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

There is, therefore, provided in the practice of this invention, a cost-effective, efficient, automated system and process for pooling samples from a multiplicity of blood or plasma donations for subsequent testing to uniquely identify blood or plasma donations which are infected with a particular virus.

The process and system of the present invention results in blood and plasma products being substantially safer because one can quickly prepare pools from blood or plasma donations and can readily test for virus contamination in the blood or plasma supply directly. Cost-effective, high-sensitivity testing can be performed immediately, and contaminated donations identified, without regard to the infectivity window period. In one embodiment of practice of the present invention, an autosampler needle is provided for direct insertion into a blood or plasma sample aliquot container in order to withdraw an aliquot portion of the contents for formation with additional aliquot portions into a pool. The autosampler needle comprises a generally tubular piercing member having a hollow interior bore which defines a fluid communication path between an orifice formed at a distal end, and aspiration tubing. The autosampler needle further comprises a generally tubular shroud which surrounds the piercing member and extends at least partially along its length in the direction of the orifice. The shroud is spaced-apart from the exterior peripheral surface of the piercing member so as to define an annular chamber surrounding the piercing member.

In an additional aspect of the present invention, the vent fitting may be connected to a pressurized gas source, such as air or dry nitrogen, which is forced into the vent chamber and the shroud's annular chamber, thereby pressurizing the sample aliquot container and causing an aliquot portion thereof to be forced into the piercing member through the orifice from whence it is extracted to form a pool.

In a more detailed embodiment of the present invention, the piercing member is constructed to terminate at a distal end in a deflected, non-coring tip so as to be easily insertable into a flexible hollow tubing segment or able to penetrate a septum formed in a branch leg of a medical Y-site.

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 aliquot portions from a multiplicity of containers in a single operation. Aliquot portions from a multiplicity of blood or plasma samples are thus safely and cost-effectively collected in accordance with the present invention and formed into pools for testing. All samples in each carousel are collected and formed into one pool. Therefore, a single needle may be used for extracting sample aliquot portions without regard to cross-contamination.

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 RNA or DNA of interest as well as the proteins contained within the plasma, thus adversely effecting the integrity of the PCR test.

Moreover, each time an aliquot of individual plasma donations is withdrawn to form a pool, the donation is subject to contamination, both from the surrounding environment and from the apparatus used to withdraw the aliquot.

Further, if the donation contains a virus, it can contaminate other donations.

Either of these methods involves considerable expense and is quite time consuming.

While relatively simple and cost effective, such a system of manual sample extraction is time consuming and requires a laboratory clinician to pay careful attention to each step of the process.

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