Diagnostic Devices And Methods

Abstract

Apparatus is disclosed for identifying at least a first target condition in a human or animal body. The apparatus comprises one or more test portions for identifying a first analyte in a biological sample from the body, the first analyte providing a marker of the first target condition, and a second analyte in the biological sample, the second analyte being different from the first analyte. The apparatus is configured to identify the first target condition in the body based on the identification of both the first and second analytes. In one embodiment, the first target condition is pregnancy, the first analyte is human chorionic gonadotropin (hCG) and the second analyte is luteinizing hormone (LH).

1 .- 44 . (canceled) 
     
     
         45 . A pregnancy test device for identifying pregnancy in a human or animal body based on a biological sample obtained from the human or animal body, the test device comprising:
 a reader that determines a level of human chorionic gonadotropin (hCG) in the biological sample and determines a level of luteinizing hormone (LH) in the biological sample, wherein the reader comprises a processor and a non-transitory computer-readable memory medium, the non-transitory computer-readable memory medium comprising instructions that cause the processor to:
 determine which of a plurality of discrete LH ranges the determined level of LH falls within, wherein the processor associates a different hCG threshold level with each one of the LH ranges; 
 select the hCG threshold level that is associated with the LH range which the determined level of LH falls within; and 
 identify pregnancy in the body if the determined level of hCG is above the selected hCG threshold level. 
   
     
     
         46 . The pregnancy test device of  claim 45 , wherein the plurality of discrete LH ranges comprises a first LH range including all LH values below a first LH threshold level, and a second LH range including all LH values above the first LH threshold level; and wherein:
 a first hCG threshold level is associated with the first LH range; and   a second hCG threshold level is associated with the second LH range, the second hCG threshold level being higher than the first LH threshold level.   
     
     
         47 . The pregnancy test device of  claim 47 , wherein the first hCG threshold level is between 1.0 and 3.0 IU/L. 
     
     
         48 . The pregnancy test device of  claim 47 , wherein the difference between the first and second hCG threshold levels is at least 5 IU/L. 
     
     
         49 . The pregnancy test device of  claim 47 , wherein the first LH threshold level is greater than 5 IU/L. 
     
     
         50 . The pregnancy test device of  claim 45 , wherein the plurality of discrete LH ranges comprises first, second and third LH ranges defined by a first LH threshold level and a second LH threshold level, the second LH threshold level being higher than the first LH threshold level;
 wherein:
 the first LH range includes all LH values below the first LH threshold level; 
 the second LH range includes all LH values between the first LH threshold level and the second LH threshold level; and 
 the third LH range includes all LH values above the second LH threshold level; and 
   wherein:
 a first hCG threshold level is associated with the first LH range; 
 a second hCG threshold level is associated with the second LH range, the second hCG threshold level being higher than the first hCG threshold level; and 
 a third hCG threshold level is associated with the third LH range, the third hCG threshold level being higher than the second hCG threshold level. 
   
     
     
         51 . The pregnancy test device of  claim 50 , wherein the first hCG threshold level is between 1.0 and 3.0 IU/L. 
     
     
         52 . The pregnancy test device of  claim 50 , wherein the difference between the first and second hCG threshold levels is at least 5 IU/L. 
     
     
         53 . The pregnancy test device of  claim 50 , wherein the difference between the second and third hCG threshold levels is at least 5 IU/L. 
     
     
         54 . The pregnancy test device of  claim 50 , wherein the first LH threshold level is greater than 5 IU/L. 
     
     
         55 . The pregnancy test device of  claim 50 , wherein the second LH threshold level is greater than 20 IU/L. 
     
     
         56 . A pregnancy test device for identifying pregnancy in a human or animal body based on a biological sample obtained from the human or animal body, the test device comprising:
 a reader that determines a level of human chorionic gonadotropin (hCG) in the biological sample and determines a level of luteinizing hormone (LH) in the biological sample, wherein the reader comprises a processor and a non-transitory computer-readable memory medium, the non-transitory computer-readable memory medium comprising instructions that cause the processor to:   select a first hCG threshold level if the determined level of LH in the biological sample is below a first LH threshold level; or   select a second hCG threshold level if the determined level of LH in the biological sample is above the first LH threshold level, the second hCG threshold level being higher than the first hCG threshold level; and   identify pregnancy in the body if the determined level of hCG is above the selected one of the first and second hCG threshold levels.   
     
     
         57 . A pregnancy test device for identifying pregnancy in a human or animal body based on a biological sample obtained from the human or animal body, the test device comprising:
 a reader that determines a level of human chorionic gonadotropin (hCG) in the biological sample and determines a level of luteinizing hormone (LH) in the biological sample, wherein the reader comprises a processor and a non-transitory computer-readable memory medium, the non-transitory computer-readable memory medium comprising instructions that cause the processor to:   identify pregnancy in the body if the determined level of hCG in the biological sample is above an hCG threshold level, the hCG threshold level being selected by the processor to be higher for relatively higher determined levels of LH in the biological sample.