Patent Description:
It is desirable to assess at high speed and low cost the amount of a biological sample in a specimen container, without opening the specimen container or removing the biological sample from the specimen container. Additionally, under certain circumstances it may be desirable to qualitatively assess the amount of the biological sample in the specimen container without quantitatively measuring the volume of the biological sample.

Pre-existing evaluation processes include the comparison of a biological sample in a specimen container to volume indicators on a label of a specimen container. However, the labels of specimen containers may be applied inconsistently or may be damaged, rendering a volume of a biological sample determined therefrom inaccurate. Other pre-existing evaluation processes utilize optical sensors and computerized analysis systems, which are complicated and expensive.

<CIT> refers to an apparatus and method for rapid determination of erythrocyte sedimentation rates for a bloodspecimen which can be linearly transposed to Westergren sedimentation rates. The method includes the steps of inducing accelerated rouleaux formation in the specimen in an amount sufficient to begin settling at substantially the decantation rate for the specimen. In one embodiment a structure which produces a very thin cross-sectional region of the specimen inside the lumen of a specimen container is provided to accelerate rouleaux formation. In an alternative embodiment, accelerated rouleaux formation is accomplished using a centrifuge. A third embodiment employs a movable rod mounted inside the specimen tube to induce accelerated rouleaux formation. All embodiments of the process next employ gravity settling the specimen in a near horizontal oriented container. Thereafter, the amount of settling occurring is determined. A sealed specimen container which permits thorough mixing of blood in a very small diameter container for use in performing the method also is provided. Another document is <CIT> which refers to a centrifuge tube shelf capable of adjusting and metering. <CIT> relates to a laboratory apparatus, in particular an apparatus for visually determining the extent of phase separation in emulsions. Further documents are <CIT> and <CIT> relate to test tubes rack comprising index mark indicating the amount of liquid in the container.

Various embodiments relate to the evaluation of an amount of a biological sample in a specimen container without removing the biological specimen from the specimen container, and apparatuses adapted for that purpose.

An apparatus for evaluating an amount of biological sample in a specimen container is provided in claim <NUM>.

A method of evaluating an amount of biological sample in a specimen container is provided in claim <NUM>.

These and other features, together with the organization and manner of operation thereof, will become apparent from the following detailed description when taken in conjunction with the accompanying drawings, wherein like elements have like numerals throughout the several drawings described below.

Various exemplary embodiments relate to an apparatus for evaluating an amount of biological sample in a specimen container, and a method of evaluating an amount of biological sample in a specimen container. The apparatus and method allow for a visual comparison of the amount of biological sample in a specimen container with a reference indicator to evaluate whether the specimen container contains an acceptable volume of the biological sample. The evaluation may be conducted without opening the specimen container and without quantitatively determining the amount of biological sample in the specimen container.

The apparatus and method may be utilized to evaluate whether the amount of biological sample in a specimen container is acceptable for a desired laboratory test. The evaluation process includes disposing a specimen container on a bottom surface of an apparatus. The apparatus has a reference indicator located at a predetermined height above the bottom surface. The height of the volume of the biological sample in the specimen container is then visually compared with the reference indicator to determine if the specimen container contains an acceptable or desirable volume of the biological sample. The evaluation process may additionally include placing a vertical surface of the specimen container in contact with a support of the apparatus. The bottom surface of the apparatus may be leveled, ensuring an accurate comparison of the height of the biological sample in the specimen container with the reference indicator. The specimen container may be illuminated with a light source, such as a light source included in the apparatus. The evaluation process includes disposing a removable member containing the reference indicator in a holder of the apparatus. The evaluation process may additionally include relatively positioning the reference indicator and an eye level of a user such that the reference indicator and the eye level of the user are located at substantially the same height.

The apparatus may be formed from any appropriate material and by any appropriate method. According to one embodiment, the apparatus may include a fixture made of wood, metal, or a polymer. The material forming at least a portion of the apparatus may be a transparent material, such that light may pass through the material and illuminate a specimen container. The apparatus may be produced from a single piece of material or by connecting individual components, for example by the use of mechanical fasteners, adhesive bonding, or welding. Alternatively, the apparatus may be formed by a <NUM>-D printing process.

