摘要:
The present invention provides specific binding assay methods and reagent systems for the quantitative or qualitative determination of an analyte in a liquid medium based on heterogeneous or homogeneous protocols. In particular, the invention relates to the use of specific binding assay techniques wherein the label is a participant in or a modulator of an enzymatic reaction whereby a first enzyme acts on a first substrate to produce a second enzyme. The second enzyme can be used to catalyze a detectable response or can act on a second substrate to produce a third enzyme. The label is chosen from the first substrate or a cofactor or modulator of the first enzyme. In one embodiment, the first substrate is a zymogen which when acted upon by the first enzyme produces a second enzyme. When the final enzyme product is used to catalyze the production of a detectable response proportional of the concentration of the analyte, amplification results providing a very sensitive assay.
摘要:
A viability test device wherein the viability of a test composition for the determination of an analyte of interest can be determined by simply wetting the device with ordinary water. The viability device can be prepared in three formats: a control or calibrator device, an internal control device and a self indicating device. Unreacted analyte, or an analog thereof, can be incorporated in a limited defined portion of a dried carrier matrix incorporated with a test composition to provide an internal control test device. When wetted with water, a positive optical response, usually color, indicates the test composition can provide a viable test for the analyte. The internal control test device is particularly advantageously used by diabetics in their own homes where a negative test response could be due to the desired control of the user's condition or due to deterioration of a test composition because of unfavourable storage conditions.