| 摘要 |
An improved rapid diagnostic device (1), assay and multifunctional buffer reagent are provided for the detection of a target analyte (10) in a fluid test sample (9). The 2-step assay utilizes a dual component flow-through device (1) comprising a test unit (2) and a post-filter unit (3) capable of receiving the fluid sample (9) and multifunctional buffer (12), respectively. The test unit (2) comprises a reaction zone (5) containing immobilized capture reagent (6) that can specifically bind to the target analyte (10), an absorbent zone (4) supporting the reaction zone (5), and optionally, a blood separation zone in lateral fluid communication with the reaction zone (5). The post-filter unit (3) comprises a label zone (7) permeated with a dried indicator reagent (8) which is capable of being placed in transient fluid communication with the reaction zone (5) of the test unit (2) during the assay procedure. The rapid diagnostic assay system reduces the number of assay reagents, method steps and time required for performance compared to other conventional assays. |