The reference indicator may be any appropriate indicator. According to one embodiment, the reference indicator may be a line or an arrow. According to an alternative example, not according to the claimed invention, the reference indicator may be a top surface of the apparatus. The apparatus may include more than one reference indicator. In one embodiment the multiple reference indicators can indicate a minimum and a maximum acceptable biological sample volume. According to another embodiment, the multiple reference indicators may be configured such that the area above a first reference indicator indicates a suitable biological sample volume for a first condition, such as a first test, and the area between the first reference indicator and the second reference indicator indicates a suitable biological sample volume for a second condition, such as a second test.

The apparatus may be configured to be utilized with any appropriate specimen container. According to one embodiment, the specimen container may be a bottle, cup, vial, or test tube. The specimen container may have a flat or curved bottom surface, and the bottom surface of the apparatus may have a shape matching the shape of the bottom surface of the specimen container.

Various embodiments of the apparatus are described below, showing specific examples of implementations of one or more of the above-described features. It is to be understood that the features can be included or omitted in any variety of permutations, and are not limited to just the specific embodiments described below.

As shown in <FIG> and <FIG>, an example, not according to the claimed invention, of the apparatus <NUM> may include a fixture <NUM> having a base <NUM> with a bottom surface <NUM> configured to support a specimen container <NUM>. The specimen container <NUM> shown in <FIG> is a bottle. The bottom surface <NUM> may be a substantially and sufficiently flat surface, such that a flat bottom surface <NUM> of the specimen container <NUM> may be reliably supported at a predetermined location.

The fixture <NUM>, as shown in the example embodiment of <FIG> and <FIG>, may include one or more supports <NUM> that may aid in supporting a substantially vertical surface <NUM> of the specimen container <NUM>. The apparatus may include one or a plurality of supports <NUM>. For example, a support <NUM> could be provided on only one side of the flat bottom surface <NUM> or support(s) <NUM> may be provided along multiple sides of the flat bottom surface <NUM>. In the illustrated example multiple supports <NUM> are provided. The apparatus <NUM> includes an opening <NUM> through which the height of the volume of the biological sample in the specimen container is visible, and the opening <NUM> may be referred to as a "viewing window.

A reference indicator <NUM> may be disposed at a predetermined height relative to the bottom surface <NUM> of the fixture <NUM>, such that the reference indicator may be visually compared to a height <NUM> of a volume of a biological sample in the specimen container <NUM>. Preferably, the reference indicator <NUM> is correlated to the particular shape of the specimen container <NUM>, such that reference indicator <NUM> provides an indication of whether the specimen container <NUM> contains an acceptable or desirable volume of the biological sample. The reference indicator <NUM> can be, for example, a line, as shown in this example. As a further alternative, the reference indicator <NUM> may be an arrow or other indicia that identifies a location above the bottom surface <NUM>.

The reference indicator <NUM> can be configured in accordance with the desired use of the apparatus <NUM>. For example, when it is desirable to determine whether at least a minimally sufficient amount of a biological sample is contained in the specimen container <NUM>, the reference indicator <NUM> can be located at a position relative to the bottom surface <NUM> of the fixture <NUM> that corresponds to height that a minimally sufficient amount of biological sample will have in the target specimen container <NUM>. The reference indicator <NUM> can be located at other positions if it is desirable to make other or different determinations regarding the amount of biological sample contained in the specimen container <NUM>. For example, the reference indicator can be located at a position corresponding to the maximum desired amount of a biological sample in specimen container <NUM>. As a further example, the reference indicator can be located at a position corresponding to an exact amount of a biological sample in specimen container <NUM>, when it is desirable to determine whether the specimen container <NUM> has such an exact amount.

Depending on the desired use of the apparatus <NUM>, the reference indicator <NUM> may include additional information that corresponds to its intended use. For example, the additional information may indicate the volume of biological sample corresponding to the reference indicator <NUM> (shown in <FIG>), whether the reference indicator <NUM> corresponds to a minimum, maximum, or exact amount of biological sample (a minimum is shown in <FIG>), and the intended target specimen container (not shown in <FIG>). Additionally, the reference indicator <NUM> can include other indicia, such as the arrow point shown in <FIG>, to highlight the location of the line and/or to indicate whether the amount of biological sample should be above, below, or equal to the line of the reference indicator <NUM>.

