Diagnostic kits to detect sp22 and sp22 antibodies

Abstract

Oral, topical and injectable contraceptives, which are based on sperm protein 22 kDa (SP22) polypeptides and antibodies and infertility diagnostics and kits are provided.

We claim: 
     
         1 . A kit for detecting SP22 in a sperm sample comprising:
 an application zone for adding a sperm sample, and   a detection zone for determining if SP22 is present on the surface of sperm in the sperm sample.   
     
     
         2 . The kit of  claim 1 , further comprising a barrier zone separating the application zone and the detection zone. 
     
     
         3 . The kit of  claim 2 , wherein barrier zone separates a subset of sperm having an average motility higher than an average motility of sperm of the sample. 
     
     
         4 . The kit of  claim 3 , wherein the barrier zone is selected from the group consisting of a barrier filter, an elongate chamber, a chamber with obstacles, and a chamber with internal walls. 
     
     
         5 . The kit of  claim 3 , wherein the barrier zone comprises a barrier filter. 
     
     
         6 . The kit of  claim 5 , wherein the barrier filter is porous. 
     
     
         7 . The kit of  claim 5 , wherein the barrier filter is a nylon mesh barrier. 
     
     
         8 . The kit of  claim 1 , wherein the detection zone comprises an SP22 antibody. 
     
     
         9 . The kit of  claim 8 , wherein the SP22 antibody is conjugated to a detectable marker. 
     
     
         10 . The kit of  claim 9 , wherein the detectable marker is selected from the group consisting of a chemiluminescent, enzymatic, fluorescent, dye or radioactive moiety. 
     
     
         11 . The kit of  claim 10 , wherein the detectable marker is peroxidase. 
     
     
         12 . The kit of  claim 8 , wherein the SP22 antibody is chemically activatable and produces a colored product upon binding to SP22. 
     
     
         13 . The kit of  claim 1 , wherein the level of SP22 in the sperm sample is determined by a color reaction in the detection zone. 
     
     
         14 . The kit of  claim 1 , wherein application zone is a first reservoir and the detection zone is second reservoir in a cup-like device. 
     
     
         15 . The kit of  claim 1 , further comprising one or more ports for adding solution directly to the detection zone. 
     
     
         16 . The kit of  claim 1 , further comprising a lateral flow device for detecting the presence of SP22 in the sperm sample. 
     
     
         17 . The kit of  claim 1 , further comprising instructions for using the kit to detect the presence of SP22. 
     
     
         18 . A kit for detecting vaginal SP22 antibodies comprising a device for collecting a vaginal sample and a monitoring device comprising SP22 conjugated to a detectable marker. 
     
     
         19 . The kit of  claim 18 , wherein the SP22 is chemically activatable and produces a colored product upon binding to SP22 antibody. 
     
     
         20 . The kit of  claim 18 , wherein the device for collecting a vaginal sample is a polyurethane or polyester swab. 
     
     
         21 . The kit of  claim 18 , wherein the device for collecting a vaginal sample is a tampon or tampon-like device. 
     
     
         22 . The kit of  claim 18 , wherein the monitoring device is a cup-like device comprising a reservoir. 
     
     
         23 . The kit of  claim 18 , wherein the monitoring device is a lateral flow device. 
     
     
         24 . The kit of  claim 23 , wherein the lateral flow device further comprises unlabeled SP22 immobilized in a detection zone. 
     
     
         25 . A method, comprising:
 separating a subset of sperm that have a higher motility than the average motility of sperm from a sperm containing sample, and   determining the presence of SP22 in sperm of the subset of sperm.   
     
     
         26 . The method of  claim 25 , wherein the sperm sample is obtained from a male mammal and the method further comprises determining a fertilization potential of the male mammal based on the presence of SP22 in sperm of the subset of sperm. 
     
     
         27 . The method of  claim 26 , wherein the mammal is a human. 
     
     
         28 . The method of  claim 26 , wherein the mammal is a non-human mammal. 
     
     
         29 . The method of  claim 25 , wherein the method further comprises determining the presence of sperm of the subset of sperm irrespective of the determining the presence of SP22 in sperm of the subset.