Multiplex STI Pathogen Detection Kit With Lateral Flow Readout

The patent extracts the electrophoresis step from the conventional PCR-diagnosis workflow and replaces it with a lateral flow assay system. The detection function is separated into specific binding components (probes attached to gold particles) that directly visualize results without requiring electrophoresis equipment or gel analysis, thereby simplifying the process while maintaining detection accuracy.

The patent introduces gold particles as an intermediary carrier that binds to specific nucleic acid probes. This intermediary system enables direct visualization of detection results through color changes on a lateral flow membrane, eliminating the need for complex electrophoresis equipment and reducing human error in result interpretation while preserving detection reliability.

The patent employs disposable lateral flow assay components including pre-prepared gold particles conjugated with specific probes, single-use test membranes, and disposable sample application cards. This eliminates the need for expensive real-time PCR equipment while maintaining rapid detection capability, as each test is self-contained and requires no sophisticated instrumentation.

The patent replaces the mechanical/optical detection system of real-time PCR (requiring expensive thermal cyclers and fluorescent detectors) with a simple lateral flow capillary action system. The detection is based on passive fluid movement and visual color changes, substituting complex mechanical systems with simple physical principles that reduce equipment costs while preserving detection speed.

The patent performs preliminary conjugation of specific nucleic acid probes to gold particles during manufacturing, creating pre-ready detection reagents. This preliminary action eliminates the need for time-consuming in-lab probe preparation and electrophoresis setup, allowing rapid detection while maintaining reliability through pre-validated specific binding pairs.

The patent skips the time-consuming electrophoresis separation and gel visualization steps by directly implementing specific probe-gold particle binding followed by lateral flow visualization. This rushes through the detection process by eliminating intermediate steps while preserving detection reliability through the specificity of nucleic acid hybridization and visual confirmation.