Patent Description:
In general, kits for collecting Covid-<NUM> specimens using a swab (or a collection rod) are available for nasal use and oral use.

In the field inspection using the nasal collection kit, the specimen is attached to a cotton ball, and then the specimen is dissolved in the extraction solution by shaking the cotton ball in a flexible tube containing the extraction solution so that a swab is removed while pressing the tube and squeezing the cotton ball. Next, a cap having a nozzle is fastened to the tube, and the tube is turned over and compressed to provide the specimen dissolved in the extraction solution to the reading device through the cap. On the other hand, in the PCR (Polymerase Chain Reaction) test, a swab is placed in the tube containing the extraction solution, and then a certain part of the swab is cut with scissors. After that, the lid is closed, and the tube is transferred. The clinical pathologist concentrates the sample in the transferred tube and extracts RNA from it to read it. Until now, there has been no way for an automated reading device to process specimens collected from a swab.

There are two reasons why it is difficult for an automated reading device to process specimens collected from a swab. Firstly, if there is a swab in the specimen container (tube), it is difficult for an automated reading device to collect a sample. The automated reading device collects specimens using a needle or pipet. In the case that the swab is loaded, unless the swab is aligned or fixed to one side, the collection hole may be blocked by the swab. Secondly, even in the case that there is no swab, if the specimen is collected out of the nasal cavity that has a lot of snot which is mucus, there is a possibility that the collection hole of the needle or pipet may be blocked by the snot.

In addition, in the case of field inspection, used swabs are problematic for disposal because of concerns about biohazards.

<CIT> is related to a container for collecting faecal specimens and comprises an extraction portion suitable for containing an extraction solution and a closure portion for closing the container. A connection means is interposed between the extraction portion and the closure portion and configured to define a closed configuration of the container. A shaped wand suitable for collecting the specimens is axially inserted into the extraction portion when the container is in the closed configuration. A filtering element divides a solubilization chamber from a sampling chamber and is suitable for enabling a flow of the extraction solution from the solubilization chamber to the sampling chamber.

<CIT> is related to a specimen collecting tool which has a small diameter portion deformable by stress applied thereto, a large diameter portion having a diameter larger than the diameter of the small diameter portion and extending from a boundary section adjacent to the small diameter portion to a second end of the specimen collecting tool, the large diameter portion having such rigidity that is not largely deformed when the specimen collecting tool is held to collect a specimen, the large diameter portion further having such rigidity that suppresses variation of an axial dimension thereof when the specimen collecting tool is inserted into a container and further pushed into a rear side of the container to be subjected to stress that is enough to deform the small diameter portion, and a specimen collector provided on the first end side of the small diameter portion. When the specimen collecting tool after collecting a specimen is inserted and farther pushed into the container to deform the small diameter portion, the length of the specimen collecting tool in an axial direction of the container is at most <NUM>% of the length of the specimen collecting tool before bending.

<CIT> is related to a collection and transfer device including a collection vessel having an opening on one end and a closure apparatus engageable therewith which has a collection device receivable within the collection vessel, and a passage therethrough for transferring a collected sample from within the collection vessel to a centrifuge or other type of vessel or microscope slide.

<CIT> is related to a sample collection implement which includes a container having an accommodation portion in which a liquid for suspending or diluting a sample is accommodated, a sample collection stick being able to be disposed in the accommodation portion, a filter provided inside the container, and a movable member that can be moved in a predetermined direction inside the container and has a function of pushing the liquid and causing the liquid to pass through the filter, when moved in the predetermined direction.

<CIT> is related to a specimen sampling tool for sampling a specimen which is composed of a tip shaft having a specimen sampling part on its tip, a hollow shaft having an inner diameter successively larger than an outer diameter of the shaft existing in the inside and a hollow shaft having a grip part on the end and having the largest diameter and is configured so that inside shafts are successively slid into the outside shafts and stored in an extraction container.

Accordingly, the present invention provides a collection kit enabling an automated reading device to process the specimen collected by a swab.

In addition, the present invention further provides a collection kit without the risk of biohazard caused by swab.

In addition, the present invention further provides a collection kit easy to use for an automated reading device so as to reduce the effort of manpower and increase the inspection speed.

