Antisera tray

Details Antisera tray Antisera tray

1999-09-13

2003-04-29

Chin, Christopher L. (Department: 1641)

Chemistry: analytical and immunological testing

Involving immune complex formed in liquid phase

Separation of immune complex from unbound antigen or antibody

C436S538000, C422S068100, C422S091000, C422S105000, C422S105000, C204S456000, C204S465000, C204S193000, C204S194000, C204S403060, C435S004000, C435S005000, C435S006120, C435S007100

Reexamination Certificate

active

06555392

ABSTRACT:

BACKGROUND ART
This invention relates to a container for storing multiple, discrete chemicals for subsequent dispensing and has particular utility as an antisera container or tray for use in an immunofixation electrophoresis system.
Immunofixation electrophoresis, referred to as IFE, is well-known as a two-stage procedure for detecting the presence of certain proteins in human serum, urine or cerebral spinal fluid. The procedure involves, as a first step, protein fraction resolution by electrophoresis. As a second step, the soluble antigen in each protein fraction is allowed to react with its antibody. The resultant antigen-antibody complexes will precipitate, at a rate dependent upon the proportion of the reactants, temperature, salt concentration and pH. The antigen-antibody complexes are then visualized by staining.
The IFE process is described in greater detail in Gebott et al, U.S. Pat. No. 4,668,363 issued May 26, 1987, which is hereby incorporated by reference. Apparatus and chemicals for performing IFE have been marketed for some time by Helena Laboratories Corporation of Beaumont, Tex.
Typically, a specimen from a single patient is diluted and then placed in multiple sample or application areas (also referred to as zones or channels) on a single electrophoretic gel plate. The purpose of utilizing multiple sample areas is to enable detection separately of total serum protein, and various proteins such as the immunoglobin heavy chains IgG, IgM, IgA and light chains Kappa and Lambda, or other proteins whose presence or absence may be of importance in medical diagnosis. As known in the prior art, various antisera (i.e., fluid containing the antibody) such as IgG, IgM, etc., are deposited on the appropriate zones and permitted to react with the antigen in the sample. The term “incubation” refers to the time interval during which the antisera and antibody are in contact such that a reaction may occur.
U.S. Pat. No. 5,137,614, issued on Aug. 11, 1992 to Golias, which is hereby incorporated by reference, is directed to a control system for verifying the effectiveness of the chemicals utilized in the immunofixation electrophoresis procedure. This is accomplished without the need to interrupt patient specimen evaluation when chemicals are replenished, since the chemical utilized on the specimens are also utilized in the control test. The control system verifies that the chemicals have retained their lability.
U.S. Pat. No. 3,844,918, issued on Oct. 29, 1974 to Crawley, which is hereby incorporated by reference, is directed to a template which includes an aperture through which serum is received. The template is placed on a mold having an extended portion which passes through the aperture. Gel is coated on one surface of the template. When the gel molds around the portion extending through the aperture, the mold is removed from the template. The template is left with a small cavity in which the serum is placed.
U.S. Pat. No. 5,403,456, issued on Apr. 4, 1995 to Bellon, which is hereby incorporated by reference, is directed to a mask which includes an orifice through which liquid is deposited on the zone of the gel, and a slit through which excess liquid is withdrawn from the zone of the gel after the incubation step. In practice, the mask is placed in close proximity to, but spaced apart from the surface of the gel, the liquid is deposited through the mask onto the gel, the mask is maintained in its relative position during the incubation step, and, thereafter, excess liquid is withdrawn through the mask. Then, of course, the mask, is removed.
It is preferred, for reasons of economy, to evaluate multiple samples (e.g., of multiple patients) simultaneously. This has been accomplished, in the past, using multiple zones on a single electrophoresis gel. Thus if six zones are required for a single patient, if the samples from six patients are to be evaluated simultaneously, then 6×6 or 36 zones or channels are used on the electrophoresis gel. Then, after the electrophoresis step, the appropriate antisera must be applied to the corresponding zone for each patient. For example, if blood samples of six patients are being evaluated simultaneously, then after the electrophoresis step, one antisera (e.g., IgG antisera) was applied sequentially to the corresponding zone for each patient using a pipette of the type which has a removable, disposable tip. Then, the tip on the pipette would be removed, and another antisera (e.g., IgM antisera) would be applied sequentially to the corresponding zone for each patient using a second disposable tip. This procedure would be repeated for each of the antisera. Of course it was possible to apply the various antisera to the corresponding zones for a single patient, and then repeat the process for the next patient, etc., but this would be cumbersome, time consuming, and create a potential for errors because of the large number of pipette tips which would be used, i.e., 36 tips in the above example.
Applicant has discovered that while multiple sample pipettes have existed for some time, prior to the present invention those multiple sample pipettes could not be used to simultaneously apply antisera to the corresponding zones for a single patient. To the contrary, notwithstanding that multiple sample pipettes were well known, single sample pipettes were used, and the replacement tips were changed before each “different” antisera.
SUMMARY OF INVENTION
The present invention overcomes the difficulties and shortcomings of the prior art by providing a container or tray, for holding and maintaining separate, multiple discrete chemicals such that a multiple sample pipette system can be used to simultaneously apply the antisera to all the zones for a single patient, thus increasing the accuracy and usability of an electrophoresis plate which permitted samples from multiple patients from being processed simultaneously.


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