Method and apparatus for fully automated nucleic acid amplification, nucleic acid assay and immunoassay

An apparatus for performing a plurality of clinical diagnostic assays substantially simultaneously, said apparatus comprising:

• a rotatable holder for carrying a plurality of test units and for rotating said test units about an axis;
• a source of rotary power coupled to said rotatable holder for rotating said rotatable holder about said axis;
• and
• a plurality of test units carried by said rotatable holder and spaced circumferentially about said axis, each of said test units comprising a sample chamber within said test unit for receiving a liquid biological sample to be assayed, a waste chamber within said test unit in fluid communication with said sample chamber for receiving said liquid biological sample from said sample chamber, a first liquid flow path within said test unit communicating between said sample chamber and said waste chamber, and at least a first immobilized reagent disposed in said first liquid flow path, each of said disposable test units being oriented with respect to said rotatable holder in a manner such that said sample chamber is located closer to said axis than said waste chamber in order to cause said liquid biological sample to flow through said first liquid flow path from said sample chamber to said waste chamber and to thereby be brought into contact with said first immobilized reagent when at least a predetermined minimum centrifugal force is exerted on said liquid biological sample by rotation of said holder at a first rotational speed;
• wherein said first liquid flow path in each of said test units comprises a channel, at least a portion of said channel being adapted to constrict to prevent the flow of said liquid biological sample through said channel in the absence of a force applied to said sample, and to expand to permit said liquid biological sample to flow through said channel when at least said predetermined minimum centrifugal force is applied to said sample by rotation of said holder at said first predetermined rotational speed.

A test unit for carrying out a clinical diagnostic assay, comprising:

• a sample chamber within said test unit for receiving a liquid biological sample to be assayed;
• a waste chamber within said test unit in fluid communication with said sample chamber for receiving said liquid biological sample from said sample chamber;
• a first liquid flow path for said liquid biological sample within said test unit communicating between said sample chamber and said waste chamber;
• at least a first immobilized reagent disposed in said liquid flow path for contacting said liquid biological sample as said sample flows from said sample chamber to said waste chamber;
• at least a first reagent chamber within said test unit in fluid communication with said first liquid flow path and said waste chamber for containing a first liquid reagent;
• and
• a second liquid flow path for said first liquid reagent within said test unit communicating from said first reagent chamber to said first liquid flow path and said waste chamber;
• wherein said sample chamber, said waste chamber and said first reagent chamber are disposed in an in-line arrangement within said test unit, with said waste chamber and said first reagent chamber disposed on opposite sides of said sample chamber, and
• wherein at least one of said first and second liquid flow paths comprises a channel, at least a portion of said channel being adapted to constrict to prevent the flow of said liquid biological sample through said channel in the absence of a force applied to said sample, and to expand to permit said liquid biological sample to flow through said channel when at least a predetermined minimum force is applied to said sample.

A test unit for carrying out a clinical diagnostic assay, comprising:

• a sample chamber within said test unit for receiving a liquid biological sample to be assayed;
• a waste chamber within said test unit in fluid communication with said sample chamber for receiving said liquid biological sample from said sample chamber;
• a first liquid flow path for said liquid biological sample within said test unit communicating between said sample chamber and said waste chamber;
• and
• at least a first immobilized reagent disposed in said first liquid flow path for contacting said liquid biological sample as said sample flows from said sample chamber to said waste chamber;
• wherein said sample chamber is provided in the form of a well having a liquid-receiving bottom portion and an upper portion communicating with said first liquid flow path, whereby a liquid biological sample only partially filling said sample chamber is unable to flow through said first liquid flow path to said immobilized reagent and said waste chamber in the absence of a force applied to said liquid biological sample which is sufficient to cause said sample to climb said well to reach said first liquid flow path;
• and
• wherein said first liquid flow path comprises a channel, at least a portion of said channel being adapted to constrict to prevent the flow of said liquid biological sample through said channel in the absence of a force applied to said sample, and to expand to permit said liquid biological sample to flow through said channel when at least a predetermined minimum force is applied to said sample.