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US 6,649,339 B1Granted
Method for producing a quality assured biological sample and composition containing the same
AssigneeBaxter Aktiengesellschaft
InventorsGerold Zerlauth, Matthias Gessner, Karl Koettnitz, Patricia Gross
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Abstract
A method for producing a pool of biological samples that is quality assured with respect to the load with microorganisms, using a nucleic acid amplification method, in which a screening pool is tested with a high sensitivity nucleic acid amplification method and can be divided into screening subpools, which are tested with a less sensitive nucleic acid amplification method, where individual samples can be picked out and eliminated, is described.
Claims10
A method for producing a pool of quality assured biological samples comprising:
- (a) testing a screening pool for the presence of a parvovirus genome equivalent, wherein the testing is performed by a first nucleic acid amplification process that has a detection limit (DL-1) for parvovirus, wherein the screening pool comprises collected aliquots from a plurality of biological samples, and wherein the testing determines whether the screening pool has a content of genome equivalents that exceeds a preset limit;
- (b) forming screening subpools from the screening pool of (a) that have a content of genome equivalents that exceed the preset limit;
- wherein the screening subpool is comprised of aliquots from a portion of the plurality;
- (c) testing the subpools of (b) for the presence of a parvovirus genome equivalent, wherein the testing is performed by a second nucleic acid amplification process that has a detection limit (DL-2) for parvovirus, wherein DL-1 is lower than DL-2;
- (d) eliminating samples corresponding to subpools that have a genome equivalent content that exceeds DL-2;
- and
- (e) combining the remaining samples to produce the pool of quality assured biological samples.
4 more elements
Dependencies are inferred from the claim text.