WO2021229564A1

WO2021229564A1 - Sampling apparatus and method

Info

Publication number: WO2021229564A1
Application number: PCT/IL2021/050528
Authority: WO
Inventors: Emil Katz; Gadi PORATH
Original assignee: Novamed Ltd.
Priority date: 2020-05-14
Filing date: 2021-05-10
Publication date: 2021-11-18
Also published as: IL274675A

Abstract

The present invention pertains to a sampling apparatus comprising a sample container for containing a liquid sample, the sample container optionally includes a container lid; and a dip element for retrieving a liquid sample for testing from the sample container, wherein the sample container comprises container graduations and container indicia; the dip element comprises dip element graduations and dip element indicia, the dip element indicia and graduations spatially correspond in reverse order to the container indicia and graduations of the sample container, to thereby aid in determining the proper depth of dipping the dip element into the liquid sample within the sample container when retrieving a sample for testing.

Description

SAMPLING APPARATUS AND METHOD

FIELD OF THE INVENTION

The present invention relates to sample collection, in particular sample containers and dip elements, for example for urine sampling and testing.

BACKGROUND OF THE INVENTION

The demand for laboratory inspections of biological samples has increased throughout the years. When a patient needs to use laboratory services for testing a biological liquid sample, for example, for revealing infections, such as a UTI (Urinary Tract Infection), including revealing the specific pathogen(s) and performing colony counts. The process usually takes a few days until the results are received. The process usually includes delivering the sample to a laboratory where biological liquids are collected, sampled, prepared for testing, and tested.

Sometimes For example, a liquid human sample may be collected at the clinic or at a nurse station, or delivered to, often in a closed container, and then a small amount of the liquid is transferred to an evacuated test tube that is forwarded to a collection center and then continues to a laboratory where it is tested. Additionally, the inspection of liquid samples for the presence and enumeration of microorganisms requires additional steps, such as streaking a culture testing surface, such as a medium in a Petri dish, and incubation. The culturing process, including screening the surface, can take several days.

While waiting for test results, a physician may prescribe preventive medicines, such as an antibiotic. In other cases, the physician may avoid treatment until receiving the lab results, that can cause a delay in necessary treatment or escalation in the condition of a sick patient. Faster laboratory results could provide an expedited analysis regarding the presence of contaminations and the condition of patients, thereby assisting physicians in providing appropriate treatment earlier and to avoid unnecessary treatments.

Lab tests that include a culturing process can be expedited by beginning the culturing process as soon as possible, and/or by avoiding errors in the process of sampling and analysis. An exemplary teaching in the field and art of the invention is provided by the Applicant of the present invention in IL patent application No.: 268395, which is incorporated by reference as if fully set forth herein. IL patent application No.: 268395 provides a system and a method of collecting, sampling, culturing, and inspecting liquid samples. The systems and methods include a liquid collection container, provided with a lid and a sampling and culturing apparatus, comprising a vessel, a cap, and an inoculating element. The sampling and culturing apparatus are suitable to be inserted through an opening in the lid of the liquid collection container, and it is releasably attached to a cap thereof.

US patent No.: 5,763,264 discloses a portable self-contained device for the detection of microorganisms in a sample of a liquid, semi-liquid or solid test material, and is incorporated by reference as if fully set forth herein. Within a single hermetically sealable vessel are a combined sampling and assay assembly, with means for withdrawal of a sample from a material to be tested and means for applying the withdrawn sample or portions thereof to the assay assembly. The combined sampling and assay assembly includes a carrier member having a head portion with a cap for sealing the vessel, a main body portion having at least one testing surface that bears a culture medium, and a tip portion. A slide on the carrier member is reciprocal between the head portion and the tip, comprising a resilient sleeve with at least one applicator tongue being resiliently biased into contact with the culture medium.

A proper depth of immersing sampling devices, such as the sampling devices disclosed herein above, within sample liquids housed within containers is essential for obtaining proper sampling and analysis. Various sampling devices having a distal sampling tip should be dipped within a liquid sample to an extent sufficient to allow retrieving an appropriate amount of the liquid sample while avoiding any overflow or over wetting of the sampling body that may disrupt proper analysis. A common phenomenon associated with sampling devices over-wetting includes improper sample streaking, leading to over cultivation and false positive or ambiguous results, requiring repeated testing.

The present invention provides an apparatus, systems and methods for aiding in guiding a user as to the proper depth of inserting sampling devices within liquid samples. SUMMARY OF THE INVENTION

The present invention relates to a sampling apparatus, system and method of testing the sample, configured to help obtain a proper sample from a sample container and test it. The sampling apparatus includes the container and an associated testing device having corresponding graduations with reverse indicia to help provide the sample in the appropriate manner.

Applicant has previously provided a system and method of retrieving a sample for analysis from a sampling container and streaking a culture medium for analysis of the sample, in Israel patent application No.: 268395. The presently disclosed sample container can be used in combination with the aforementioned system and method but need not be exclusively used therewith.

An aspect of the invention pertains to a sampling apparatus comprising: a sample container for containing a liquid sample, the sample container optionally including a container lid; and a dip element for retrieving a liquid sample for testing from the sample container, wherein the sample container comprises container graduations and container indicia; the dip element comprises dip element graduations and dip element indicia, the dip element indicia and graduations spatially correspond in reverse order to the container indicia and graduations of the sample container, to thereby aid in determining the proper depth of dipping the dip element into the liquid sample within the sample container when retrieving a sample for testing.

