Sensitive Detection of Bacteria Contaminated Platelets

Lynntech, Inc., College Station TX

Investigators

Abstract

DESCRIPTION (provided by applicant): Bacterial contamination of platelets is the leading cause of morbidity and mortality from a transfusion-transmitted infection. Bacterial contamination rates for platelets have been estimated to occur at a frequency of 1 in 2,000 to 1 in 3,000 platelet units. The risk of receiving a bacterially contaminated platelet is 50 to 250 times higher than the combined risk of transfusion-related infections from HIV, hepatitis B and C, and human T cell leukemia (HTLV I/II) viruses. There are several technical approaches for bacterial detection in platelets but none have been widely accepted. . They either detect the metabolic substrates/products, the cell's marker, or the bacteria itself. Although molecular tests based on amplification techniques allow better sensitivity, but they are far more expensive and usually require special personnel and equipment. In addition, they are subject to frequent false positive. Lynntech proposes an ultra-sensitive and fast method to detect the presence of bacterial contamination in platelets. This method can be used near the time of platelet being released for transfusion. The method uses electrochemistry to confirm the presence of bacteria. If the electrochemical result is above a threshold value, it signals the need to discard the platelet product. This technology does not require nucleic acid amplification or long incubation periods. The process will take less than 30 min to complete, and it can be fully automated to reduce contamination and labor cost. The technology is anticipated to be able to detect bacteria at a level between 102 to 103 CFU per/ml. In short, this quick and reliable testing method can be used just before a platelet concentrate is issued to a patient. This will help reduce the delay in processing and release of platelet units that are currently associated with culture based methods. Fast response time and the potential for high throughput testing will not only lower the cost of analysis but also significantly reduce the number of cases of infections and fatalities, improving the patients' quality of lives and saving the health care system millions of dollars annually.