Automated method and system for testing blood samples

Abstract

An automated system and process is provided for pooling samples from a multiplicity of blood or plasma donations for subsequent testing to uniquely identify any such blood or plasma donations which may be infected with a particular virus. The system includes an autosampler needle which is directly inserted into a blood or plasma sample aliquot container in order to withdraw an aliquot portion of the contents for forming a sample pool with aliquot portions of other blood or plasma samples. The autosampler comprises a tubular piercing member having a hollow interior bore and a tubular shroud surrounding the piercing member.

Description

FIELD OF THE INVENTIONThe present invention relates generally to systems and processes for preparing and analyzing samples taken from plasma donations to uniquely identify donations which are virus contaminated. In particular, the invention relates to an apparatus and process for forming individual, separately sealed containers for holding samples of the same plasma as is contained in a donation. The invention also relates to an automated apparatus and process for forming initial screening test pools in a safe, cost effective manner.BACKGROUND OF THE INVENTIONBlood, plasma, and biological fluid donation programs are essential first steps in the manufacture of pharmaceutical and blood products that improve the quality of life and that are used to save lives in a variety of traumatic situations. Such products are used for the treatment of immunologic disorders, for the treatment of hemophilia, and are also used in maintaining and restoring blood volume during surgical procedures and o...

AI Technical Summary

Benefits of technology

In a more detailed embodiment of the invention, a multiplicity of gasketed openings are provided in the carousel cover and a pooling manifold including a multiplicity of vented autosampler needles is connected to the distal end of the movable arm. As sample aliquot containers are indexed past the row of gasketed openings, the movable arm lowers the array of autosampler needles into communication with the containers, so as to withdraw a...

Problems solved by technology

Therefore, tests directed to the detection of antibodies may give a false indication for an infected donor if performed during the window period, i.e., the period between viral infection and the production of antibodies.

PCR testing is, however, very expensive and since the general donor population includes a relatively small number of donors infected with the viruses of interest, individual testing of each donation is not cost effective or economically feasible.

While reducing the number of PCR tests, and the costs associated therewith, this method results in a substantial waste of a significant number of virus free donations.

Multiple freeze-thaw cycles may adversely effect the recovery of the...

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