An aspect of the invention pertains to a sampling system comprising: a sample container for containing a liquid sample, the sample container optionally including a container lid; and a dip element for retrieving a liquid sample for testing from the sample container, wherein the sample container comprises container graduations and container indicia; the dip element comprises dip element graduations and dip element indicia, the dip element indicia and graduations spatially correspond in reverse order to the container indicia and graduations of the sample container, to thereby aid in determining the proper depth of dipping the dip element into the liquid sample within the sample container when retrieving a sample for testing. In one or more embodiments, the dip element graduations are spaced apart in correspondence with the container graduations of the sample container.

In one or more embodiments, the dip element graduations are spaced apart with respect to the container graduations in an essentially identical manner. In one or more embodiments, the dip element graduations are spaced apart with respect to the container graduations in a ratio of above 1:1.

In one or more embodiments, the dip element graduations are spaced apart with respect to the container graduations in a ratio of below 1:1.

In one or more embodiments, the dip element graduations are spaced apart with respect to the container graduations in a ratio of below 1 : 1 , a ratio of above 1:1, and/or in the same ratio.

In one or more embodiments, the sample container indicia indicate a volume level.

In one or more embodiments, the sample container indicia indicate a relative sample level.

In one or more embodiments, the apparatus configured such that a proper depth of dipping the dip element within the liquid sample is when an indicium of the dip element indicia is aligned with a top surface of the sample container or a lid thereof, and corresponds to an indicium of the sample container indicia indicating the liquid sample level.

In one or more embodiments, the dip element comprises a tip portion at its distal end for dipping thereof within the liquid sample of the sample container.

In one or more embodiments, the apparatus configured such that when an indicium of the dip element indicia is aligned with a top surface of the sample container or a lid thereof, and corresponds to an indicium of the sample container indicia indicating the liquid sample level, no more than the tip portion of the dip element is dipped within the liquid sample.

In one or more embodiments, the dip element is a dip stick comprising a streaking element at its distal end and optionally a testing surface (e.g., with an agar medium) along one or more faces thereof. In one or more embodiments, the streaking element includes one or more prongs.

In one or more embodiments, the apparatus configured such that when an indicium of the dip stick indicia is aligned with a top surface of the sample container or a lid thereof, and corresponds to an indicium of the sample container indicia indicating the liquid sample level, no more than the streaking element of the dip stick is dipped within the liquid sample.

In one or more embodiments, the apparatus configured such that when an indicium of the dip stick indicia is aligned with a top surface of the sample container or a lid thereof, and corresponds to an indicium of the sample container indicia indicating the liquid sample level, no more than the prongs of the dip stick is dipped within the liquid sample.

In one or more embodiments, the dip element is a dip card comprising at least one testing strips at its distal end.

In one or more embodiments, the apparatus configured such that when an indicium of the dip card indicia is aligned with a top surface of the sample container or a lid thereof, and corresponds to an indicium of the sample container indicia indicating the liquid sample level, no more than the testing strip of the dip card is dipped within the liquid sample.

In one or more embodiments, the dip element comprises a gripping portion at its proximal end.

In one or more embodiments, the sample container comprises a lid attachable thereto, with an opening configured to allow the dip element to pass therethrough.

In one or more embodiments, the opening having an opening cover for reversibly sealing the opening of the lid.

In one or more embodiments, the opening having a form of a slit, an ellipse, a circle, a rectangular, or a square.

In one or more embodiments, the indicia of the sample container and the indicia of the dip element are identical but appear in a reverse order with respect to each other when the dip element is inserted in the sample container. In one or more embodiments, the indicia of the sample container and the indicia of the dip element are selected from numerals, letters, symbols, images, geometric structures and a combination thereof.

In one or more embodiments, the indicia and/or graduations are in the form of adhesives, print, engraves, labels or prominent symbols.

In one or more embodiments, the dip element is selected from a sampling device for testing the presence of microorganisms (e.g., bacteria, viruses or the alike), or a sampling device for testing the presence of drugs (e.g., Tetrahydrocannabinol (THC), Methamphetamines (mAmp), and Opioids (OPI)).

In one or more embodiments, there is an offset in the positioning of the container indicia with respect to the dip element indicia and the offset is equal to a fraction of the length of the streaking element. In one or more embodiments, there is an offset in the positioning of the container indicia with respect to the dip element indicia and the offset is equal to a fraction of the length of the distal tip of the dip element. In one or more embodiments, there is an offset in the positioning of the container indicia with respect to the dip element indicia and the offset is equal to a fraction of the length of the distal end of the dip element.

In one or more embodiments, the dip element has fewer dip element indicia than the container indicia such that dip element is shorter in length that is a fraction of the length of the streaking element.

In one or more embodiments, the dip element comprises a testing surface with agar medium on one or more faces thereof for allowing cultivation of microorganisms thereon and wherein the graduations and indicia disposed alongside at least one of the testing surfaces.

An aspect of the invention pertains to a method of obtaining a liquid sample from a sample container, the method comprising: dipping a dip element into a liquid sample within a sample container, wherein the sample container comprises container graduations and container indicia; the dip element comprises dip element graduations and dip element indicia, the dip element indicia spatially correspond in reverse order to the container indicia of the sample container, wherein the proper level of dipping the dip element is when an indicium of the dip element indicia is aligned with a top surface of the sample container or a lid thereof, and corresponds to an indicium of the sample container indicia indicating the liquid sample level in the sample container. In one or more embodiments, the dip element further comprises a streaking element and the method further comprises streaking a testing surface having a microorganism culture media using the streaking element.

In one or more embodiments, the method further comprises incubating the dip element for a predetermined period of time, optionally, within an incubator. In one or more embodiments, the method further comprises analyzing colonies formed following the incubation of the dip element.

