1. Field of the Invention
The present invention pertains to a method and apparatus for performing and analyzing a lateral flow assay. More specifically, the invention provides a method and apparatus for determining the amount of an analyte present in a subject sample.
2. Description of Related Art
Immunoassay technology provides simple and relatively quick means for determining the presence of analytes in a subject sample. The information provided from immunoassay tests are often critical to patient care. Assays are typically performed to detect the presence of particular analytes, such as antibodies that are present when a human subject has a particular disease or condition. Assays practiced under the known art are numerous, and may include assays for diseases such as H. pylori, AIDS or conditions such as pregnancy.
The advancement of immunoassay technology now allows for assay tests to be performed without the complex and expensive equipment used in hospitals and laboratory settings. Devices for performing assays are now available for home or point of care use to quickly determine the presence of a disease or condition. Such devices typically provide qualitative results for the analyte-or condition being tested for. Examples of such devices include strips that become visually distinguishable when the analyte being sought is detected.
However, devices for qualitative analysis of assays are often prone to user error, and lack the accuracy of sophisticated equipment that perform and analyze the assays in hospitals and laboratories. For instance, assay devices often require the user to visually interpret an ongoing chemical reaction. In some applications, if the user mis-times reading the assay device by even a few minutes, the result of the assay may turn from negative to positive. Still, other devices fail to sufficiently distinguish positive from negative results.
Readers are provided in the known art for determining or analyzing the results of assays more accurately. In general, readers provide an improvement in that they may analyze an assay result, thereby removing subjective factors that cause human error. However, whereas readers may reduce operator subjectivity in reading or interpreting assay results, they do not help to control for or help mitigate other sources of assay variability. Such sources may include variability introduced by incorrect assay run times, uncontrolled reaction temperatures, or other possible operator-induced variability.
The present invention addresses these and other shortcomings of the known art.
USPTO Backgrounds
USPTO Backgrounds