JP2007057549A - Method of providing liquid component and solid component of sample used in analytical technique - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a method of providing a liquid component and a solid component of a sample used in an analytical technique. <P>SOLUTION: This method of providing an Aliquat of the sample containing the liquid component and the solid component used in the analytical technique has a step constituted to hold an Aliquat of a sample containing a liquid component and a solid component proportional to the liquid component and the solid component of the sample, and for bringing the sample into contact with an arranged sample collection device, and a step for bringing therein the sample collection device into an Aliquat holding state to provide the ant quart used in the analytical technique. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to the technical field of sample collection and sample transport for use in various testing or analytical techniques.

  The related art will be described below, but none is recognized as prior art to the appended claims.

  U.S. Pat. No. 5,709,838 discloses a sampling device for sampling material and transporting the collected sample to a test kit. This sample collection device consists of a spatula and a handle. The spatula portion can be detached from the handle so that it can be left in the test container. This apparatus has been found to be useful for both samples on dry grains and materials dissolved in an evaporable medium.

  A device for sampling hemoglobin from stool is disclosed in US Pat. No. 5,460,781. The device includes a fiber bundle that can extract moisture and hemoglobin from a stool sample with different viscosities without bringing solid material into the analytical test. This device needs to be placed at multiple points on the stool sample to ensure that sufficient sample is collected.

  U.S. Pat. No. 4,225,557 discloses an apparatus including a diagnostic test strip that can be in direct contact with a stool sample, and a device that is covered or closed so that the stool sample can be sealed prior to analysis. .

  Another method for transporting a stool sample is disclosed in US Pat. No. 4,492,124. In this method, an elongated handle and a cylindrical extraction device are used. Extracting the sample The extraction device is pushed into the sample to be filled with the sample. The extraction device is then removed from the sample and released from the handle into a container suitable for transport and / or testing. The sample is removed through the extraction device by pushing the sample extraction device or by washing the sample from the sample extraction device.

  U.S. Pat. No. 5,543,115 discloses a sample handling device with sample collection means having an elongated shaft and a groove. Collected samples are collected in channels between device grooves. The device has been found useful for collecting samples consisting of any solid or semi-solid material.

  U.S. Pat. No. 5,066,463 discloses a stool inspection device, which comprises a stirring rake that is used to collect a stool sample and then transport it to the hollow portion of the device. Yes.

  International Patent Publication No. 97-32529 discloses an apparatus for removing clogged feces from a patient. The device has a shaft that includes a flexible protrusion to flatten the wrapped fecal mass.

According to US Pat. Nos. 5,238,847 and 5,215,713, test kits are disclosed for detecting analytes in a paste-like sample that can be applied using a spatula. The sample can be applied over the sample area.
US Pat. No. 5,709,838 US Pat. No. 5,460,781 U.S. Pat. No. 4,225,557 US Pat. No. 4,492,124 US Pat. No. 5,543,115 US Pat. No. 5,066,463 International Patent Publication No. 97-32529 US Pat. No. 5,238,847 US Pat. No. 5,215,713

  The present invention relates to a method for providing an aliquot of a sample consisting of solid and liquid components. The claimed sample collection method improves reproducibility and facilitates the delivery of difficult specimen matrices for various analytical or clinical test procedures. The sample collection method is compatible with a wide range of sample viscosities and solids. The sample collection method collects both a liquid component and a solid component of a sample, and collects a sample that is a specimen of the original sample component. If there is no sample to be a sample, the factor to be detected does not appear at the corresponding concentration and may not be detected at the time of detection. Sample collection methods can be used to transport samples for a wide range of test methodologies. The analytical technique may be any method for identifying one or more components of a sample. This analytical test method includes, but is not limited to, for example, simple spectrophotometric analysis, radiophotometric analysis, chemical analysis, immunoassay analysis, nucleic acid analysis, and chromatographic analysis . When a sample is obtained from a patient or when analyzing the chemical constituents of a sample, this test method allows a variety of analytes, including trace amounts of blood, Clostridium difficile toxins, or other infectious agents. Samples for (analyte) can be examined.