Unless otherwise defined, all technical or/and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods or/and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting. BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative presentation of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

In the drawings:

Fig. 1 is a perspective view of a dip element of a sampling apparatus, in accordance with embodiments of the present invention. Fig. 2 is a perspective view of the dip element with agar incorporated therewith, for microorganism's cultivation, in accordance with embodiments of the present invention.

Fig. 3 is a perspective view showing proper streaking of a dip element, i.e., streaking in isolation, in accordance with embodiments of the present invention.

Fig. 4 is a perspective view showing improper streaking, over dipping and no isolation, of a dip element, in accordance with embodiments of the present invention.

Fig. 5 is a perspective view of the apparatus, namely the dip element and a sample container having corresponding graduations with reverse 1 to 5 numeral indicia, in accordance with embodiments of the present invention.

Fig. 6 is a perspective view of the apparatus of Fig. 5 wherein the liquid sample in the container reaches a level of 3 and the dip element retrieves a liquid sample therefrom, in accordance with embodiments of the present invention.

Fig. 7 is a perspective view of the apparatus of Fig. 5 wherein the liquid sample in the container reaches a level of 4 and the dip element retrieves a liquid sample therefrom, in accordance with embodiments of the present invention.

Fig. 8 is a perspective view of the apparatus of Fig. 5 wherein the liquid sample in the container reaches a level of 1 and the dip element retrieves a liquid sample therefrom, in accordance with embodiments of the present invention.

Fig. 9 is a perspective view of the apparatus wherein the dip element and the sample container have corresponding graduations with reverse 20 to 100 numeral indicia, in accordance with embodiments of the present invention.

Fig. 10 is a perspective view of the apparatus of Fig. 9 wherein the liquid sample in the container reaches a level of 60 and the dip element retrieves a liquid sample therefrom, in accordance with embodiments of the present invention.

Fig. 11 is a perspective view of a dip element in the form of a dip card and a sample container having corresponding graduations with reverse 1 to 5 numeral indicia, in accordance with embodiments of the present invention.

Fig. 12 is a perspective view of the apparatus of Fig. 11 wherein the liquid sample in the container reaches a level of 3 and the dip element retrieves a liquid sample therefrom, in accordance with embodiments of the present invention. Fig. 13 is a perspective view of the apparatus of Fig. 11 wherein the liquid sample in the container reaches a level of 5 and the dip element retrieves a liquid sample therefrom, in accordance with embodiments of the present invention.

Fig. 14 is a perspective view of the apparatus of Fig. 11 wherein the liquid sample in the container reaches a level of 1 and the dip element retrieves a liquid sample therefrom, in accordance with embodiments of the present invention.

Fig. 15 is a perspective view of the dip element having stabilizing wings and a sample container having corresponding graduations with reverse 1 to 5 numeral indicia, in accordance with embodiments of the present invention.

Fig. 16 is a perspective view of a dip element within a Petri dish, in accordance with embodiments of the present invention.

Fig. 17 is a perspective view of the apparatus, namely the dip element and sample container wherein the dip element comprises agar media and indicia with graduations alongside the agar media, in accordance with embodiments of the present invention.

Fig. 18 is a perspective view of the apparatus of Fig. 17, wherein the liquid sample in the container reaches a level of 4 and the dip element retrieves a liquid sample therefrom, in accordance with embodiments of the present invention.

It should be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements are exaggerated relative to each other for clarity. Further, where considered appropriate, reference numerals have been repeated among the figures to indicate corresponding elements.

DETAILED DESCRIPTION OF THE INVENTION

It is understood that the invention is not limited to the particular methodology, devices, items or products etc., described herein, as these may vary as the skilled artisan will recognize. It is also to be understood that the terminology used herein is used for the purpose of describing particular embodiments only and is not intended to limit the scope of the invention. The following exemplary embodiments may be described in the context of sampling apparatus and portions thereof for ease of description and understanding. However, the invention is not limited to the specifically described products and methods and may be adapted to various applications without departing from the overall scope of the invention. All ranges disclosed herein include the endpoints. The use of the term “or” shall be construed to mean “and/or” unless the specific context indicates otherwise.

The present invention pertains to a sampling apparatus, a system and a method of testing the sample, configured to help obtain a proper sample from a sample container and test it.

V arious forms of sampling devices for retrieving a liquid sample from a container and analyzing thereof exist. Many such devices incorporate a distal tip dedicated for collecting an amount of the liquid sample. In some exemplary sampling devices, the distal tip includes a streaking element for collecting a liquid specimen and streaking thereof onto an agar medium for subsequent cultivation of microorganisms. In other exemplary devices the distal tip includes one or more absorbent strips which when immersed within a liquid sample, the sample migrates upwardly due to a capillary action toward detection molecules (e.g., antibodies). An overflow or insufficient depth of dipping may provide false results of the assay. Hence, the present invention affords a method and an apparatus for aiding in determining the depth of dipping a sampling device or a distal tip thereof within a container with a liquid sample.

The herein sampling apparatus includes a container for containing a liquid sample and a dip element for dipping within the liquid present in the container. The container and associated dip element have graduations with reverse indicia to help retrieve the sample in the appropriate manner. The apparatus configured such that an indicium pointing to the level of sample within the container indicates the depth of dipping the dip element within the sample. Namely, the same indicium of the dip element should be leveled/aligned with a top surface of the container or a lid thereof.