The reference indicator <NUM> may be permanently affixed to the fixture <NUM>. For example, the reference indicator <NUM> may be located on one or more of the supports <NUM>. As shown in <FIG>, the reference indicator <NUM> can be, for example, printed in ink on the support <NUM>. Alternatively, the reference indicator <NUM> could be formed as a notch, groove, or other physical differentiator on the support <NUM>. It is understood that the reference indicator <NUM> could be located on a portion of the fixture <NUM> other than a support <NUM>.

The description above has focused on a single stall or bay of the apparatus <NUM>. However, the apparatus <NUM> may have multiple stalls such that the apparatus <NUM> can accommodate more than one specimen container <NUM> for evaluation at a single time. Each stall may, or may not, have associated support(s) <NUM>. Additionally, the apparatus <NUM> may be configured such that only a single reference indicator <NUM> is provided for all of the stalls, as shown in <FIG> and <FIG>. Alternatively, a reference indicator <NUM> can be provided for each of the stalls (not shown in <FIG> and <FIG>). Moreover, while it is preferred that the apparatus have the bottom surfaces <NUM> of the respective stalls collectively disposed in substantially the same plane, it is contemplated that the bottom surfaces <NUM> of the respective stalls may not be disposed in the same plane, i.e., they may be disposed at different heights relative to one another, to accommodate different specimen containers <NUM> or different desired measurements, for example.

An alternative example, not according to the claimed invention, embodiment shown in <FIG> illustrates other possible features of an apparatus <NUM> according to the present invention. In this example, the apparatus <NUM> includes a reference indicator <NUM> and a secondary reference indicator <NUM>. As shown in <FIG>, the reference indicator <NUM> may be associated with a minimum acceptable biological sample amount, and the secondary reference indicator <NUM> may be associated with a maximum acceptable biological sample amount.

The example of the apparatus <NUM> shown in <FIG> also includes a feature intended to increase the precision of the evaluation. In particular, since a biological sample is typically a liquid, the precision of the evaluation of the volume of liquid can be adversely impacted if the specimen container <NUM> is not in a fully upright position. For example, if the specimen container <NUM> is effectively tilted, the height of the biological sample in the specimen container will be offset. Accordingly, the apparatus <NUM> may additionally include levelling device <NUM>, preferably disposed in the base <NUM> of the fixture <NUM>, which is configured to indicate an orientation of the bottom surface <NUM>. Using the leveling device <NUM>, the orientation of the bottom surface <NUM> can be properly established to ensure that the specimen container is in essentially a fully upright position. Preferably, the leveling device <NUM> is a spirit level, also known as a line level.

The example, not according to the claimed invention, of the apparatus <NUM> shown in <FIG> is an alternative approach for locating the reference indicator <NUM> at a position relative to the bottom surface <NUM> of the fixture <NUM>. In this example, the reference indicator <NUM> may be provided on a member <NUM>, such as a sheet or card, which is preferably transparent. In this example, the member <NUM> can be sized such that the reference indicator <NUM> extends and overlays the specimen container <NUM> to facilitate visual comparison of the reference indicator <NUM> and the height <NUM> of a volume of a biological sample in the specimen container <NUM>. The proper location of the reference indicator <NUM> relative to the bottom surface <NUM> can be established by placing the bottom of the member <NUM> against the bottom surface <NUM>.

The member <NUM> can be affixed to the fixture <NUM>, either removably or permanently. For example, the member <NUM> can be affixed to the support <NUM> by an adhesive that allows the member <NUM> to be removed from and subsequently reattached to the support <NUM>. This approach also allows the member <NUM> to be attached to different ones of the supports <NUM>. Additionally, this approach allows different members <NUM>, having reference indicators <NUM> located at different heights, to be affixed to the fixture <NUM>. Consequently, the apparatus <NUM> can be used with different types of specimen containers <NUM> by attaching only a member <NUM> appropriate for the type of specimen container <NUM> being tested at a given time. Each member <NUM> may include indicia indicating the type of specimen container <NUM> to which the member <NUM> pertains or a type of test for which the indicated amount of biological sample is acceptable.

