farrell, B (2008) Emerging technologies that facilitate the field use of rapid diagnostic tests. Proceedings of the SPIE Defense, Security and Sensing Conference, March 2008.Google Scholar
  6. 6.
  7. 7.
  8. 8.
    Rosenstein, R. (Jan. 7, 1997) Solid phase chromatographic immunoassay. US Patent 5591645.Google Scholar
  9. 9.
    Charlton, D. (Nov. 26, 2002) Test device and method for colored particle immunoassay. US Patent 6485982.Google Scholar
  10. 10.
    Tisone, T.C. (Apr. 14, 1998) Precision metered aerosol dispensing apparatus. US Patent 5738728.Google Scholar
  11. 11.
    Tisone, T.C. (Apr. 28, 1998) Precision metered solenoid valve dispenser. US Patent 5743960.Google Scholar
  12. 12.
    Tisone, T.C. (Jun. 29, 1999) Dispensing apparatus having improved dynamic range. US Patent 5916524.Google Scholar
  13. 13.
  14. 14.
    www.whatman.com (Fusion 5)

Copyright information

© Humana Press, a part of Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.BioDot, Inc.Irvine

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