  Regarding the test method that can be realized by the present invention, the ability to transport a sample uniformly and reproducibly irrespective of the density or viscosity of the sample means that there is an advantage over the current sampling method. The method of the present invention is also convenient and minimizes exposure of sample material while confining the sample in the sample collection device until transported to the reaction vessel or test vessel. it can.

  In a first aspect, the invention is characterized in a method for providing an aliquot of a sample comprising a liquid component and a solid component used in an analytical technique. The method comprises the steps of contacting the sample to a sample collection device configured and retained to hold an aliquot of a sample having a liquid component and a solid component proportional to the liquid and solid components of the sample, wherein the sample The collection device is in a state of holding an aliquot of the sample and includes providing an aliquot for use in the analytical technique.

  This method is intended to obtain an aliquot of a sample having a liquid component and a solid component when the analyte of interest is distributed in both the liquid and solid components of the sample. Samples where the claimed method is useful for sampling include, but are not limited to, for example, non-biological sources to confirm the presence of one or more potential components And samples having biological origin such as stool, saliva, runny nose, nasal breath, whole blood, pus, other exudates, or tissue homogenates. “Sample aliquot” means a portion of a previously collected sample, a portion of a sample that can be taken from a natural location, such as a burned or injured site or nasal cavity, or a sample or preparation vessel It is a part of the sample. Those skilled in the art are familiar with various means for collecting samples. One skilled in the art can determine the required amount of sample comprising the aliquot based on the analyte to be detected and the sensitivity of the analytical technique used. This analytical technique may be any method for detecting the presence and amount of the analyte of interest that may be contained within the sample aliquot. A person skilled in the art can determine an analysis technique suitable for a selected sample to be analyzed.

  A sample collection device is placed on or in the sample to expose the liquid and / or solid component of the sample, and the liquid and / or solid component of the sample is fixed relative to the sample collection device, The sample contacts the sample collection device. When the sample collection device is moved horizontally or rotationally with respect to the sample, it is required that the liquid component and the solid component, which are proportional to the sample, be transported and attached to the sample collection device. Is done. The sample collection device is constructed and arranged to hold an aliquot of a sample having a liquid component and a solid component proportional to the liquid and solid components of the sample. That is, the sample collection device can retain both the liquid and solid components of the sample aliquot, if present, without loss of material until transported for use in the analytical procedure. Proportional means that the liquid and solid components of the aliquot are a sample of these relative component quantities in the sample.

  Once the sampling device has taken the appropriate amount of sample, an aliquot is provided for use in the analytical procedure. That is, aliquots are removed from the sampling device for use in the analytical technique. Aliquots can be removed by direct contact with a sample collection device that holds the sample aliquot or by immersing the sample collection device in a solution that is later used in the analytical procedure. This solution can be stored in a reaction vessel. This solution facilitates the extraction of the analyte from the sample aliquot, contains reagents used in the analytical procedure (test solution), or simply has a liquid useful for removing the aliquot from the sample collection device. But you can. Physical treatments such as stirring, shaking, and / or squeezing the sample collection device within the reaction vessel can facilitate transport of aliquots from the sample collection device to the solution.

  In a preferred embodiment, the sample collection device is a brush. A brush is a brush designed to collect cells. The sample is a stool. The analytical method is for detecting Clostridium difficile toxin. The analytical technique is an optical immunoassay. The sample is a slurry or suspension having a non-biological origin. The sample is selected from the group consisting of saliva, runny nose, nasal breath, whole blood, pus, cell exudate, or tissue homogenate. Providing the aliquot includes immersing the spray collection device in the test solution. The contacting step includes pushing the sample collection device into the sample, rotating the sample collection device within the sample, and removing the sample collection device from the sample. Aliquots are transferred to the reaction vessel. Aliquots are delivered directly to the test surface.