The example, not according to the claimed invention, embodiment shown in <FIG>, <FIG>, and <FIG> is yet another alternative approach for locating the reference indicator <NUM> at a position relative to the bottom surface <NUM> of the fixture <NUM>. In this example, a holder <NUM> is provided on the fixture <NUM>. The holder <NUM> can be, for example, a slot and/or a sleeve that will receive the member <NUM>. The holder <NUM> is preferably transparent so that the reference indicator <NUM> and the height <NUM> of a volume of a biological sample in the specimen container <NUM> will both be visible through the holder <NUM>. The holder <NUM> should be affixed to the fixture <NUM> such that reference indicator <NUM> is properly positioned relative to the bottom surface <NUM>. This can be achieved in a variety of ways, including carefully positioning the holder <NUM> on the fixture <NUM> or by placing the bottom of the holder <NUM> against the bottom surface <NUM>.

The holder <NUM> can be affixed to the fixture <NUM>, either removably or permanently, to thereby affix the member <NUM> to the fixture. For example, the holder <NUM> can be affixed to the support <NUM> by an adhesive. Preferably, the adhesive allows the holder <NUM> to be removed from and subsequently reattached to the support <NUM>. This approach would allow the holder <NUM> to be attached to different ones of the supports <NUM>.

The use of the holder <NUM> allows different members <NUM>, having reference indicators <NUM> located at different heights, to be inserted into the holder <NUM> and affixed to the fixture <NUM>. Consequently, the apparatus <NUM> can be used with different types of specimen containers <NUM> by inserting into the holder <NUM> only a member <NUM> appropriate for the type of specimen container <NUM> being tested at a given time. As noted above, each member <NUM> may include indicia indicating the type of specimen container <NUM> to which the member <NUM> pertains or a type of test for which the indicated amount of biological sample is acceptable.

An alternative example, not according to the claimed invention, of the apparatus <NUM> is shown in <FIG>, which allows the member <NUM> and/or the holder <NUM> to be affixed to the fixture <NUM> in a different manner than described above. In this example, a groove or slot <NUM> is created in the base <NUM> of the fixture <NUM>. The member <NUM> and/or the holder <NUM> can be disposed in the groove <NUM> to affix the member <NUM> and/or holder <NUM> to the fixture <NUM> and to thereby locate the reference indicator <NUM> at a position relative to the bottom surface <NUM> of the fixture <NUM>.

As shown in the example, not according to the claimed invention, embodiment of <FIG>, the apparatus <NUM> may include a support <NUM> with a shape that matches at least a portion of the contour of the vertical surface <NUM> of the specimen container <NUM>. In this example, the apparatus <NUM> includes a bottom surface <NUM> configured to support a specimen container <NUM>. The specimen container <NUM> shown in <FIG> is a cup. A reference indicator <NUM> may be disposed at a predetermined height relative to the bottom surface <NUM>, such that the reference indicator may be visually compared to a height <NUM> of a volume of a biological sample in the specimen container <NUM>. The bottom surface <NUM> may be a flat surface such that a flat bottom surface <NUM> of the specimen container <NUM> may be supported. The support <NUM> can support a substantially vertical surface <NUM> of the specimen container <NUM>. The support <NUM> preferably has a shape that matches at least a portion of the contour of the vertical surface <NUM> of the specimen container <NUM>. In the configuration shown in <FIG>, the supports <NUM> of the different stalls of the apparatus are separated, however, they could be formed as a continuous member, as shown in <FIG>.

As shown in the example, not according to the claimed invention, of <FIG> and <FIG>, the apparatus <NUM> may include a light source <NUM> configured to illuminate the specimen container <NUM> to facilitate the visual comparison of the reference indicator <NUM> with the height <NUM> of the volume of biological sample in the specimen container <NUM>. In this example, the base <NUM> has a bottom surface <NUM> configured to support the specimen container <NUM>. The specimen container <NUM> shown in <FIG> and <FIG> is a vial. The reference indicator <NUM> may be disposed at a predetermined height relative to the bottom surface <NUM>. The apparatus can include a support <NUM>, which may support a substantially vertical surface <NUM> of the specimen container <NUM>.

