Screening arrangement for screening immunoassay tests and agglutination tests

Abstract

Immunoassay tests or agglutination tests run on samples of bodily fluid to detect the presence of particular compounds such as drugs in the body may be screened in the screening device. A test membrane is inserted into the screening device and illuminated. The reflected image is detected and the digitised data processed. For immunoassay tests, the digitised data is segmented and data for the test region is compared to that from the control region and the background regions to determine whether the test data exhibits any significant results. For agglutination tests, the digitised data is processed to determine the number and size of the areas of coagulation to determine whether the test data exhibits any significant results. A swab for taking a bodily sample incorporates a run fluid capsule. Once an adequate sample of bodily fluid has been collected and the swab is placed in contact with the test membrane, the run fluid capsule is pierced by a spike provided on the swab, the run fluid mixes with the sample and the mixture is conveyed to the test membrane. Alternatively or in addition the swab has a main tube and a capillary tube. A run detector in the capillary tube detects when an adequate sample of bodily fluid has been taken.

1 - 17 . (canceled)  
     
     
         18 . A screening device for interpreting the results of an agglutination test, said test having areas of coagulation and background areas, said device comprising: 
 a light source for illuminating said test;    an array of photosensitive detectors for detecting the intensity of light from said light source which is reflected from said areas of coagulation and background areas of said agglutination test;    a digitiser, coupled to the output of said array of photosensitive detectors, for representing said intensity of the detected light by a data array;    a threshold processor, coupled to the output of said digitiser, for thresholding said digitised data to distinguish between background areas and areas of coagulation;    a first data processor, coupled to said threshold processor, for identifying from said thresholded data areas of coagulation and estimating the size of said areas of coagulation;    a second data processor, coupled to the output of said first data processor, for determining whether said areas of coagulation exhibit a statistically significant result; and    an output, coupled to said second data processor, for outputting the results from said second data processor.    
     
     
         19 . A screening device according to  claim 18 , wherein a noise reduction processor is coupled between the output of said digitiser and said first data processor for performing noise reduction on said digitised data.  
     
     
         20 . A method of screening an agglutination test, said test having areas of coagulation and background areas, said method comprising the steps of: 
 illuminating said test;    detecting the intensity of light which is reflected from said areas of coagulation and background areas of said agglutination test;    representing the intensity of said detected light in a data array;    thresholding said data array to distinguish between background areas and areas of coagulation;    identifying areas of coagulation and estimating the number of said areas of coagulation;    determining whether said areas of coagulation exhibit a statistically significant result; and    outputting said results.    
     
     
         21 . A method according to  claim 20 , wherein noise reduction of said digitised data is performed prior to thresholding said digitised data.  
     
     
         22 . A swab for taking a sample of bodily fluid and transferring said sample to a test strip, said swab comprising: 
 a collection pad, a tube, a run fluid chamber and an elongate spike;    said tube having a bore running axially along its length and having open upper and lower ends, said lower end of said tube being disposed axially adjacent to and in communication with said collection pad;    said run fluid chamber being located in said bore of said tube; and    said elongate spike being moveable in said bore of said tube from a sampling position to a sample transferring position, said elongate spike being axially remote from said run fluid chamber in said sampling position and piercingly contacting said run fluid chamber in said sample transferring position.    
     
     
         23 . A swab according to  claim 22 , wherein a detector is provided for detecting that an adequate sample of bodily fluid has been collected.  
     
     
         24 . A swab according to  claim 23 , wherein said detector is located in said tube and comprises a dye release pad and a dye receptor pad, said dye release pad being positioned in closer axial proximity to said collection pad than said dye receptor pad, and said tube being substantially transparent in the vicinity of said dye receptor pad.  
     
     
         25 . A swab according to  claim 24 , wherein a filter pad is located axially between said collection pad and said dye release pad.  
     
     
         26 . A swab according to  claim 22 , wherein an outer tube is provided, said outer tube being open at the lower end thereof and housing said upper end of said tube; said elongate spike being held captive between said tube and said outer tube, said outer tube being moveable relative to said tube whereby movement of said outer tube relative to said tube causes said elongate spike to move from said sampling position to said sample transferring position.  
     
     
         27 . A swab for taking a sample of bodily fluid and transferring said sample to a test strip, said swab comprising: 
 a collection pad, a main tube, a run detector and a capillary tube;    said main tube having an axial bore and being open at the lower end thereof, said lower end of said tube being disposed axially adjacent to and in communication with said collection pad; and    said capillary tube being open at the upper and lower ends thereof, said open lower end of said capillary tube being in communication with said collection pad and said run detector being located in said capillary tube, the distance between said run detector and said collection pad being such that said run detector detects when an adequate sample of bodily fluid has been collected.    
     
     
         28 . A swab according to  claim 27 , wherein the wall of said main tube defines a port, said open lower end of said capillary tube being connected to said port and communicating with said main tube.  
     
     
         29 . A swab according to  claim 28 , wherein said run detector comprises a dye release pad and a dye receptor pad, said dye release pad being positioned in closer proximity to said lower end of said capillary tube than said dye receptor pad.  
     
     
         30 . A swab according to  claim 27 , wherein a pierceable run fluid chamber is located in said main tube.