  A brush is a preferred sample collection device. However, as will be appreciated by those skilled in the art, a sample collection device may have any form of material that can capture and retain each component of the sample in an amount that represents the liquid and solid components of the sample. Also good. The brush has bristles fixed to the handle. A person skilled in the art knows from the detailed brush characteristics, the shape of the brush, the shape of the bristles in the brush, the density of the bristles in the brush, the length of the brush, the length of the bristles in the brush, the shape of the bristles The material composition of the bristles, the distribution pattern of the bristles within the brush section, and the handle design of the brush can be easily determined. Furthermore, one of ordinary skill in the art can readily determine how to select a commercially available brush and how to construct a brush useful in providing an aliquot of a particular sample.

  In a preferred embodiment, the brush is designed to collect cells. The phrase “brush designed to collect cells” means a brush useful for obtaining cells from the cervix and the like. These brushes are called cytological brushes. An example of such a brush is the CYTOBRUSH ™ cytological brush (Medscand, AB, Malmo, Sweden). There are many designs available as cytological brushes. Some designs include US Pat. No. 3,881,464, US Pat. No. 4,759,376, US Pat. No. 5,133,361, US Pat. No. 5,713,369, and International Patent Publications. No. 91-16855. These brushes are designed to sample the cervix and cervix for cancer testing. These brushes comprise bristles that are straight and have a uniform length and density. By changing the length and distribution of the bristles, the shape of the brush may be adjusted and formed. Alternatively, bristles can be spirally wound around the brush shaft. You may change the length of the brush.

  This sample collection method is particularly suitable for use in transporting diarrhea-like stool samples with good reproducibility. This is because such samples contain both liquid and solid components.

  Analytical techniques for detecting toxins formed by Clostridium difficile are well known to those skilled in the art and include, but are not limited to, cytotoxin assays, immunoassays, and optical immunoassays. Law (OIA®).

  The optical immunoassay means a method based on the interaction between light and a thin film. Some kind of modulation occurs in the light that interacts with the thin film, generally resulting in a phase delay. Other effects can also be used. Depending on the design of the thin film device, the light interferes destructively, resulting in a visible color change, using ellipsometry, comparative ellipsometry, fixed angle ellipsometry, or other ellipsometry Changes occur in the measured deflection. When visible color changes occur, a simple reflectometer can be used in place of the eyes as a color change detector. The thin film surface can be analyzed using surface shape metrology, scanning tunneling microscopy, or atomic force microscopy. Due to light attenuation due to interaction with the thin film, one or more wavelengths of the light are suppressed or amplified, the intensity of the monochromatic or polychromatic light is changed, and the degree of polarization of the light (intensity and / or The deflection wavelength or degree of deflection) changes or other measurable phenomena occur. As a result of the synthesis of these light changes, attenuation may occur. The thin film may be an inorganic, organic or inorganic / organic thin film. The thin film is constructed on an optical support. This optical support is chosen to be compatible with the detection method used in the final analysis format. The thin film is selected to be compatible with the optical support, detection method, and other components (such as the antibody receiving layer) of the analytical system. For material selection and material compatibility criteria see US Pat. No. 5,550,063, US Pat. No. 5,482,830, US Pat. No. 5,468,606, US Pat. No. 5,639, 671 and RM Ostroff, et al., Chin. Chem., 44, 2031-2035, 1998.

  The sample is preferably a slurry or suspension having a non-biological origin. “Slurry” means a liquid containing a minute solid component. A “suspension” is a two-layer system consisting of finely divided solids that are dispersed in a liquid, such as a liquid formulation. “Non-biological origin” means not derived from any plant or animal. The sample may be of any biological origin, but is preferably saliva, runny nose, nasal breath, whole blood, pus, cell exudate, or tissue homogenate.

  Aliquots contained within the sample collection device can be transported to a “reaction vessel” prepared for use in analytical techniques. The reaction vessel is a container having, but not limited to, a polypropylene tube and a vessel made of glass, polyethylene, or quartz. When the sample is transferred to the reaction vessel, it must be sufficiently diffused in the test solution. This is accomplished by immersing a portion of the sample collection device that holds the sample aliquot into the test solution. Alternatively, analytical techniques are performed, for example, membrane-based analytical devices for immunoassay or nucleic acid analysis, microscope slides for fluorescence or microscopic analysis, or solid culture plates for bacterial analysis. An aliquot of sample can be transferred directly to a “test surface” which is an arbitrary surface.