The present invention for achieving the above-mentioned objectives provides a collection kit for collecting a bio-sample as defined in the accompanying claims.

Preferably, the tube accommodates the extraction solution and the collection rod together. Further, the tube has an access part formed on the inner surface thereof.

Preferably, the cap has a through hole formed near its periphery; and the handle part of the collection rod can be inserted with a tight fit into the through hole. Further, the cover can be opened by external force.

Preferably, the collection rod has a cut groove formed on the handle part. Further, the handle part can have a stopper to be caught by the cap at the boundary of the collection unit. Further, the collection rod can have a sealing part above the stopper.

According to the present invention described above, there is no risk of biohazard caused by swab. In addition, a collection kit according to the present invention is easy to use for an automated reading device so as to reduce the effort of manpower and increase the inspection speed.

These embodiments are illustrative for the purpose of illustrating the present invention, and is not intended to limit the scope of the present invention.

<FIG> depicts the configuration of a collection kit <NUM> according to an embodiment of the present invention. As shown in <FIG>, the collection kit <NUM> according to this embodiment includes a cap <NUM>, a collection rod <NUM>, and a tube <NUM>.

The collection kit <NUM> collects a bio-sample (or specimen) with a collection rod <NUM>, and accommodates it in a tube <NUM> to which a cap <NUM> is fastened. Since the specimen and extraction solution are accommodated in the tube <NUM>, the cap <NUM> is made of an elastic material for airtightness relative to the tube <NUM>.

<FIG> shows a detailed configuration of a collection rod <NUM> in the collection kit <NUM> shown in <FIG>. <FIG> illustrate the coupling of a tube <NUM> and a cap <NUM> in the collection kit <NUM> shown in <FIG>.

As shown in <FIG>, the collection rod <NUM> is bar-shaped, has a collection unit <NUM> and a handle part <NUM>, and is formed of a material that can be easily curved. A positioning part <NUM> is formed between the collection unit <NUM> and the handle part <NUM>. The positioning part <NUM> allows the collection unit <NUM> to be positioned at the lower end of the tube <NUM> as the cap <NUM> and the tube <NUM> are fastened together.

The handle part <NUM> has a stopper <NUM> at the boundary with the collection unit <NUM>. The stopper <NUM> restricts the cap <NUM> from moving toward the collection unit <NUM>.

A cut groove <NUM> is formed in a portion of the handle part <NUM> above the stopper <NUM>. The cut groove <NUM> is formed approximately a length corresponding to the height of the cap <NUM> away from the stopper <NUM>. When collecting the specimen, in order to properly collect the specimen, the length of the collection rod <NUM> inserted into the nose is required to be longer than the length of the tube <NUM>. However, since the long collection rod <NUM> makes it difficult to transfer the collected specimen in a position as shown in <FIG>, the collection rod <NUM> can be cut at the cut groove <NUM> to facilitate transfer. If the cut groove <NUM> is formed approximately a length corresponding to the height of the cap <NUM> away from the stopper <NUM>, the remaining length of the collection rod <NUM> protruding from the top surface of the cap <NUM> becomes very small when the collection rod <NUM> is cut at the cut groove <NUM>.

A sealing part <NUM> is formed between the stopper <NUM> and the cut groove <NUM>. The sealing part <NUM> prevents the extraction solution or specimen from leaking into a gap between the cap <NUM> and the collection rod <NUM>. A depth line <NUM> is formed at an upper portion of the cut groove <NUM>. The depth line <NUM> works as a reference line of the depth at which the collection rod <NUM> is inserted into the human body (eg, in the nose).

<FIG> is a side cross-sectional view showing that the cap <NUM> is fastened to the tube <NUM>. <FIG> is a plan view seen from the dashed line A-A' shown in <FIG> is a bottom view.

