Surgery – Diagnostic testing – Liquid collection
Reexamination Certificate
1999-10-08
2001-07-10
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Liquid collection
Reexamination Certificate
active
06258045
ABSTRACT:
BACKGROUND OF THE INVENTION
The subject invention relates to a device and method for collection, transport, storage, processing (e.g., separation of cells from serum), and compatibility with laboratory analysis of a biological sample obtained from a living organism. In particular, the subject invention relates to a device and method used in the analysis of a biological component in a dried blood or urine sample obtained from an animal.
In laboratory and clinical settings, it is often necessary to take, contain, transport, and store biological samples, such as blood or blood products, for purposes of analysis of various components in the sample. The analysis of biological fluids to confirm the levels or concentrations of various components contained therewithin is an accepted clinical practice for the determination of proper functioning of various biological systems. Liquid sample collection, handling, transport, and storage, which is the conventional approach, has many problems associated with it including: (1) the risk of container breakage or leakage which causes loss of sample and the danger of infection; (2) sample instability during shipment and storage; (3) refusal of transport carriers to accept liquid biohazardous shipments; and (4) collection of more sample than is necessary for testing, to ensure quantities compatible with common laboratory methods of serum or plasma preparation and subsequent analysis.
To overcome these problems, in one approach, a biological sample, e.g., a drop or two of whole blood, has been collected on filter paper and dried prior to transport. These dried blood spot samples are mailable and are accepted by all common carriers. Despite the improved handling of dry samples, however, analysis of certain dissolved blood components is not currently possible from a whole blood sample unless the red blood cells are first separated from the blood plasma or serum. The most conventional manner of separating serum or plasma from blood cells is by centrifugation.
In the case of certain blood component determinations, the handling of the blood samples can also be a critical part of the ultimate accuracy of measurement in the sample. Therefore, even when a blood sample is removed from the body, the concentration of the component within a liquid blood sample can change over time. Dried blood spots have the advantage of helping to preserve certain components for later analysis.
There is currently a need for a simple, yet accurate device for collection, transport, preparation, and storage of a dried blood plasma or serum sample from whole blood, for subsequent extraction and analysis of components in the dried plasma or serum sample. Testing in the laboratory affords more sophisticated equipment, highly trained personnel, professional quality control, and cost effective solutions.
BRIEF SUMMARY OF THE INVENTION
The subject invention concerns a device for use in collection, separation, stabilization, preservation, transport, storage, and elution of a biological sample for laboratory analysis of particular components in the sample, methods of use for the device, and kits comprising the device.
Specifically, the subject invention concerns a device which is useful for collection of a whole blood sample, allowing separation of the blood cells from the blood serum or plasma, drying the blood serum or plasma sample on the device, transporting the collected and dried blood serum or plasma sample to a laboratory or other facility for analysis, and extracting an analyte of interest from the sample for determining presence or absence of the analyte or, if present, the concentration thereof.
Briefly, one embodiment of the subject device comprises a plurality of separate components, including a quantitation member for facilitating delivery of a particular volume or amount of sample to a collection member. The sample can also be passed through another component, e.g., a separation member which can separate certain undesirable components from the components of interest in the sample. For example, blood cells, e.g., red blood cells, can be separated from blood plasma or serum containing an analyte which is to be tested for, or measured. The collection member, which can be an absorbent or non-absorbent filter or membrane material, can serve to collect the component of interest in the sample, e.g., serum or plasma, provide a surface for drying of the component of interest, and a means for storage of that component for subsequent transport to, and analysis in, a laboratory. The device can have a plurality of any one of the quantitation, separation, or collection members.
One preferred embodiment has a plurality of separation members, including one which also can be useful as a quantitation member. Specifically, the quantitation member serves to collect overflow of sample so that a defined volume of sample component of interest is delivered to the collection member, over which the other described members are superimposed. For example, the separation/overflow member can be a track etched membrane, as is well-known in the art, or can be a screen material which can spread the liquid sample such that a particular volume of the sample is provided in each cell of the screen. This embodiment is termed the “multilaminate configuration.”
In one such embodiment of the multilaminate configuration, namely, the “trilaminate configuration,” a separation member is contactingly disposed above or below a layer of material which provides a spreading or quantitative effect for the separated serum or plasma. The separated serum or plasma then absorbs into or adsorbs onto a collection member disposed below the spreading or quantitative material and the separation member. Thus, the trilaminate configuration comprises a substantially three-layered collection device, having a separation member, a quantitation member, and a collection member.
Alternatively, in certain embodiments of the subject invention, the quantitation member can be a material having a wicking property, e.g., standard capillary tube such as is used in routine laboratory work (typical volumes are 5-50 microliters), or can be an absorbent or non-absorbent material which has quantitative liquid volume properties for liquids, or an encased fiber bundle or other like configuration which accepts a quantitative liquid uptake and can deliver a predetermined volume of sample to another component of the device.
The separation member can be an absorbent, adsorbent, non-absorbent, or non-adsorbent material, for delivering the sample to the serum/plasma collection member via capillary action. The separation member can also provide a separation function for selectively separating different components within the sample, or can provide a quantitative volumetric measurement function. The separation member, useful for separating a component of interest from an undesired component in the biological sample prior to introduction of the component of interest to the collection member, according to one embodiment, can be a substantially circular section of absorbent filter paper having a predetermined standard size.
In one embodiment, a device according to the subject invention comprises a first wicking or quantitation member and a second “separation member,” as described. A third “collection member” component is substantially circular and disposed in contact with the separation member for collecting sample therefrom. Preferably, a device of this embodiment is configured to include a substantially circular collection member contacting a substantially circular separation member which is contactingly disposed between the quantitation or wicking member and the circular collection member. This configuration is referred to herein as a “dual pad” configuration.
The members, namely, the quantitation member, the separation member, and the collection member, must contact one another for transferring the sample from one member to the other. These members can be abutted to one another, can overlap, or can be superimposed over one another. The separation member and col
Peddicord Julie
Ray Robert A.
Stangarone Robert
Akerman & Senterfitt
FlexSite Diagnostics, Inc.
Marmor II Charles
Winakur Eric F.
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