  A method according to a further preferred embodiment is a method for providing an aliquot of a stool sample for use in an optical immunoassay for detecting Clostridium difficile toxin. The method comprises the steps of contacting a placed sample collection brush with the stool configured to retain the liquid and solid components of the stool sample in proportion to the liquid and solid components of the stool sample; Providing a aliquot for use in an optical immunoassay for Clostridium difficile toxin, wherein the device is holding a sample aliquot.

  In a further preferred embodiment, before the optical immunoassay is performed, an aliquot is transferred to the reaction vessel, which is a brush designed to collect cells.

  Other features and advantages of the invention will be apparent from the following detailed description and claims relating to the preferred embodiments.

  All references, publications, and patents cited herein are fully integrated here as one.

  The following embodiments are illustrated to further illustrate various aspects and embodiments according to the present invention, and are not intended to limit the scope of the invention at all.

(Example 1: Selection and configuration of brush)
A preferred sample collection device is a brush, a cytological brush used to collect cells from the cervix (Oosina Englewood, NJ; Hardwood Products, Co., Guilford, ME; Medical Packaging Corp., Camarillo) , CA). However, as will be apparent to those skilled in the art, brushes of various types and designs are suitable for using the creped method. The skilled artisan can also determine which commercially available brushes are suitable for a particular sample based on the liquid and solid components of the sample, taking into account the brush characteristics described. Let's go. Alternatively, one skilled in the art will be able to design a suitable brush based on the sample composition and the brush characteristics described. In the present invention, a brush is placed directly in the sample and used to remove a specific amount of sample. The brush can then be inserted into a test tube or other reaction vessel and mixed with the reaction reagent. By mixing the sample in solution using a brush, it is possible to react with the desired analyte and form a uniform sample substrate for continuous testing. The main advantage of using a brush to sample a sample is that solid material, viscous material, and liquid can be captured between each bristol of the brush. The substance is securely held in the brush and can be transported to a suitable reaction vessel without touching the sampler. If sample aliquots are taken from the body, such as a wound or nasal passage, the brush should be sterilized before use.

  A variety of cytological brushes are commercially available. Consider when choosing a commercially available design, or when designing a new brush that will be used to obtain aliquots from samples ranging from solid samples containing small amounts of liquid to samples that are primarily liquid Verify the power factor. For the selected brush, the shape of the device brush, the density of the bristles in the brush, the length of the brush, the length of the bristles in the brush, the diameter of the bristles, the material composition of the bristles, and the distribution of the bristles in the brush It is necessary to consider the pattern. The design of the brush handle should also be considered. The handle must be long enough that the user does not touch the sample. However, the handle must be robust enough to penetrate the sample under the pressure required to penetrate the sample without breaking, without breaking the sample. The handle must also be compatible with the reaction vessel in which the sample is transported and the sample can be easily stirred in the reaction medium. If the sample is collected directly from the wound or nasal passage, a more flexible handle may be desirable.

  The shape of the brush portion of the device determines the sample volume (aliquot) that is transferred to the reaction vessel. The shape of the brush is determined by the length of the brush part, the length of the bristles in the brush part, the density of the bristles, and the pattern of the bristol distribution in the brush part. Bristles may be formed in a spiral shape over the brush portion. This forms a continuous distribution of Bristol. Bristles may be formed in independent rows. The shape of the brush portion is determined by the length of each bristol. The bristles may have one or more lengths, the lengths can be changed for each column, or the lengths can be changed by changing the bristles or the like.

  The hardness of Bristol depends on the composition and diameter of the material used during Bristol manufacture. Most bristles of commercially available brushes are made of nylon. The material used during Bristol production also affects the hydrophobic properties of the brush. Bristol needs to have several hardness levels to help penetrate and collect the sample.

