Kimberly-Clark's improvements in the field of lateral flow diagnostics include:
- Innovations to reduce the hook effect
- Simultaneous analysis of multiple analyte components
- Use of time-resolved fluorescence to increase sensitivity
- Unique preparation techniques that use magnetic particles to purify and sensitize both samples and the reporter substances on the strips
These innovations are supported by a patent estate consisting of over 60 granted patents and patent applications.
Hook Effect Reduction
The hook effect results in a dangerous false negative; reducing or eliminating it is a major benefit. Several methods of reducing the hook effect have been proposed, such as incubating samples in the presence of more than one receptor. However, lateral-flow test strips often find their greatest utility in the field – for example, at the scene of an accident or at a chemical or biological spill. Time is of the essence, and a false negative can be highly dangerous.
This technology provides for an inexpensive method to reduce the hook effect without requiring long wait times. This is achieved by utilizing the increased size of the tagged molecules and the smaller size of the untagged molecules as a differentiator, which allows a majority of the tagged molecules to reach the limited reagents in the reporting area first.
Additional methods to increase accuracy include combining analyte molecules with fluorescing particles, using a reporter and magnetic particles, using an LED to excite the fluorescing particles and a photo diode to detect them inexpensively.
Lateral Flow Platform Benefits
- Quantitative diagnostics from inexpensive and disposable lateral-flow test strip technology
- Methods to ensure high accuracy in both presence/absence tests and in determining the quantity of target present
- Methods to allow multiple simultaneous tests on the same lateral-flow strip
- Sample conditioning methods that may virtually eliminate the hook effect
- Test strip design methods that also detect and compensate for the hook effect