Self-contained device for carrying out specific binding assays

Claim 1

A device for detecting an analyte in a test sample comprising a tube member having an upper and a closed lower end, the tube member being subdivided into an upper and an initially dry lower internal compartment, the compartments being separated by a first breakable seal having extended therethrough a rod member having an upper and lower terminus, the lower terminus initially extending into the lower compartment. the lower terminus having attached thereto means for puncturing the first seal and a plurality of filaments, the filaments having attached thereto a binding partner specific for the analyte. the first seal having the rod extended therethrough being capable of preventing fluid communication between the upper and lower compartments when the puncture means resides initially in the lower compartment, the upper compartment having contained therein a solution for suspending the analyte, the upper end of the tube having disposed thereon a cover having means for introducing the test sample into the upper compartment, the cover further having a second breakable seal having the rod extended therethrough, the device being such that after the sample is introduced into the solution in the upper compartment, the upper terminus of the rod can be pulled away from the tube by a predetermined distance causing the puncture means to break the first seal thereby causing the solution to flow into the lower compartment where the analyte and the binding partner can react to form a complex on the filaments, the device further being such that the rod can then be pulled outside the tube causing the puncture means and filaments to pass through the first seal and to break and pass through the second seal, the broken seals being capable of wringing excess solution from the filaments.

Claim 2

A device for detecting an analyte in a test sample comprising a tube member having an upper and a closed lower end, the tube member being subdivided into an upper and an initially dry lower internal compartment, the compartments being separated by a first breakable seal having extended therethrough a rod member having an upper and lower terminus, the lower terminus initially extending into the lower compartment. the lower terminus having attached thereto means for puncturing the first seal and a plurality of filaments, the filaments having attached thereto a binding partner specific for the analyte. the first seal having the rod extended therethrough being capable of preventing fluid communication between the upper and lower compartments when the puncture means resides initially in the lower compartment, the upper compartment having contained therein a solution for suspending the analyte, the upper end of the tube having disposed thereon a cover having means for introducing the test sample into the upper compartment, the cover further having a second breakable seal having the rod extended therethrough, the device being such that after the sample is introduced into the solution in the upper compartment, the upper terminus of the rod can be pulled away from the tube by a predetermined distance causing the puncture means to break the first seal thereby causing the solution to flow into the lower compartment where the analyte and the binding partner can react to form a complex on the filaments, the device further being such that the rod can then be pulled outside the tube causing the puncture means and filaments to pass through the first seal and to break and pass through the second seal, the broken seals being capable of wringing excess solution from the filaments.