Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving virus or bacteriophage
Patent
1998-05-20
2000-05-16
Marschel, Ardin H.
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving virus or bacteriophage
435 6, 435 912, 536 253, C12Q 170, C12Q 168, C07H 2100
Patent
active
060635630
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 spaced-apart 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 high-sensitivity 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 N-dimensional matrix or grid. Each element of the matrix is identified by a matrix identifier, X.sub.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.
REFERENCES:
patent: 4527383 (1985-07-01), Bingham
patent: 4820297 (1989-04-01), Kaufman et al.
patent: 4846005 (1989-07-01), Bacehowski et al.
patent: 4900321 (1990-02-01), Kaufman et al.
patent: 5176995 (1993-01-01), Snisky et al.
patent: 5364526 (1994-11-01), Matkovich et al.
patent: 5423792 (1995-06-01), Oxley
patent: 5591573 (1997-01-01), Whalen et al.
patent: 5780222 (1998-07-01), Peddada et al.
Garcia, et al., Evaluation of a Pooling Method for Routine Anti-HCV Screening of Blood Donors to Lower the Cost Burden on Blood Banks in Countries Under Development, Journal of Medical Virology, vol. 49, No. 3, Jul. 1996.
Nubling, et al., Virus Testing of Plasma Pools and Blood Products by Nucleic Acid Amplification, Hamostaseologie, R.K. Schattauer Verlagsgeselischatt mbH 1996: 16:274-6.
J. Saldanha and P. Minor, A Sensitive PCR Method for Detecting HCV RNA in Plasma Pools, Blood Products, and Single Donations, Journal of Medicine Virology 43:72-76 (1994).
J. Saldanha, Assays for Viral Sequences and Their Value in Validation of Viral Elimination, Brown F(ed):Virological Safety Aspects of Plasma Derivatives. Dev Biol Stand. Basel. Karger. 1993. vol. 81, pp. 231-236.
J. Saldanha and P. Minor, Collaborative Study to Assess the Suitability of an HCV RNA Reference Sample for Detection of an HCV RNA in Plasma Pools by PCR, Vox Sanguinis International Journal of Transfusion Medicine, 1996:70:148-151.
J. Saldanha and P. Minor, Detection of human parvovirus B19 DNA in plasma pools and blood products derived from these pools: implications for efficiency and consistency of removal of B19 DNA during manufacture, British Journal of Haematology, 1996, 93, 714-719.
J. Saldanha and P. Minor, Incidence of Hepatitis C Virus RNA in Anti-HCV-Negative Plasma Pools and Blood Products, Vox Sanguinis International Journal of Transfusion Medicine, 1996; 70:232-234.
Zeijlemaker, et al., Meeting Report, EPFA-NIBSC Workshop on `Nucleic Acid Amplification Assays and Plasma Products` Nov. 23, 1994, Helsinki, Finland, .COPYRGT. 1995 The International Association of Biological Standardization, Biologicals 23, pp. 317-326.
Matsuda J. et al., Preliminary Report on an Automated Screening Test for Detection of Antibody to Human Immunodeficiency Virus Type 1 in Whole Blood. Clinical Infectious Diseases 19:327-8 1994.
Kim, H-S., Smithies, O., Recombinant Fragment Assay for Gene Targetting Based on the Polymerase Chain Reaction. Nucleic Acids Research 16:8887-8903 1988.
Gresser, I., ed., Interferon 1981 vol. 3, Academic Press, NY, 1981, p. 102.
Conrad Andrew J.
Heldebrant Charles M.
Peddada Lorraine B.
Alpha Therapeutic Corporation
Marschel Ardin H.
Tung Joyce
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