The present invention may afford the following attributes: comfortable and rapid dipping; user friendly; prevents over or insufficient dipping; optionally, includes an opening within a lid of the container allowing insertion of a dip element therethrough and thereby minimizes exposure of personnel staff to contaminants within the liquid sample; and minimizes repeated testing due to improper dipping of the dip element within the liquid sample.

As used herein the term "sampling device", and its derivatives, is interchangeable with the terms: "dip element" and "test device" and refers to devices for analyzing a sample which include a tip portion for retrieving a liquid specimen. The herein apparatus includes one or more dip elements suitable for collecting a liquid specimen by dipping/immersing a distal tip thereof within a liquid sample. The dip element may be used for analyzing the presence of various types of microorganisms, or drugs within the liquid specimen.

Non-limiting examples of sampling devices are disclosed in IL patent application No.: 268395 and in US patent No.: 5,763,264, the contents of which are incorporated herein by reference. Other examples of sampling devices may be in the form of dip cards having strips at their distal end which are configured to absorb a liquid specimen and allow capillary flow of the specimen towards detection molecules. Such devices are typically suitable, but not necessarily for testing presence of drugs in the specimen.

The dip element may include a distal tip which is suitable for collecting a liquid sample for testing. Optionally, proper liquid collection includes dipping no more than the distal tip within the liquid sample. Optionally, the distal tip includes a streaking element with one or more prongs or a strip element with one or more strips for absorbing a liquid.

The space/distance between the graduations and indicia of the dip element may be equal. The space/distance between the graduations and indicia of the dip element may be non- equal. The space/distance between the graduations and indicia of the container may be equal. The space/distance between the graduations and indicia of the container may be non-equal. The space/distance between the graduations and indicia of the dip element graduations with respect to the space/distance between the graduations and indicia of the container may be in a ratio of above 1:1. The space/distance between the graduations and indicia of the dip element graduations with respect to the space/distance between the graduations and indicia of the container may be in a ratio of below 1 : 1.The space/distance between the graduations and indicia of the dip element graduations with respect to the space/distance between the graduations and indicia of the container may be in a ratio of 1:1.

Optionally, proper liquid collection/dipping includes dipping up to 20 mm, 18 mm, 16 mm, 14 mm, 12 mm, 10 mm of a distal tip of a dip element within a liquid sample. For example, proper liquid collection may include dipping up to 9 mm, up to 8 mm, up to 7 mm, up to 6 mm, up to 5 mm, or up to 4 mm of a distal tip of a dip element within a liquid sample.

Optionally, proper liquid collection/dipping includes dipping up to 20 mm, 18 mm, 16 mm, 14 mm, 12 mm, 10 mm of a streaking element of a dip element within a liquid sample. For example, proper liquid collection may include dipping up to 9 mm, up to 8 mm, up to 7 mm, up to 6 mm, up to 5 mm, or up to 4 mm of a streaking element of a dip element within a liquid sample.

Optionally, proper liquid collection/dipping includes dipping up to 20 mm, 18 mm, 16 mm, 14 mm, 12 mm, 10 mm of dip strips of a dip element within a liquid sample. For example, proper liquid collection may include dipping up to 9 mm, up to 8 mm, up to 7 mm, up to 6 mm, up to 5 mm, or up to 4 mm of dip strips of a dip element within a liquid sample.

The herein invention is suitable for testing various body or non-body liquid samples. Non limiting examples of body liquids include urine, sweat, blood, and saliva. Other non-body liquids may include, milk, wine, water specimens, medications/dmgs, beverages etc.

Various forms of containers for housing specimens are applicable and contemplated such as, but not limited to, cup-like containers 10, and 110 shown in Figs. 5-15, having a flat bottom surface. However, it should be noted that other forms of containers are contemplated, such as containers having cone-like structures (not shown).

The indicium of the container and dip element may be in various forms as long as they appear in a reverse order when the dip element is inserted within the container. Non limiting examples of suitable indicia include symbols, letters, and numbers.

Illustrative embodiments of the invention are described below. In the interest of clarity, not all features/components of an actual implementation are necessarily described. Various dip elements for dipping within a liquid sample and thereby retrieving a liquid sample for further analysis and testing may be used in conjunction with the herein application. Exemplary dip elements and containers are illustrated in the following figures.

FIGs. 1-2 illustrate an exemplary dip element 20 including a cap 26 at a proximal end 28 thereof which may conveniently be used for gripping while dipping within a sample container, such as sample container 10 shown in FIGs. 5-8 and 11-15, or sample container 110 shown in Figs. 9-10. Dip element 20 may be provided along with a vessel (e.g., a tube, not shown) for storing thereof until use. The cap 26 can be further used to allow engagement of dip element 20 along with cap 26 to a dedicated vessel/tube.

Dip element 20 includes a dip stick 22 having a distal tip portion with a streaking element 34 with one or more prongs 31 at a distal end 35 of the stick which is configured to retrieve an amount of a liquid sample for further testing. Dip stick 22 may optionally include a testing surface 30 with an agar medium for microorganisms cultivation (Fig. 2). The testing surface 30 may be divided into two or more culture surfaces, e.g., with different agar media (not shown) or with similar agar media. The testing surface 30 may be disposed on one or more facets of the dip stick 22.

In order to perform the streaking in isolation testing, prongs 31 of streaking element 34 need to come in contact with the liquid sample, and then to streak the agar media of testing surface 30. As will be illustrated in greater detail below with reference to Figs. 3-4, the streaking element 34 may be moveable along a length of the dip stick 22 and, following contacting a liquid sample, streak the surface of testing surface 30 to allow cultivation and further analysis of any microorganisms present in the liquid sample. Hence, in order to perform the streaking testing, prongs 31 of streaking element 34 need to come in contact with a liquid sample, and then streak the agar media of testing surface 30 while moving along the dip stick 22 from distal end 35 to proximal end 28.