  The bristles may be cut during manufacture to include a blunt end and a sharp end. Sharp edges are preferred because they help to penetrate and hold samples with a harder viscosity.

  The density of Bristol must be sufficient to form a part that collects a more fluid sample. The fluid is held between the bristles by electrostatic seals and the formation of a seal against the bristle that is stronger than the air / liquid interaction. Harder samples will simply adhere by viscosity.

  The proper design of the brush for a particular sample collection application is selected based on empirical observations of brush performance as a sample transport device. Sample hardness and composition ranges for a given sample type need to be utilized in the evaluation. This ensures that the sampling device can collect a sufficient volume of sample for all possible sample viscosities. Primarily, analytical test methods and inherent limitations on detection determine the sample volume required. A very sensitive method requires a smaller amount of sample than a less sensitive method. Similarly, very sensitive methods are less sensitive to the amount of liquid reagent that can be introduced into the reaction vessel in order to interact with the sample collected from the brush. However, the test reagent volume should be optimized to ensure complete sample recovery by adding as little reagent as possible. Reagents include buffers, solvents, detergents, acids, bases, detection reagents and the like. The test reagent may dissolve the collected sample and simply assist in suspending the collected sample, or may change the components of the sample for later detection. In the range of sample viscosity, the reproducibility of sample recovery should be assessed for at least a detectable amount of analyte to be tested using analytical techniques.

  The brush selected must be compatible with the sample and reagents. This means that the substance must not be released into the sample or test reagent so as to interfere with or inhibit the analytical technique. For the test method, the brush should not dissolve in the test reagent unless it can be demonstrated that the recovery of the analyte is not affected by the dissolution of the brush. The brush must not hold a sample (aliquot) during the removal process. Alternatively, the brush should not be combined with other test reagents to reduce the sensitivity of the method.

  Based on the above parameters, one of ordinary skill in the art can select and design a brush to be used in providing aliquots from a wide range of samples with a variety of clays used in various analytical techniques.

  The sample collection process using a brush is very simple. Hold the brush handle and push the brush part into the sample so as to cover the brush part of the sample collection device. A long brush section can be used to collect sufficient sample without completely penetrating the sample. If the brush material is not exposed to the sample, the sample collection becomes too unstable. As the brush penetrates the sample, the handle is rotated to expose all of the brush portion to the sample, improving sample collection. The brush is then removed from the sample and the sample aliquot is transferred to the reaction vessel. In some instances, such as direct immunofluorescence, a sample device may be used to smear a sample onto a test surface such as a microscope slide. One or more test reagents may be placed in the reaction vessel to facilitate removal of the adherent sample from the brush bristles. The test reagent and sample may be mixed using a sample collection device or brush. Depending on the sample, external vibrations may be applied to the brush (by stirring, shaking, or deforming) to squeeze the sample aliquot into the reaction vessel. One conventional method is to place the sampling device and reaction fluid in a flexible polypropylene tube, in which the user squeezes the side of the tube to deform the bristles in the brush. Can do. When the brush is deformed, the sample aliquot is released. Once a homogeneous mixture is obtained, the sampling device is discarded. At this time, it must be discarded so as to meet any regulatory or environmental conditions depending on the type of sample to be analyzed. Thus, a test fluid can be prepared and analyzed using a pre-set analysis technique.

(Example 2: Use of sample collection method)
In a variety of sampling situations, a very wide range of sample viscosities exists for potential sample collection devices. The following examples illustrate the use of the claimed sampling method, but are not intended to be limiting. With this sample collection device, aliquots of previously collected samples can be used. Alternatively, the sample collection device can be used to collect samples directly from a burn scar or wound or nasal route for later cultivation or analysis, or for collection from a production or preparation container. The sample collection device must not allow fibers to adhere from a cotton swab etc. to the collection location in the body.

  Depending on the manufacturing process, a slurry with varying viscosity or solid content can be formed. Prior to the next step in the manufacturing process, or prior to disposal or disposal, the components of the slurry need to be determined as a function of one or more components in the slurry. The sample may be an intermediate synthetic slurry from a drug manufacturing process that needs to be tested using analytical techniques such as HPLC for the active drug component.

