System for detecting bacteria in blood, blood products, and fluids of tissues

Abstract

The invention provides methods for screening for the presence of a clinically relevant amount of bacteria in donor blood or a blood product from a donor mammal, particularly blood or a blood product that will be transferred from the donor mammal to a recipient mammal. The method comprises contacting a sample of the donor blood or a blood product with a set of binding agents that comprises binding agents that specifically bind to Gram-negative bacterial antigen and / or binding agents that specifically bind to Gram-positive bacterial antigen, and determining binding of the set of binding agents to the sample, wherein binding indicates the presence of a clinically relevant amount of Gram-positive bacteria and / or Gram-negative bacteria in the donor blood or blood product and no binding indicates the absence of a clinically relevant amount of Gram-positive bacteria and / or Gram-negative bacteria in the donor blood or blood product.The invention further provides methods and kits for screening for the presence of a clinically relevant amount of Gram-positive bacteria, Gram-negative bacteria, or both Gram-positive and Gram-negative bacteria in a donor tissue by screening the fluid in which the donor tissue is stored.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims benefit from U.S. Provisional Patent Application No. 60 / 144,442 filed Jul. 16, 1999, the entire contents of which is hereby incorporated by reference.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The invention relates to the screening of blood or a blood product (including whole blood, hematopoietic stem cells, leukocytes, plasma, serum, red blood cells, and platelets) or a donor tissue for the presence of a clinically relevant amount of bacteria. More particularly, the invention relates to the screening for the presence of a clinically relevant amount of contaminating bacteria in blood and blood products or donor tissue that will be used for transfusion or transplantation.[0004]2. Summary of the Related Art[0005]Transfusion of blood and blood products is a therapeutically important aspect of patient care. Transplantation of donor tissues and organs is likewise therapeutically important. The absen...

AI Technical Summary

Benefits of technology

The patent describes a method for detecting bacteria in blood or blood products using a set of binding agents that specifically bind to bacterial antigens. This allows for the rapid screening of blood or blood products for clinically relevant amounts of bacteria before they are transferred to a recipient mammal. The method can be used with both Gram-negative and Gram-positive bacteria, and can detect even small amounts of bacteria in a sample. The binding agents used in the method can be detectable labeled with a reporter molecule, such as an enzyme or a radio-labeled molecule. The technical effect of this patent is to provide a reliable and efficient method for detecting bacteria in blood or blood products to ensure their safety for transplantation.

Problems solved by technology

Thus, if blood contaminated with a clinically relevant amount of bacteria were to be transfused to a recipient patient, the recipient patient might suffer complications, particularly since transfusions of blood and / or blood products are often performed when the patient is undergoing major surgery, or is otherwise vulnerable.

Despite the need for a safe, microbe-free supply of blood or a blood product, no rapid, efficient method exists for detecting the presence of contaminating bacteria in blood or a blood product.

Although these culture-based blood testing techniques are useful for determining the particular type of bacteria that is infecting a patient's blood, the length of the time required to perform these techniques makes them impractical to use to test donor blood and blood products or donor organs.

Thus, there may be no time to test the donated blood (or blood product) or organ with a culture-based technique before the donated blood or organ is needed for use.

In addition, donated organs and blood or blood products have a relatively short shelf-life due not only to a loss of function of the donated material, but also to an increase in amount of any contaminating bacteria present.

Moreover, these culture-based blood testing techniques take too long to routinely screen platelets, which have a short shelf-life (approximately 5 days post-donation), for transfusion use.

(Transfusion 34(9): 750-755 (1994)) teaches another technique for detecting a particular contaminating bacteria in blood using labelled nucleic acid probes to hybridize to the genetic material of potential contaminants The probes used in these studies, however, are very limited in the number of micro-organisms that can be detected and, unfortunately, no commercially viable test has emerged from this technology.

Given their complexity, these techniques are too labor-intensive and too time-costly to be routinely used to screen blood or blood products for bacterial contamination.

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