Rapid Test Apparatus

Abstract

Provided herein are methods and devices for rapid testing of solid, semi-solid, or liquid specimens, such a stool, blood, urine, saliva, or swab specimens of the cervix, urethra, nostril, throat, and for environmental testing.

1 . A device for testing a specimen, comprising:
 (a) a test assembly comprising   (i) a sample receiving chamber;   (ii) a test chamber;   (iii) a septum wall separating the sample receiving chamber and the test chamber;   (iv) an opening in the septum wall so that the sample receiving chamber and the test area are in fluid communication;   (v) a reagent member positioned in the test chamber, the reagent member having a wick on and a test area comprising at least one assay reagent;   (vi) a breakable seal for preventing flow of the sample from the sample receiving chamber to the test chamber; and   (viii) means for breaking the seal and allowing the sample to flow from the sample receiving chamber to the test chamber.   
     
     
         2 . The device of  claim 1 , where the sample receiving chamber includes a test buffer. 
     
     
         3 . The device of  claim 1 , where the means for breaking the seal is attached to a lower end of the le receiving chamber. 
     
     
         4 . The device of  claim 1 , where the test assembly is formed of a plastic selected from the group sting of polyethylene, polypropylene, polystyrene polyvinyl, and acrylonitrile butadiene styrene. 
     
     
         5 . The device of  claim 1 , further comprising:
 (b) a cap including a handle and an insert section sized to fit within an upper end of the test assembly.   
     
     
         6 . The device of  claim 1 , where the reagent member is a lateral flow test strip. 
     
     
         7 . The device of  claim 1 , comprising at least two reagent members. 
     
     
         8 . The device of  claim 1 , comprising from 3-5 reagent members. 
     
     
         9 . The device of  claim 1 , where the assay reagent detects hemoglobin. 
     
     
         10 . The device of  claim 1 , where the assay reagent detects a hapto-hemoglobin complex. 
     
     
         11 . A method of using the device of  claim 1 , comprising:
 introducing a sample solution into the sample receiving chamber; mixing the sample with a buffer in the sample receiving chamber; breaking the seal;   introducing the sample into the test chamber through the opening; and   reacting the sample with the assay reagent of the reagent member.   
     
     
         12 . The method of  claim 11 , where said device further includes a cap including a handle and an t sized to fit within an upper end of the test assembly, the method further comprising:
 lowering the handle such that the insert section is inserted into the test assembly to move the means for breaking the seal to break the seal.