The cap <NUM> is installed so that a filter <NUM> is detachably mounted in the lower portion of the central portion of the cap <NUM>. A through hole <NUM> is formed near the periphery of the cap <NUM>. The handle part <NUM> of the collection rod <NUM> is inserted from below into the through hole <NUM> with a tight fit. A locking groove <NUM> for cooperation with the stopper <NUM> (e.g., see <FIG>) is formed at the lower end of the through hole <NUM>. Since the collection rod <NUM> is inserted into the through hole <NUM> that is formed near the periphery of the cap <NUM>, it will be positioned on one side of the tube <NUM>, and any interference of the collection rod <NUM> can be prevented when an automated reading device collects specimens from the tube <NUM> with a needle, a pipet, a collection tip, or the like. Since the cap <NUM> is formed of an elastic material such as rubber, airtightness is maintained between the through hole <NUM> and the collection rod <NUM>.

A cover <NUM> is formed above the filter <NUM> (or the upper portion of the central portion of the cap <NUM>). The cover <NUM> is provided with an incision 306a and a non-incised part 306b. The incision 306a is in the shape of almost a full circle centered on the center of the cap <NUM>, and the cover is made of a thin film except for the non-incised part 306b, and is not cut during the collection and transfer process. The cover <NUM> is cut at the incision 306a only when an automated reading device applies an external force such as compression of a collection tip or the like to it (as a result of which the cover <NUM> is loosened from the cap at the incision 306a).

The tube <NUM> includes a vessel part <NUM> containing an extraction solution <NUM> for dissolving the specimen, and a body <NUM> to be mounted on a tube rack (not shown). An access part <NUM> is formed in the form of a channel on one side on the inner surface of the vessel part <NUM> such that the collection unit <NUM> of the collection rod <NUM> can reach to the bottom of the vessel part <NUM>. The access part <NUM> is adjacent to (substantially aligned with) the through hole <NUM> when the cap <NUM> and the tube <NUM> are fastened together. The access part <NUM> is inclined toward the central part of the tube <NUM> so as to guide the collection unit <NUM> of the collection rod <NUM> to the lower central part of the vessel part <NUM>.

The tube <NUM> has a slope part <NUM> at the lower part of the access part <NUM>. As the vessel part <NUM> continues along the slope part <NUM> downward, the inner diameter of the vessel part <NUM> decreases. The slope part <NUM> allows the pushed-down filter <NUM> to get into close contact with the inner surface of the vessel part <NUM> while the filter <NUM> is moving downward.

<FIG> illustrate the positional relationship between the collection rod <NUM> and the cap <NUM> in the collection kit shown in <FIG>.

<FIG> shows the position of the cap <NUM> as the specimen is collected using the collection rod <NUM>. <FIG> shows the position of the cap <NUM> when the cap <NUM> is fastened to the tube <NUM>. The cap <NUM> moves down along the collection rod <NUM> until the locking groove <NUM> reaches the stopper <NUM> of the collection rod <NUM>.

When the collection rod <NUM> is inserted into the tube <NUM> along the access part <NUM> after the cap <NUM> was moved down as shown in <FIG>, the collection rod <NUM> is curved along the slope of the access part <NUM>. When the collection rod <NUM> is inserted into the tube <NUM> with an appropriate depth using the depth line <NUM> and the cap <NUM> is fastened to the tube <NUM>, the collection unit <NUM> to which the specimen is attached is located at the bottom of the vessel part <NUM>. Then, the handle part <NUM> of the collection rod <NUM> is cut using the cut groove <NUM> and the collection kit <NUM> is transferred to an automated reading device (not shown). Because the cut (removed) handle part <NUM> has no specimen attached to it, there is no risk of biohazard so that it can be disposed of freely. The sealing part <NUM> (see <FIG>) prevents the extraction solution or specimen from leaking into the gap between the through hole <NUM> of the cap <NUM> and the collection rod <NUM> during the transfer process. Because the collection unit <NUM> that has the specimen attached to it is accommodated in the tube <NUM> and transferred, the specimen is sufficiently dissolved by the extraction solution so that the reading device can extract more specimens.

<FIG> is a side cross-sectional view illustrating how a specimen dissolved in an extraction solution <NUM> is collected by a tip <NUM> in the collection kit <NUM> shown in <FIG>. As shown in <FIG>, the collection rod <NUM> is cut at the cut groove <NUM> and mounted on the automated reading device.

