Alpha Therapeutic Corporation

H Edward Matveld

Charles M Heldebrant

John J Whalen, Iii

Michael E Chlebowski

Andrew J Conrad

Lorraine B Peddada

A process is provided for preparing samples of blood, blood plasma, blood serum, or plasma proteins, including blood factor products, for PCR testing which minimizes contaminants which may interfere with the analysis. The process includes centrifugation of the initial sample to form a sample pellet, removing at least a portion of the supernatant from the pellet, and washing the pellet with an aqueous buffer. The buffer and washed pellet are then centrifuged, and a portion of the remaining supernatant is removed along with any contaminants contained therein. The clean, substantially contaminant-free pellet is then processed for PCR analysis.

Process for purification of PCR test samples

Systems, processes and devices are provided which are useful for testing blood or plasma donations to detect those specific donations which are contaminated by virus above a predetermined level. An apparatus and process is described which forms individual, separately sealed, and connected sample-containing pouches from a flexible hollow tubing segment connected to a fluid donation container. The tubing segment is sealed at spaced-apart intervals along its length, with tubing segment portions in the intervals between the seals defining pouches, each of which contains a portion of a plasma sample. The contents of the pouches are formed into pools which are subsequently tested for virus contamination by a high sensitivity test such as PCR. When a pool tests positive, indicating it is contaminated by a virus, a further pouch is removed from each of the tubing segments used to form the initial pool. Subsequent pouches are divided into approximately equal sized subgroups and their contents separately formed into subpools. A selected one of the subgroup pools is then tested for virus contamination. The test process is iterated, with each pool that tests positive being further subdivided into two successively smaller subgroups, until two final subgroups are formed, each comprising a single pouch corresponding to a single plasma donation. The final two pouches are subsequently PCR tested in order to determine and uniquely identify the corresponding contaminated donation.

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North Hollywood, CA, United States of America

H Edward Matveld