The light source <NUM> is configured to illuminate the biological sample in the specimen container <NUM>. The illumination of the biological sample may make easier the visual comparison of the height <NUM> of the biological sample in the specimen container <NUM> with the reference indicator <NUM>. The light source <NUM> preferably is located within the base <NUM>. The light source <NUM> can be positioned below the bottom surface <NUM> of the fixture. The bottom surface <NUM> is preferably sufficiently transparent to allow the transmission of light to the specimen container <NUM>. The light source <NUM> can be a conventional source of light suitable for the intended use, and it can be controlled by conventional circuitry. The light source <NUM> may be battery powered.

As shown in the embodiment of <FIG>, the apparatus <NUM> may include a light source <NUM> configured to illuminate the specimen container <NUM> to facilitate the visual comparison of the reference indicator <NUM> and the secondary reference indicator <NUM> with the height <NUM> of the volume of biological sample in the specimen container <NUM>. In this embodiment, the base <NUM> has a bottom surface <NUM> configured to support the specimen container <NUM>. The specimen containers <NUM> shown in <FIG> are bottles. The reference indicator <NUM> and the secondary reference indicator <NUM> may be disposed at predetermined heights relative to the bottom surface <NUM>. The apparatus can include a support <NUM>, which may support a substantially vertical surface <NUM> of the specimen container <NUM>.

The light source <NUM> is configured to illuminate the biological sample in the specimen container <NUM>. The illumination of the biological sample may make easier the visual comparison of the height <NUM> of the biological sample in the specimen container <NUM> with the reference indicator <NUM>. The light source <NUM> preferably is located within the support <NUM>, adjacent a substantially vertical surface <NUM> of the specimen container. The light source <NUM> can be a conventional source of light suitable for the intended use, and it can be controlled by conventional circuitry. The light source <NUM> may be a light emitting diode, such as a battery powered light emitting diode. The light source <NUM> may be controlled by a switch <NUM>.

A leveling device <NUM> is provided on the apparatus <NUM> such that the orientation of the bottom surface <NUM> can be properly established to ensure that the specimen container <NUM> is in essentially a fully upright position. Preferably, the leveling device <NUM> is a spirit level, also known as a line level.

The reference indicator <NUM> and the secondary reference indicator <NUM> are provided on a member <NUM> that engages a holder <NUM> provided on a fixture <NUM> of the apparatus <NUM>. The holder <NUM> can be, for example, a slot and/or a sleeve that will receive a corresponding portion of the member <NUM>. The holder <NUM> is provided on the fixture <NUM> such that reference indicator <NUM> and secondary reference indicator <NUM> are properly positioned relative to the bottom surface <NUM>. As shown in <FIG>, <FIG> and <FIG>, the holder <NUM> may be in the form of a T-shaped groove that accepts a corresponding T-shaped protruding portion <NUM> of the member <NUM>. The engagement of the protruding portion <NUM> with the holder <NUM> securely affixes the member <NUM> to the fixture <NUM>.

The use of the holder <NUM> allows different members <NUM>, having reference indicators <NUM> and <NUM> located at different heights, to be inserted into the holder <NUM> and affixed to the fixture <NUM>. Consequently, the apparatus <NUM> can be used with different types of specimen containers <NUM> by inserting into the holder <NUM> only a member <NUM> appropriate for the type of specimen container <NUM> being tested at a given time. Each member <NUM> may include indicia indicating the type of specimen container <NUM> to which the member <NUM> pertains or a type of test for which the indicated amount of biological sample is acceptable.

As shown in <FIG>, the area above the secondary reference indicator <NUM> indicates a suitable biological sample volume for a first condition, such as a first test, and the area between the reference indicator <NUM> and the secondary reference indicator <NUM> indicates a suitable biological sample volume for a second condition, such as a second test. For example, the area above the secondary reference indicator <NUM> may indicate a biological sample volume suitable for a first test for a given condition, while the area between the reference indicator <NUM> and the secondary reference indicator <NUM> indicates a biological sample volume suitable for a second test for the given condition that requires less biological sample volume than the first test.