As shown in Figs. 1-2, streaking element 34 is initially located at the bottom of the media of testing surface 30 (distal end 35 of dip stick 22) and can be stabilized thereto via a hook 29.

Figs. 3-4 show testing surface 30 after the streaking process, so that streaking element 34 is located at the top. The wet prongs 31 come in contact with testing surface 30 and scratch it, thus performing the streaking process. After the streaking process, dip stick 22 is taken for incubation, optionally when placed/stored within a suitable vessel/tube.

Cap 26 may be removeable from dip stick 22 such that in the initial state dip stick 22 is connected to cap 26 optionally stabilized thereto via a dedicated pin (as pin 43 in Fig. 16) that can be inserted into a dedicated hole within the cap 26 (not shown), thus connecting dip stick 22 to cap 26.

Figs. 5-8, show an exemplary apparatus 40 including a sample container 10, for housing a liquid sample (e.g. sample 24) provided by a patient, such as a urine sample. Sample apparatus 40 also includes dip element 120 which may be similar to dip element 20 shown in FIGs. 1-2, here for illustrative purposes not including testing surface 30. Dip element 120 has a dip stick 122 for retrieving a sample 24 (e.g., as in Figs. 6-8) from sample container 10 via opening 18 (as in Fig. 6). Container 10 is having container graduations 12 with container indicia 14. Dip stick 122 includes dip stick graduations 36 with dip stick indicia 38. Stick graduations 36 spatially correspond to container graduations 12 of the sample container 10 and stick indicia 38 numerically and spatially correspond to the container indicia 14 of the sample container 10, however, stick indicia 38 are in reverse order with respect to container indicia 14 when container 10 and stick 122 disposed in a vertical position.

Sample container 10 further includes a container lid 16 attachable to sample container 10. Lid 16 can be removed in order to open container 10, thus allowing filling container 10 with liquids (in particular a liquid sample for analysis). After container 10 is filled and closed by a user, it is usually handled by a lab technician for testing. Container lid 16 may have an opening 18 therein (see Fig. 6) and a container opening cover 21 for reversibly sealing the opening 18 of lid 16. A dip element, such as dip element 120 or any other dip element shown herein can be inserted into container 10 through the opening 18, in order to perform tests. Container 10 may also include an opening 52 for an evacuating test tube which may be covered by a second cover (not shown).

Various forms of lid 16 openings, such as opening 18, and suitable covers, such as cover 21, for allowing insertion of various forms of dip elements are contemplated. The opening and corresponding cover may have, for example, an ellipse-like, a slot-like, a circle-like, a rectangular-like, or a square-like structure. It should be understood that in simplified versions of the apparatus, sample container 10 may be constituted without any lid or by including a lid without an opening or cover. Such containers would be potentially suitable for home use rather than for clinical, laboratory or hospital use, or in cases whereby the containers need not be transported before the sampling occurs.

When a test sample is to be taken from sample 24, one can determine the level (e.g., “3” as in Fig. 6) of the sample in container 10 and lower dip stick 122 into the container 10 until the same indicium (i.e., indicium "3") is leveled/aligned with a top surface 19 of lid 16 (Fig. 6). As a result, sample streaking element 34 will be dipped into sample 24 and testing surface 30, will not be dipped. In such configuration, merely the streaking element 34 will be dipped into liquid sample 24. It should be noted that dipping testing surface 30 into sample 24 can be detrimental in that more and/or larger colonies than desired may be formed, hindering analysis.

Figs. 3-4 further respectively illustrate proper (Fig. 3) and improper (Fig. 4) dipping of dip element 20 within a liquid sample. In Fig. 3, a proper streaking (i.e., with suitable isolation/distancing between the individual streaks) is shown, following dipping only streaking element 34 of dip element 20 in liquid sample 24. In Fig. 4, an improper dipping (without suitable isolation/distancing of the individual streaks) of dip element 20 within a liquid sample is shown. Here (Fig. 4), more than streaking element 34 was dipped within the liquid sample, i.e., at least a portion of the agar media of testing surface 30 was immersed within the sample, resulting in many large colonies 41, with no isolation between colonies, hindering analysis. It should be noted that, insufficient dipping would cause collection of an insufficient amount of sample material, which may lead to a false negative test result. Hence, the present apparatus assists in providing improved sample testing by way of determining the proper depth of dipping the dip element 20/120, or any other dip element illustrated herein within container 10.

It should be understood that there can be a slight offset in the positioning or numbering of container indicia 14 with respect to dip element indicia 38 (or the numbering of the dip element with respect to the container indicia) to account for the length of streaking element 34 (in particular prongs 31), in order to provide for a desired prong immersion in sample 24. As can be noted, the indicia 14 of container 10 starts from bottom, whereas indicia 38 starts just after the streaking element 34. As such, when an indicium of dip element indicia 38 is aligned with a top surface of sample container 10 (or lid 16 thereof), and corresponds to a sample indicium of sample container indicia 12, only a tip portion and not more than the length of prongs 31 is dipped within the liquid sample.

One exemplary offset in the numbering can be where dip element 22 has fewer indicia 38 than the container indicia 14; i.e. stick 22 is slightly shorter, in a length/distance that is a fraction of the length of streaking element 34, in particular prongs 31.

