Method of PCR testing of pooled blood samples
First Claim
1. A method for uniquely identifying viral positive biological fluid donations in the fewest number of highsensitivity test cycles, the method comprising:
 providing a multiplicity of biological fluid donations;
defining an ndimensional matrix, where n is an integer, the matrix further comprising a multiplicity of elements, each element defined by an intersection of the ndimensions of the matrix, each individual element identified by a respective matrix notation, the matrix notation comprising at least an index for each dimension of the array;
taking a sample from each of the multiplicity of biological fluid donations;
mapping each sample to a respective particular one of each element of the matrix, each individual sample identified by its corresponding element'"'"'s respective matrix notation;
taking aliquots from each sample, the number of aliquots taken from each sample defined by the number of dimensions characterizing the matrix;
forming subpools from the aliquots of each sample, each subpool containing an aliquot from all samples identified by a matrix notation in which one dimensional index is fixed, each respective subpool identified by said fixed dimensional index;
providing the subpools to a highsensitivity testing facility, wherein all of the subpools are tested for viral indication in a single highsensitivity test cycle;
determining the respective fixed dimensional indices of subpools which return a positive viral indication; and
combining said fixed dimensional indices into a matrix notation, thereby unambiguously identifying a unique matrix element defined by the matrix notation, thus unambiguously identifying a uniquely viral positive sample.
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Abstract
Systems, processes, and devices are provided which are useful for testing blood or plasma donations to detect those specific donations which are contaminated by a virus above a predetermined level. An apparatus and process is described which forms individual, separately sealed and connected sample containers from a flexible hollow tubing segment connected to a fluid donation container. The tubing segment is sealed at spacedapart intervals along its length, with tubing segment portions in the intervals between the seals defining containers, each of which holds a portion of a plasma sample. The contents of the containers are formed into pools which are subsequently tested for virus contamination by a highsensitivity test such as PCR The pools are tested in accordance with an algorithm by which a sample from each donation is mapped to each element of an Ndimensional matrix or grid. Each element of the matrix is identified by a matrix identifier, X_{rcs}, where rcs defines the dimensional index. An aliquot is taken from each sample, and subpools are formed, each subpool comprising aliquots of samples in which one dimensional index is fixed. All of the subpools are tested in one PCR test cycle. The dimensional indicia of each positive subpool is evaluated mathematically in accordance with a reduction by the method of minors, thereby unambiguously identifying a unique element in the grid, thereby unambiguously identifying a uniquely positive blood or plasma donation.
9 Citations
24 Claims

1. A method for uniquely identifying viral positive biological fluid donations in the fewest number of highsensitivity test cycles, the method comprising:

providing a multiplicity of biological fluid donations; defining an ndimensional matrix, where n is an integer, the matrix further comprising a multiplicity of elements, each element defined by an intersection of the ndimensions of the matrix, each individual element identified by a respective matrix notation, the matrix notation comprising at least an index for each dimension of the array; taking a sample from each of the multiplicity of biological fluid donations; mapping each sample to a respective particular one of each element of the matrix, each individual sample identified by its corresponding element'"'"'s respective matrix notation; taking aliquots from each sample, the number of aliquots taken from each sample defined by the number of dimensions characterizing the matrix; forming subpools from the aliquots of each sample, each subpool containing an aliquot from all samples identified by a matrix notation in which one dimensional index is fixed, each respective subpool identified by said fixed dimensional index; providing the subpools to a highsensitivity testing facility, wherein all of the subpools are tested for viral indication in a single highsensitivity test cycle; determining the respective fixed dimensional indices of subpools which return a positive viral indication; and combining said fixed dimensional indices into a matrix notation, thereby unambiguously identifying a unique matrix element defined by the matrix notation, thus unambiguously identifying a uniquely viral positive sample.  View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 20, 21, 22)


10. A method for uniquely identifying viral positive biological fluid donations in the fewest number of highsensitivity test cycles, the method comprising:

providing a multiplicity of biological fluid donations; defining an ndimensional matrix, where n is an integer, the matrix further comprising a multiplicity of elements, each element defined by an intersection of the ndimensions of the matrix, where each individual element identified by a respective matrix notation X_{i} . . . N, wherein the subscript of the matrix notation defines the dimensional indices of the array; taking N aliquots from each sample of each of the multiplicity of biological fluid donations, the number of aliquots taken from each sample defined by the number of dimensional indices comprising the array; forming subpools from the aliquots of each sample, each subpool comprising an aliquot from all of the samples identified by a matrix notation in which one dimensional index is fixed; providing the subpools to a highsensitivity testing facility, wherein all of the subpools are tested for viral indication in a first highsensitivity test cycle; and evaluating the dimensional indicia of each subpool which returned a viral positive indication in the first highsensitivity test cycle, in accordance with a reduction by the method of minors, the evaluation identifying a unique element defined by the dimensional indicia of each positive subpool if only a single subpool representing each dimensional index returns a positive viral indication,, thus unambiguously identifying a viral positive sample.  View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 19, 23, 24)

1 Specification