  Soil samples can have varying viscosities depending on the moisture content and the degree of contamination within the sample area. Thus, the sample is a contaminated soil sample and one or more contaminants may be extracted and analyzed to monitor the decontamination process. Tailing from the mining site can be tested for residual precious metals or toxins. Similarly, mining slurries can be tested while processing for recovery rates, contaminants, and the like. This sampling method can be used when collecting yeast paste in a beer or wine fermentation process. The yeast paste can be tested for contamination and / or microbial activity. The active material is returned to the fermenter so that it can be utilized in the next fermentation process. In the drug fermentation process, the recombinant microorganisms that produce the drug are sampled and evaluated for contamination and / or activity. Similarly, this sampling method is used to sample processed raw meat for bacteria and other types of contaminants. In particular, this sample is used to sample other types of processed foods and beverages, such as by sampling the infant food before final packaging, or by selectively removing the final packed product. Collection methods are used. A preferred use is to collect and transport stool samples.

  An example of a sample collection problem that occurs with a sample whose viscosity changes will be described using a stool sample. Collecting a stool sample is important for many medical conditions. For example, a very small amount of blood can reveal colon cancer, rectal cancer, or a precancerous condition. It is difficult to safely handle and efficiently transport stool samples to the test method. In particular, stool samples with diarrhea symptoms range from stool that is well-shaped in terms of viscosity to very loose and almost watery. The present invention is for collecting samples with various viscosities found in clinical samples, such that analytes of interest that may be present as liquid and / or solid components of a stool sample are transported to an analytical technique. One transport system is provided. It is very suitable to test saliva to detect respiratory infections. Types of respiratory infections include tuberculosis virus, respiratory syncytium virus (RS virus), and influenza. This method is also extremely useful for sampling saliva.

(Example 3: Analysis of Clostridium difficile toxin)
A preferred sample to be analyzed is a toxin produced by Clostridium difficile known as a causative agent of diarrheal symptoms for a specific number of patients. This toxin is detected by a method widely known as standard cytotoxic analysis, immunoassay, or most preferably optical immunoassay (OIA®) (US Pat. No. 5,486,606). U.S. Pat. No. 5,541,057 and U.S. Pat. No. 5,550,063).

  In order to perform optical immunoassay for Clostridium difficile toxin, the following components are required. First, it is necessary to select an optical substrate. To perform this analysis, a reflective optical substrate having a known reflectivity, such as silicon or glass coated with amorphous silicon, is selected. Since this test is designed for single use quantitative analysis, visual signal display is preferred. In order to form a visual signal, the optical substrate must be coated with an anti-reflection (AR) film. The material selected for the anti-reflective coating must be associated with the optical substrate for reflectivity and the theory (determined using standard optical calculations) for subsequent biological membrane presence It is corrected using a typical thickness. The antireflection film is silicon nitride, silicon nitrogen oxide, silicon monoxide, zirconium dioxide, titanium dioxide, and other materials are also suitable for forming this layer. In this case, vapor grown silicon nitride was used.

  Once the optical device is designed, a bonding layer made of siloxane having a branched structure is applied to the optical surface. This bonding layer provides a suitable environment for bonding, holding and more stable biological capture reagents. The capture reagent or receptive material can be selected from any biological component that will react specifically to the sample of interest. In this case, polyclonal antibodies against the toxin are produced by Clostridium difficile. The antibody film is formed by immersing the optical device coated with the bonding film in a solution containing the antibody for a predetermined time. After removal from the coating solution, the optical device is rinsed with distilled water, dried, and coated with a protective film on it for further stability. The completed optical device is then divided into individual test surfaces to form a plastic analytical device. One skilled in the art can configure other optical immunoassay devices that generate visual signals or signals that the machine detects based on the disclosure of US Pat. No. 5,418,136. it can.