Another exemplary offset type situation can be in the positioning of container indicia 14 on container 10. An extrapolation of the container indicia 14 to top of container 10 (i.e. where the indicium of the dip element 20 is to be aligned, exemplified by lid 16) should be where the indicium resulting from the extrapolation is slightly offset with the indicium at distal end 35 of dip element 20. Again, this offset should be a fraction of the length of streaking element 34, in particular prongs 31.

Yet another exemplary situation that can result in an offset is where an indicium relating to zero of container indicia 14 is spaced apart from the bottom of container 10. Once again, this offset (spacing) should be a fraction of the length of prongs 31.

In contrast, when performing a test without graduated sample container 10 and dip element 20 having respective graduations 12, 36 and respective indicia 14, 38, a lab operator must be careful to only dip prongs 31 of streaking element 34 into the sample inside container 10, without dipping testing surface 30.

FIGs. 7 and 8 similarly illustrate liquid samples 24 reaching a level of 4 and 1, respectively, as illustrated in indicium 14, and this indicates the proper depth of dipping dip stick 122 in the sample container 10. Hence, proper dipping is when the indicium 4 (Fig. 7) and indicium 1 (Fig. 8) in indicia 38 of dip stick 122 are level with the top of lid

16 of sample container 10.

Figs. 9-10 illustrate yet another exemplary apparatus 50, here including a container 110 which is similar to container 10 of Figs. 5-8 but includes container indicia

17 with graduations 15 indicating a sample volume. Container indicia 17 with graduations 15 are similar and correspond to indicia 37 with graduations 33 of dip element 220, however in reverse order. In Fig. 10, container 110 includes a liquid sample having a level at the indicium "60" of indicia 17. A proper depth of dipping the dip element 220; within the liquid sample 24 is when the indicium "60" of the dip element indicia 37 is aligned with a top surface of the sample container 110 or lid 16, thus corresponding to the indicium "60" of the sample container indicia 17.

As noted above, with the improved instant apparatus (sample container 110 and dip element 220), the lab operator may simply view the level of sample 24 in the container in accordance with container indicia 17 (for example at a container sample level of "60 ml" as illustrated in Fig. 10) and inserts dip stick 222 into the container 110 to the point where the indicium indicia 37 is the same numeral as the level of sample 24 in container 110. As such, the prongs 31 of streaking element 34 will be dipped into the sample without wetting media of testing surface 30.

Figs. 11-12 show a sampling apparatus 60 including a sample container 10 (as in Figs. 5-8), however, dip element is in the form of a dip card 25. Dip card 25 has at least one absorbent test strips 32 which allow a liquid specimen to migrate upwardly by capillary action toward antibodies or other detection molecules present in analysis panels 39. Similar to the effect as described above, due to the relative configurations of container graduations 12 and container indicia 14 with respect to dip card graduations 36 and dip card indicia 38 (namely their corresponding spatial relationship and reverse numeration), sample test strips 32 can conveniently be dipped into sample 24 whereas the rest of dip card 25 will not be dipped. FIGs. 12, 13 and 14 illustrate liquid samples 24 reaching a level of 3, 5, and 1, respectively, indicating the proper depth of dipping dip card 25 in the sample container 10, namely such that the respective indicium 3, 5, and 1 of dip card 25 are level with the top of lid 16 of sample container 10. As shown, when an indicium (As in FIGs. 12, 13 and 14, reaching a level of 3, 5, and 1, respectively) of the dip card 25 indicia 38 is aligned with a top surface of the sample container 10 or a lid 16 thereof, and corresponds to an indicium of the sample container indicia 14 indicating the liquid sample level (As in FIGs. 12, 13 and 14, reaching a level of 3, 5, and 1, respectively), no more than the testing strip 32 of the dip card 25 is dipped within the liquid sample 24.

Fig. 15. shows yet another exemplary apparatus 70 with another exemplary dip element 320, which is similar to dip element 20 of Figs. 2-4, but further includes flexible movable wings 42 held in place by cap 26 (Fig. 15) and moved sideways for stabilization purposes in Fig. 16. When a lab technician receives a sample in sample container 10 from a patient, the technician needs to open cover 21 of container 10, and then take out dip element 320 from a storage vessel within which dip element 320 resides (not shown), and insert only prongs 31 into sample 24, as described above. After that, the technician may take the dip element 320 and insert it back into the storage vessel (not shown), for further incubation, optionally at a temperature of 37°C. Here the indicium 38 and graduations 36 disposed on wings 42. The function of wings 42 will be explained in greater detail along the description when referring to Fig. 16.

Following incubation for an appropriate time that allows growth of microorganisms, cap 26 can be detached from dip element 320, to allow placement thereof in a petri dish 100 or on any other surface suitable for scanning.

Fig. 16 shows dip stick 322, after it has been placed within petri dish 100. The placement of dip stick 322 on a dish 100 allows performing screening of the testing surface 130, for example a digital screening by a digital reader, or any other suitable means for different types of scans. Another example for reading the results is by taking a photograph of the testing surface 130 by an image acquisition apparatus, and then performing image processing in order to get the results. Testing surface 130 may be geometrically suitable to be placed inside a typical petri dish 100, but of course the dish can be replaced with any other dish. Identification elements can also be provided on the dip stick 322, such as a barcode label including identification details or any other desired information. In addition, after placing dip stick 322 into petri dish 100, dip stick 322 can undergo an incubation process, prior to the screening process, while located on the dish 100.

