Method for the rapid diagnosis of targets in human body fluids

Abstract

More particularly, the present invention relates to a method for the detection of a target, e.g. pathogen in a human body fluid wherein a body fluid sample is collected with a swab member.

1 . A device for the detection of a target which is selected from pathogens and/or allergy-associated components in a body fluid comprising 
 (i) a sample application zone,    (ii) a detection zone,    (iii) a swab member for collecting a sample fluid, and    (iv) means for fixing the swab member in a position which directly contacts the sample application zone in fluid communication therewith.    
   
   
       2 . The device according to  claim 1 , further comprising a housing with a first window for directly contacting the swab member with the sample application zone and a second window over the detection zone for reading the results.  
   
   
       3 . The device according to  claim 1 , further comprising a waste zone downstream from the sample application zone and the detection zone.  
   
   
       4 . The device according to  claim 1 , further comprising a carrier backing.  
   
   
       5 . The device according to  claim 1 , further comprising an absorbent pad upstream from the sample application zone and the detection zone.  
   
   
       6 . The device according to  claim 1 , wherein said sample application zone contains at least one labeled specific binding partner capable of binding to an analyte and migrating to the detection zone.  
   
   
       7 . The device according to  claim 6 , wherein the detection zone contains an immobilized specific binding partner which binds to the analyte.  
   
   
       8 . The device according to  claim 7 , wherein the detection zone further comprises a control line containing an immobilized specific binding partner which binds said labeled binding partner and indicates the functionality of the device.  
   
   
       9 . The device according to  claim 1 , further comprising a conjugate zone which contains at least one labeled specific binding partner capable of binding to an analyte and migrating to the detection zone.  
   
   
       10 . The device according to  claim 9 , wherein said labeled specific binding partner is labeled with an optically detectable label.  
   
   
       11 . The device according to  claim 6 , wherein said labeled specific binding partner is specific for a virus, microorganism or parasite.  
   
   
       12 . The device according to  claim 6 , wherein said labeled specific binding partner is specific for an allergen or antiallergen.  
   
   
       13 . The device according to  claim 1 , wherein said sample fluid is fluid from a body surface selected from mucous membrane fluids, secretions from glands and secretions from lesions or blisters.  
   
   
       14 . The device according to  claim 13 , wherein said sample fluid is selected from oral, nasal, ocular, genital, and rectal fluids, and secretions from skin lesions or blisters.  
   
   
       15 . The device according to  claim 14 , wherein said sample fluid is an eye fluid.  
   
   
       16 . The device according to  claim 11 , wherein said labeled specific binding partner is specific for a virus, microorganism or parasite which causes conjunctivitis.  
   
   
       17 . The device according to  claim 11 , wherein said labeled specific binding partner is specific for a pathogen selected from the group consisting of adenoviruses, herpes viruses, Chlamydia, cytomegaloviruses, pseudomonas, streptococci, haemophilus, staphylococci, amoebae and combinations thereof.  
   
   
       18 . The device according to  claim 1 , wherein said swab member collects a sample volume of about 0.1 μl to about 100 μl.  
   
   
       19 . The device according to  claim 18 , wherein said sample volume is about 0.5 μl to about 10 μl.  
   
   
       20 . The device according to  claim 1 , wherein said swab member is sterile.  
   
   
       21 . The device according to  claim 1 , wherein the swab member is initially separate from the sample analysis device.  
   
   
       22 . The device according to  claim 1 , wherein the swab member is an integrated part of the device.  
   
   
       23 . The device according to  claim 1 , where said device is a chromatographic test strip.  
   
   
       24 . The device according to  claim 1 , wherein said device has two parts connected by a hinge, wherein the swab member is on one part, and the sample application zone and detection zone are on another part, such that when said hinge is closed, the swab member is held in direct contact with the sample application zone.