Transfusion registry network for genetically characterized blood products

Abstract

Disclosed is a registry system, including member institutions, in which transfusion donors and recipients are registered following genotyping, which would typically take place in a member institution, or a member institution would have access to the genotyping information, if performed outside. The registry database can be accessed and searched by members seeking samples of particular type(s). Systems are disclosed for maintaining economic viability of genotyping in connection with transfusions, by maximizing the number of units placed with the minimal number of candidate donors typed. Genotyping of potential donors, and product supply, is matched to forecasted demand. Genotyping can also be limited to the more clinically relevant markers. The registry system can also be integrated with one format of assay which generates an image for analysis, whereby the imaged results can be analyzed and redacted by experts in a central location, and then transmitted back to the patient or their representative.

1 . A method for operating a registry offering access to genotyped prospective transfusion donors, for matching to a transfusion recipient of given genotype or phenotype, in a manner increasing the probability of having an acceptable donor for any recipient querying the registry, over said probability where donors are not stratified and typed as set forth below, while reducing the total number of prospective donors to be genotyped over the number required to be genotyped where donors are not stratified and typed as set forth below, comprising:
 stratifying prospective donors and recipients into subpopulations; and   for each subpopulation, genotyping sufficient numbers of donors of different genotypes or phenotypes to fulfill anticipated demand from recipients of particular genotypes or phenotypes.   
     
     
         2 . The method of  claim 1  wherein blood units are collected from donors of different genotypes or phenotypes to fulfill anticipated demand for blood units from recipients of particular genotypes or phenotypes. 
     
     
         3 . The method of  claim 2  wherein the registry includes several member institutions, and the inventories of the member institutions include genotyped blood units and genotyped donors who agreed to be available to donate. 
     
     
         4 . The method of  claim 1  wherein following genotyping of the number of donors anticipated to be required to match a preset fraction of the anticipated demand from recipients, additional donors are not genotyped. 
     
     
         5 . The method of  claim 1  wherein genetic markers likely to be present in a subpopulation and indicative of a clinically significant adverse event, if mismatched between donor and recipients, are genotyped. 
     
     
         6 . The method of  claim 1  further including providing incentives to retain donors having particular genotypes. 
     
     
         7 . The method of  claim 6  wherein said incentives include extending authorization to said donors having particular genotypes for preferential access, as against other recipients, to the registry in the event said donors require transfusion. 
     
     
         8 . A method for reducing clinically significant adverse clinical events in transfusion recipients to less than the number said events encountered if not using the method herein, comprising ranking the genetic markers which are related to clinically significant events in order of their clinical significance, matching donors and recipients for only those markers which are associated with a clinical significance greater than a threshold value, and providing donors with transfusions from matched recipients. 
     
     
         9 . The method of  claim 8  wherein donors and recipients are not genotyped for other markers. 
     
     
         10 . A method for reducing clinically significant adverse clinical events in transfusion recipients to less than the number of said events encountered if not using the method herein, comprising:
 stratifying prospective donors and recipients into subpopulations;   determining, in each subpopulation, genetic markers which are associated with clinically significant adverse events;   matching donors and recipients for those markers which have a clinical significance greater than a threshold; and   providing donors with transfusions from matched recipients.   
     
     
         11 . The method of  claim 10  wherein donors and recipients are not genotyped for markers with a significance below the threshold. 
     
     
         12 - 13 . (canceled) 
     
     
         14 . The method of  claim 10  wherein the genetic markers include RhCE, Kidd, Kell, Duffy, Dombrock, MNS, and combinations of markers of RhCE, Kidd, Kell, Duffy, Dombrock and MNS. 
     
     
         15 - 16 . (canceled) 
     
     
         17 . A method of centralization of molecular diagnostics within a network of member institutions, comprising:
 providing to each member institution an assay delivery system capable of uploading assay data to a central server in a standardized format;   providing, through or on said central server, automated analysis and interpretation of uploaded data to generate preliminary assay results;   providing, through or on said central server, access to and expert review of said preliminary assay results, whereby, following said review, final assay results are generated, which are suitable for release to patients or their representatives.   
     
     
         18 . The method of  claim 17  wherein the communication of preliminary and final assay results maintains patient anonymity. 
     
     
         19 . A method of increasing the fraction of repeat donations above that experienced when not using the following method by incentivizing selected genotyped donors, wherein said incentives include extending authorization to said donors having particular genotypes for preferential access, as against other recipients, to the registry in the event said donors require transfusion, and providing transfusions to said genotyped donors requiring transfusion.