Wings 42 are configured as stabilization elements to prevent movement of dip stick 322 within petri dish 100. The flexibility of wings 42 and their tendency to move toward the edges of dish 100 can be obtained by different mechanical methods, for example, by injection molding techniques. The friction between wings 42 and dish 100 prevents the movement of dip stick 322 in relation to dish 100. Dip stick 322 can include any number of wings 42 to hold it in place while positioned on a screening surface or inside any other element. Other stabilization elements suitable to prevent the movement of dip stick 322 in relation to the screening surface can be used while performing, for example, digital marking of the colonies and automatic specific colony pick-up for additional tests, such as sensitivity. The screening process includes rapid identification of microorganisms and identification of mix pathogens, usually by color. The apparatus and method provide a process that does not require manual handling of the components (in particular prongs 31) that come in contact with the sample. The lab operator touches only cap 26 of the culturing apparatus, when dipping the prongs 31 of the streaking element 34 inside sample 24, when inserting the components back into the storage vessel of the culturing apparatus, and also when placing testing surface 30 onto or inside petri dish 100, or the like. Thus, contamination is minimized and other pathogens that can influence clinical results and reduces the waiting time for tests results.

Fig. 16 also shows typical colonies 41 on media of testing surface 130. Colonies 41 are located along longitudinal lines, which are created as a result of growth during incubation, after the streaking process. Fig. 16 shows dip stick 322 after an incubation process, which resulted in colony growth, at a stage suitable for screening.

Figs. 17 and 18 illustrate yet another exemplary apparatus 80 in which the indicium 38 and graduations 36 are positioned on dip element 420 alongside the testing surface 230 with agar media, optionally within a dedicated groove (not shown). In this arrangement, the lab technician may see both the testing surface 30 and indicium 38 and graduations 36 when retrieving a sample from the sample container 10.

The present invention further pertains to a method of obtaining a liquid sample from a sample container for testing, the method comprising: dipping a dip element, such as dip elements 20, 120, 220, 320 or 420 into a liquid sample 24 within a sample container, such as a sample container 10, or 110, wherein the sample container 10/110 comprises container graduations 12 and container indicia 14/17; the dip element 20/120/220/320/420 comprises dip element graduations 36 and dip element indicia 37/38, the dip element indicia 37/38 spatially correspond in reverse order to the container indicia 14/17 of the sample container, wherein the proper level of dipping the dip element 20/120/220/320/420 is when an indicium of the dip element indicia 37/38 is aligned with a top surface of the sample container 10/110 or a lid 16 thereof and corresponds to an indicium of the sample container indicia 14/17 indicating the liquid sample level in the sample container 10/110.

In one or more embodiments, the dip element further comprises a streaking element 34 and the method further comprises streaking a testing surface 30/130 having a microorganism culture media using the streaking element 34. In one or more embodiments, the method further comprises incubating the dip element 20/120/220/320/420 for a predetermined period of time, optionally, within an incubator. In one or more embodiments, the method further comprises analyzing colonies formed following the incubation of the dip element 20/120/220/320/420.

Each of the following terms: 'includes', 'including', 'has', 'having', 'comprises', and 'comprising', and their linguistic equivalents, as used herein, means 'including, but not limited to', and is to be taken as specifying the stated component(s), feature(s), characteristic(s), parameter(s), integer(s), or step(s), and does not preclude addition of one or more additional component(s), feature(s), characteristic(s), parameter(s), integer(s), step(s), or groups thereof.

The term 'consisting essentially of’ as used herein means that the scope of the claim is limited to the specified elements and those that do not materially affect the basic and novel characteristic(s) of the claimed device and materials.

Each of the phrases 'consisting of and 'consists of, as used herein, means 'including and limited to'.

The term 'method', as used herein, refers to steps, procedures, manners, means, or/and techniques, for accomplishing a given task including, but not limited to, those steps, procedures, manners, means, or/and techniques, either known to, or readily developed from known steps, procedures, manners, means, or/and techniques, by practitioners in the relevant field(s) of the disclosed invention.

Throughout this disclosure, a numerical value of a parameter, feature, characteristic, object, or dimension, may be stated or described in terms of a numerical range format. Such a numerical range format, as used herein, illustrates implementation of some exemplary embodiments of the invention, and does not inflexibly limit the scope of the exemplary embodiments of the invention. Accordingly, a stated or described numerical range also refers to, and encompasses, all possible sub-ranges and individual numerical values (where a numerical value may be expressed as a whole, integral, or fractional number) within that stated or described numerical range. For example, a stated or described numerical range 'from 1 to 6' also refers to, and encompasses, all possible sub-ranges, such as 'from 1 to 3', 'from 1 to 4', 'from 1 to 5', 'from 2 to 4', 'from 2 to 6', 'from 3 to 6', etc., and individual numerical values, such as T, Ί.3', '2', '2.8', '3', '3.5', '4', '4.6', '5', '5.2', and '6', within the stated or described numerical range of 'from 1 to 6'. This applies regardless of the numerical breadth, extent, or size, of the stated or described numerical range.

Moreover, for stating or describing a numerical range, the phrase 'in a range of between about a first numerical value and about a second numerical value', is considered equivalent to, and meaning the same as, the phrase 'in a range of from about a first numerical value to about a second numerical value', and thus, the two equivalently meaning phrases may be used interchangeably.

The term 'about', is some embodiments, refers to ±30 % of the stated numerical value. In further embodiments, the term refers to ±20 % of the stated numerical value. In yet further embodiments, the term refers to ±10 % of the stated numerical value.

The term 'distal' refers to the part which, in use, is situated away from the point of attachment or origin or a central point especially of the body.

The term 'proximal' hereinafter refers to the part which, in use, is situated closer or proximate to the point of attachment or origin or a central point especially of the body.