As shown in the example, not according to the claimed invention, of <FIG>, the apparatus <NUM> may include a bottom surface <NUM> contoured to match the specimen container <NUM> and may have a reference indicator <NUM> formed by a top or upper surface of fixture <NUM>. The particular specimen container <NUM> shown in <FIG> is a test tube. The bottom surface <NUM> may be a curved surface such that a curved bottom surface <NUM> of the specimen container <NUM> may be supported. The apparatus <NUM> may additionally include a support <NUM> that may support a substantially vertical surface <NUM> of the specimen container <NUM>. The support <NUM> may have a shape that matches at least a portion of the contour of the vertical surface <NUM> of the specimen container <NUM>.

The reference indicator <NUM> may be formed by the upper surface of the apparatus <NUM>. As before, the reference indicator <NUM> may be disposed at a predetermined height relative to the bottom surface <NUM>, such that the reference indicator may be visually compared to a height <NUM> of a volume of a biological sample in the specimen container <NUM>.

The apparatuses described above, and appropriate variations and permutations of them, can be used to efficiently and accurately evaluate an amount of biological sample in a specimen container. The specimen container merely needs to be disposed in the fixture on the bottom surface thereof. The height of the volume of the biological sample can then be compared to the reference indicator, which is disposed at a predetermined height relative to the bottom surface. Consequently, a quick and accurate determination can be made regarding whether the specimen container has an appropriate amount of biological sample. Preferably, the reference indicator and an eye level of a user can be relatively positioned such that the reference indicator and the eye level of the user are located at substantially the same height. Such relative positioning can be achieved through vertical positioning of the reference indicator and/or the eye level of the user. The location of the reference indicator at an eye level of a user improves the speed and accuracy of the visual comparison of the reference indicator to the height of the volume of the biological sample in the specimen container. A meniscus may be formed by the biological sample in the specimen container. In such cases that a meniscus is formed by the biological sample in the specimen container, the visual comparison of the height of the volume of the biological sample to the reference indicator includes the comparison of the center of the meniscus formed by the biological sample to the reference indicator.

The apparatuses described herein allow the low cost and accurate determination of whether the amount of a biological sample in a specimen container is acceptable for a desired laboratory test. The apparatuses allow the evaluation of the amount of the biological sample with high speed and without opening the specimen container or removing the biological sample from the specimen container. Additionally, the amount of the biological sample in the specimen container may be determined qualitatively without quantitatively measuring the volume of the biological sample. The apparatuses described herein may be utilized to determine, for example, whether the amount of biological sample present in a specimen container is suitable for a blood culture test, a chlamydia/gonorrhea test, a chlamydia test, a gonorrhea test, a urine culture test, a coagulation test, a human papilloma virus DNA test, and a human papilloma virus mRNA test.

Claim 1:
An apparatus (<NUM>) for evaluating an amount of biological sample in a specimen container, comprising:
a removable member (<NUM>) comprising a protruding portion (<NUM>);
a fixture (<NUM>) with a bottom surface (<NUM>) configured to receive a specimen container (<NUM>) containing a biological sample and to support a bottom surface of the specimen container (<NUM>);
a holder (<NUM>) connected to the fixture (<NUM>) and configured to removably engage with the protruding portion (<NUM>) of the removable member (<NUM>) in a predetermined position relative to the bottom surface (<NUM>) of the fixture (<NUM>) such that a lower end of the removable member (<NUM>) rests on top of a portion of the holder (<NUM>); and
a reference indicator (<NUM>) provided on the removable member (<NUM>), wherein the holder (<NUM>) is configured to affix to the fixture (<NUM>) to locate the reference indicator (<NUM>) at a predetermined height above the bottom surface (<NUM>) of the fixture (<NUM>),
wherein the holder (<NUM>) comprises a shape corresponding to the shape of the protruding portion (<NUM>) such that the holder (<NUM>) receives the protruding portion (<NUM>) to securely affix the removable member (<NUM>) to the fixture (<NUM>),
wherein the lower end of the removable member (<NUM>) is an end of the removable member (<NUM>) that is closest to the bottom surface (<NUM>), and
wherein the reference indicator is configured to facilitate a visual comparison of the reference indicator with a height (<NUM>) of a volume of the biological sample in the specimen container (<NUM>) to determine whether the specimen container contains an appropriate amount of the biological sample.