  The Clostridium difficile optical immunoassay (CdTOX AOIA) is performed as follows. Insert the sample collection device into the stool sample and rotate it so that Bristol fills with stool contents. After filling the brush bristles, the bristles are removed from the sample and the bristles are rotated relative to the sample container wall to remove excess contents. Thereafter, the brush is conveyed to a flexible polypropylene reaction tube containing 300 μl of antibody (enzyme conjugate solution). Mix the sample and conjugate solution using a brush, squeeze the tube and discard the brush. The OIA analysis is performed by delivering a drop of the sample / conjugate solution to the OIA surface and incubating at room temperature for 5 minutes. If Clostridium difficile toxin is present in the sample, a complex is formed between the enzyme conjugate solution, the toxin, and the antibody that binds to the OIA surface. Wash with buffered salt solution and a flow of clean dry air. Add one drop of the precipitating enzyme base to the OIA surface and incubate at room temperature for 5 minutes. In the presence of the complex described above, the enzyme reacts with this base to form a precipitate. If a precipitate is present, a visually detectable thin film is formed on the OIA surface.

(Example 4: Use of sampling device)
Four commercially available brushes with different dimensions were compared for the ability to sample the suspension. (See Table 1.) The brushes used are the short brush and standard (std) brush from Medical Packing Corp. (MPC, Camarillo, CA) and the short brush and standard from Oosina (Englewood, NJ) ( std) It was a brush. Using this brush, a suspension of protein, particles, and other materials was sampled to give the sample a viscosity that mimics a diarrhea sample. The viscosity of the sample is a thick paste. In order to sample the suspension described above in Clostridium difficile analysis, various 10 brushes were used. The weight of the collected contents is calculated and reported by subtracting the weight of the single brush from the filled brush (see Table 1). % CV is the average divided by the standard deviation and means the sampling error. As shown in Table 1, the amount of sample (aliquot) that can be captured by the brush varies with the design of the brush, and surprisingly the amount of sample collection depends on the sample collection method using the brush. A constant amount of sample can be collected with very little reproducibility.

  Other embodiments are within the claims.

Claims (15)

A method for providing an aliquot of a sample containing a liquid component and a solid component used in an analytical technique,
Contacting the sample with a sample collection device configured to hold an aliquot of the sample having a liquid component and a solid component proportional to the liquid and solid components of the sample; and
At this time, the sample collection device is holding the sample aliquot,
Providing an aliquot for use in an analytical technique. The method of claim 1, comprising:
The method according to claim 1, wherein the sampling device is a brush. The method of claim 2, comprising:
A method wherein the brush is designed to collect cells. The method of claim 1, comprising:
The method wherein the sample is feces. The method of claim 4, comprising:
The analysis method is for detecting Clostridium difficile toxin. The method of claim 1, comprising:
The analysis method is an optical immunoassay method. The method of claim 1, comprising:
The method wherein the sample is a slurry or suspension having a non-biological origin. The method of claim 1, comprising:
The method wherein the sample is selected from the group consisting of saliva, runny nose, nasal breath, whole blood, pus, cell exudate, or tissue homogenate. The method of claim 1, comprising:
The step of providing aliquot is
Immersing the sample collection device in a test solution. The method of claim 1, comprising:
The step of contacting
Pushing the sample collection device into the sample;
Rotating the sample collection device within the sample;
Removing the sample collection device from the sample. The method of claim 1, comprising:
The aliquot is transported to a reaction vessel. The method of claim 1, comprising:
A method wherein the aliquot is delivered directly to the test surface. A method of providing an aliquot of a stool sample for use in an optical immunoassay for detecting Clostridium difficile toxin, the method comprising:
Contacting the stool with a sample collection brush configured and held to hold the liquid and solid components of the stool sample proportional to the liquid and solid components of the stool sample;
At this time, the sample collection device is holding the sample aliquot,
Providing aliquots for use in an optical immunoassay for Clostridium difficile toxin. 14. A method according to claim 13, comprising:
A method wherein the aliquot is transferred to a reaction vessel before the optical immunoassay is performed. 14. A method according to claim 13, comprising:
A method wherein the brush is a brush designed to collect cells.