It is to be fully understood that certain aspects, characteristics, and features, of the invention, which are, for clarity, illustratively described and presented in the context or format of a plurality of separate embodiments, may also be illustratively described and presented in any suitable combination or sub-combination in the context or format of a single embodiment. Conversely, various aspects, characteristics, and features, of the invention which are illustratively described and presented in combination or sub combination in the context or format of a single embodiment, may also be illustratively described and presented in the context or format of a plurality of separate embodiments.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the broad scope of the appended claims.

All publications, patents, and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be constmed as necessarily limiting.

Claims

1. A sampling apparatus comprising: a sample container for containing a liquid sample, the sample container optionally includes a container lid; and a dip element for retrieving a liquid sample for testing from the sample container, wherein the sample container comprises container graduations and container indicia; the dip element comprises dip element graduations and dip element indicia, the dip element indicia and graduations spatially correspond in reverse order to the container indicia and graduations of the sample container, to thereby aid in determining the proper depth of dipping the dip element into the liquid sample within the sample container when retrieving a sample for testing.

2. The apparatus of claim 1, wherein the dip element graduations are spaced apart in correspondence with the container graduations of the sample container.

3. The apparatus of claim 1 or 2, wherein the dip element graduations are spaced apart with respect to the container graduations in a ratio of above 1:1.

4. The apparatus of any one of claims 1 or 2, wherein the dip element graduations are spaced apart with respect to the container graduations in a ratio of below 1:1.

5. The apparatus of any one of claims 1-4, wherein one or more of the dip element graduations are spaced apart with respect to the container graduations in a ratio of below 1:1, a ratio of above 1:1, and/or in the same ratio.

6. The apparatus of any one of claims 1-5, wherein the sample container indicia indicate a volume level.

7. The apparatus of any one of claims 1-6, wherein the sample container indicia indicate a relative sample level.

8. The apparatus of any one of claims 1-7, configured such that a proper depth of dipping the dip element within the liquid sample is when an indicium of the dip element indicia is aligned with a top surface of the sample container or a lid thereof, and corresponds to an indicium of the sample container indicia indicating the liquid sample level.

9. The apparatus of any one of claims 1-8, wherein the dip element comprises a tip portion at its distal end for dipping thereof within the liquid sample of the sample container.

10. The apparatus of claims 8 and 9, configured such that when an indicium of the dip element indicia is aligned with a top surface of the sample container or a lid thereof, and corresponds to an indicium of the sample container indicia indicating the level of the liquid sample, no more than the tip portion of the dip element is dipped within the liquid sample.

11. The apparatus of any one of claims 1-10, wherein the dip element is a dip stick comprising a streaking element at its distal end and optionally a testing surface along one or more faces thereof.

12. The apparatus of claim 11, configured such that when an indicium of the dip element indicia are aligned with a top surface of the sample container or a lid thereof, and corresponds to an indicium of the sample container indicia indicating the level of the liquid sample, no more than the streaking element of the dip stick is dipped within the liquid sample.

13. The apparatus of any one of claims 1-10, wherein the dip element is a dip card comprising at least one testing strip at its distal end.

14. The apparatus of claim 13, wherein the dip card comprises dip card indicia and the apparatus is configured such that when an indicium of the dip card indicia is aligned with a top surface of the sample container or a lid thereof, and corresponds to an indicium of the sample container indicia indicating the liquid sample level, no more than the testing strip of the dip card is dipped within the liquid sample.

15. The apparatus of any one of claims 1-14, wherein the dip element comprises a gripping portion at its proximal end.

16. The apparatus of any one of claims 1-15, wherein the sample container comprises a lid attachable thereto, with an opening configured to allow the dip element to pass therethrough.

17. The apparatus of claim 16, wherein the opening having an opening cover for reversibly sealing the opening of the lid.

18. The apparatus of claim 16, wherein the opening having a form of a slit, an ellipse, a circle, a rectangular, or a square.

19. The apparatus of any one of claims 1-18, wherein the indicia of the sample container and the indicia of the dip element are identical but appear in a reverse order with respect to each other when the dip element is inserted in the sample container.

20. The apparatus of any one of claims 1-19, wherein the indicia of the sample container and the indicia of the dip element are selected from numerals, letters, symbols, images, geometric structures or a combination thereof.

21. The apparatus of any one of claims 1-20, wherein the indicia and/or graduations are in the form of adhesives, prints, engraving, labels, prominent symbols, or a combination thereof.

22. The apparatus of claim 9 or 10, wherein there is an offset in the positioning of the container indicia with respect to the dip element indicia and the offset is equal to a fraction of the length of the tip portion.

23. The apparatus of claim 11 or 12, wherein there is an offset in the positioning of the container indicia with respect to the dip element indicia and the offset is equal to a fraction of the length of the streaking element.

24. The apparatus of any one of claim 11 or 12, wherein the dip element has fewer dip element indicia than the container indicia such that dip element is shorter in length that is a fraction of the length of the streaking element.

25. The apparatus of any one of claims 1-24, wherein the dip element comprises a testing surface with agar medium on one or more faces thereof for allowing cultivation of microorganisms thereon and wherein the graduations and indicia disposed alongside at least one of the testing surface.

26. A method of obtaining a liquid sample from a sample container, the method comprising: dipping a dip element into a liquid sample within a sample container, wherein the sample container comprises container graduations and container indicia; the dip element comprises dip element graduations and dip element indicia, the dip element indicia spatially correspond in reverse order to the container indicia of the sample container, wherein the proper level of dipping the dip element is when an indicium of the dip element indicia is aligned with a top surface of the sample container or a lid thereof, and corresponds to an indicium of the sample container indicia indicating the liquid sample level in the sample container.