Nucleic acid amplification reaction station for disposable test devices

Abstract

An instrument for conducting nucleic acid amplification reactions in a disposable test device is provided. The test device includes a first reaction chamber containing a first nucleic acid amplification reagent (e.g., primers and nucleotides) and a second reaction chamber either containing, or in fluid communication, with a second nucleic acid amplification reagent (e.g., an amplification enzyme such as RT). The instrument includes a support structure receiving the test device. A temperature control system maintains the first reaction chamber at a first elevated temperature but simultaneously maintains the second nucleic acid amplification reagent at a second temperature lower than the first temperature so as to preserve the second nucleic acid amplification reagent. An actuator operates on a fluid conduit in the test device to place the first and second reaction chambers in fluid communication with each other after a reaction has occurred in the first reaction chamber at the first temperature. A pneumatic system is also provided that assists in fluid transfer of a reaction solution from the first chamber to the second chamber.

1 - 20 . (canceled) 
     
     
         21 . A disposable nucleic acid amplification test device for insertion into an amplification station conducting an amplification reaction using the test device, the test device comprising:
 a body defining a first chamber for receiving a sample and a second chamber for conducting a nucleic acid amplification reaction therein, wherein the sample is transferred from the first chamber to the second chamber;   a valve controlling the transfer of the sample from the first chamber to the second chamber; and   a barrier between the environment and the sample after addition of the sample to the first chamber;   wherein the portion of the body of the test device defining the second chamber has an external configuration sized and shaped so as to place the second chamber into thermal contact with controlled heating elements provided in the analytical instrument when the test device is inserted into the instrument, the controlled heating elements regulating the temperature of the second chamber.   
     
     
         22 . The test device of  claim 21 , further comprising one or more chambers for wash operations on the sample. 
     
     
         23 . The test device of  claim 21 , wherein the valve is operated on to open the valve by a mechanical actuator external to the test device. 
     
     
         24 . The test device of  claim 21 , wherein a nucleic acid amplification reaction enzyme is in fluid communication with the second chamber. 
     
     
         25 . The test device of  claim 24 , wherein the enzyme is in pellet form. 
     
     
         26 . The test device of  claim 21 , wherein the barrier comprises a cover. 
     
     
         27 . The test device of  claim 21 , wherein the barrier comprises a membrane.