The collection tip <NUM> is mounted on an automated reading device (not shown) so that when the collection tip <NUM> presses on the cover <NUM>, the incision 306a is cut. When the collection tip <NUM> is moved further downward by the reading device, the filter <NUM> installed in the lower portion of the central part of the cap <NUM> is moved (pushed down) to the slope part <NUM>. The slope part <NUM> allows the filter <NUM> to be in close contact with the inner surface of the vessel part <NUM>.

The specimen attached to the collection unit <NUM> is dissolved by the extraction solution <NUM>. Snot in the extraction solution in which the specimen is dissolved is filtered by the filter <NUM>. Only the upper extraction solution 307a passing through the filter <NUM> is collected by the collection tip <NUM>. In this way, if the collection kit <NUM> is used, it does not require a separate preprocessing for specimen reading, so it is easy to use an automated reading device, reducing the effort of manpower and increasing the inspection speed.

If the distance between the stopper <NUM> and the collection unit <NUM> is too small, the specimen attached to the collection unit <NUM> may not be sufficiently immersed in the extraction solution <NUM>, and a collection unit <NUM> may be located on the upper part of the filter <NUM> moved downward by the collection tip <NUM>. Unless the specimen is sufficiently immersed in the extraction solution <NUM>, a part of the specimen is not dissolved in the extraction solution <NUM>. When the collection unit <NUM> is located on the upper part of the filter <NUM>, snot and the like may block the collection hole of the collection tip <NUM>. If the stopper <NUM> is too far from the collection unit <NUM>, the collection rod <NUM> may prevent the filter <NUM> from being sufficiently submerged in the extraction solution <NUM>.

<FIG> is a side cross-sectional view illustrating how a specimen dissolved in an extraction solution is collected by a tip <NUM> in a collection kit <NUM> according to another embodiment of the present invention.

In the collection kit <NUM>, the through hole into which the collection rod is inserted with a tight fit, is not formed in the cap <NUM>. Instead, at a suitable point on the upper portion of the collection unit <NUM> the collection rod is cut with scissors or the like so as to accommodate the collection unit <NUM> in the tube <NUM>. When the tip <NUM> mounted on the reading device (not shown) applies an external force, the cover <NUM> is opened, and the tip <NUM> moves a filter <NUM> detachably mounted on the lower central part of the cap <NUM> to the lower part of the tube <NUM>. The specimen attached to the collection unit <NUM> is dissolved by the extraction solution, filtered by the filter <NUM>, and then collected by the collection tip <NUM>.

<FIG> is a side cross-sectional view illustrating how a specimen dissolved in an extraction solution is collected by a tip <NUM> in the collection kit <NUM> according to another embodiment of the present invention.

In the collection kit <NUM>, the through hole into which the collection rod is inserted with a tight fit, is not formed in the cap <NUM>. The specimen attached to the collection unit is dissolved by the extraction solution accommodated in the tube <NUM>, and the collection rod is immediately discarded. When the tip <NUM> mounted on the reading device (not shown) applies an external force, the cover <NUM> is opened, and the tip <NUM> moves a filter <NUM> detachably mounted on the lower central part of the cap <NUM> to the lower part of the tube <NUM>. The specimen dissolved by the extraction solution is filtered by the filter <NUM>, and then collected by the collection tip <NUM>.

Claim 1:
Collection kit (<NUM>, <NUM>, <NUM>) for collecting a bio-sample, comprising
- a tube (<NUM>, <NUM>, <NUM>) for accommodating an extraction solution;
- a cap (<NUM>, <NUM>, <NUM>) to be fastened to the tube; and
- a collection rod (<NUM>) for collecting a sample, comprising a collection unit (<NUM>, <NUM>) and a handle part (<NUM>); and
- a collection tip for collecting dissolved specimens from the tube;
wherein the collection kit further comprises a filter (<NUM>, <NUM>, <NUM>) mounted in a lower central part of the cap, and the cap comprises a cover (<NUM>, <NUM>, <NUM>) above the filter, wherein the cover is configured to be opened by pressure of the collection tip (<NUM>, <NUM>, <NUM>), and characterized in that the filter is detachably mounted in the cap and is configured to be moved from the cap to a lower part of the tube by the collection tip.